Its no accident that most people tend to sleep at night and are awake during the day. Our sleep-wake cycle is determined by our circadian rhythm, the bodys internal clock. Like old-time clocks, this internal clock needs to be reset every day, and is adjusted by first exposure to light in the morning.

Our circadian rhythms are controlled by multiple genes and are responsible for a variety of important functions, including daily fluctuations in wakefulness, body temperature, metabolism, digestion, and hunger. Circadian rhythm also controls memory consolidation (the formation of long-term memories occurs during sleep); the timing of hormone secretion (for example, the hormones controlling body growth work mostly at night); and body healing.

While the circadian sleep phase typically occurs at night, there are a range of times during which the sleep phase can occur, with some people programmed to sleep from early evening to early morning (known as morning larks), while others stay up late and sleep late (known as night owls). In addition to determining the timing of their sleep, a persons circadian tendency can also affect their choice of emotional coping skills, such as assertiveness or rationalization, and their predisposition to psychological disorders.

An irregular circadian rhythm can have a negative effect on a persons ability to sleep and function properly, and can result in a number of health problems, including mood disorders such as depression, anxiety, bipolar disorder, and seasonal affective disorder.

A recent study suggested that the night-owl type might have a greater predisposition to psychological disturbances. The authors found that the different circadian types were likely to have different coping styles to emotional stressors, and the ones adopted by the morning larks seemed to result in better outcomes and fewer psychological problems. This was a correlational study, so the reason for adopting different styles wasnt explained, but this study emphasizes the great impact circadian rhythms have on health and functioning.

Most of the evidence on the relationship between mood problems and circadian rhythm comes from studies of shift workers, whose sleep periods are out of sync with their circadian rhythm. Multiple studies show an increased prevalence of depression in night-shift workers. One meta-analysis showed that night-shift workers are 40% more likely to develop depression than daytime workers. Conversely, circadian rhythm disturbances are common in people with depression, who often have changes in the pattern of their sleep, their hormone rhythms, and body temperature rhythms.

Symptoms of depression may also have a circadian rhythm, as some people experience more severe symptoms in the morning. The severity of a persons depression correlates with the degree of misalignment of the circadian and sleep cycles.

Many successful treatments of depression, including bright light therapy, wake therapy, and interpersonal and social rhythm therapy, also directly affect circadian rhythms. (For the impact of circadian rhythm on the occurrence and treatment of depression related to bipolar disorder, please see this blog post on light therapy for bipolar disorder.)

Misalignment of the circadian rhythm may also provoke anxiety. Shift work results in a sleep disorder when your nighttime work shifts affect your ability to fall asleep and stay asleep, causing you to have excessive sleepiness during the day that in turn results in distress and affects your ability to function normally. Nurses with shift work disorder have increased anxiety scores on questionnaires. In a study on jet lag, in which travel changes the time of the external environment so that it is no longer synchronized with the internal clock and disrupts sleep, travelers had elevated anxiety and depression scores.

In seasonal affective disorder, people feel down and depressed in the winter months. Researchers believe this is due to changes in circadian rhythms as a result of seasonal changes in the length of daylight. People with seasonal affective disorder feel better using artificial morning light to realign their circadian rhythm with their sleep-wake cycle.

There is no way to change your circadian type since it is genetically determined, though there is some natural change that occurs during your lifespan. For example, our circadian sleep phase tends to shift later during adolescence (more owls) and advances earlier as we age (more like the lark).

If you find that your circadian sleep phase is out of sync with your desired schedule, you can either shift your social life to match your circadian rhythm, or try to shift your circadian rhythm to match your social life. It may be easier to try to shift your work and social life to your circadian rhythm: an example would be a person who has a delayed circadian rhythm and likes to sleep late and wake up late switching from a job with a 7 AM start time to a job which allows him or her to start working later around 10 AM. The other option would be talking to a sleep physician and doing ongoing work to try to shift your circadian rhythm to match your work and social life to an earlier wakeup time.

In general, the best way to improve your mood is to get a good nights sleep by matching your circadian rhythm to your sleep-wake cycle. Exposure to light in the morning helps synchronize the clock. Exposure to bright light at night, including bright artificial lights and screen time on laptops, tablets, and phones, can cause disruption in circadian rhythm and may contribute to worsening mood and negative consequences for health.

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KARLA ANDERSON

Stay-at-home orders during this pandemic, have led to many long hours sitting in front of a computer at an unfamiliar desk or your kitchen table as you work from home or homeschool your kids. Then, you retreat to the couch to hide from the news only to binge-watch an entire Netflix series without getting up from your seat. A sedentary lifestyle isnt healthy, and it could put you at increased risk for developing a blood clot such as a deep vein thrombosis (DVT).

WHAT IS A DVT?

A blood clot is a clump of blood that has changed from a liquid to a gel-like or semisolid state. Clotting is a necessary process that can prevent you from losing too much blood in certain instances, such as when youre injured or cut. When a clot forms inside one of your veins, it wont always dissolve on its own. This can be a very dangerous and even life-threatening situation.

A blood clot in a large vein, usually in your leg, is called a deep vein thrombosis. A DVT can partly or completely block the flow of blood through the vein (causing swelling of the area below) and can move or break off and travel to the lungs. When the clot moves to the lungs its known as a pulmonary embolism and can cause death. A pulmonary embolism requires immediate medical attention.

When you sit for a long period of time, the blood flow to your legs slows down, and when your legs are still and hanging down, blood tends to pool in the muscular beds of the calf. These factors can make it easier for a clot to form and increase your risk for DVT.

SYMPTOMS OF A BLOOD CLOT

Many people that form a DVT never notice any symptoms. Symptoms include:

Swelling of your leg or arm

Pain or tenderness not caused by an injury

Skin that is warm to the touch, with swelling or pain

Redness of the skin, with swelling or pain

As mentioned, individuals with a DVT are at an increased risk for a pulmonary embolism. If you have difficulty breathing, chest pain that worsens with a deep breath, cough blood, or a faster than normal or irregular heartbeat, seek immediate attention.

PREVENTING BLOOD CLOTS

The good news is that blood clots can be prevented and treated if you understand your risk factors and get treatment quickly. Risk factors include:

Advanced age

Birth control methods that contain estrogen or hormone therapy

Cancer and cancer treatments

Chronic diseases such as heart and lung conditions, or diabetes

Family history of blood clots

Hospitalization for illness or surgery

Obesity

Severe trauma, such as a car accident

Smoking

Sitting too long, especially with legs crossed or confined to bed/wheelchair

Your physician will decide what treatment is best for you based on factors such as age, overall health, medical history, extent of the condition and symptoms. Treatment may include any of the following:

Medications such as blood thinners or clot-dissolving medications

Vena cava filter inserted to catch clots, usually only recommended for patients unable to take medication and blood thinners

Simple lifestyle modifications can help reduce your risk. Some simple tips to keep your blood flowing include:

Take short walk breaks as often as you can. Try taking a phone call on the go or using a headset so you can move freely around the home.

Try chair exercises. Simple leg raises, ankle flexing, and calf raises are low-impact ways to keep blood circulating.

Make time for play. When your work is done, include time to get active. Go for bike ride, walk with your family, or even play hide-and-seek with your kids in the yard its all about movement.

Its important that you understand how your lifestyle plays a role in your health. Talk with your doctor about your risk for blood clots and what you can do to prevent them.

Karla Anderson, MD, is a vascular surgeon with UPMC. She sees patients at the Heart & Vascular Institute, 740 High St., Suite 3001, Williamsport. For more information on blood clots and vascular health, visit UPMCSusquehanna.org/Vascular.

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Taking vitaminsseemed much more exciting when we were children. From the Flintstones brand to fruity liquids to gummies, getting your nutrients was much more of a treat than a task. Cut to two decades later, and vitamins are way less alluring. The good news is that gummies aren't just for kids anymorein fact, adult gummies have been on shelves for a long time, and their increasing popularity has encouraged more brands to jump on the bandwagon, making vitamins an enjoyable part of our day once again. Below, we interviewed a few top nutritionists and wellness experts and asked them to share the best gummy vitamins.

Take a look at what they had to say below.

Vitafusion Women's Supercharged Multi ($10)

"Vitafusion's SimplySupercharged Multivitamin is a good one," says Alissa Rumsey, MS, RD, founder of Alissa Rumsey Nutrition and Wellness. "You only need to take two gummies a day, and it only has three grams of sugar. It also has the simplest ingredients in the vitamin as well as having a good amount of vitamin D and B. Vitamin D is especially good for the winter months and for people who do not get a lot of sun on a daily basis."

Nature Made Vitamin C ($18)

"I prefer Nature Made gummy vitamins," says Lisa Moskovitz, RD, CDN. "They are USP verified, which means they are tested and meet specific requirements set out by the United States Pharmacopeia."

Olly Flawless Complexion ($14)

The Olly brand utilizes the research and savvy of naturopathic physician Taryn Forrelli, ND, who says that theseskin-geared gummies "deliver purifying antioxidants and minerals to support cell detox, hormone health, and proper metabolism, plus a concentrated botanical blend of spearmint, Aronia berry, and dandelion."

Hum Nutrition Hair Sweet Hair ($25)

Sarah Greenfield, RD, loves theseHum gummies because of their proven ingredients. "Some key nutrients include biotin, or B7, which helps the body break down proteins needed for hair growth," she explains. "One study found women experiencing hair loss had a biotin deficiency and adding biotin supplements helped increase hair growth. Zinc plays a role in immune function and also helps maintain the health of hair follicles, leading to the growth of healthier hair.Fo-ti, a Chinese herb is included to help decrease graying by increasing melanin (hair pigment) production."

Story continues

Nordic Naturals Omega-3 Gummy Fish ($30)

WhileAmy Shapiro MS, RD, CDN, advocates forgummy vitaminsprimarily for children or adults who have trouble swallowing pills, she's a fan of theNordic Naturals brand for gummies, especially its omega-3 blend. It's ideal for those with picky palates or vegetarians (eggs and fish like salmon, herring, and mackerel are high in omega-3).

Rainblow Light Rainbow Light Sunny Gummies ($27)

Shapiro is also a fan of the brand Rainbow Light and recommends its gummy varieties. They're totally natural with no artificial flavors, colors, or preservatives.

MyKind Organics Women's Multi Organic Fruit + Vitamin Chews ($25)

"I generally stay away from recommending gummies to clients as nutritional supplementation because many brands are actually packed with artificial ingredients and loads of sugars. However,Garden of Life brand makes the cleanest organic and non-GMO gummies on the market! Not to mention, it makes a variety for men, women, and kids that are loaded with necessary vitamins and minerals. Well done, Garden of Life!" says Dana Kofsky of Wellness Styled.

SmartyPants Adult Complete Daily Gummy Vitamins ($21)

"I absolutely adore SmartyPants gummy vitamins!The brand isorganic, sustainable, taste amazing and are family-owned.It makes it oh so easy to live sustainably by using post-recycled materials inits bottles in an effort to do itspart in protecting our planet. It is so important to trust in a brand and know that you are helping the planet along the way. SmartyPants has truly been an amazing part of me and my kids' daily routine for years," says Lo Roxburgh, author and wellness expert also known as the Body Whisperer.

Gem Daily Vitamin Subscription (one month) ($39)

Shauna Faulisi, a holistic nutritionist and founder of Soul Wellness Method in Los Angeles, doesn't recommend gummy vitamins as a first step to a healthy diet, preferring her clients to get vitamins and minerals through vegetables, clean fats, and proteins, and taking specific supplements based on their individualized needs. But she understands there may be limitations: "I know that it's not always possible to purchase and get on a regiment with many different supplements to take based on schedule, access to fresh foods, and monetary resourcesand I think one should embrace whatever added wellness regimen they can bring into their life, large or small, and feel proud about it!" she says. "My go-to recommendation for gummy vitamins are GemThe brand uses dates as a binder and sweetener, along with fiber and omega-filled chia seeds to bind.Gemhasa variety of vitamins and minerals as well as the adaptogen ashwagandha to help ease stress. It also hasone of my favorite anti-aging ingredients, the powerful antioxidant, astaxanthin. Gem is an incredibly well-thought-out daily supplement that uses only the purest, whole food ingredients to get the job done."

Next up: No Lie: These Vitamins Will Make Your Hair, Skin, and Nails Flawless

This post was updated by Sarah Yang.

This article originally appeared on The Thirty

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By Rocky Swift and Christine Soares

TOKYO: In the global hunt for coronavirus treatments, a Japanese antiviral medicine known as Avigan has won plaudits from Prime Minister Shinzo Abe and $128 million in government funding. But it's not the only game in town.

Camostat, a 35-year old pancreatitis drug made by Osaka-based Ono Pharmaceutical Co , has captured the interest of scientists in Japan and overseas with little fanfare or state assistance.The two compounds are among dozens undergoing testing around the globe and illustrate how the race to develop treatments and vaccines is still wide open despite politicians such as Abe and U.S. President Donald Trump promoting the potential benefits of certain drugs.

Gilead Science Inc's remdesivir has pulled into the lead after promising early trial results prompted emergency approval in the United States and Japan. While remdesivir has shown promise in reducing recovery times of hospitalised patients, the search continues for additional treatment options.

Abe's administration has pledged to give away free supplies of the drug, with some 43 countries making formal requests. Fujifilm chairman Shigetaka Komori is a longtime backer of Abe, though the cabinet has denied there is any connection between their relationship and the government's promotion of Avigan.The use of Avigan is decided by doctors and its approval will depend on medical and scientific evaluation in due course, said Fujifilm spokeswoman Kana Matsumoto. "The use of Avigan has nothing to do with the relationship between the Prime Minister and any particular company," she said.

DESTRUCTIVE TO FETUSES

Avigan, known generically as favipiravir, was developed in the late 1990s by a company that was later purchased by Fujifilm as part of its transition from photo businesses to healthcare. The drug works by short-circuiting the reproduction mechanism of certain RNA viruses such as influenza.

Avigan can be taken as a pill, which would make it more accessible than Gilead's remdesivir, currently administered only as an intravenous infusion. But the mechanism that makes Avigan effective against viruses also makes it destructive to the rapid cell growth of fetuses. After being tested against a range of viruses, Avigan was finally approved in Japan in 2014, but only for emergency use against flu epidemics, and it was licensed in China where it has since gone off patent.

Also clinically unproven is a camostat mesylate. Developed by Ono Pharmceutical, most famous for its blockbuster Opdivo cancer drug, camostat is a protease inhibitor that has been used primarily to treat pancreatitis and some types of cancer. But past laboratory and animal tests against SARS-CoV-1 showed it has antiviral functions, and it can be safely administered in high enough doses to match the concentrations that were effective in the lab.

A study published in the scientific journal Cell in March found that camostat blocks an enzyme essential for the entry of the coronavirus into the lungs, drawing researchers' interest. One of them was Dr. Joseph Vinetz, a professor at the Yale School of Medicine, who is ready to launch a clinical trial of camostat.

"It's got a 35-year track record, so it seemed to be a very safe drug," he said. "I said we've got to try it. I'm a physician and we're desperate for anything we can give to people."

Vinetz is still trying to raise money for the trial. "I'm 100% certain that we needed to start this trial a month ago. And we can have a definitive result in a month." Ono launched camostat, known commercially in Japan as Foipan, as a treatment for chronic pancreatitis in 1985 and postoperative reflux esophagitis in 1994. The company is now supplying the drug for COVID-19 studies in Japan and overseas, according to spokesman Yukio Tani.

Itzchak Levy at the Sheba Medical Center in Israel launched a self-funded camostat trial in April. "Up to now we recruited 14 patients and look forward to further recruitment," Levy said. Another trial being carried out at the University of Kentucky is testing whether camostat can inhibit the virus's preferred pathway into human cells, and with hydroxychloroquine - the malaria drug touted by Trump -- also block the back door, boosting the treatment's effectiveness.

Existing science behind camostat's mechanism of action and tolerance in patients "is why we were enthusiastic about its potential," said Elijah Kakani, an assistant professor at the university involved in the research. "However, at this point we need to temper our enthusiasm and be objective in our evaluation of this medication for the problem at hand."

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CHICAGO May 14, 2020 (Thomson StreetEvents) -- Edited Transcript of Veru Inc earnings conference call or presentation Wednesday, May 13, 2020 at 12:00:00pm GMT

Veru Inc. - CFO & Chief Administrative Officer

* Mitchell S. Steiner

Veru Inc. - Chairman, President & CEO

Veru Inc. - Director of IR

Oppenheimer & Co. Inc., Research Division - MD & Senior Analyst

Independent Portfolio Consultants, Inc. - Investment Strategist

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

Good morning, ladies and gentlemen, and welcome to Veru Inc.'s investors' conference call. (Operator Instructions) Please note that this event is being recorded. I would now like to turn the conference over to Mr. Sam Fisch, Veru Inc.'s Director of Investor Relations. Please go ahead.

Samuel Fisch, Veru Inc. - Director of IR [2]

Good morning. The statements made in this conference call that are not historical in nature are forward-looking statements. Such forward-looking statements reflect the company's current assessment of the risks and uncertainties related to our businesses. Our actual results and future developments could differ materially from the results or developments in such forward-looking statements. Factors that may cause actual results or developments to differ materially include such things as the risks related to the development of the company's product portfolio, risks related to the ability of the company to obtain sufficient financing on acceptable terms we need to fund development and company operations, risks related to competition, government contracting risks and other risks detailed in the company's press releases, shareholder communications and Securities and Exchange Commission filings. For additional information regarding such risks, the company urges you to review its 10-Q and 10-K SEC filings.

I would now like to turn the conference over to Dr. Mitchell Steiner, Veru Inc.'s Chairman, CEO and President.

Mitchell S. Steiner, Veru Inc. - Chairman, President & CEO [3]

Thank you, Sam, and good morning. With me on this morning's call are Michele Greco, CFO and CAO; Phil Greenberg, Executive Vice President, Legal; and Sam Fisch, Director of Investor Relations. Thank you for joining our call. Veru is an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer. Today, we will update you on the clinical development of our drug pipeline and the commercialization of our products as well as provide financial highlights for the second quarter fiscal year 2020.

Here is a brief update on the advancement of the prostate cancer drug pipeline, VERU-111 in prostate cancer. We have made significant progress in the clinical development program for VERU-111, a novel proprietary first-in-class oral-targeted antitubulin agent for men who have metastatic castration-resistant prostate cancer and have also become resistant to a novel androgen blocking agent, enzalutamide or abiraterone, but prior to IV chemotherapy, also referred to as the prechemotherapy stage. Unfortunately, there is a large number of these affected men.

According to published scientific reports, about 15% to 25% of men who have metastatic castration-resistant prostate cancer and started treatment with a novel androgen blocking agent will not respond all to this therapy. And about 75% to 85% of men will initially respond to treatment with an androgen blocking agent but their cancer will start progressing in about 9 to 15 months. So essentially, within 12 months, the majority of these men will have tumor progression. And a new orally available drug with a different mechanism of action that could be prescribed by urologists and medical oncologists, like the investigative drug VERU-111, is greatly needed for these men.

The Phase Ib portion of the Phase Ib/II clinical study enrolled 39 subjects from 7 clinical sites in the United States. A standard 3x3 design was used to establish the maximum tolerated dose to select a recommended clinical dose for the Phase II study and to assess the preliminary evidence of antitumor activity of VERU-111 in men with metastatic castration-resistant prostate cancer, who have also become resistant to at least 1 novel androgen blocking agent.

Oral dosing escalated from 4.5 to 81 milligrams in the 7 days of dosing, followed by 14 days of no drug for each 21-day cycle. After no dose-limiting toxicity was observed in the 7 days of dosing per cycle, the dose was then increased in the next cohort of patients. Additionally, the dosing schedule has expanded at 21 days of continuous dosing per cycle.

As for safety, the maximum tolerated dose of VERU-111 was determined to be 72 milligrams as 3 of 11 men had reversible grade 3 diarrhea, no grade 3 diarrhea was observed at doses of 63 milligrams or less per day. At doses of VERU-111 of 63 milligrams less per day, the most common adverse events were mild to moderate nausea, vomiting, diarrhea and fatigue. There were no reports of neurotoxicity and no neutropenia was observed at 63 milligrams and lower for the continuous oral dosing, daily dosing for a 21-day cycle.

Efficacy or antitumor activity was assessed by measuring serum PSA and by standard imaging with bone and CT scans. In the 8 men that received at least 4 21-day cycles of oral VERU-111 at any dose based upon their 21-day cycle baseline PSAs, 6 of the 8 men, which is 75%, had decreases in their PSA levels; 4 of 8 men had -- which is 50%, demonstrated greater than or equal to 30% decline in PSA; and 2 of 8 men, which is 25%, have greater or equal to 50% decline in PSA.

Based upon the Prostate Cancer Working Group 3 and the Response Evaluation Criteria in Solid Tumors, which is RECIST 1.1 criteria, these are conventional criteria, objective tumor responses we're seen in 2 of 8, which is 25% of patients, in soft tissue and bone, which were partial responses; and 5 of 8 men, 63%, had stable disease. Objective tumor responses and PSA declines lasted longer than 12 weeks. The primary end point used in the pivotal studies, efficacy studies for the treatment of metastatic castration-resistant prostate cancer is median time to cancer progression by imaging, bone and CT scans.

In the current study, the median duration of response or time to cancer progression has not been reached, as 7 of the 8 men are still being treated on the study with an average duration of response of 10 months. The range is between 6 and 14 months. There were an additional 3 subjects on the study that have not yet completed the 4-day -- the 4 21-day cycles. Therefore, there is a total of 10 men that is still being treated on the study.

To better understand the clinical relevance of these preliminary findings, it's important to note that all patients with metastatic castration-resistant prostate cancer at the time of enrollment in the Phase Ib had evidence of disease progression with at least 1 novel androgen blocking agent drug, whether it's abiraterone or enzalutamide. In a contemporary series recently reported in the scientific literature for this similar population of men, the median observed time to cancer progression, while being treated with an alternative androgen blocking agent, was about 3.4 months.

We have already initiated enrolling in an open-label Phase II portion of the clinical trial in approximately 26 men with metastatic castration and a novel androgen blocking agent-resistant prostate cancer prior to and prior to any IV chemotherapy using the recommended dose and schedule that was selected from the Phase Ib, which is the 63-milligram oral daily dosing for a continuous 21-day cycle. We are on track to complete enrollment this quarter.

We have the clinical safety and the antitumor data necessary from the Phase Ib clinical study to move forward to select the patient population, dose and schedule for the Phase III registration trial. We plan to meet with the FDA next quarter to discuss our proposed registration trial design, which is an open-label, single pivotal Phase III to evaluate the efficacy and safety of VERU-111 versus an alternative androgen blocking agent in men with metastatic castrate-resistant prostate cancer, who have developed cancer progression while receiving 1 androgen blocking agent.

These recent clinical results have allowed the company to potentially accelerate the clinical development of VERU-111 for the treatment of metastatic castration and androgen blocking agent of resistant prostate cancer. Consequently, Veru has changed its strategy of investing in an additional Phase II studies of other cancer types to focus on obtaining approval of VERU-111 as quickly as possible by focusing on the study design, obtaining FDA agreement and initiating and completing a Phase III registration trial for this unmet medical need. We look forward to updating everyone on the results of the FDA meeting.

We have strong IP protection for VERU-111. The composition of matter patents are issued, with expiry in 2031 in the U.S., with a possible patent extension to 2036. Method of use patents for prostate cancer in the U.S. are issued and expiry date is in 2031. We have issued composition and method of use patents in the major markets -- major world markets, including EU and Japan.

The prechemotherapy space in men, who have metastatic castration and androgen blocking agent-resistant prostate cancer, is currently one of the fastest-growing unmet medical need segments in advanced prostate cancer. There are currently no FDA-approved drugs for this indication. According to Accuvia, oral drugs like abiraterone and enzalutamide for advanced prostate cancer had over $6 billion in 2018 global annual sales and $3.1 billion in the U.S. Men who have failed these novel androgen blocking agents are the patients that VERU-111 is currently targeting, which we estimate represents a $5 billion annual global market.

In summary, the clinical development objective is to position VERU-111, which has a unique drug mechanism of action as it does not target the androgen receptor, as the next go-to drug in men who have metastatic castration-resistant prostate cancer and who have developed prostate cancer progression while being treated with an androgen blocking agent, like abiraterone or enzalutamide, but prior to IV chemotherapy. An advantage of VERU-111 is that it could be potentially prescribed by not only the medical oncologists but also the urologists, who is the usual physician managing these types of patients. We plan to present the full clinical data set in an upcoming major scientific meeting. These clinical results firmly position Veru as an oncology-focused biopharmaceutical company.

Next, I will update you on VERU-100, our proprietary peptide drug candidate for the treatment of hormone-sensitive advanced prostate cancer, an established multibillion-dollar global market. The target product profile of VERU-100 is commercially and scientifically compelling as having a number of anticipated advantages over currently available androgen deprivation therapies.

VERU-100 is a long-acting gonadotropin-releasing hormone, called GnRH antagonist, designed to be administered as a small-volume subcutaneous 3-month depot injection without a loading dose. As a GnRH antagonist, it is intended to immediately suppress testosterone, with no testosterone surge upon initial or repeated administration and no testosterone micro increases, which may adversely affect patient outcomes, a problem which potentially occurs with the approved LHRH agonist drugs like Lupron, Zoladex and Eligard. Currently, there are no GnRH antagonists commercially approved for treatment beyond 1 month, making VERU-100, if approved, the only commercially available GnRH antagonist 3-month depot, which is an attractive choice for androgen deprivation therapy.

As previously mentioned, we have received agreement from FDA that the development program for VERU-100 may follow an expedited pathway. Based on this FDA input, the company plans to commence a single open-label, multicenter, dose-finding Phase II clinical trial in approximately 35 men, followed by a single open-label, multicenter Phase III clinical trial in only approximately 100 men. Veru is in the process of scaling up GMP manufacturing of drug product to prepare the clinical trial -- prepare for the clinical trial to VERU-100. Given the effects of COVID-19, it will be at least a quarter delay in this program. But otherwise, we expect the company's development program to resume as workers are returning to the GMP facility.

The company intends to submit an Investigational New Drug Application in the second half of 2020, so we can commence the open-label Phase II study by Q4 calendar year 2020. As it is an open-label Phase II study, we will be able to update you periodically on our progress towards reaching the primary end point, the reduction of testosterone to castrate levels in real-time during late 2020 and early 2021. The planned development pathway for VERU-100 agreed upon by FDA represents a lower-cost investment opportunity for a major product that can address the shortfalls of the current $2.6 billion global ADT market.

Our next product candidate in clinical trial is zuclomiphene, a novel proprietary oral nonsteroidal estrogen receptor agonist being evaluated to treat hot flashes, the most common side effect in men on androgen deprivation therapy for advanced prostate cancer and a major reason why men want to stop androgen deprivation therapy. We enrolled 93 men in a multicenter, double-blind, placebo-controlled dose finding study, Phase II study. And we're evaluating 2 doses, 10-milligram and 50-milligram zuclomiphene versus placebo. We reported positive top line interim results a few weeks ago. We determined that the 10-milligram dose was the no-effect dose, and the 50-milligram zuclomiphene demonstrated estrogenic activity and a reduction in the frequency of hot flashes from baseline to day 42.

We also reported on the safety from the current blinded aggregate clinical database from our placebo-controlled trial. Based on the study's interim findings, zuclomiphene appears to be well tolerated. We have not received any reports of gynecomastia, painful breasts or venous thromboembolic events, which are common side effects in men treated with high doses of estrogen.

Because of the continuing effects of COVID-19 and the related strains on the health system and regulatory agencies, we will be delayed in obtaining a face-to-face end-of-Phase II meeting with FDA for the zuclomiphene program in order to obtain agreement on the Phase III clinical program design that will be acceptable for approval. We will provide details of the design and timing of this study after we have our FDA meeting. Veru estimates that the peak U.S. revenue potential for zuclomiphene citrate to be between $580 million to $639 million. Currently, there are no FDA-approved drugs for this indication.

Although Veru is focused in prostate cancer and oncology, due to the urgency of the current global pandemic and the fact that VERU-100 has the potential to treat both SARS-CoV-2 infection and the associated reactive, severe lung inflammation in COVID-19 patients at risk for acute respiratory distress syndrome, the company is compelled to pursue this COVID-19 indication even though this indication is not the primary focus of our company. Drugs that target microtubules have broad antitumor -- antiviral activity by disrupting the intracellular transport of viruses, such as SARS-CoV-2, along the microtubules.

Microtubule trafficking is critical for viruses that cause infection. Furthermore, microtubule depolymerization agents that target alpha and beta tubulin subunits of microtubules, like a drug called colchicine, also have strong anti-inflammatory effects, including the potential to treat the cytokine-release syndrome, also known as the cytokine storm, which is induced by the SARS-CoV-2 viral infection that seems to be associated with the high COVID-19 mortality rates.

VERU-111 is an oral, first-in-class microtubule depolymerization agent that targets the colchicine binding site of alpha and beta tubulin subunits to inhibit microtubules. The company met with the FDA and has received agreement on the clinical development of VERU-111 as a potential dual, antiviral and anti-inflammatory agent to combat COVID-19 under the new FDA program Coronavirus Treatment Acceleration Program, CTAP. As reported yesterday, FDA granted Veru commission to proceed with a Phase II double-blind, randomized 1:1 placebo-controlled clinical trial evaluating daily doses of VERU-111 versus placebo for 21 days in 40 hospitalized patients. There'll be 20 in the VERU-111 and 20 in the placebo subjects, and these are subjects that tested positive for SARS-CoV-2 virus and are deemed to be at high-risk for acute respiratory distress syndrome.

The primary efficacy end point will be the proportion of patients that are alive and without respiratory failure at day 29. Secondary end points will include measured improvements on the WHO disease severity scale. It's an 8-point ordinal scale, which captures the COVID-19 disease symptoms and signs, including hospitalization, to progression of pulmonary symptoms, to mechanical ventilation as well as death. The study is expected to commence in 2 weeks. We're excited about the potential for VERU-111 to treat both the viral infection and potential for -- to treat both the viral infection and the inflammatory response caused by the virus. The Phase II primary end point -- this is critical, the Phase II primary end point is being alive without respiratory distress is a clinically meaningful one.

Because of the urgent need for effective and timely therapeutics to combat COVID-19, the company has applied for significant grant funding through both the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services, called BARDA, and the Defense Advanced research Projects agency of the U.S. Department of Defense, called DARPA, to expedite the clinical development of VERU-111 for COVID-19.

The coronavirus pandemic continues to paralyze the economy and threaten lives across the world. An effective drug to treat COVID-19 is still desperately needed. And this Phase II study will expeditiously determine whether VERU-111 has efficacy and safety against COVID-19. There's really no downside to conducting this small study, especially as we get the nondilutive funding. And if VERU-111 has efficacy, the upside is substantial for patients.

Veru's ability to advance the clinical development of our proprietary prostate cancer drugs that address unmet medical needs in large markets is being substantially supported by investments from 2 commercial sources of revenue: the FC2 Internal Condom as well as PREBOOST Roman Swipes, which is a 4% benzocaine wipe for premature ejaculation. The company also expects revenues from TADFIN, which the NDA is expected to be submitted in late 2020, early 2021, which will provide additional resources to support the company's clinical development program. As you can see from the earnings release, in Q2 fiscal year 2020, we continue to have significant growth in revenue and gross profit from these commercial products.

Although Ms. Greco will cover the detailed financial result highlights in a few moments. I would like to make a few comments. We again have the pleasure of reporting robust growth in fiscal year 2020 and expect further increases of FC2 sales in both the public sector and prescription sales in the U.S. for the rest of the year. We had a $7 million -- we had $7 million in revenue from the prescription business for Q2 fiscal year 2020 compared to $2.6 million for Q2 fiscal year 2019, an increase of 168%. In fact, to give you a sense of the growth trajectory for all of fiscal year 2019, we sold 159,000 FC2 prescribed units. And for just the first quarter -- first 2 quarters of fiscal year 2020, we sold 171,891 FC2 prescribed units.

Focusing on the Veru's commercial segment, which is made up of FC2, PREBOOST Roman Swipes and drug commercialization costs, we have net revenues increase in Q2 fiscal year 2020 to $9.9 million compared to $7 million in Q2 fiscal year 2019, which is up 43%. Gross profits for Q2 fiscal year 2020 was $7.4 million compared to $4.6 million in Q2 for fiscal year 2019, which is up 61%. In fact, our gross margin climbed to 75% of net revenues from 66%.

Our operating income from this segment significantly increased to $6.2 million from $2.8 million. Net revenue for fiscal year-to-date 2020 was $20.5 million compared to fiscal year-to-date 2019 of $13.3 million. This is an increase of 54%. Our income from operations for this segment of the business was $12 million for fiscal year-to-date 2020, up from $6.2 million in fiscal year-to-date 2019, an increase of 94.6%.

As you can see, our base commercial business is doing very well. And as a stand-alone business would be quite valuable, experiencing significant growing revenue and incomes from operations. This continued revenue growth and profit and positive cash flow from this base commercial business has allowed us to substantially invest in the development of our prostate cancer clinical programs, which enhances the entire value of Veru for our shareholders.

We intend to continue this revenue growth trajectory, with not only the current growth of revenues from FC2 and PREBOOST but also from the revenues that we expect to generate from the commercialization of the company's proprietary Tadalafil and Finasteride Combination capsule for the treatment of BPH, called TADFIN. We're collecting 12-month stability data on TADFIN manufacturing batches and expect to submit the NDA by the end of 2020 to just beginning of 2021.

In the United States, we're exploring commercially launching TADFIN through telemedicine channels. As you have seen, we've had great success with our other products using this sales channel. We expect to -- revenues from TADFIN to add substantially to near-term revenues with high gross margins, to existing and growing revenues from FC2 and the PREBOOST Roman Swipes business.

I will now turn the call over to Michele Greco, CFO and CAO, to discuss the financial highlights. Michele?

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Michele Greco, Veru Inc. - CFO & Chief Administrative Officer [4]

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Thank you, Dr. Steiner. As Dr. Steiner indicated, we started off the year with 2 great quarters. Let's start our highlight with the second quarter results for the 3 months ended March 31, 2020.

FC2 unit sales totaled $6.9 million compared to $9.8 million in the prior year second quarter. Total net revenues were up 43% to $9.9 million from $7 million in the prior year second quarter. The company reported quarterly sales growth in its U.S. prescription business and in PREBOOST. Net revenue from the U.S. prescription business was up 168% to $7 million from $2.6 million in the prior year second quarter. Gross profit was up 61% to $7.4 million from $4.6 million in the prior year second quarter. Gross margin increased to 75% from 66% in the prior year second quarter. The increase in gross margin is driven primarily by the increase in the U.S. prescription business.

These financial results do not reflect the new tender orders that will be coming from South Africa. We previously announced that we won 75% of the South African tender, representing up to 120 million units over 3 years for the total tender. This translates to approximately 30 million units per year for our company and potentially $10.4 million in revenue per year for a total of approximately $30 million over 3 years. We expect these new orders from South Africa to ship in greater volumes during the third quarter of this fiscal year.

Operating expenses for the quarter increased by $1 million to $7.7 million compared to the prior year second quarter of $6.7 million due to the increase in research and development costs of $1 million. Nonoperating expenses were $644,000 compared to $1.9 million in the prior year second quarter and primarily consisted of interest expense and the change in the fair value of the derivatives liabilities related to the synthetic royalty financing. We entered the synthetic royalty financing during March of 2018.

For the quarter, we recorded a tax benefit of $133,000 compared to a tax expense of $25,000 in the prior year second quarter. The effective tax rate for this quarter of 14% is due to recording a valuation allowance against the net operating loss generated for the quarter in the U.S. The bottom line results for the second quarter of fiscal 2020 was a net loss of $811,000 or $0.01 per diluted common share compared to a net loss of $4 million or $0.06 per diluted common share in the prior year second quarter.

Now turning to highlights of the results for the 6 months ended March 31, 2020. For the first 6 months of fiscal 2020, the FC2 unit sales totaled 17 million compared to 17.2 million units in the prior year period. Total net revenues were up 54% to $20.5 million from $13.3 million in the prior year period. The company reported growth in FC2 sales in the U.S. prescription business and in PREBOOST. Net revenue from the U.S. prescription business was up 158% to $13 million from $5 million in the prior year period.

And just to note, for all of fiscal year 2019, the U.S. prescription revenue was $14.1 million. Net revenue for PREBOOST Roman Swipes was $574,000 compared to $180,000 in the prior year period. Gross profit was up 59% to $14.7 million from $9.3 million in the prior year period. Gross margin increased to 72% from 69% in the prior year period due primarily to the increase in the U.S. prescription business.

Operating expenses increased by $4.4 to $16.8 million compared to the prior year period of $12.4 million driven primarily by the increase in research and development costs of $4 million. Nonoperating expenses were $2.2 million compared to $2.9 million in the prior year period, and primarily consisted of interest expense and the change in the fair value of the derivative liabilities related to the synthetic royalty financing.

For the 6-month period, we recorded a tax benefit of $210,000 compared to a tax expense of $118,000 in the prior year period. The effective tax rate for the 6 months of 4.9% is due to recording a valuation allowance against the net operating loss generated for the 6 months in the U.S. The company has net operating loss carryforwards for U.S. federal tax purposes of $42.7 million with $14.4 million expiring in years through 2038, and $28.3 million, which can be carried forward indefinitely. And our U.K. subsidiary has net operating loss carryforwards of $61.7 million, which do not expire.

The bottom line results for the first 6 months of fiscal 2020 was a net loss of $4.1 million or $0.06 per diluted common share compared to a net loss of $6.2 million or $0.10 per diluted common share in the prior period. The reduction in the net loss of $2.1 million is due primarily to the increase in our net revenues, which is offset by the increase in our research and development costs.

Turning to our balance sheet. As of March 31, 2020, our cash balance was $2.6 million and our accounts receivable were $5.8 million compared to a cash balance of $6.3 million and accounts receivable of $5 million at September 30, 2019. During the 6 months ended March 31, 2020, we used cash of $4.9 million for operating activities compared with using cash of $4 million in the prior period.

Overall, we're delighted to see the continued increases in sales in the U.S. FC2 prescription business and the increasing sales of PREBOOST Roman Swipes to Roman Health Ventures and look forward to increasing sales in the global public sector business in the third quarter. These revenue sources continue to be a source of funds we use to invest in our promising pharmaceutical clinical programs as we continue to transform our company into an oncology and urology biopharmaceutical company with a focus on developing novel medicines for the management of prostate cancer.

Now I'd like to turn the call back to Dr. Steiner.

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Mitchell S. Steiner, Veru Inc. - Chairman, President & CEO [5]

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Thank you, Michele. We have enjoyed yet another strong financial quarter, which has allowed us to significantly advance our clinical programs. In fact, we now have had 10 straight quarters of growth in our FC2 U.S. prescription business. Looking forward to the rest of fiscal year 2020 and early fiscal year 2021, we expect our revenues to continue to be strong and growing towards a record year.

With the improving performance of the commercial business, we believe that we'll be able to substantially invest in the continued clinical development of our prostate cancer and other cancer drug product candidates as well as to submit the NDA and, if approved, commercially launch TADFIN to -- through Internet sales, which would provide even more revenue, adding to the already growing revenue from FC2 and from PREBOOST Roman Swipes. We are creating a very valuable commercial business, which includes both the urology specialty pharmaceuticals and the female health company divisions.

With the new clinical data from the VERU-111 prostate cancer program, we must prioritize and focus our efforts towards the execution of the Phase III registration program for this unmet need in prostate cancer. This begins by obtaining regulatory clarity from both FDA and EMA on the clinical trial design. We have reached an important company clinical milestone that well positions Veru as an oncology biopharmaceutical company.

We anticipate a steady flow of important positive news for Veru over the next few months to a year. One, for VERU-111, our oral selective antitubulin, we will report an open-label efficacy and safety clinical results from the Phase II clinical trials of VERU-111. And we will meet with the FDA and report on the Phase III clinical trial program.

For VERU-100, our novel peptide GnRH antagonist 3-month depot formulation, we will complete GMP manufacturing of clinical supply, we'll submit the IND, and we'll initiate the Phase II clinical trial. With zuclomiphene, our oral estrogen receptor agonist, we will have a face-to-face meeting with the FDA for -- face-to-face and a Phase II meeting with FDA.

We plan to initiate and complete the Phase II clinical program for COVID-19 and subjects of high-risk to acute respiratory distress syndrome. We'll submit the NDA for TADFIN. We would have secured partnerships with some of our drug products. And we plan to continue to demonstrate robust growing revenues for our commercial products FC2 and PREBOOST Roman Swipes.

We're committed to driving shareholder value by transforming Veru into an oncology company. We will initially focus our efforts to providing substantial benefits to prostate cancer patients by developing and commercializing VERU-111 as well as our other oncology products to address unmet medical needs in the management of their disease.

With that, I now open the call to questions. Operator?

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Questions and Answers

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Operator [1]

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(Operator Instructions) The first question comes from Brandon Folkes of Cantor Fitzgerald.

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Brandon Richard Folkes, Cantor Fitzgerald & Co., Research Division - Analyst [2]

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Congratulations on all the progress. And on VERU-111, granted you haven't met with the regulatory agencies, could you perhaps just elaborate about how you're thinking about the Phase III design? Anything you can say maybe around the size and number of patients?

And then how are you thinking about what is the hurdle you think physicians in practice will want to see in that Phase III to use VERU-111 in practice? And then, lastly, maybe just on COVID-19. Should we think of this as a potential revenue-generating opportunity for the company? Or is this going to be similar to what we think from other companies, where it's really just a public duty-type thing?

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Mitchell S. Steiner, Veru Inc. - Chairman, President & CEO [3]

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Thank you. All excellent questions. So let's talk about the Phase III design for the -- for VERU-111. So what I can do is I can refer you to the ALAPARIB, that's A-L-A-P-R-I-B -- so A-L-A-P-A-R-I-B study that's in front of the FDA as we speak. It's very instructive in terms of how we're thinking about our clinical trial. So this is one I believe will get approved. This is a patient population that's similar to our patient population. These are patients with metastatic castration-resistant prostate cancer that have failed an androgen blocking agent. Some of them had chemo, but just some -- but mostly the same patient population.

And the reason I bring that up is because it is a registration trial, and the FDA has allowed them to use as an active comparator patients that have placed on an alternative androgen blocking agent. So that means if you think of our patient populations, they fail castration, so they're castration resistant. They put on an androgen blocking agent, either enzalutamide or abiraterone, and then they get randomized to alternative androgen blocking agent. It means if they start out with abiraterone, they get put on enzalutamide. If they start with enzalutamide, they get put on abiraterone. That's what I mean by alternative androgen blocking agent, okay?

And that's your comparator arm. The FDA has allowed that in 3 of the nonmetastatic studies that have been approved, and it's being allowed in this study. So that's why we feel pretty good. The end point of that study, just like those other 3 clinical studies were nonmetastatic, is progression-free survival, radiographic progression-free survival or imaging-based progression-free survival. Another way of saying that is when cancer progresses and you can see it on either bone scan or CT scan, that's deemed a failure, okay? They've accepted that, okay?

The active comparator, in this case, is an oral agent that's going after patients -- that ALAPARIB is going after patients that have a genetic mutation, which is really a small segment of the population. That's why we want to be the go-to drug. We want to be the drug that will treat anybody, not anybody that has a genetic mutation. So that's a much bigger market.

And the -- and in that study, interestingly, they hit -- the hurdle they have to hit is in the treatment and then back up, in terms of the trial size, because you can do progression-free survival, imaging-based progression-free survival, sort of 800 patients or 1,000 patients in the study. That study, I think, is about 250 patients. So the range is going to be around the 250 to 300 mark. It's a much smaller study. And quite frankly, it's a shorter study. And the reason it's a shorter study is because the comparator arm, the active control, fails in about 3.4 to 3.6 months. So if you go for a year, you've got 3 of those cycles. And so follow-up is not very long, unfortunately, for the patient. But your benchmark that you're going up against is about 3.4, 3.6 months median progression-free survival and radiographic progression-free survival. And for ALAPARIB, they showed a 7.4-month advantage. And everybody believes it's going to get approved, okay?

So I shared that with you because I think we're going to be very similar to that. I think our trial design -- our trial size will be between 250 and 300. I think we're going to have an end point of imaging-based progression-free survival. I think we'll be able to compare our agent VERU-111 against an alternative blocking -- alternative androgen blocking agent. I think the hurdle that we need to hit is going to be about 3.4 to 3.6 months.

I have comfort to know that in the Phase Ib, the median duration of response is 10 months, with a range between 6 and 14 months. It feels good but, of course, you have to be careful. It is Phase Ib, but that gives you comfort that we should be in good shape from the standpoint of being able to beat that. And that's the kind of design.

So it feels safe because we're not asking the agency to do something new. And -- but it also gives you a sense of why we're excited about going into a Phase III registration program because these patients are around so recruitment should be pretty straightforward. And it's completely an unmet medical need. And there's enough regulatory precedent that we can feel comfortable around trial design.

As it relates to your second question, which has to do with COVID-19. That's nice you're doing it, and you're going to do like Gilead and just kind of give it away and give all the doses to the government and show 3 or 4 days of hospital benefit and move on. Now we're a small company, and we think we have an innovative compound, VERU-111.

Excerpt from:
Edited Transcript of FHCO earnings conference call or presentation 13-May-20 12:00pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

Business partners Soyama Mthongana and Athenkosi Denga, both 26, started farming in Peddie in the Eastern Cape in 2011, but only formalised their business, Lizwe Meat, in 2015.

Growing up in Port Elizabeth, the pair learnt about farming from their fathers and grandfathers, who ran livestock. From the outset, Mthongana and Dengas goal was to build on the knowledge they had gained from their families, and find innovative ways to farm better at a commercial level.

When starting out on their own, they decided to run farms independently from their families.

Setting an exampleDenga says that one of the purposes of their business operation is to demonstrate that black South African youth can produce quality beef cattle.

We cant leave unchallenged the stigma that farming is for the older generation.

He adds that a successful livestock business requires substantial financial investment in land, labour and infrastructure, as well investing time and resources to upskill oneself. This is why he and Mthongana took up studies specifically to help them in their business operation.

Between them, they hold degrees in marketing, accounting and business administration. Denga is in the process of completing a masters degree that researches ways of improving beef sales in South Africa.

The partners farming operation is run on leased land.

Were in year four of a 10-year lease of a 600ha farm. About 400ha is suitable for grazing, Denga says.

They have a commercial beef cattle herd consisting of 88 Bonsmara, Brangus and Hereford-type animals.

The genetic traits of these breeds, such as good feed conversion, are well suited to the environment we farm in. The weaners produced by the herd perform well in the feedlot.

The South African market requires cattle that produce tender carcasses with a high meat-to-bone ratio and uniform marbling.

They have three bulls and 85 female animals and produce about 75 weaners a year. From 2015 they decided to farm only one breed, and chose the Bonsmara because of its good performance record in the feedlot industry.

They are still in the process of converting their existing mixed herd to a pure Bonsmara herd by bringing in more Bonsmara bulls.

Over the long term, they also intend acquiring more land to grow their operation further.

Grazing campsDenga and Mthongana have implemented a rotational grazing system.

Without this system, the farm will be overgrazed, and it will take a long time to recover, he says.

They have four camps, and use two for their female animals, keeping between 40 and 45 in each camp. The bulls are kept in the third camp and the fourth is left to rest.

According to Denga, the cattle should be moved on before the grass is grazed down to its roots, as this has a negative effect on regrowth.

Production systemDuring the breeding season, one bull is taken to each female animal camp and a third is alternated between the two camps, so at times there are two bulls in one camp. The bulls run with the cows/heifers for three months, and calving is in October.

At the moment, we achieve a conception rate of 90%. However, were working on this by improving the genetics of the herd, says Denga.

They implement a strict culling regime; any cow that fails to produce one calf a year is culled. The calves stay with their dams until they are weaned at seven to eight months.

Their calving rate is about 90% and their weaning rate 95%.

Calves are not weighed at birth, but at weaning; the partners aim for a weaning weight of 210kg, at which point the weaners can be marketed to feedlots.

To ensure the health of our herd, we maintain constant communication with the provincial agriculture department state veterinarian, Dr Chauke Maluleke, to find out what diseases are prevalent in the area, and we vaccinate and treat animals accordingly, says Denga.

Feedlots and auctionsIn addition to selling weaners directly to feedlots, Mthongana and Denga sell their cattle through auctions, which they organise in partnership with GWK and the National Agricultural Marketing Council (NAMC).

Auctions are not easily accessible for emerging and communal farmers because of the costs associated with them.

Transport to and from the auction for individual farmers can be prohibitively high.

This was the main reason we decided to become involved in auctions, and host them in such a way that theyd become more widely accessible, Denga says.

They conducted market research about which areas needed access to markets, and started by focusing on an area close to Mthatha in the former Transkei.

According to Denga, the livestock at auctions sells itself as people can see which animals are in good health.

These events also give farmers an opportunity to benchmark themselves against other farmers, and share information on how to improve the quality of their animals.

In addition, auctions create healthy competition between farmers and inspire them to produce better-quality livestock.

Denga adds that some older farmers are not knowledgeable about the South African red meat grading system and the market demand for tender beef from younger animals.

In our experience, many of the older farmers we deal with dont understand that this is where the industry is going, he says.

Denga says he and Mthongana hold most of their auctions close to the end of the year, when the majority of farmers want to sell their cattle to satisfy increased demand. The auctions are hosted in temporary structures set up at different venues in the rural areas.

We try to meet the farmers who participate halfway by offering them a reasonable rate to assist with transport to and from the auction venues, says Denga.

Auctions also represent a safer way for farmers to sell their cattle, as all proceeds from sales are transferred electronically, which is more secure than dealing on the informal market, says Denga.

Agriculture has great potential to contribute to South Africas economy. We believe that farming is where the countrys next generation of millionaires will come from.

Email Athenkosi Denga at [emailprotected], or Soyama Mthongana at [emailprotected].

See more here:
Two young cattle farmers bring auctions to communal areas - Farmer's Weekly

Recommendation and review posted by Bethany Smith

Not intended for UK-based media

- Results from two studies of BAVENCIOto be featured in ASCO press briefing

- Primary efficacy, biomarker and HRQoL analyses for tepotinib, the first MET inhibitor to have received a regulatory approval for NSCLC with METgene alterations

- Two-year follow-up for first-in-class bifunctional immunotherapy bintrafusp alfatargeting TGF-/PD-L1, in second-line NSCLC

ROCKLAND,Massachusetts, May 13, 2020 /PRNewswire/ --EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada,today announced data for its innovative investigational agents and investigational uses of marketed medicines to be presented at the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program, to be held virtually from May 29-31.

This year, ASCO will be highlightingduring its embargoed presscast on Tuesday, May 26 and at the plenary session on Sunday, May 31the Phase III JAVELIN Bladder 100 study (Abstract# LBA1) of BAVENCIO (avelumab) in the first-line maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC)*. Additional data will be presented for early- to late-stage molecules discovered and developed in-house that demonstrate the Company's commitment and relentless drive to discover, develop and deliver innovative treatment options in its hope to turn cancer patients into cancer survivors. Research from several investigator-sponsored and collaborative research studies also will be shared. This includes a late-breaking oral presentation of results of the investigator-sponsored, multicenter Phase II TROPHIMMUN study of avelumab for the treatment of chemotherapy-resistant gestational trophoblastic tumors (Cohort A), which also will be featured in the ASCO press program (Abstract# LBA6008).

"Despite the many advances in cancer treatment, we have an urgency to continue to discover and develop innovative treatment options that will have a major impact on the lives of people living with cancer,"said Luciano Rossetti, Global Head of Research & Development for EMD Serono. "Taking on this challenge, we've applied our deep knowledge of cancer biology to highly focused areas to develop the first-in-class oral MET inhibitor, tepotinib, which received the first approval anywhere in the world for the treatment of NSCLC with MET gene alterations, and our first-in-class bifunctional fusion protein immunotherapy, bintrafusp alfa, both of which have promising outcomes featured at this year's ASCO meeting."

For tepotinib, approved in Japan for the treatment of patients withunresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with METexon 14 (METex14)skipping alterationsand the first oral MET inhibitor indicated for the treatment of advanced NSCLC harboring MET gene alterations to receive a regulatory approval, data will be presented from the primary analysis of the VISION study with promising activity in patients with advanced EGFR/ALK wild-type, METex14 skipping NSCLC who were prospectively enrolled using liquid biopsy or tissue biopsy. Results (Abstract #9556) include6-month follow-updata for the primary endpoint of objective response rate (ORR) as determined by independent review committee. Secondary endpoints include ORR as assessed by investigators, duration of response, disease control rate, progression-free survival, molecular responses, and safety data. Additionally, patient-reported outcomes (PROs) of health-related quality of life (HRQoL) for the VISION study will be presented at the meeting (Abstract# 9575). These outcomes are the first time HRQoL have been reported for patients with METex14skipping NSCLC.

For bintrafusp alfa, a novel bifunctional fusion protein targeting TGF- and PD-L1, two-year follow-up data from a global Phase I study in second-line NSCLC will be presented (Abstract# 9558). These data continue to show manageable safety with durable responses and encouraging long-term survival, especially in patients with high PD-L1 expression (80%). The overall safety profile has remained consistent since the interim analysis, with no new safety signals or deaths and one additional treatment-related discontinuation (blood alkaline phosphatase increased). Studies in the bintrafusp alfa lung cancer program include:

The Company's broad portfolio of investigational DNA damage response (DDR) inhibitors represents multiple development paths, including combinations with other agents and modalities. A trial-in-progress poster (Abstract #TPS4117) will review a multicenter Phase Ib/II study evaluating the safety, tolerability, pharmacokinetics and efficacy of the DNA-PK inhibitor peposertib (formerly M3814) in combination with capecitabine and radiotherapy as neoadjuvant treatment in patients with locally advanced rectal cancer.

*BAVENCIO is under clinical investigation for the first-line maintenance treatment of advanced UC. There is no guarantee that BAVENCIO will be approved for first-line maintenance treatment of advanced UC by any health authority worldwide.

Tepotinib is currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.

Bintrafusp alfa is currently under clinical investigation and not approved for any use anywhere in the world.

About BAVENCIO (avelumab)

BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody. BAVENCIO has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, BAVENCIO has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.10-12 In November 2014, Merck KGaA, Darmstadt, Germany and Pfizer announced a strategic alliance to co-develop and co-commercialize BAVENCIO.

BAVENCIO Approved Indications

BAVENCIO (avelumab) in combination with axitinib is indicated in the US for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

In the US, the FDA granted accelerated approval for BAVENCIO for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Avelumab is currently approved for patients with MCC in 50 countries globally, with the majority of these approvals in a broad indication that is not limited to a specific line of treatment.

BAVENCIO Important Safety Information from the US FDA-Approved Label

BAVENCIO can cause immune-mediated pneumonitis, including fatal cases. Monitor patients for signs and symptoms of pneumonitis, and evaluate suspected cases with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold BAVENCIO for moderate (Grade 2) and permanently discontinue for severe (Grade 3), life-threatening (Grade 4), or recurrent moderate (Grade 2) pneumonitis. Pneumonitis occurred in 1.2% of patients, including one (0.1%) patient with Grade 5, one (0.1%) with Grade 4, and five (0.3%) with Grade 3.

BAVENCIO can cause hepatotoxicity and immune-mediated hepatitis, including fatal cases. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hepatitis. Withhold BAVENCIO for moderate (Grade 2) immune-mediated hepatitis until resolution and permanently discontinue for severe (Grade 3) or life-threatening (Grade 4) immune-mediated hepatitis. Immune-mediated hepatitis occurred with BAVENCIO as a single agent in 0.9% of patients, including two (0.1%) patients with Grade 5, and 11 (0.6%) with Grade 3.

BAVENCIO in combination with axitinib can cause hepatotoxicity with higher than expected frequencies of Grade 3 and 4 alanine aminotransferase (ALT) and aspartate aminotransferase (AST) elevation. Consider more frequent monitoring of liver enzymes as compared to when the drugs are used as monotherapy. Withhold BAVENCIO and axitinib for moderate (Grade 2) hepatotoxicity and permanently discontinue the combination for severe or life-threatening (Grade 3 or 4) hepatotoxicity. Administer corticosteroids as needed. In patients treated with BAVENCIO in combination with axitinib, Grades 3 and 4 increased ALT and AST occurred in 9% and 7% of patients, respectively, and immune-mediated hepatitis occurred in 7% of patients, including 4.9% with Grade 3 or 4.

BAVENCIO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold BAVENCIO until resolution for moderate or severe (Grade 2 or 3) colitis until resolution. Permanently discontinue for life-threatening (Grade 4) or recurrent (Grade 3) colitis upon reinitiation of BAVENCIO. Immune-mediated colitis occurred in 1.5% of patients, including seven (0.4%) with Grade 3.

BAVENCIO can cause immune-mediated endocrinopathies, including adrenal insufficiency, thyroid disorders, and type 1 diabetes mellitus.

Monitor patients for signs and symptoms of adrenal insufficiency during and after treatment, and administer corticosteroids as appropriate. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) adrenal insufficiency. Adrenal insufficiency was reported in 0.5% of patients, including one (0.1%) with Grade 3.

Thyroid disorders can occur at any time during treatment. Monitor patients for changes in thyroid function at the start of treatment, periodically during treatment, and as indicated based on clinical evaluation. Manage hypothyroidism with hormone replacement therapy and hyperthyroidism with medical management. Withhold BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) thyroid disorders. Thyroid disorders, including hypothyroidism, hyperthyroidism, and thyroiditis, were reported in 6% of patients, including three (0.2%) with Grade 3.

Type 1 diabetes mellitus including diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Withhold BAVENCIO and administer antihyperglycemics or insulin in patients with severe or life-threatening (Grade 3) hyperglycemia, and resume treatment when metabolic control is achieved. Type 1 diabetes mellitus without an alternative etiology occurred in 0.1% of patients, including two cases of Grade 3 hyperglycemia.

BAVENCIO can cause immune-mediated nephritis and renal dysfunction. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater nephritis. Withhold BAVENCIO for moderate (Grade 2) or severe (Grade 3) nephritis until resolution to Grade 1 or lower. Permanently discontinue BAVENCIO for life-threatening (Grade 4) nephritis. Immune-mediated nephritis occurred in 0.1% of patients.

BAVENCIO can result in other severe and fatal immune-mediated adverse reactions involving any organ system during treatment or after treatment discontinuation. For suspected immune-mediated adverse reactions, evaluate to confirm or rule out an immune-mediated adverse reaction and to exclude other causes. Depending on the severity of the adverse reaction, withhold or permanently discontinue BAVENCIO, administer high-dose corticosteroids, and initiate hormone replacement therapy, if appropriate. Resume BAVENCIO when the immune-mediated adverse reaction remains at Grade 1 or lower following a corticosteroid taper. Permanently discontinue BAVENCIO for any severe (Grade 3) immune-mediated adverse reaction that recurs and for any life-threatening (Grade 4) immune-mediated adverse reaction. The following clinically significant immune-mediated adverse reactions occurred in less than 1% of 1738 patients treated with BAVENCIO as a single agent or in 489 patients who received BAVENCIO in combination with axitinib: myocarditis including fatal cases, pancreatitis including fatal cases, myositis, psoriasis, arthritis, exfoliative dermatitis, erythema multiforme, pemphigoid, hypopituitarism, uveitis, Guillain-Barr syndrome, and systemic inflammatory response.

BAVENCIO can cause severe or life-threatening infusion-related reactions. Premedicate patients with an antihistamine and acetaminophen prior to the first 4 infusions and for subsequent infusions based upon clinical judgment and presence/severity of prior infusion reactions. Monitor patients for signs and symptoms of infusion-related reactions, including pyrexia, chills, flushing, hypotension, dyspnea, wheezing, back pain, abdominal pain, and urticaria. Interrupt or slow the rate of infusion for mild (Grade 1) or moderate (Grade 2) infusion-related reactions. Permanently discontinue BAVENCIO for severe (Grade 3) or life-threatening (Grade 4) infusion-related reactions. Infusion-related reactions occurred in 25% of patients, including three (0.2%) patients with Grade 4 and nine (0.5%) with Grade 3.

BAVENCIO in combination with axitinib can cause major adverse cardiovascular events (MACE) including severe and fatal events. Consider baseline and periodic evaluations of left ventricular ejection fraction. Monitor for signs and symptoms of cardiovascular events. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue BAVENCIO and axitinib for Grade 3-4 cardiovascular events. MACEoccurred in 7% of patients with advanced RCC treated with BAVENCIO in combination with axitinib compared to 3.4% treated with sunitinib. These events included death due to cardiac events (1.4%), Grade 3-4 myocardial infarction (2.8%), and Grade 3-4 congestive heart failure (1.8%).

BAVENCIO can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to a fetus including the risk of fetal death. Advise females of childbearing potential to use effective contraception during treatment with BAVENCIO and for at least 1 month after the last dose of BAVENCIO. It is not known whether BAVENCIO is excreted in human milk. Advise a lactating woman not to breastfeed during treatment and for at least 1 month after the last dose of BAVENCIO due to the potential for serious adverse reactions in breastfed infants.

The most common adverse reactions (all grades, 20%) in patients with metastatic Merkel cell carcinoma (MCC) were fatigue (50%), musculoskeletal pain (32%), diarrhea (23%), nausea (22%), infusion-related reaction (22%), rash (22%), decreased appetite (20%), and peripheral edema (20%).

Selected treatment-emergent laboratory abnormalities (all grades, 20%) in patients with metastatic MCC were lymphopenia (49%), anemia (35%), increased aspartate aminotransferase (34%), thrombocytopenia (27%), and increased alanine aminotransferase (20%).

The most common adverse reactions (all grades, 20%) in patients with locally advanced or metastatic urothelial carcinoma (UC) were fatigue (41%), infusion-related reaction (30%), musculoskeletal pain (25%), nausea (24%), decreased appetite/hypophagia (21%), and urinary tract infection (21%).

Selected laboratory abnormalities (Grades 3-4, 3%) in patients with locally advanced or metastatic UC were hyponatremia (16%), increased gamma-glutamyltransferase (12%), lymphopenia (11%), hyperglycemia (9%), increased alkaline phosphatase (7%), anemia (6%), increased lipase (6%), hyperkalemia (3%), and increased aspartate aminotransferase (3%).

Fatal adverse reactions occurred in 1.8% of patients with advanced renal cell carcinoma (RCC) receiving BAVENCIO in combination with axitinib. These included sudden cardiac death (1.2%), stroke (0.2%), myocarditis (0.2%), and necrotizing pancreatitis (0.2%).

The most common adverse reactions (all grades, 20%) in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were diarrhea (62% vs 48%), fatigue (53% vs 54%), hypertension (50% vs 36%), musculoskeletal pain (40% vs 33%), nausea (34% vs 39%), mucositis (34% vs 35%), palmar-plantar erythrodysesthesia (33% vs 34%), dysphonia (31% vs 3.2%), decreased appetite (26% vs 29%), hypothyroidism (25% vs 14%), rash (25% vs 16%), hepatotoxicity (24% vs 18%), cough (23% vs 19%), dyspnea (23% vs 16%), abdominal pain (22% vs 19%), and headache (21% vs 16%).

Selected laboratory abnormalities (all grades, 20%) worsening from baseline in patients with advanced RCC receiving BAVENCIO in combination with axitinib (vs sunitinib) were blood triglycerides increased (71% vs 48%), blood creatinine increased (62% vs 68%), blood cholesterol increased (57% vs 22%), alanine aminotransferase increased (ALT) (50% vs 46%), aspartate aminotransferase increased (AST) (47% vs 57%), blood sodium decreased (38% vs 37%), lipase increased (37% vs 25%), blood potassium increased (35% vs 28%), platelet count decreased (27% vs 80%), blood bilirubin increased (21% vs 23%), and hemoglobin decreased (21% vs 65%).

Please see full US Prescribing Information and Medication Guide available at http://www.BAVENCIO.com.

About tepotinib

Tepotinib is an oral MET inhibitor that is designed to inhibit the oncogenic MET receptor signaling caused by MET (gene) alterations, including both METex14 skipping alterations and MET amplifications, or MET protein overexpression. Discovered in-house at Merck KGaA, Darmstadt, Germany, it has been designed to have a highly selective mechanism of action,7 with the potential to improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations.Tepotinibis currently under clinical investigation in NSCLC and not yet approved in any markets outside of Japan.Merck KGaA, Darmstadt, Germany is actively assessing the potential of investigating tepotinib in combination with novel therapies and in other tumor indications. Tepotinib is approved under the brand name TEPMETKO in Japan for the treatment of unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) with MET exon 14 (METex14) skipping alterations. The brand name TEPMETKO is not approved for use outside of Japan.

About bintrafusp alfa

Bintrafusp alfa (M7824), discovered in-house at Merck KGaA, Darmstadt, Germany, is a potential first-in-class investigational bifunctional fusion protein designed to simultaneously block two immunosuppressive pathways, TGF- and PD-L1, within the tumor microenvironment. This bifunctional approach is thought to control tumor growth by potentially restoring and enhancing anti-tumor responses.In preclinical studies, bintrafusp alfa has demonstrated antitumor activity both as monotherapy and in combination with chemotherapy. Based on its mechanism of action, bintrafusp alfa offers a potential targeted approach to addressing the underlying pathophysiology of difficult-to-treat cancers.

INTR@PID is the global clinical trial program investigating the potential co-localized, dual inhibition of TGF- and PD-L1 with bintrafusp alfa (M7824) in multiple tumor types. Current clinical trial information can be found on the INTR@PID website at http://www.intrapidclinicaltrials.com. To date, more than 850 patients with various types of solid tumors have been treated globally in the bintrafusp alfa INTR@PID clinical development program.

All Merck KGaA, Darmstadt, Germany, press releases are distributed by e-mail at the same time they become available on the EMD Group Website. In case you are a resident of the USA or Canada please go to http://www.emdgroup.com/subscribeto register for your online subscription of this service as our geo-targeting requires new links in the email. You may later change your selection or discontinue this service.

About EMD Serono, Inc.

EMD Serono - the biopharmaceutical business of Merck KGaA, Darmstadt,Germany in the U.S. andCanada- is engaged in the discovery, research and development of medicines for patients with difficult to treat diseases. The business is committed to transforming lives by developing and delivering meaningful solutions that help address the therapeutic and support needs of individual patients. Building on a proven legacy and deep expertise in neurology, fertility and endocrinology, EMD Serono is developing potential new oncology and immuno-oncology medicines while continuing to explore potential therapeutic options for diseases such as psoriasis, lupus and MS. Today, the business has approximately 1,500 employees around the country with commercial, clinical and research operations based in the company's home state ofMassachusetts.www.emdserono.com.

About Merck KGaA, Darmstadt, Germany

Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany generated sales of 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark "Merck" internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company's technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

Contacts:

Media:Julissa Viana781 206 5795

Investor Relations+49 6151 72-3321

Originally posted here:
Breakthrough Innovation in Cancer Care From EMD Serono Pipeline to Be Presented at ASCO 2020 - WFMZ Allentown

Recommendation and review posted by Bethany Smith

ALAMEDA, Calif.--(BUSINESS WIRE)--AgeX Therapeutics , Inc. (AgeX: NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported financial and operating results for the first quarter ended March 31, 2020.

The human tragedy of this pandemic has long tentacles that effect numerous businesses including AgeX, said Greg Bailey M.D., Chairman. Given the current global economic landscape, and the changes that businesses will need to make to accommodate to a post pandemic world, we feel that new business model aligns well to be able to function in this new environment. We see enormous opportunity to license and joint venture PureStem and HLA-G while implementing a definitive plan to begin preclinical trials on tissue regeneration under the leadership of Michael West and Michael May. We will update you in the future as these plans progress.

AgeX has completed a company restructuring to help set it up for success in the future. The combination of company priorities, cash position and the COVID-19 pandemic led to employee lay-offs designed to support the evolution of AgeX's current team to execute on strategic business goals going forward and to ensure cash is directed at near-term priorities to deliver maximum shareholder value. AgeX has a dual business strategy to diversify risk and maximize opportunities. It plans to continue to pursue its licensing and collaboration strategy for its two primary technology platforms, UniverCyte immunotolerance technology for the generation of universal cells, and PureStem cell derivation and manufacturing technology for the production of therapeutic cells with potential advantages, including industrial scalability and lower manufacturing costs. Since the launch of its licensing and collaboration strategy in January 2020, AgeX has delivered a research collaboration in Japan focused on developing universally transplantable cells for therapeutic use based on UniverCyte, entered into a neural stem cell therapy research collaboration for neurological disorders utilizing PureStem at a California University, and AgeX licensee ImStem Biotechnology received the first-ever clearance of a cell therapy derived from AgeXs embryonic stem cells by the FDA to enter human studies.

In addition, AgeX remains committed to pursuing in-house cell therapy product development and plans to raise money to build the optimal team to deliver on its products, AGEX-BAT1 for metabolic diseases such as type II diabetes and AGEX-VASC1 for tissue ischaemia. AgeXs budgetary and personnel adjustments will result in the deferral of in-house product development and may also lead to AgeX seeking arrangements with other companies in the cell therapy or biopharma industry for the development of its product candidates and technology, or outsourcing of some of that work to service providers until further funding can be obtained to rebuild in-house research and development staff for one or more of those programs. Development of AgeXs iTR technology may be done at AgeXs subsidiary Reverse Bioengineering, Inc. subject to successful financing of the subsidiary.

Upwards of 80% of healthcare expenditures in the United States relates to chronic degenerative disease and aging is a principle underlying cause of such conditions, said Michael D. West, Ph.D., AgeXs Chief Executive Officer. Therefore, the ability to manufacture to scale young clinical-grade cells capable of regenerating functionality in diverse tissues of the body has the potential to transform healthcare as we know it today. Perhaps even more noteworthy is the potential of reversing developmental aging in the body itself through AgeXs iTR technology. Our goal in the coming year is to advance the development of our intellectual property with the goal of bringing value to our shareholders.

Q1 Highlights

Liquidity and Capital Resources

AgeX is in need of additional capital to finance its operations. On March 30, 2020, AgeX entered into a Secured Convertible Facility Agreement (the New Loan Agreement) with Juvenescence Limited pursuant to which AgeX may borrow funds from time to time. On April 1, 2020 AgeX drew the initial $500,000, and may draw additional funds from time to time subject to Juvenescences discretion, prior to the contractual repayment date on March 30, 2023. AgeX may not draw down more than $1 million in any single draw. More information about the New Loan Agreement can be found in AgeXs Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on March 30, 2020 and May 14, 2020, respectively.

On April 13, 2020, AgeX obtained a loan in the amount of $432,952 from Axos Bank under the Paycheck Protection Program (the PPP Loan). The PPP Loan will bear interest at a rate of 1% per annum. No payments will be due on the PPP Loan during a six month deferral period commencing on the date of the promissory note. Commencing one month after the expiration of the deferral period, and continuing on the same day of each month thereafter until the maturity date of the PPP Loan, monthly payments of principal and interest will be due, in an amount required to fully amortize the principal amount outstanding on the PPP Loan by the maturity date. The maturity date is April 13, 2022. The principal amount of the PPP Loan is subject to forgiveness under the PPP to the extent that PPP Loan proceeds are used to pay expense permitted by the PPP, including payroll, rent, and utilities (collectively, Qualifying Expenses), during the time frame permitted by the PPP. AgeX intends to use the PPP Loan amount for Qualifying Expenses. However, no assurance is provided that AgeX will obtain forgiveness of the PPP Loan in whole or in part.

Staff Reductions

During April 2020, AgeX initiated staff layoffs that affected 12 employees, primarily research and development personnel. AgeX has paid approximately $105,000 in accrued payroll and unused paid time off and other benefits and expects to recognize approximately $194,800 in restructuring charges in connection with the reduction in staffing, consisting of contractual severance and other employee termination benefits, substantially all of which are expected to be settled in cash. The staff reductions followed AgeXs strategic review of its operations, giving consideration to the status of its product development programs, human resources, capital needs and resources, and current conditions in the capital markets resulting from the COVID-19 pandemic.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeXs most recent projected cash flows, and considering that loans from Juvenescence in excess of an initial $500,000 advance under the New Loan Agreement will be subject to Juvenescences discretion, AgeX believes that its cash and cash equivalents, the $500,000 loan under the New Loan Agreement, the PPP Loan and reduction in staff in May 2020 would not be sufficient to satisfy its anticipated operating and other funding requirements for the twelve months following the filing of AgeXs Quarterly Report on Form 10-Q for the three months ended March 31, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

First Quarter 2020 Operating Results

Revenues: Total Revenues for the first quarter of 2020 were $515,000 as compared with $388,000 for the first quarter of 2019. AgeX revenue is primarily generated from subscription and advertising revenues from the GeneCards online database through its subsidiary LifeMap Sciences, Inc. Revenues in 2020 also included approximately $86,000 of allowable expenses under its research grant from the NIH as compared with $15,000 in the same period in 2019.

Operating expenses: Operating expenses reported for the three months ended March 31, 2020 were $3.7 million as compared to $3.4 million for the same period in 2019. On an as-adjusted basis, operating expenses for the three months ended March 31, 2020 were $3.2 million as compared to $2.8 million for the same period in 2019.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses increased by $0.3 million to $1.6 million during the three months ended March 31, 2020 from $1.3 million during the same period in 2019. The increase was primarily attributable to an increase of $0.2 million in scientific consultants, $0.2 million in laboratory facilities and equipment related expenses and maintenance, $0.1 million in personnel related expenses allocable to research and development, and $0.1 million in depreciation and amortization of laboratory equipment and improvements. These increases were offset to some extent by a decrease of $0.3 million in shared services from Lineage Cell Therapeutics, Inc. (Lineage) with the termination of the Shared Facilities and Services Agreement on September 30, 2019.

General and administrative expenses for the three months ended March 31, 2020 remained consistent with the same period in 2019 of $2.1 million despite bearing the full lease and facilities related costs since April 2019, and an increase in head count with the employment of AgeXs own finance team since October 1, 2019. These increases were offset by a decrease in shared facilities and services fees from Lineage following the termination of the Shared Facilities and Services Agreement on September 30, 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)

March 31,

2020

December 31,

2019

(Unaudited)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

468

$

2,352

Accounts and grants receivable, net

366

363

Prepaid expenses and other current assets

1,238

1,339

Total current assets

2,072

4,054

Continue reading here:
AgeX Therapeutics Reports First Quarter 2020 Financial Results and Provides Business Update - Business Wire

Recommendation and review posted by Bethany Smith

The report on the global Progenitor Cell Product market is comprehensively prepared with main focus on the competitive landscape, geographical growth, segmentation, and market dynamics, including drivers, restraints, and opportunities. It sheds light on key production, revenue, and consumption trends so that players could improve their sales and growth in the GlobalProgenitor Cell Product Market.It brings to light key factors affecting the growth of different segments and regions in the global Progenitor Cell Product market. It also offers SWOT, Porters Five Forces, and PESTLE analysis to thoroughly examine the global Progenitor Cell Product market.It offers a detailed analysis of the competition and leading companies of the global Progenitor Cell Product market. Here, it concentrates on the recent developments, sales, market value, production, gross margin, and other important factors of the business of top players operating in the global Progenitor Cell Product market.

Key companies operating in the global Progenitor Cell Product market include:NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

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With deep quantitative and qualitative analysis, the report provides encyclopedic and accurate research study on important aspects of the global Progenitor Cell Product market. It gives a detailed study on manufacturing cost, upstream and downstream buyers, distributors, marketing strategy, and marketing channel development trends of the global Progenitor Cell Product market. Furthermore, it provides strategic bits of advice and recommendations for players to ensure success in the global Progenitor Cell Product market.

Segmental Analysis

The report has classified the global Progenitor Cell Product industry into segments including product type and application. Every segment is evaluated based on growth rate and share. Besides, the analysts have studied the potential regions that may prove rewarding for the Progenitor Cell Product manufcaturers in the coming years. The regional analysis includes reliable predictions on value and volume, thereby helping market players to gain deep insights into the overall Progenitor Cell Product industry.

Global Progenitor Cell Product Market Segment By Type:

, Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cells (NPCs), Endothelial progenitor cells (EPC), Others

Global Progenitor Cell Product Market Segment By Application:

Progenitor Cell Product

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Progenitor Cell Product industry. In order to fulfil the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key companies operating in the global Progenitor Cell Product market includeNeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, R&D Systems, Lonza, ATCC, Irvine Scientific, CDI

Regions and Countries

The Middle East and Africa(GCC Countries and Egypt)North America(the United States, Mexico, and Canada)South America(Brazil etc.)Europe(Turkey, Germany, Russia UK, Italy, France, etc.)Asia-Pacific(Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

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What is the size and CAGR of the global Progenitor Cell Product market?

Which are the leading segments of the global Progenitor Cell Product market?

What are the key driving factors of the most profitable regional market?

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Table of Contents

Table of Contents 1 Progenitor Cell Product Market Overview1.1 Progenitor Cell Product Product Overview1.2 Progenitor Cell Product Market Segment by Type1.2.1 Pancreatic progenitor cells1.2.2 Cardiac Progenitor Cells1.2.3 Intermediate progenitor cells1.2.4 Neural progenitor cells (NPCs)1.2.5 Endothelial progenitor cells (EPC)1.2.6 Others1.3 Global Progenitor Cell Product Market Size by Type1.3.1 Global Progenitor Cell Product Sales and Growth by Type1.3.2 Global Progenitor Cell Product Sales and Market Share by Type1.3.3 Global Progenitor Cell Product Revenue and Market Share by Type1.3.4 Global Progenitor Cell Product Price by Type1.4 North America Progenitor Cell Product by Type1.5 Europe Progenitor Cell Product by Type1.6 South America Progenitor Cell Product by Type1.7 Middle East and Africa Progenitor Cell Product by Type 2 Global Progenitor Cell Product Market Competition by Company2.1 Global Progenitor Cell Product Sales and Market Share by Company (2014-2019)2.2 Global Progenitor Cell Product Revenue and Share by Company (2014-2019)2.3 Global Progenitor Cell Product Price by Company (2014-2019)2.4 Global Top Players Progenitor Cell Product Manufacturing Base Distribution, Sales Area, Product Types2.5 Progenitor Cell Product Market Competitive Situation and Trends2.5.1 Progenitor Cell Product Market Concentration Rate2.5.2 Global Progenitor Cell Product Market Share of Top 5 and Top 10 Players2.5.3 Mergers & Acquisitions, Expansion 3 Progenitor Cell Product Company Profiles and Sales Data3.1 NeuroNova AB3.1.1 Company Basic Information, Manufacturing Base and Competitors3.1.2 Progenitor Cell Product Product Category, Application and Specification3.1.3 NeuroNova AB Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.1.4 Main Business Overview3.2 StemCells3.2.1 Company Basic Information, Manufacturing Base and Competitors3.2.2 Progenitor Cell Product Product Category, Application and Specification3.2.3 StemCells Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.2.4 Main Business Overview3.3 ReNeuron Limited3.3.1 Company Basic Information, Manufacturing Base and Competitors3.3.2 Progenitor Cell Product Product Category, Application and Specification3.3.3 ReNeuron Limited Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.3.4 Main Business Overview3.4 Asterias Biotherapeutics3.4.1 Company Basic Information, Manufacturing Base and Competitors3.4.2 Progenitor Cell Product Product Category, Application and Specification3.4.3 Asterias Biotherapeutics Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.4.4 Main Business Overview3.5 Thermo Fisher Scientific3.5.1 Company Basic Information, Manufacturing Base and Competitors3.5.2 Progenitor Cell Product Product Category, Application and Specification3.5.3 Thermo Fisher Scientific Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.5.4 Main Business Overview3.6 STEMCELL Technologies3.6.1 Company Basic Information, Manufacturing Base and Competitors3.6.2 Progenitor Cell Product Product Category, Application and Specification3.6.3 STEMCELL Technologies Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.6.4 Main Business Overview3.7 Axol Bio3.7.1 Company Basic Information, Manufacturing Base and Competitors3.7.2 Progenitor Cell Product Product Category, Application and Specification3.7.3 Axol Bio Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.7.4 Main Business Overview3.8 R&D Systems3.8.1 Company Basic Information, Manufacturing Base and Competitors3.8.2 Progenitor Cell Product Product Category, Application and Specification3.8.3 R&D Systems Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.8.4 Main Business Overview3.9 Lonza3.9.1 Company Basic Information, Manufacturing Base and Competitors3.9.2 Progenitor Cell Product Product Category, Application and Specification3.9.3 Lonza Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.9.4 Main Business Overview3.10 ATCC3.10.1 Company Basic Information, Manufacturing Base and Competitors3.10.2 Progenitor Cell Product Product Category, Application and Specification3.10.3 ATCC Progenitor Cell Product Sales, Revenue, Price and Gross Margin(2014-2019)3.10.4 Main Business Overview3.11 Irvine Scientific3.12 CDI 4 Progenitor Cell Product Market Status and Outlook by Regions4.1 Global Progenitor Cell Product Market Status and Outlook by Regions4.1.1 Global Progenitor Cell Product Market Size and CAGR by Regions4.1.2 North America4.1.3 Europe4.1.4 Asia-Pacific4.1.5 South America4.1.6 Middle East and Africa4.2 Global Progenitor Cell Product Sales and Revenue by Regions4.2.1 Global Progenitor Cell Product Sales Market Share by Regions (2014-2019)4.2.2 Global Progenitor Cell Product Revenue Market Share by Regions (2014-2019)4.2.3 Global Progenitor Cell Product Sales, Revenue, Price and Gross Margin (2014-2019)4.3 North America Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.3.1 North America Progenitor Cell Product Sales by Countries4.3.2 United States4.3.3 Canada4.3.4 Mexico4.4 Europe Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.4.1 Europe Progenitor Cell Product Sales by Countries4.4.2 Germany4.4.3 France4.4.4 UK4.4.5 Italy4.4.6 Russia4.5 Asia-Pacific Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.5.1 Asia-Pacific Progenitor Cell Product Sales by Regions4.5.2 China4.5.3 Japan4.5.4 South Korea4.5.5 India4.5.6 Australia4.5.7 Indonesia4.5.8 Thailand4.5.9 Malaysia4.5.10 Philippines4.5.11 Vietnam4.6 South America Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.6.1 South America Progenitor Cell Product Sales by Countries4.6.2 Brazil4.7 Middle East and Africa Progenitor Cell Product Sales, Revenue, Price and Gross Margin4.7.1 Middle East and Africa Progenitor Cell Product Sales by Countries4.7.2 Turkey4.7.3 GCC Countries4.7.4 Egypt4.7.5 South Africa 5 Progenitor Cell Product Application5.1 Progenitor Cell Product Segment by Application5.1.1 Medical care5.1.2 Hospital5.1.3 Laboratory5.2 Global Progenitor Cell Product Product Segment by Application5.2.1 Global Progenitor Cell Product Sales by Application5.2.2 Global Progenitor Cell Product Sales and Market Share by Application (2014-2019)5.3 North America Progenitor Cell Product by Application5.4 Europe Progenitor Cell Product by Application5.5 Asia-Pacific Progenitor Cell Product by Application5.6 South America Progenitor Cell Product by Application5.7 Middle East and Africa Progenitor Cell Product by Application 6 Global Progenitor Cell Product Market Forecast6.1 Global Progenitor Cell Product Sales, Revenue Forecast (2019-2025)6.1.1 Global Progenitor Cell Product Sales and Growth Rate Forecast (2019-2025)6.1.2 Global Progenitor Cell Product Revenue and Growth Rate Forecast (2019-2025)6.2 Global Progenitor Cell Product Forecast by Regions6.2.1 North America Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.2 Europe Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.3 Asia-Pacific Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.4 South America Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.2.5 Middle East and Africa Progenitor Cell Product Sales and Revenue Forecast (2019-2025)6.3 Progenitor Cell Product Forecast by Type6.3.1 Global Progenitor Cell Product Sales and Revenue Forecast by Type (2019-2025)6.3.2 Pancreatic progenitor cells Growth Forecast6.3.3 Cardiac Progenitor Cells Growth Forecast6.4 Progenitor Cell Product Forecast by Application6.4.1 Global Progenitor Cell Product Sales Forecast by Application (2019-2025)6.4.2 Global Progenitor Cell Product Forecast in Medical care6.4.3 Global Progenitor Cell Product Forecast in Hospital 7 Progenitor Cell Product Upstream Raw Materials7.1 Progenitor Cell Product Key Raw Materials7.1.1 Key Raw Materials7.1.2 Key Raw Materials Price7.1.3 Raw Materials Key Suppliers7.2 Manufacturing Cost Structure7.2.1 Raw Materials7.2.2 Labor Cost7.2.3 Manufacturing Expenses7.3 Progenitor Cell Product Industrial Chain Analysis 8 Marketing Strategy Analysis, Distributors8.1 Sales Channel8.2 Distributors8.3 Downstream Customers 9 Research Findings and Conclusion 10 Appendix10.1 Methodology/Research Approach10.1.1 Research Programs/Design10.1.2 Market Size Estimation10.1.3 Market Breakdown and Data Triangulation10.2 Data Source10.2.1 Secondary Sources10.2.2 Primary Sources10.3 Author List10.4 Disclaimer

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Progenitor Cell Product Market 2020| Worldwide Industry Share, Size, Gross Margin, Trend, Future Demand, Analysis by Top Leading Player and Forecast...

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The coronavirus, as we all know, has brought our economy to its knees. As the search for vaccines and treatments accelerates, geneticists are now looking to our genes to understand why some recover quickly or show no symptoms, while others die. To do so, they are searching DNA databases and cross-referencing them with COVID-19 cases. This research holds great promise for addressing the pandemic.

Yet if scientists do find answers in our genes, we need to consider the implications for genetic privacy. Armed with the ability to identify who is vulnerable and who is not, how will society proceed?

On the one hand, health care providers could use genetic testing to help vulnerable patients stay safe. But there would also be a temptation to use genetic testing in the workplace. Companies could use genetic test results to manage the risks for all employees, for example by controlling the activities of those who are most vulnerable. Businesses will also see opportunities to use genetic test results in the marketplace, for example by tailoring insurance offerings according to genetic risk. Currently, there are some limited legal protections against genetic discrimination and health privacy intrusions, but the pandemic has already led the federal government toscale backsome of those protections for the time being.

Although the rationale for expanded genetic testing is obviously meant for the greater good, such testing could also bring with it a host of privacy and economic harms. In the past, genetic testing has also been associated with employment discrimination. Even before the current crisis, companies like 23andMe and Ancestry assembled and started operating their own private long-term large-scale databases of U.S. citizens genetic and health data. 23andMe and Ancestry recently announced they would use their databases to identify genetic factors that predict COVID-19 susceptibility.

Other companies are growing similar databases, for a range of purposes. And the NIHs AllofUs program is constructing a genetic database, owned by the federal government, in which data from one million people will be used to study various diseases. These new developments indicate an urgent need for appropriate genetic data governance.

Leaders from the biomedical research community recently proposed a voluntary code of conduct for organizations constructing and sharing genetic databases. We believe that the public has a right to understand the risks of genetic databases and a right to have a say in how those databases will be governed. To ascertain public expectations about genetic data governance, we surveyed over two thousand (n=2,020) individuals who altogether are representative of the general U.S. population. After educating respondents about the key benefits and risks associated with DNA databasesusing information from recent mainstream news reportswe asked how willing they would be to provide their DNA data for such a database.

The results were surprising. Initially, we believed people would generally approve of donating their genetic data for altruistic reasons, such as for example, finding a vaccine for COVID-19, so we assumed they would be more willing to provide their data to a hospital or university compared with a tech company or pharmaceutical firm. But we found a fairly similar level of willingnessregardless of who owns the database. While 37 percent were unwilling to provide their DNA data to a technology company (like 23andMe), about the same percent were unwilling to provide it to a hospital (40 percent), a government health institute (37 percent), a pharmaceutical firm (40 percent) or a university (35 percent).

The most important thing our survey revealed was that the willingness of individuals to provide their genetic data depended greatly on the kinds of policies that would govern that data. Thus, in order to find a vaccine for COVID-19, we must have genetic data governance policies that inspire confidence and that will prompt the public to donate their genetic data. Willingness to provide genetic data increased the most when people were told they would have the ability to control how their stored data is reused or shared in the future. This willingness also increased when people were assured they could have their data deleted at any point.

Conversely, one of the policies that reduced willingness to contribute the most was the retention of data indefinitely without a specified date for destruction. These patterns held equally among people who were willing to provide their data as an altruistic donation and people who were only willing to provide their data in exchange for payment of some kind. The patterns also held regardless of the type of organization the respondent was being asked about, that is whether tech company, hospital, government, pharmaceutical firm or university.

Not surprisingly, we also found that willingness to provide genetic data increased greatly when contributors knew that the organization would be using state-of-the-art cybersecurity to protect their data.

Together, these findings indicate two principles to guide needed regulation and any code of conduct for genetic databases.

The first is personal agency and control. People want to know that they can control the end uses of their DNA data. This principle puts the burden on database owners to obtain additional permissions when they want to reuse or share data. It also means designing databases so each entry has an expiration date and can be selectively removed. Technologies exist to support this principle, and some organizations are using them.

The second is equal treatment of all organizations. The same rules should apply regardless of an organizations sector (e.g., for-profit, nonprofit, government); industry (health care, technology, consumer/lifestyle and so on); or size. Such distinctions make little sense in an era when data are routinely moved, shared and reused across organizations, sectors and industriesoftenwithout the full understanding of the peopleincluded in the data.

How can these principles be integrated with existing law and regulation? One approach would be to treat genetic sequence data as personal health information under HIPAA. This is consistent with the current understanding that genetic data can neither be truly de-identified nor completely stripped of sensitive informational content. Organizational policies for data access and cybersecurity can then follow health sector guidelines at a minimum.

Naturally, when biomedical researchers think about rules for genetic information databases, they want to avoid excessive limits on using the data. After all, such limits may slow scientific progress and reduce the societal benefits of the databases. But as suggested by the recent consumer genetics slowdown, without appropriate rules in place, the public may become wary of participating. Thus, it is imperative to consider public opinion of genetic data collection, the safeguarding of the data, and the use of DNA databases.

Our research suggestsour proposed principles for genetic database governance will help preserve the publics willingness to contribute their genetic informationwhich may be our only hope of defeating the coronavirus.

The authors are co-principal investigators on a grant by the Robert Wood Johnson Foundation to research the governance of genetic testing as part of corporate wellness programs. Their article Evolving public views on the value of ones DNA and expectations for genomic database governance: Results from a national survey, co-authored with Allison Gaddis and Jennifer McCormick, was published by PLOS ONE.

Read more about the coronavirus outbreak from Scientific American here, and read coverage from our international network of magazines here.

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The Answer to a COVID-19 Vaccine May Lie in Our Genes, But ... - Scientific American

Recommendation and review posted by Bethany Smith

COLUMBIA, Md., May 15, 2020 /PRNewswire/ -- The Foundation Fighting Blindness, the world's leading organization searching for treatments and cures for inherited retinal diseases, has introduced many improvements and upgrades to its My Retina Tracker Registry. Overall, the upgraded platform makes this best-in-class patient database even easier to use for patients, industry, and investigators who access de-identified data for research studies and clinical trial recruitment. Launched in 2013, more than 15,500 IRD patients are active in the Registry. The patient-driven registry is accessible at MyRetinaTracker.org.

"The My Retina Tracker Registry has been an invaluable resource for both IRD patients and research communities. It provides a secure venue for patients to get on the radar screens of therapy developers both industry and researcher partners who are recruiting for clinical trials and conducting studies using human data," says Brian Mansfield, PhD, executive vice president of research and interim chief scientific officer. "From the start, we have been strongly committed to security of privacy coupled with ease-of-use for both patients and professionals. These enhancements are part of our continual process to maximize the registry's usability and efficiently integrate it with our genetic testing programs."

Highlights of upgrades and enhancements:

The Foundation also offers no-cost genetic testing for those affected with IRDs. The Open Access Genetic Testing Program, allows for any eye care professional in the U.S. to order the no-cost test along with a no-cost genetic counseling session for their IRD patients. Neither membership to My Retina Tracker Registry, nor clinician pre-approval, is needed to participate in the Open Access Genetic Testing Program and receive free testing and genetic counseling.

If a person who is tested chooses to join My Retina Tracker Registry, their data is automatically uploaded into their profile from the genetic testing laboratory.

Current sponsors of the new My Retina Tracker Registry include: The George Gund Foundation, Eloxx Pharmaceuticals, Sofia Sees Hope, AGTC and MeiraGTx. Sponsors of the Open Access Genetic Testing Program include: ProQR, Blueprint Genetics, InformedDNA, Sophia Sees Hope, and The George Gund Foundation.

About the Foundation Fighting BlindnessEstablished in 1971, the Foundation Fighting Blindness is the world's leading private funding source for retinal degenerative disease research. The Foundation has raised more than $760 million toward its mission of accelerating research for preventing, treating, and curing blindness caused by the entire spectrum of retinal degenerative diseases including: retinitis pigmentosa, age-related macular degeneration, Usher syndrome, and Stargardt disease. VisitFightingBlindness.orgfor more information.

Media Contact:Chris AdamsVice President, Marketing & Communicationscadams@fightingblindness.org410-423-0585

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Foundation Fighting Blindness Launches Upgraded My Retina Tracker Registry for People with Inherited Retinal Diseases (IRDs) - Herald-Mail Media

Recommendation and review posted by Bethany Smith

In the season premiere of actressCourteney Coxs Facebook Watch Series Nine Months WithCourteney Cox, she opens up about her experience discovering she had aMTHFR gene mutation. Not only does this mutation make pregnancy difficult, but it also increases risk of types of cancer which is why genetic testing is crucial for everyone.

In her Facebook Watch stream, Cox, 55, revealed that she had suffered miscarriages in the past and four years ago discovered that it was due toMTHFR gene mutation. According to a study from theNational Center for Biotechnology Information (NCBI), this gene mutation also increases the risk of breast cancer as well as ovarian cancer. Additionally, Coxs father, Richard Lewis Cox, passed away after battling cancer in 2001.

Related:Sadness Is Not Always A Bad Thing Coping After Losing A Parent To Cancer

About four years ago, I found out I have something called a MTHFR gene mutation, which dictates how my body methylates, Cox explained in the video. I suffered miscarriages, my dad died of a really rare cancer, and depression runs in my family, which made my doctor think I should get this gene checked out. I discovered that I have the worst version of the mutation and my body doesnt methylate the way its supposed to.

For many people, genetic testing is a crucial step in understanding whether youre more or less at risk for a cancer diagnosis. Some specific gene mutations are directly linked to types of cancers, and by going through genetic testing, doctors will be able to identify these mutations in people. This is especially the case when it comes to ovarian cancer, which is linked toBRCA-1 and BRCA-2 gene defects.

Dr. Kellie Schneider explains why genetic testing is important to detect ovarian cancer

Genetic testing is important for several different reasons,Dr.Kellie Schneider, a gynecologic oncologist at Novant Health in Charlotte, North Carolina, tells SurvivorNet. Ovarian cancer is a relatively rare cancer so when we see it in a patient we worry theres something that put them genetically at risk for that cancer.We would want to know for their sake and their familys sake if we need to be screening for any additional cancers once they are in remission from their ovarian cancer.

Related: Ovarian Cancer: Understanding the Different Categories of Genetic Testing- What You Got From Your Parents & Whats Changed Since You Were Born

Genetic testing cannot only help a possible patient, but also their family members. Breast cancer survivor Amy Armstrong talked to SurvivorNet about why she got genetically tested for stomach cancer, which runs in her family.

[My mom] uncovered that she had a very rare stomach cancer gene called CDH1, Amy said. If you have this gene, not only is it incredibly rare, but youre also confronted [with] making a pretty big decision to avoid getting stomach cancer. You have to have a prophylactic gastrectomy. When my mom found out that she had the gene, it had a domino effect for not only her siblings to be tested for the gene, but also her children and 3 out of 4 of us, my siblings, tested positive for the gene.

According to Armstrong, CDH1 is a dominant gene so theres a 50/50 chance of passing it on to a child. In order to avoid passing this gene to her family, she underwent a prophylactic gastrectomy (stomach removal) to reduce her chance of getting cancer.

Breast cancer survivor Amy Armstrong shares why she went through genetic testing

Learn more about SurvivorNet's rigorous medical review process.

In the season premiere of actressCourteney Coxs Facebook Watch Series Nine Months WithCourteney Cox, she opens up about her experience discovering she had aMTHFR gene mutation. Not only does this mutation make pregnancy difficult, but it also increases risk of types of cancer which is why genetic testing is crucial for everyone.

In her Facebook Watch stream, Cox, 55, revealed that she had suffered miscarriages in the past and four years ago discovered that it was due toMTHFR gene mutation. According to a study from theNational Center for Biotechnology Information (NCBI), this gene mutation also increases the risk of breast cancer as well as ovarian cancer. Additionally, Coxs father, Richard Lewis Cox, passed away after battling cancer in 2001.

About four years ago, I found out I have something called a MTHFR gene mutation, which dictates how my body methylates, Cox explained in the video. I suffered miscarriages, my dad died of a really rare cancer, and depression runs in my family, which made my doctor think I should get this gene checked out. I discovered that I have the worst version of the mutation and my body doesnt methylate the way its supposed to.

For many people, genetic testing is a crucial step in understanding whether youre more or less at risk for a cancer diagnosis. Some specific gene mutations are directly linked to types of cancers, and by going through genetic testing, doctors will be able to identify these mutations in people. This is especially the case when it comes to ovarian cancer, which is linked toBRCA-1 and BRCA-2 gene defects.

Dr. Kellie Schneider explains why genetic testing is important to detect ovarian cancer

Genetic testing is important for several different reasons,Dr.Kellie Schneider, a gynecologic oncologist at Novant Health in Charlotte, North Carolina, tells SurvivorNet. Ovarian cancer is a relatively rare cancer so when we see it in a patient we worry theres something that put them genetically at risk for that cancer.We would want to know for their sake and their familys sake if we need to be screening for any additional cancers once they are in remission from their ovarian cancer.

Related: Ovarian Cancer: Understanding the Different Categories of Genetic Testing- What You Got From Your Parents & Whats Changed Since You Were Born

Genetic testing cannot only help a possible patient, but also their family members. Breast cancer survivor Amy Armstrong talked to SurvivorNet about why she got genetically tested for stomach cancer, which runs in her family.

[My mom] uncovered that she had a very rare stomach cancer gene called CDH1, Amy said. If you have this gene, not only is it incredibly rare, but youre also confronted [with] making a pretty big decision to avoid getting stomach cancer. You have to have a prophylactic gastrectomy. When my mom found out that she had the gene, it had a domino effect for not only her siblings to be tested for the gene, but also her children and 3 out of 4 of us, my siblings, tested positive for the gene.

According to Armstrong, CDH1 is a dominant gene so theres a 50/50 chance of passing it on to a child. In order to avoid passing this gene to her family, she underwent a prophylactic gastrectomy (stomach removal) to reduce her chance of getting cancer.

Breast cancer survivor Amy Armstrong shares why she went through genetic testing

Learn more about SurvivorNet's rigorous medical review process.

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Actress Courteney Cox Says MTHFR Gene Mutation Made Pregnancy Difficult The Importance Of Genetic Testing To Detect Cancer Risk - SurvivorNet

Recommendation and review posted by Bethany Smith

A recent market intelligence study on the Genetic Testing Devices market2020incorporates proprietary techniques and assessment tools to screen the Genetic Testing Devices market for the forecast period, 2020-2026. Additionally, valuable insights pertaining to the market size, share and growth rate of Genetic Testing Devices market offers a greater chance of success for all business owners, products, and new technology.

Major Genetic Testing Devices market players covered by this research report are:

Myriad GeneticsCepheidLuminexSeegeneBioRad LaboratoriesWaferGen BiosystemsIntegraGenBioMerieuxInterpace DiagnosticsQiagenElitechElitechAbbott LaboratoriesBiocartisPerkinElmerRoche DiagnosticsEKF DiagnosticsQuest Diagnostics

Request for Sample Report @ https://www.reportspedia.com/report/life-sciences/global-genetic-testing-devices-market-report-2019,-competitive-landscape,-trends-and-opportunities/28940 #request_sample

Incorporated with Info-graphics, charts, tables and figures, this research report Genetic Testing Devices Market Size, Type Analysis, Application Analysis, End-Use Industry Analysis, Regional Outlook, Competitive Strategies And Forecasts, 2020- 2026is based on a wide-ranging research of the entire Global market and covering all its sub-segments through comprehensively thorough classifications. Insightful analysis and valuation are created from superior primary and secondary information sources with data and information derived from industry specialists across the value chain. The report provides historical market data for 2015-2019, base year estimates for 2020, and forecasts from 2020 to 2026.

Research Methodology:

The research report provides trustworthy primary and secondary research. It also depends on the most recent analysis techniques to organize extremely detailed and accurate research studies such as this Genetic Testing Devices Market. It uses data triangulation, top-down and bottom-up approaches, and advanced Genetic Testing Devices Market research processes to come out with comprehensive and industry-best market research reports.

Classification by Type is as follows:

Type 1Type 2Type 3

Classification by Application is as follows:

Application 1Application 2Application 3

Inquire Here For More Details Or Custom Content @ https://www.reportspedia.com/report/life-sciences/global-genetic-testing-devices-market-report-2019,-competitive-landscape,-trends-and-opportunities/28940 #inquiry_before_buying

Genetic Testing Devices Market 2020 Dynamics:

Drivers:(Developing regions and growing markets)

Boundaries:(Regional, Key Player facing Issues, Future Barriers for growth)

Opportunities:(Regional, Growth Rate, Competitive, Consumption)

Regional Segmentation:

TOC of Genetic Testing Devices Market 2020 Report Includes:

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Global Genetic Testing Devices Market Outlook, Opportunities, Key Players, Growth, Competitive Landscape, Trends and Forecast by 2026 - Cole of Duty

Recommendation and review posted by Bethany Smith

BIRMINGHAM, Ala. - Is personalized medicine cost-effective? University of Alabama at Birmingham researcher Nita Limdi, Pharm.D., Ph.D., and colleagues across the United States have answered that question for one medical treatment.

Patients experiencing a heart attack -- known as a myocardial infarction or an acute coronary syndrome -- have sharply diminished blood flow in coronary arteries, with a high risk of heart failure or death. Coronary angioplasty, a procedure to open narrowed or blocked arteries in the heart, and percutaneous coronary intervention, known as PCI or stenting, can restore blood flow to minimize damage to the heart. These procedures reduce the risk of subsequent major adverse cardiovascular events, or MACE, which include heart attacks, strokes or death.

But then, a treatment decision has to be made.

After stenting, all patients are treated with two antiplatelet agents for up to one year. Which combination of antiplatelets is best? The answer comes through pharmacogenomics, says Limdi, a professor in the UAB Department of Neurology and associate director of UAB's Hugh Kaul Precision Medicine Institute.

Pharmacogenomics combines pharmacology, the study of drug action, with genetics, the study of gene function, to choose the best medication according to each patient's personal genetic makeup. This is also called precision medicine -- tailored medical treatment for each individual patient.

The most commonly used antiplatelet combination after PCI is aspirin and clopidogrel, which is trademarked as Plavix. Clopidogrel is converted to its active form by an enzyme called CYP2C19. However, patients respond to clopidogrel differently based on their genetic makeup.

More than 30 percent of people have loss-of-function variants in the CYP2C19 gene that decrease the effectiveness of clopidogrel. The FDA warns that these patients may not get the full benefit of clopidogrel, which would increase the risk of MACE. So the FDA advises doctors to consider a different treatment such as prasugrel or ticagrelor, trademarked as Effient and Brillinta, to replace clopidogrel.

While most patients undergoing PCI receive clopidogrel without receiving any CYP2C19 loss-of-function testing, academic institutions like UAB that offer precision medicine use pharmacogenomics to guide the selection of medication dosing.

In 2018, Limdi and other investigators across nine United States universities -- all members of the Implementing Genomics in Practice consortium, or IGNITE -- showed that patients with loss-of-function variants who were treated with clopidogrel had elevated risks. There was a twofold increase in MACE risk for PCI patients, and a threefold increase in MACE risk among patients with acute coronary syndrome who received PCI, as compared to patients prescribed with prasugrel or ticagrelor instead of clopidogrel. Prasugrel and ticagrelor are not influenced by the loss-of-function variant and can substitute for clopidogrel, but they are much more costly and bring a higher risk of bleeding.

The IGNITE group then leveraged this real-world data to conduct an economic analysis to determine the best drug treatment for these heart disease patients.

A study led by Limdi and colleagues, published in the Pharmacogenomics Journal, examines the cost-effectiveness of genotype-guided antiplatelet therapy for acute coronary syndrome patients with PCI. This cost-effectiveness study is the first to use real-world clinical data; many cost-effectiveness studies use clinical trial data, which tends to exclude the sicker patients normally seen in clinical practice.

The study compared three main strategies: 1) treating all patients with clopidogrel, 2) treating all patients with ticagrelor, or 3) genotyping all patients and using ticagrelor in those with loss-of-function variants.

"We showed that tailoring antiplatelet selection based on genotype is a cost-effective strategy," Limdi said. "Support is now growing to change the clinical guidelines, which currently do not recommend genotyping in all cases. Evidence like this is needed to advance the field of precision medicine."

Costs, QALYs and ICERs

In the analysis, Limdi and colleagues considered differences in event rates for heart attacks and stent thrombosis in patients receiving clopidogrel versus ticagrelor versus genotype-guided therapy, during the one-year period following stenting. They also included medical costs from those events that are borne by the payer, such as admissions, procedures, medications, clinical visits and genetic testing. The analysis considered variations in event rates and medication costs over time to ensure that the results held under different scenarios.

The study uses an economic measure -- the QALY, which stands for the quality-adjusted life year.

"First, we looked at which strategy provided the highest QALY," Limdi said. "The QALY is the gold standard for measuring benefit of an intervention -- in our case, genotype-guided treatment compared to treatment without genotyping. Universal ticagrelor and genotype-guided antiplatelet therapy had higher QALYs than universal clopidogrel -- so those are the best for the patient."

But health care resources are not infinite. So, Limdi and colleagues then evaluated whether those interventions that have higher QALYs were also reasonable from a cost perspective. This analysis considered the willingness to pay. What would a payor or a patient pay for the highest QALY?

"In our case, the payor would recognize that ticagrelor is more expensive than clopidogrel -- $360 per month vs. $10 per month -- and there is a $100 cost for each genetic test," Limdi said. "So, from the payor perspective, the more effective strategy (one with a higher QALY) -- if more expensive (higher cost) -- would have to lower the risks of bad outcomes like heart attacks and strokes for the gains in QALY that are at, or below, the willingness-to-pay threshold."

A calculation called incremental cost-effectiveness ratios, or ICERs, assesses the incremental cost of the benefit (improvement in QALY). In the United States, a treatment is considered cost-effective if its associated ICER is at or below the willingness-to-pay threshold of $100,000 per QALY.

"In our assessment, the two strategies with the highest QALY had very different ICERs," Limdi said. "The genotype-guided strategy was cost-effective at $42,365 per QALY. Universal ticagrelor was not; it had an ICER of $227,044 per QALY."

The researchers also looked at some secondary strategies for a real-world reason. A number of clinicians now prescribe ticagrelor or prasugrel for the first 30 days after PCI, which is considered a period of greater risk, and then switch their patients to the less expensive drug clopidogrel.

The secondary analysis allowed Limdi and colleagues to explore the cost-effectiveness of giving all patients ticagrelor for 30 days, and then switching them to clopidogrel, without genetic testing, versus switching the patients based on genotype. Both strategies were better -- in terms of QALYs -- than a universal switch to clopidogrel at 30 days. However, neither of the two appeared to be cost-effective. Because these secondary strategies used estimated parameters, "the findings should only be considered as hypothesis-generating," Limdi said.

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Precision medicine guides choice of better drug therapy in severe heart disease - Science Codex

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You cant accuse a monitor lizard of being a picky eater.

The carnivorous, fork-tongued reptiles feed on insects, spiders, bird eggs, mollusks, crabs, fish, amphibians and rodents dead or alive. Deer represent a large portion of the diets of the Komodo dragon, the largest monitor lizard species, which is native to eastern Indonesia.

Theyll feed at garbage piles and eat chicken bones. Whatevers available, said Fred Kraus, an evolutionary biologist at the University of Michigan. They probably would take puppies too, if they get them.

Monitor lizards have been found living on the most far-flung islands of Micronesia in the Pacific Ocean. For decades, people assumed humans dropped off these unfussy carnivores, turning them into especially threatening ecological invaders. But a study published Wednesday in Royal Society Open Science refutes this presumption, demonstrating that the monitor lizards of Palau, the Western Caroline Islands and the Mariana Islands are previously undescribed species native to those islands.

The team of scientists argues that the lizards likely rode ocean currents up to 1,500 miles in some cases, from Indonesia northeastward, where they naturally colonized these Pacific islands hundreds of thousands of years ago.

Some of those islands are so remote. Its pretty difficult to explain how they got there, said Valter Weijola, a biologist at Finlands University of Turku and lead author of the study. But his teams research shows they made this ocean crossing without help from humans. And since their disembarkment, theyve evolved into two distinct species.

Researchers examined more than 50 Micronesian monitor lizard specimens from museums around the world. First, they compared physical characteristics, measuring and noting details like body proportions, scale pattern and tongue color.

Then they ran molecular tests on tissue samples. DNA sequencing and analysis revealed two Micronesian species were genetically distinct from other known monitor lizards in the Asia-Pacific region. It also suggested each evolved in geographic and genetic isolation long before any humans arrived in Micronesia.

Used this way, DNA analysis can be a bit like looking at an ecological question through a microscope and a telescope simultaneously.

It takes you back in time and allows you to see things in greater detail, said Julie Lockwood, a Rutgers University ecologist and invasive species biologist who was not involved in the study.

That the islands included in the study have never been in contact with any continental landmass, nor with each other, indicates the lizards must have arrived overseas, perhaps on a raft of vegetation.

Theyre predisposed to being swept out to sea, Dr. Kraus said. They can survive a good while, riding that current.

It is possible that humans, particularly German and Japanese colonialists, introduced monitor lizards to some Micronesian islands during the early 20th century. But the study proves at least some of the islands monitor lizards got there before humans.

Because the lizards have been presumed to be invasive predators, local officials and inhabitants of these Micronesian islands have tried to curb or eradicate these populations.

Poisonous cane toads, for example, were brought to Kayangel Atoll in Palau to reduce monitor lizards predation on livestock. In the early 2010s, bounty programs in Angaur State, Palau, culled hundreds. And on Cocos Island off Guams coast, monitor lizard populations have been controlled to protect an endangered native bird. More plans are underway, according to the paper, to eradicate monitor lizards from Losiep Island in the Caroline Islands.

Whether a species is invasive or not reshapes conversations around conservation, Dr. Lockwood said. In a similar scenario in 2012, genetic testing revealed that red foxes preying on threatened shorebirds in the southeastern United States had arrived through the expansion of a natural Canadian range and not from an overseas translocation, as previously believed.

You may still have a reason to cull a predator population. But you cant use their native or nonnative status as justification, she said. Its possible well uncover more of these.

Researchers hope the revelation that monitor lizard species are natives could shift eradication efforts toward the islands other known invasives, such as brown tree snakes, feral pigs and nonnative deer, cats and rats.

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These Large Carnivorous Lizards Are Right Where They Belong - The New York Times

Recommendation and review posted by Bethany Smith

The Global Predictive Genetic Testing Market research report covers the size (value, production and consumption), splits the breakdown (data status 2015-2019 and forecast to 2027), by manufacturers, region, type and application. All the information in the research report is collected through primary and secondary research. Primary research collected by using various methods such as interviews, surveys and observation of analysts and secondary research grabbed by using well known paid sources, trade journals, and industry databases. The Predictive Genetic Testing Market report also utilizes qualitative and quantitative methods for analyzing data gathering from various industry analysts and market players.

Major Key Players for Global Predictive Genetic Testing Market. The report focuses on global major leading industry players of Predictive Genetic Testing market such as: Key players profiled in the report include: 23,Me Inc., Abbott, Ambry Genetics, BGI, Biocartis Group NV, Bio-Helix Co. Ltd., bioMerieux SA, Blueprint Genetics, Cepheid, Counsyl Inc., deCODE Genetics, GeneDx, Genomic Health Inc., Genomictree Inc., HTG Molecular Diagnostics Inc., Illumina Inc., IntegraGen, Invitae Corporation, LabCorp

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Global Predictive Genetic Testing market report is divided into different segments such as product type Predictive Testing, Consumer Genomics, Wellness Genomics and applications types Breast and Ovarian Cancer, Cardiovascular screening, Diabetic Screening and Monitoring, Colon Cancer, Other, and report covers the various geographical regions such as North America, Asia-Pacific, Europe, Africa, South America, and other regions. Also, various countries included are Canada, U.K., France, the U.S., Russia, China, India, and Germany and so on.

On the basis of the market shares, revenue, and other important factors all the segments are included in the Predictive Genetic Testing market report. And the reports various segments are adding the growth in the global Predictive Genetic Testing market. The report also provides information on the current key trends according to the segment analysis. With the help of all this detailed information existing and new market players getting the exact promising regions of the global Predictive Genetic Testing market. The research report also offers an independent analysis of the segments according to the market opportunity.

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According to the current market situation, Predictive Genetic Testing market manufacturers understand, collect and auspicious convey appraisal on effect of COVID-19 fiasco on numerous companies and their customers to help them in taking fantastic business choices. This research report also analyzes the market status, market share, growth rate, future trends, market drivers, opportunities and challenges, risks and entry barriers, sales channels, distributors and Porters Five Forces Analysis.

Global Predictive Genetic Testing Market Segments and Sub-segments:

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There are 13 Chapters to display the Global Predictive Genetic Testing market:

Chapter 1: Market Overview, Drivers, Restraints and Opportunities, Segmentation overviewChapter 2: Market Competition by ManufacturersChapter 3: Production by RegionsChapter 4: Consumption by RegionsChapter 5: Production, By Types, Revenue and Market share by TypesChapter 6: Consumption, By Applications, Market share (%) and Growth Rate by ApplicationsChapter 7: Complete profiling and analysis of ManufacturersChapter 8: Manufacturing cost analysis, Raw materials analysis, Region-wise manufacturing expensesChapter 9: Industrial Chain, Sourcing Strategy and Downstream BuyersChapter 10: Marketing Strategy Analysis, Distributors/TradersChapter 11: Market Effect Factors AnalysisChapter 12: Market ForecastChapter 13: Predictive Genetic Testing Research Findings and Conclusion, Appendix, methodology and data source.

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Pivotal Findings of the Global Predictive Genetic Testing Market Report:

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Global Predictive Genetic Testing Market Report 2020- Covering Impact of COVID-19, Financial Information, Developments, SWOT Analysis by Global Top...

Recommendation and review posted by Bethany Smith

On May 8, the Food and Drug Administration (FDA) granted accelerated approval of Retevmo (selpercatinib), the first RET inhibitor, for people with non-small-cell lung cancer (NSCLC) and two types of thyroid cancer with specific genetic mutations.

Innovations in gene-specific therapies continue to advance the practice of medicine at a rapid pace and offer options to patients who previously had few, Richard Pazdur, MD, director of the FDAs Oncology Center of Excellence, said in a press release.

Retevmo, from Eli Lilly and companywhich obtained the drug, then known as LOXO-292, when it acquired Loxo Oncology last yearis a selective inhibitor of a receptor tyrosine kinase known as RET. This enzyme plays a role in cell proliferation, and mutations or fusions in the RET gene can drive cancer development. RET alterations are rare overall, occurring in less that 1% of all cancers and 2% of NSCLC, but they are more frequent in certain cancer types.

Drugs that work against cancers with a specific genetic alteration anywhere in the body are known as pancancer, or site-agnostic, therapies. Retevmo, however, was approved for specific cancer types. It is indicated for adults with metastatic RET fusion-positive NSCLC and for adults and adolescents (age 12 and up) with advanced or metastatic RET fusion-positive thyroid cancer or advanced or metastatic RET-mutant medullary thyroid cancer. Medullary thyroid cancer, which involves a specific type of cell, is uncommonaccounting for only 4% of all thyroid cancersbut it frequently has RET mutations.

Retevmo can be used regardless of prior treatment history, both by those who have tried prior systemic medications and those starting treatment for the first time.

The accelerated approval was based on promising findings from the Phase I/II LIBRETTO-001 trial. Study results were previously presented at the 2018 American Society of Clinical Oncology annual meeting,the 2019 World Conference on Lung Cancerand the 2019 European Society for Medical Oncology Congress.

LIBRETTO-001 enrolled people with NSCLC, thyroid cancer and a variety of other solid tumors with RET mutations or fusions. Both previously treated patients and those starting systemic treatment for the first time were eligible. Everyone was treated with Retevmo, taken as a pill twice daily; there was no placebo group.

Retevmo led to an overall response ratemeaning complete or partial tumor shrinkagein 64% of the 105 previously treated people with NSCLC, rising to 85% for the 39 patients new to treatment. The mediation duration of response was 17.5 months for the treatment-experienced group, and was not reached in the newly treated group because a majority were still responding.

When he presented preliminary study findings last year, Alexander Drilon, MD, of Memorial Sloan Kettering Cancer Center in New York City, noted that Retevmo appeared particularly active against cancer that had spread to the brain. Ten of the 11 people with brain metastasis (91%) experienced shrinkage of cancer in the brain, including 18% with complete remission.

In the clinical trial, we observed that the majority of metastatic lung cancer patients experienced clinically meaningful responses when treated with selpercatinib, including responses in difficult-to-treat brain metastases, Drilon said in a Lilly press release. The approval of selpercatinib marks an important milestone in the treatment of NSCLC, makingRET-driven cancers now specifically targetable in the same manner as cancers with activating EGFR and ALK alterations, across all lines of therapy.

Looking at the participants with thyroid cancer, the overall response rate was 69% for the 55 treatment-experienced patients and 73% for the 88 previously untreated people with RET-mutant medullary thyroid tumors. Here, the duration of response was 22.0 months for the previously untreated group and not reached for the treatment-experienced group. In the smaller subset of 19 previously treated and eight newly treated people with RET fusion-positive thyroid cancer, the overall response rates were 79% and 100%, respectively. Response duration was 18.4 months in the former group and not reached in the latter group.

RETalterations account for the majority of medullary thyroid cancers and a meaningful percentage of other thyroid cancers, saidLori Wirth, MD, of Massachusetts General Hospital Cancer Center. For patients living with these cancers, the approval of selpercatinib means they now have a treatment option that selectively and potently inhibitsRET.

Treatment with Retevmo was generally safe and well tolerated, with just 5% of participants stopping treatment because of adverse events. The most common adverse reactions include diarrhea, constipation, dry mouth, fatigue, swelling, rash, high blood pressure, elevated ALT and AST liver enzymes, elevated glucose, cholesterol and creatinine, and various other laboratory test abnormalities.

The product label for Retevmo includes warnings about several potential serious side effects: liver toxicity, severe high blood pressure, bleeding, heart rhythm abnormalities, hypersensitivity reactions and slow wound healing. Retevmo can cause fetal harm if used during pregnancy.

A Lilly spokesperson told FiercePharma that Retevmo would be available from specialty pharmacies within a week at a list price of about $20,600 for a 30-day supply.

Drugs that receive accelerated approval based on response rates in early studies are expected to undergo further testing in larger randomized trials to confirm clinical benefits such as improved survival, and the FDAcan rescind approval if they dont measure up. Two Phase III trials, Libretto-431 for NSCLC (ClinicalTrials.gov number NCT04194944) and Libretto-531 for medullary thyroid cancer (ClinicalTrials.gov number NCT04211337), are currently underway.

Another investigational RET inhibitor, Blueprint Medicines pralsetinib (formerly known as BLU-667) has also demonstrated good activity in an early study, with overall response rates of 60% for NSCLC patients who used prior platinum-based chemotherapy and 71% for previously untreated people.

The availability of RET inhibitors underscores the need for genetic testing to determine which patients have gene mutations or fusions that could make them eligible for these new targeted therapies. Next-generation sequencing of a tumor tissue biopsy sample or liquid biopsy using a blood sample can reveal multiple actionable genetic alterations. However, there is currently no FDA-approved companion test specifically for RET alterations.

Increasingly, through the use of comprehensive biomarker testing, patients with metastatic cancer have an opportunity to receive a treatment tailored to the specific genomic nature of their tumor, Andrea Ferris, president and chief executive officer of LUNGevity, said in the Lilly press release. We urge patients to ask their doctors about broad biomarker tests that includeRETalterations.

Click here for full prescribing information for Retevmo.

Click here to learn more about lung cancer.

Click here to learn more about thyroid cancer.

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FDA Approves RET Inhibitor Retevmo for Lung and Thyroid Cancer - Cancer Health Treatment News

Recommendation and review posted by Bethany Smith

COLLEGE STATION, Texas SeniorsRaenaEldridge and Benjamin Walker of the Texas A&M womens and mens swimming & diving programs have been nominated for the H. Boyd McWhorter Scholar-Athlete Post-Graduate Scholarship.The H. Boyd McWhorter Scholar-Athlete Post-Graduate Scholarship has been presented by the Southeastern Conference since 1986 to the league's top male and female scholar-athletes. The SEC will name the 2020 recipients, chosen by a committee of Faculty Athletics Representatives from the 14 SEC institutions, in late May.Eldridge recently earned her degrees from A&M, majoring in animal science and genetics. The Rockwall, Texas, native has garnered CSCAA Scholar All-America honors every year of her career, while also being named to the SEC Academic Honor Roll each season. For the second straight year, Eldridge was awarded Bill Erwin Scholar-Athlete of the Year honors, recognizing the top male and female student-athletes at Texas A&M who balance athletics and academics while maintaining above a 3.25 GPA, at the recent Building Champions Awards. Eldridge has served as a project leader for the Aggie Research Scholars Program and as a Student Technician of the Genetics Research Lab. Eldridge captained the womens squad as a junior and senior, and earned CSCAA All-America honors twice, while helping her team to three straight SEC Championships.Walker recently earned his degree in accounting from the Mays Business School. He was a two-timeCSCAAScholar All-American and has earned a spot on the SEC Academic Honor Roll in each year of his career. Walker, who hails from The Woodlands, Texas, made A&M history as a junior when he became the program's first individual swimming SEC Champion, winning the 200 Breast. He again claimed gold in the event with a school-record time of 1:51.92, while helping both medley relay teams to podium finishes at the 2020 SEC Championships. The three-timeCSCAAAll-American also holds the Texas A&M all-time school record in the 100 Breast, and was part of the record-holding 200 and 400 medley relay teams, both setting a new program mark at this year's SEC Championships. A team captain in his final season, Walker helped A&M move up the dual meet rankings, rising as high as fourth for the team's highest ranking since the 2001 season.The SEC provides the league's male and female McWhorter Scholar-Athlete of the Year Post-Graduate Scholarship recipients with a $20,000 post-graduate scholarship. The 26 remaining male and female finalists for the award will also receive a $10,000 post-graduate scholarship.

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Eldridge, Walker Named McWhorter Scholar-Athlete of the Year Nominees - KAGSTV.com

Recommendation and review posted by Bethany Smith

- Data to be Presented Underscore Progress in Addressing Unmet Needs Across Multiple Tumor Types -

- Additional Results for Recently FDA-Approved TUKYSA(tucatinib) to be Featured in Oral Presentation -

Seattle Genetics, Inc. (Nasdaq:SGEN) today announced the presentation of new data from its expanding pipeline of marketed and investigational therapies in the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place on May 29-31. Thirteen abstracts including an oral presentation of new data from patients with brain metastases who were part of the pivotal HER2CLIMB trial of TUKYSA (tucatinib) in patients with previously treated HER2-positive metastatic breast cancer will highlight the company’s continued progress in advancing research in cancers that have a significant unmet need.

Over the past six months, we have been able to deliver on our promise of bringing important new medicines to certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer through two U.S. FDA approvals,” said Clay Siegall, Ph.D., Chief Executive Officer at Seattle Genetics. We look forward to sharing data in the ASCO virtual scientific program that reinforce our ability to rapidly advance novel targeted agents across multiple tumor types.”

An Expanding Portfolio of Marketed Therapies

Key data presentations will showcase progress for certain patients with HER2-positive metastatic breast cancer and metastatic urothelial cancer as well as for patients with classical Hodgkin lymphoma (HL). Highlights include:

TUKYSA Update in Patients with Brain Metastases

Results for TUKYSA in combination with trastuzumab and capecitabine in patients with brain metastases from the HER2CLIMB pivotal trial of previously treated patients with HER2-positive metastatic breast cancer will be featured in an oral session (Abstract #1005). Data will be presented from these exploratory analyses on findings from the TUKYSA arm of the study on reduction in the risk of death (OS), reduction in the risk of intracranial progression or death (CNS-PFS) and improvement of the intracranial confirmed objective response rate (ORR-IC) compared to trastuzumab and capecitabine. Data will be presented by Nancy U. Lin, Director of the Metastatic Breast Cancer Program in the Susan F. Smith Center for Women’s Cancers at Dana-Farber in Boston, MA, during an oral presentation available on demand at 8:00 a.m. ET on May 29, 2020. A separate analysis of adverse events (AE) from the same trial will be presented (Abstract #1043; poster presentation).

PADCEV (enfortumab vedotin-ejfv) in Combination and in Other Solid Tumors

Additional results and durability data from the phase 1b EV-103 trial of PADCEV plus pembrolizumab in first-line metastatic urothelial cancer will be presented (Abstract #5044), and a separate Trials-in-Progress poster will provide details about a new randomized cohort added to the EV-103 study, Cohort K, which is evaluating PADCEV as monotherapy or in combination with pembrolizumab (#TPS5092). Both presentations will be featured in the Genitourinary CancerKidney and Bladder session. Data from the Cohort K, along with other data from the EV-103 trial evaluating PADCEV combined with pembrolizumab as first-line therapy for cisplatin-ineligible patients, could potentially support registration under accelerated approval regulations in the United States.

Additionally, information about the phase 2 EV-202 trial, which is studying PADCEV in six different types of locally advanced and metastatic solid tumors (HR-positive/HER2-negative and triple-negative breast cancers, squamous and non-squamous non-small cell lung cancers, head and neck cancer and gastroesophageal cancers), will be discussed in a Trials-in-Progress poster during the Developmental Therapeutics Molecularly Targeted Agents and Tumor Biology Poster Session (Abstracts #TPS3647).

ADCETRIS® (brentuximab vedotin) Continues to Advance

Data to be presented on ADCETRIS will demonstrate the company’s progress in efforts to continue expanding clinical research on combination regimens and monotherapy in a variety of HL and peripheral T-cell lymphoma (PTCL) patient populations, including in both older and younger disease settings. A poster presentation will highlight the potential of ADCETRIS in combination with nivolumab or dacarbazine and as a monotherapy for previously untreated older HL patients who typically have poorer outcomes than younger patients due to comorbidities and toxicities related to standard first-line chemotherapy (Abstract #8032). The primary analysis from an ongoing clinical trial evaluating ADCETRIS plus nivolumab in children, adolescents and young adults with standard-risk relapsed or refractory classical HL will also be presented (Abstract #8013; poster discussion). Lastly, two Trials-in-Progress poster presentations will highlight ongoing clinical trials evaluating ADCETRIS as a monotherapy in frontline older HL or CD30-expressing PTCL patients and in a combination regimen in frontline advanced-stage HL patients (Abstracts #TPS8069 and #TPS8068).

A Strong, Diverse Pipeline of Investigational Therapies

An additional four Trials-in-Progress posters for investigational therapies will showcase the company’s continued clinical development of pipeline candidates in first-line cervical cancer (Abstract #TPS6095), metastatic breast cancer (Abstract #TPS1104), metastatic pancreatic ductal adenocarcinoma (PDAC) (Abstract #TPS4671) and other solid tumors (Abstract #TPS3652).

The abstracts published in advance of the ASCO meeting were made available today on the ASCO website. All data presentations will be available on-demand on May 29, 2020.

Details of Key Seattle Genetics Presentations at ASCO20 Virtual:

Abstract Title

Abstract #

Presentation Type

Presenter

ADCETRIS® (brentuximab vedotin)

Nivolumab and brentuximab vedotin (BV)-based, response‐adapted treatment in children, adolescents, and young adults (CAYA) with standard-risk relapsed/refractory classical Hodgkin lymphoma (R/R cHL): Primary analysis

8013

Poster discussion

P. Cole

Frontline Brentuximab Vedotin as Monotherapy or in Combination for Older Hodgkin Lymphoma Patients

8032

Poster presentation

C. Yasenchak

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: Durability results of enfortumab vedotin plus pembrolizumab for locally advanced or metastatic urothelial carcinoma

5044

Poster presentation

J. Rosenberg

TUKYSA (tucatinib)

Tucatinib vs Placebo Added to Trastuzumab and Capecitabine for Patients with Previously Treated HER2+ Metastatic Breast Cancer with Brain Metastases (HER2CLIMB)

1005

Oral presentation

N. Lin

Management of adverse events in patients with HER2+ metastatic breast cancer treated with tucatinib, trastuzumab, and capecitabine (HER2CLIMB)

1043

Poster presentation

A. Okines

Trials-in-Progress

ADCETRIS® (brentuximab vedotin)

Frontline brentuximab vedotin in Hodgkin lymphoma and CD30-expressing peripheral T-cell lymphoma for older patients and those with comorbidities

TPS8069

Poster presentation

C. Yasenchak

Brentuximab Vedotin in Combination with Nivolumab, Doxorubucin, and Dacarbazine in Newly Diagnosed Patients with Advanced Stage Hodgkin Lymphoma

TPS8068

Poster presentation

J. Friedman

PADCEV (enfortumab vedotin-ejfv)

Study EV-103: New randomized cohort testing enfortumab vedotin as monotherapy or in combination with pembrolizumab for locally advanced or metastatic urothelial carcinoma

TPS5092

Poster presentation

N. Mar

EV-202: A Phase 2 Study of Enfortumab Vedotin in Patients With Select Previously Treated Locally Advanced or Metastatic Solid Tumors

TPS3647

Poster presentation

J. Bruce

Investigational Therapies

Phase 1b/2 trial of tisotumab vedotin (TV) ± bevacizumab (BEV), pembrolizumab (PEM), or carboplatin (CBP) in recurrent or metastatic cervical cancer (innovaTV 205/ENGOT-cx8/GOG-3024)

TPS6095

Poster presentation

I. Vergote

SGNLVA-001: A phase 1 open-label dose escalation and expansion study of SGN-LIV1A administered weekly in breast cancer

TPS1104

Poster presentation

H. Beckwith

SGN228-001: A phase 1 open-label dose escalation and expansion study of SGN-CD228A in select advanced solid tumors

TPS3652

Poster presentation

A. Patnik

Phase 1 study of SEA-CD40, gemcitabine, nab-paclitaxel, and pembrolizumab in patients (pts) with metastatic pancreatic ductal adenocarcinoma (PDAC)

TPS4671

Poster presentation

A. Coveler

About ADCETRIS (brentuximab vedotin)

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. Seattle Genetics and Takeda are jointly developing ADCETRIS.

About PADCEV (enfortumab vedotin-ejfv)

PADCEV is an antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalization and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis). PADCEV is co-developed by Seattle Genetics and Astellas.

About TUKYSA (tucatinib)

TUKYSA is an oral medicine that is a tyrosine kinase inhibitor of the HER2 protein. In vitro (in lab studies), TUKYSA inhibited phosphorylation of HER2 and HER3, resulting in inhibition of downstream MAPK and AKT signaling and cell growth (proliferation), and showed anti-tumor activity in HER2-expressing tumor cells. In vivo (in living organisms), TUKYSA inhibited the growth of HER2-expressing tumors. The combination of TUKYSA and the anti-HER2 antibody trastuzumab showed increased anti-tumor activity in vitro and in vivo compared to either medicine alone.

ADCETRIS (brentuximab vedotin) U.S. Important Safety Information

BOXED WARNING

PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

Administer G-CSF primary prophylaxis beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III/IV cHL or previously untreated PTCL.

Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent doses.

Most Common (20% in any study) Adverse Reactions

Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

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Seattle Genetics Highlights Data from Expanding Oncology Portfolio During Virtual Scientific Program of the 2020 ASCO Annual Meeting - Stockhouse

Recommendation and review posted by Bethany Smith

Since the outbreak of the COVID-19 pandemic a few months ago, doctors and researchers have been wondering about the causes behind the disparate effects of the infection, whose spectrum ranges from the absolute absence of symptoms to extremely serious symptoms such as , for example, acute respiratory distress syndrome, which cause death on more than a few occasions. What explains such variability? Does the answer reside in our genes?

TLR receivers

Coronaviruses have raised such questions for more than 15 years. In a first study of the severe acute respiratory syndrome (SARS) outbreak in 2003, Ralph Baric and colleagues at the University of North Carolina at Chapel Hill found that inactivation of a gene caused by a mutation turned mice into highly sensitive to SARS-CoV, the disease-causing coronavirus. The gene in question, TICAM2, encodes a helper protein that is involved in the activation of a family of receptors, that of the toll-like receptors (TLR). These are involved in the mechanisms of innate immunity, which constitutes the first line of defense against pathogenic microbes.

Now the focus has shifted to SARS-CoV-2, the new coronavirus responsible for COVID-19, but TLRs have garnered interest again, this time following attempts to explain the marked prevalence of sex. male among people with a serious infection.

According to a national epidemiological study carried out in France and published on April 23, up to 73 percent of those admitted by COVID-19 in intensive care units in that country were men. Differences in habits and hormonal nature would partially explain this preponderance, but genes would have something to do with the situation as well. Unlike men, women have two X chromosomes, so they have twice as many copies of the TLR7 gene, an essential detector of viral activity that enhances the immune response capacity.

Blood groups

The genetics of blood groups also seems to provide clues to a persons risk of severe coronavirus infection. In late March, Peng George Wang of the Southern China University of Science and Technology released the results of a study by his team, not yet externally reviewed, comparing the distribution of blood groups in 2,173 COVID-19 patients treated at three hospitals in the cities of Wuhan and Shenzhen with that of other uninfected citizens in those areas. Blood group A would be associated with a higher risk of contracting the virus, in contrast to type O, which would confer more protection for reasons that are still unknown.

The SARS outbreak of the past decade offers lessons. ABO blood groups are based on two types of carbohydrates (or sugars) present on the surface of red blood cells. The first corresponds to type A and the second to type B. Each sugar molecule is synthesized by an enzyme whose gene is present in two forms (one is responsible for type A and the other is responsible for type B). A third encodes an inactive version of the enzyme: type O (from the German ohne, without). The person carrying the two active enzyme variants, A and B, has type AB blood.

Both carbohydrates, A and B, act as antigens, that is, they trigger the production of antibodies that recognize the antigens that the individual lacks, which is why precautions must be taken in blood transfusions. In the ABO system, type O blood is the richest in antibodies, since it contains both anti-A and anti-B antibodies, while type AB blood does not have any.

In 2008 Jacques Le Pendu of the University of Nantes and his collaborators investigated an in vitro model of SARS-CoV. They found that the anti-A antibody neutralizes the binding of the viruss protein S to the ACE2 receptor (angiotensin-converting enzyme), a necessary step for the infection of the cell to be consumed (as soon as to anti-B antibody, data not yet available).

ACE1 versus ACE2

Another protein very close to ACE2 involved in the control of blood pressure is the angiotensin converting enzyme type 1 (ACE1). The ACE1 gene of the latter is polymorphic, that is, there are several variants (or alleles) thereof, of which D is associated with a reduced expression of the related ACE2 gene. As a result, cells carrying the ACE1 D gene have fewer receptors that serve as a gateway for the SARS-CoV virus. The frequency of the ACE1 D variant is not the same in all countries, especially in Europe, which raises the question of whether the geographical distribution of this variant could not be interrelated with the prevalence of COVID-19. Would this reflect the epidemiology of infection on a global scale? The investigations of the team led by Marc De Buyzere, at the University of Ghent, point in that direction.

Using data from 25 countries (from Portugal to Estonia and from Turkey to Finland), Belgian researchers have calculated that 38 percent of the variability in the prevalence of the disease is explained by the frequency of the D allele of ACE1. Furthermore, a similar correlation is observed in mortality statistics. They also highlight that the D allele is rare in the population of two Asian countries that have been severely affected by SARS-CoV-2.

Another genetic component that could explain vulnerability to the new coronavirus is the genes that encode human leukocyte antigens (HLA), a set of proteins that prevent the immune system from attacking the body itself. These proteins constitute the main histocompatibility complex (MHC), which marks all the cells and tissues of their own and differentiates them from everything that is not. Reid Thompson and colleagues at the Oregon Health and Science University in Portland have discovered a link between certain HLA genes and the severity of COVID-19.

People with the HLA-B * 46: 01 variant appear to be especially vulnerable to SARS-CoV-2, as was previously demonstrated with SARS-CoV. In contrast, the HLA-B * 15: 03 variant would confer a certain degree of protection. Determining a persons HLA gene envelope, using quick and inexpensive analysis, would help better predict the severity of the infection and detect those in whom vaccination would be a priority, according to the researchers.

Major projects

To learn more about the genetic variants that influence SARS-CoV-2 infection, a multitude of projects are underway. In one of them, Andrea Ganna, from the University of Helsinki, has launched the COVID-19 Host Genetics Initiative, which aims to unite the efforts of the international community of geneticists working on this issue. For his part, Jean-Laurent Casanova, from the Parisian Necker Pediatric Hospital and Rockefeller University in New York, coordinates a similar project that seeks to discover the genetic variants that favor the most serious forms of COVID-19 in minors. 50 years.

There is no doubt that we are not equal to SARS-CoV-2, but if we discover what causes such differences, perhaps we can alleviate them.

Loc Mangin

Find here all the contents of Research and Science on the COVID-19 pandemic. You can also access articles published by Scientific American and other international editions through this web.

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Recommendation and review posted by Bethany Smith

Global Milk Thistle Health Tonic Market Size, Status and Forecast 2020-2026

This report studies the Milk Thistle Health Tonic market with many aspects of the industry like the market size, market status, market trends and forecast, the report also provides brief information of the competitors and the specific growth opportunities with key market drivers. Find the complete Milk Thistle Health Tonic market analysis segmented by companies, region, type and applications in the report.

New vendors in the market are facing tough competition from established international vendors as they struggle with technological innovations, reliability and quality issues. The report will answer questions about the current market developments and the scope of competition, opportunity cost and more.

The major players covered in Milk Thistle Health Tonic Market: Health Genesis, Pure Encapsulations, Regis, Solgar, Aksuvital, BEC, NC, Life Extension, Swisse, HerbsofGold

The final report will add the analysis of the Impact of Covid-19 in this report Milk Thistle Health Tonic industry.

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Global Milk Thistle Health Tonic Market: Competitive Landscape

This section of the report identifies various key manufacturers of the market. It helps the reader understand the strategies and collaborations that players are focusing on combat competition in the market. The comprehensive report provides a significant microscopic look at the market. The reader can identify the footprints of the manufacturers by knowing about the global revenue of manufacturers, the global price of manufacturers, and production by manufacturers during the forecast period of 2020 to 2026.

This report focuses on the global Milk Thistle Health Tonic status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Milk Thistle Health Tonic development in United States, Europe, China, Japan, Southeast Asia, India, and Central & South America.

The Milk Thistle Health Tonic market is a comprehensive report which offers a meticulous overview of the market share, size, trends, demand, product analysis, application analysis, regional outlook, competitive strategies, forecasts, and strategies impacting the Milk Thistle Health Tonic Industry. The report includes a detailed analysis of the market competitive landscape, with the help of detailed business profiles, SWOT analysis, project feasibility analysis, and several other details about the key companies operating in the market.

Segment by Type

Segment by Application

The study objectives of this report are:

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The Milk Thistle Health Tonic market research report completely covers the vital statistics of the capacity, production, value, cost/profit, supply/demand import/export, further divided by company and country, and by application/type for best possible updated data representation in the figures, tables, pie chart, and graphs. These data representations provide predictive data regarding the future estimations for convincing market growth. The detailed and comprehensive knowledge about our publishers makes us out of the box in case of market analysis.

Key questions answered in this report

Table of Contents

Chapter 1: Global Milk Thistle Health Tonic Market Overview

Chapter 2: Milk Thistle Health Tonic Market Data Analysis

Chapter 3: Milk Thistle Health Tonic Technical Data Analysis

Chapter 4: Milk Thistle Health Tonic Government Policy and News

Chapter 5: Global Milk Thistle Health Tonic Market Manufacturing Process and Cost Structure

Chapter 6: Milk Thistle Health Tonic Productions Supply Sales Demand Market Status and Forecast

Chapter 7: Milk Thistle Health Tonic Key Manufacturers

Chapter 8: Up and Down Stream Industry Analysis

Chapter 9: Marketing Strategy -Milk Thistle Health Tonic Analysis

Chapter 10: Milk Thistle Health Tonic Development Trend Analysis

Chapter 11: Global Milk Thistle Health Tonic Market New Project Investment Feasibility Analysis

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Recommendation and review posted by Bethany Smith

The union representing some 400 workers on the Terra Nova FPSOoil platform is sounding the alarm about a scenario that could see the vessel not produce any oil for the next two years.

"The members are very worried about their future, and the future of Newfoundland (and Labrador)," said Unifor Local 2121 president Dave Mercer.

Companies that supply the offshore are also feeling the pinch from an oil industry that has been thrown into crisis by a global pandemic.

"The impact directly is the loss of some supply ships that we supply. They're tied up or moved on somewhere else. We don't have that business or as much," said Gary Squires, manager at St. John's-based Campbell's Ship Supplies, which providessupplies to supply ships and drill rigs in the offshore.

Campbell's has a workforce of 25, and so far has been able to avoid any layoffs, said Squires.

His comments reflecta moodnow permeating an industry that represents some 30 per cent of the value of the province's gross domestic product, and uncertainty about the future of the Terra Nova FPSO is the latest dark cloud to cast a shadow over the offshore sector.

"Now it's time for the government to step up," said Mercer, whose union represents nearly 800 workers on the Terra Nova and Hibernia oil platform.

Workers on the Hebron and SeaRose FPSO platforms are not unionized.

Suncor, the majority owner and operator of Terra Nova, confirmed this week that it was unable to formalize a Plan B for a life extension overhaulof the aging floating, production, storage and offloading vessel, which has been producing oil on the Grand Banks since 2002.

As a result,the partnership that owns the vessel has decided to remove the Terra Nova from the offshore by this summer,and sail it to port at a location yet to be named, for an unknown duration.

"Obviously we're very concerned about the impacts to industry, the impacts to employment, the impacts to Newfoundlanders and Labradorians of the challenges that the industry is facing," said provincial Natural Resources Minister Siobhan Coady.

Coadyhas been in discussions with the operator, but said there's no indication yet how many jobs will be lost, or when the Terra Nova might return to the offshore and resume production, but she acknowledged it could very well be 2022.

Mercer said the union is also scrambling for information.

"It's all so fluid," he said.

Suncor released a statement Tuesday that said, "No decisions have been made to shut down production operations on Terra Nova until 2022."

But with so much uncertainty caused by the global pandemic, oil markets that are extremely volatile, and the immense planning that goes into a refit like the one proposed for the Terra Nova, insiders predict a lengthy shutdown for the vessel.

The Terra Nova was supposed to be at a dockyard in Spain by now, undergoing a half-billion-dollar life extension refit that would extend the oil field for 10 years, and allow the vessel to produce an additional 80 million barrels of oil.

But with Spain hit hard by the COVID-19 virus, those plans have been scuttled, and when Suncor was unable to come up an with an alternative plan, the decision was made to mothball the vessel.

That means the number of producing fields in the offshore will fall from four to three, and the hundreds of workers whose livelihoods are connected to the Terra Nova are now in doubt.

"There's only so much we can say. It's becoming very difficult to take care of our members," said Mercer.

The Terra Nova hasn't produced oil since it was ordered late last year to suspend operations by the board that regulates the offshore for a safety infraction.

There were hopesthat Suncor could resume production and carry out the refit at a later date, but sources say some partners were unwilling to spend the money required to recertify the Terra Nova, at a time when companies are slashing spending in order to manage through a collapse in the market.

Suncor was engaged in ongoing talks with the Canada-Newfoundland and Labrador Offshore Petroleum Board about a plan to restart production, but a resolution was never reached.

"As of yesterday we were still in very active discussions with Suncor on their recent proposal to resume production and thought those discussions were continuing," the C-NLOPB wrote in a statement to CBC.

"While we sympathize with the workforce affected by yesterday's announcement, we are not privy to the commercial considerations faced by Suncor and its partners."

Meanwhile, calls for the federal government to offer a lifeline to the oil sector continue.

"Wereally need is an investment in accelerating exploration in offshore Newfoundland and Labrador," said Coady.

The province and industry groups want Ottawa to offer tax breaks and other incentives to encourage oil companies to keep looking for new discoveries, similar to those offered in Norway and the United Kingdom.

Federal Natural Resources Minister Seamus O'Regansaid Wednesday he is in talks with the province and those in the industry.

"We are looking for options," said O'Regan, who specifically referenced "incentive-based exploration."

But O'Regan would not put a timeline on when those measures might be announced.

"We want to make sure we get it right," he said

Read more from CBC Newfoundland and Labrador

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As Suncor ponders Terra Nova's future, N.L. offshore workers worry about their own - CBC.ca

Recommendation and review posted by Bethany Smith

The Global Biaxially Oriented Polyethylene Terephthalate (BOPET) Film Market is expected to record a value of US$24.84 billion in 2024, growing at a CAGR of 6.83%, during 2020-2024. The factors such as rising demand for plastic packaging, accelerating manufacturing of electronic products, growth in digital printing, increasing retail sales of food and grocery, expansion of pharmaceutical industry and rapid urbanization are expected to drive the market growth. However, the growth of the market would be challenged by the heavy production cost of BOPET film and high prices of BOPET film. A few notable trends may include rising production capacity of flat panel display, rising growth of cosmetic products, development of biodegradable and water soluble films and rising awareness about the BOPET films.

The global BOPET film market is evolving rapidly over vast rates every year, owing to the continuous increase in its market demand. BOPET film has become a crucial component of every end-use sector due to the presence of versatile qualities. The BOPET striking features such as product quality, shelf life extension, high tensile strength and high durability make it an ideal product for packaging. The enormous application in packaging industry is the major reason for the BOPET film industry growth.

The fastest growing regional market was Asia-Pacific, due to the rapid urbanization, particularly in China and India. Rapid urbanization has led to the continuous changes in peoples lifestyles. Urban people have adopted a modern way of living, which contributed to the increase in BOPET film consumption as a premium product for various household purposes, including packaging. Therefore, Asia-Pacific has witnessed a modest growth in BOPET film market, which is further expected to contribute considerably to the global BOPET film market in coming years.

Scope of the report:

The report provides a comprehensive analysis of the global Biaxially Oriented Polyethylene Terephthalate (BOPET) film market.

The major regional and country markets (Asia-Pacific, Americas, Europe and ROW), along with the country coverage of China, India and North America have been analyzed.

The market dynamics such as growth drivers, market trends and challenges are analyzed in-depth.

The competitive landscape of the market, along with the company profiles of leading players (Toray Industries, Kolon Industries, Polyplex Corporation, Uflex Ltd., Jindal Poly Film Ltd. and Essel Propack) are also presented in detail.

Key Target Audience:

Plastic and Polyester manufacturers

Raw Material suppliers and distributors

End Users (food & beverage, pharmaceutical, E&E, imaging & graphics, etc.)

Investment Banks

Government Bodies & Regulating Authorities

Table of Contents

1. Overview

1.1 Introduction

1.2 Manufacturing Process of BOPET Films

1.3 Advantages of BOPET Film

1.4 Applications of BOPET Film

1.5 Importance of BOPET Film In Packaging

2. Global Market Analysis

2.1 Global BOPET Film Market by Value

2.2 Global BOPET Film Market Forecast by Value

2.3 Global BOPET Film Installed Capacity

2.4 Global BOPET Film Installed Capacity Forecast

2.5 Global BOPET Film Installed Capacity by Regions

2.6 Global BOPET Film Production Volume

2.7 Global BOPET Film Production Volume Forecast

2.8 Global BOPET Film Market Demand

2.9 Global BOPET Film Market Demand Forecast

2.10 Global BOPET Film Market Demand by Regions

3. Regional Market Analysis

3.1 Asia-Pacific

3.1.1 Asia-Pacific BOPET Film Installed Capacity

3.1.2 Asia-Pacific BOPET Film Installed Capacity Forecast

3.1.3 Asia-Pacific BOPET Film Installed Capacity by Regions

3.1.4 China BOPET Film Installed Capacity

3.1.5 China BOPET Film Installed Capacity Forecast

3.1.6 India BOPET Film installed Capacity

3.1.7 India BOPET Film Installed Capacity Forecast

3.1.8 Asia-Pacific BOPET Film Market Demand

3.1.9 Asia-Pacific BOPET Film Market Demand Forecast

3.1.10 Asia-Pacific BOPET Film Market Demand by Regions

3.1.11 China BOPET Film Market Demand

3.1.12 China BOPET Film Market Demand Forecast

3.1.13 India BOPET Film Market Demand

3.1.14 India BOPET Film Market Demand Forecast

3.2 Americas

3.2.1 Americas BOPET Film Installed Capacity

3.2.2 Americas BOPET Film Installed Capacity Forecast

3.2.3 Americas BOPET Film Installed Capacity by Regions

3.2.4 North America BOPET Film Installed Capacity

3.2.5 North America BOPET Film Installed Capacity Forecast

3.2.6 North America BOPET Film Production Volume

3.2.7 North America BOPET Film Production Volume Forecast

3.2.8 Americas BOPET Film Market Demand

3.2.9 Americas BOPET Film Market Demand Forecast

3.2.10 Americas BOPET Film Market Demand by Regions

3.2.11 North America BOPET Film Market Demand

3.2.12 North America BOPET Film Market Demand Forecast

3.2.13 North America BOPET Film Market Demand by Applications

3.2.14 North America Packaging & Metalizing BOPET Film Market Demand

3.2.15 North America Packaging & Metalizing BOPET Film Market Demand Forecast

3.2.16 North America Industrial BOPET Film Market Demand

3.2.17 North America Industrial BOPET Film Market Demand Forecast

3.2.18 North America Electrical & Electronic BOPET Film Market Demand

3.2.19 North America Electrical & Electronic BOPET Film Market Demand Forecast

3.2.20 North America Imaging & Graphics BOPET Film Market Demand

3.2.21 North America Imaging & Graphics BOPET Film Market Demand Forecast

3.3 Europe

3.3.1 Europe BOPET Film Market Demand

3.3.2 Europe BOPET Film Market Demand Forecast

3.4 ROW

3.4.1 ROW BOPET Film Market Demand

3.4.2 ROW BOPET Film Market Demand Forecast

4. Market Dynamics

4.1 Growth Drivers

4.1.1 Rising Demand for Plastic Packaging

4.1.2 Accelerating Manufacturing of Electrical and Electronic Products

4.1.3 Growth in Digital Printing

4.1.4 Increasing Retail Sales of Food and Grocery

4.1.5 Expansion of Pharmaceutical Industry

4.1.6 Rapid Urbanization

4.1.7 Environmental-Friendly

4.2 Key Trends and Developments

4.2.1 Rising Production Capacity of Flat Panel Display

4.2.2 Increasing Growth of Cosmetics Products

4.2.3 Development of Bio-Degradable and Water-Soluble Films

4.2.4 Rising Awareness about BOPET Packaging Films

4.3 Challenges

4.3.1 Heavy Manufacturing Cost of BOPET Films

4.3.2 High Prices of BOPET Films

5. Competitive Landscape

5.1 Global Market

5.1.1 Major BOPET Producers by Installed Capacity

5.1.2 Key Players Revenue Comparison

5.1.3 Key Players Market Capitalization Comparison

5.2 Indian Market

5.2.1 Key Players Business Model Competency Framework

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Global Biaxially Oriented Polyethylene Terephthalate (BOPET) Film Market (By Installed Capacity, Production, Demand and Region) : Insights, Trends and...

Recommendation and review posted by Bethany Smith

13 May 2020 --- Salt reduction remains high on the agenda for food manufacturers and brands tapping into increased demand for healthy products with a clean label. Under pressure following official recommendations from the World Health Organization (WHO) to drive down salt intake in the global population by 30 percent by 2025, food innovators face the ongoing challenges on lessening their reliance on sodium. This must be achieved, of course, without compromising on taste and delivering on health and wellness characteristics demanded by consumers who still expect the enrichment, complexity and premiumization in their savory choices with a low salt label.

Low sodium-based launches have grown considerably over the past five years, notes Innova Market Research, with a 7 percent average annual growth of food & beverage launches tracked with low/reduced sodium claims (Global, 2015-2019). Baby & Toddler foods have the highest percentage of launches with low/reduced sodium claims, citing the importance of salt reduction from an early age while Sauces & Seasonings and Soft Drinks are second and third, respectively. This is followed by Snacks (9 percent), Bakery (7 percent) and Cereals (6 percent).

While salt reducing focused NPD is obviously popular across various categories, taking away some of the standards from a manufacturers toolbox, such as salt, MSG and yeast extract, can create taste challenges.

Food manufacturers are now looking for solutions that allow them to reduce the sodium levels of their products, while also achieving the great taste and texture that consumers expect. It is, however, not only food producers who are increasingly aware of the importance of salt reduction in food public consciousness and awareness of the health impact of excess sodium has risen just as much, Mark Austin, Global Business Development Manager, DSM Food Specialties tellsFoodIngredientsFirst.

A recent DSM survey, which interviewed 5,000 people across 10 countries, found that 65 percent of respondents seek foods that contain less salt, while 71 percent and 66 percent of people questioned also reported looking for products that have lower levels of sugar and fat respectively.

This means that to really meet consumer needs for better-for-you products, producers must take a holistic approach to develop healthier options, considering not just salt reduction, but sugar and fat, too. The clean label movement has seen more consumers seeking products with shorter and more recognizable ingredient lists, with 71 percent of people in DSMs survey checking product labels and 66 percent buying goods made with ingredients they are familiar with, he continues.

When it comes to salt reduction, this means that producers must continue to look towards creating clean label solutions with reduced sodium content that appeal to consumers, Austin adds.

DSMs portfolio of yeast extract solutions for salt reduction can support food manufacturers in delivering healthy, tasty and appealing products. Yeast extracts are widely known for their rich savory taste profile, which can help producers create an authentic taste in low-sodium products. Part of DSMs sodium reduction toolbox, the Maxarome portfolio including Maxarome Select is ideally suited for a broad range of savory applications and can reduce salt levels in food, without compromising on taste or texture.

Suitable for both plant-based and meat dishes, these solutions have the ability to enhance the salty perception of goods, while delivering on umami, meaty or vegetable flavors, and masking off-notes and bitterness, notes Austin.

Processed food remains the leading contributor to salt intake in peoples diets. In industrial countries, approximately 75-80 percent of dietary salt is obtained through processed food, while 5-10 percent occurs naturally and the remaining 10-15 percent stems from salt that is added during cooking or at the table, continues Austin.

With the pressure from public health associations to reduce sodium intake continuing to grow, however, the need for manufacturers to adapt to ensure their product offering meets these demands is increasingly important, he says.

Click to Enlarge

Salt in the plant-based spaceSalt levels in plant-based products have recently come under scrutiny by UK organization, Action on Salt (AoS). It has recently published studies linking cutting salt helps support lower blood pressure which, it says, provide strong evidence for salt reduction as a major public health strategy for the UK which currently has voluntary salt reduction targets.

In the plant-based space specifically, AoS calls on the government to get tough on the eating out sector which lags far behind the food sold in retailers. This follows AoSs recent survey findings that show many healthy sounding plant-based and vegan meals served at UK restaurants, fast food and coffee chains, contain more salt than eight McDonalds hamburgers. Nearly half (45 percent) of meals eaten out of the home contain 3 g or more salt in just a single meal thats half the maximum daily limit for an adult. Additionally, over one in five dishes provide more than half an adults maximum daily recommendation for saturated fat.

Recognizing the demand for reduced salt in plant-based formulations, Roquette recently expanded its plant-based protein ingredient range that taps into the salt reduction trend. NUTRALYS L85M is a new specialty ingredient that further expands the existing range of NUTRALYS pea protein from Roquette. Beyond new tastes and new textures, Roquette will now offer its customers the ability to create plant-based meats with less salt to meet consumers demands and expectations when managing their daily sodium intake.

For Laura Queiroz Simon, Biorigin Global Product Manager, sodium reduction is no longer a trend, it is a confirmation of conscious consumption. She flags several categories that tap into convenience trends such as snacks and ready meals, as having a lot of opportunities to reduce the sodium content and to be more pressured by consumers and regulatory bodies.

Plant-based recipes tend to have a neutral taste profile and to compensate by giving more savory to these recipes the food companies are using salt. We know that consumers are aware and are pressuring the plant-based food industries to reformulate their recipes to reduce the salt and use clean label ingredients, she tells FoodIngredientsFirst.

The consumption is pushed by health concerns and consumers know that there is no point in consuming less meat in favor of plant alternatives if these recipes have a long list of ingredients with artificial additives and colors. Its well known that consumers avoid buying products with ingredients that are difficult to understand and are focusing on looking for products that contain ingredients perceived as natural, she says.

Meanwhile, Biorigin brings ingredients that help to reduce up to 50 percent sodium. Naturally rich in amino acids and nucleotides, there is a line of specific ingredients to promote the umami flavor the fifth basic flavor that brings a subtle and market sensation, increasing salivation and it is often perceived as a combination of sweet and salty flavors, allowing to compensate the salty taste loss and provide the overall recipe taste balance.

Bioenhance SFE 201 is designed to deliver a clean savory and umami notes, working in synergy with the recipe and compensating the sodium reduction. It is also able to mask off flavors when using different salts than Sodium Chloride (NaCl).

Biorigin offers a range of yeast extracts from standard savory to umami and roasted profiles to fulfill several applications and sodium reduction challenges and natural flavors that improve the salt perception with no sodium addition, maintaining the recipe taste profile, the company flags.

No need to compromiseFor Eelco Heintz, Product & Innovation Manager atNiacet, increasing consumer awareness of the harmful effects of excessive sodium consumption on health is driving demand for sodium reducing ingredients. At the same time, several countries have introduced legislation trying to tackle the issue. As a result, consumers are making a conscious effort to reduce sodium consumption and proactively checking sodium content on labels, he tells FoodIngredientsFirst.

As alternatives to the commonly used sodium-based preservatives gain ground, antimicrobials have an important role to play. There is no need to compromise between food safety and a healthy sodium content, he notes.

Next to sodium reduction there is an increased demand for shelf life extension and improved safety in a variety of food types, adds Heintz. Sodium-based preservatives are common, but there are preservation ingredients available that do not contain any sodium. Provian K, made with potassium salts, is one such example of a preservative that is proven to keep food safe and extend shelf life while reducing salt. Similarly, clean label solutions, such as Provian NDV, are made from naturally fermented vinegar and also contain no sodium, he explains.

Provian products are powdered organic acid-based preservatives, which makes it possible to simultaneously address both trends of salt reduction and increased shelf life.Originally, we focused on processed meat and poultry products, but this quickly expanded to other processed foods like fish, salads, spreads and a variety of ready-to-eat (RTE) products, Heintz notes.

Processed foods often contain a lot of salt, partly due to the high quantities of sodium-based preservatives used in them. However, by using high quality preservatives, manufacturers can create healthier products with lower levels of sodium. Preservatives such as Provian are highly effective at lower dosages, which will increase safety and extend shelf-life while reducing the amount of sodium in the final product, he says.

Not everyone is aware of the consequences of high salt intake. There are often cases of the public media warning against high salt intake, usually related to kidney or cardiovascular disease. Additionally, there is a clear trend visible of healthy and conscious living in the wider population. However, more can still be done, and it is obvious that awareness of sodium intake and a healthy sodium/potassium balance needs to be part of this trend, Heintz says.

Another category where salt reduction is an emerging trend is bakery. Baked goods substantially contribute to the daily sodium intake and a reduction is necessary to reach the goals set by governments and WHO. The industry has seen a voluntary reduction of sodium chloride content, but more still needs to be done. ProBake, from Niacet, offers world-leading standards in mold control with preservative options that contain no sodium, he adds.

Whats next?Rising demand for healthier, low-sodium food with a great taste and texture will continue to fuel product innovation and reformulation. Broader health trends will continue to drive thegrowing consumer trend for low-sodium clean label ingredients in their food. Consumers like the idea of products with easily identifiable ingredients, which can be difficult with preservatives as they often need to be labeled with a chemical name. However, preservatives made from natural ingredients can be used in products with natural claims and clean label ingredients. Niacets Provian NDV, for instance, is an effective clean label preservative, made from naturally fermented vinegar.

Manufacturers are searching for effective nutritional solutions for salt reduction that help them meet the trend for better-for-you food and stay ahead of the curve. Meanwhile, the continuing boom for plant-based products, innovation and R&D, will drive the need for more salt reducing solutions globally while more regulation is expected to be introduced around the world, forcing formulators who havent already done so to act.

By Gaynor Selby

To contact our editorial team please email us at editorial@cnsmedia.com

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Salt reduction: Preservation without sodium and delivering on taste - FoodIngredientsFirst

Recommendation and review posted by Bethany Smith

Thanks to hours spent working from your couch, back-to-back Zoom happy hours or just staying idle while binging a new TV show, you may find yourself moving your body less than ever during the coronavirus pandemic. Since youre not exactly overexerting yourself these days, what gives?

The short answer is this: While you may be doing less physical activity, your brain has kicked into overdrive. In other words, the exhaustion you feel is not all in your head (or technically, in this case, it actually is.)

Although you may not be commuting to work, taking your weekly spin classes or spending weekends running errands, our drastically new coronavirus lifestyles can have a bigger impact on mental health and energy levels than we might think.

Ive probably been the most unproductive Ive ever been, said Madonna Matta, a 24-year-old graduate student from Austin, Texas. Im just tired all the time. I dont know if it may be the food Im eating more carbs, less veggies or the lack of structure, but I just feel melancholy.

Generally, exercising would make me feel more energetic and lively and now the opposite has made me sluggish, Matta continued. Sometimes, it feels easier to just sleep and pretend everything were living through is fake.

For Cathrine Nelson, a 27-year-old content creator in Providence, Rhode Island, the way she feels depends on the day.

I woke up at 8 a.m. the other day and had a full day, Nelson said. Another day, I slept in until 11 a.m., listened to some podcasts and went to bed early. Ive had productive days and almost completely inactive days. I feel like I am on a slow-motion roller coaster. I dont know when I am going to hit my next peak or my next drop.

bernardbodo via Getty Images

Why stress leads to so much fatigue

While certain stressors can be helpful for focusing and problem-solving like when you need to make a deadline or when youre driving and someone swerves in front of you they are meant to be temporary. The long-term stress we may feel as a result of COVID-19 and the constant flow of news about it is not to be underestimated, and it can exact wear and tear on the body.

People face challenges that really activate the sympathetic nervous system, so its kind of classic fight or flight response, said Craig N. Sawchuk, a psychologist at the Mayo Clinic. You get the hormone release to help keep us going like adrenaline and cortisol those are good. Its really adaptive that our body can flip that switch. But its not meant to be a constant burn, either. And thats where we run into these physical problems.

According to Sawchuk, when your brain is constantly trying to adapt to uncertainty, fear and challenges like it has during this entire pandemic it takes a toll over time. Your body physically gets tired from managing all the emotional stress.

And thats where you start to see some of the energy problems starting to happen where were fatigued, Sawchuk said. We may be actually resting a lot more, sometimes unintentionally so, but its not a restorative type of rest.

Energy expenditure extends beyond just physical activity. We burn up energy processing emotion, regulating our feelings, thinking, worrying and adapting to new challenges.

We think of physical, emotional and mental energy all drawing from that same pot, so we can think of multiple systems in our lives are constantly on and in turn, are constantly draining and wearing away at us, Sawchuk said.

Granger Wootz via Getty Images

How to boost your energy, even just a little

There are ways you can boost your energy at home and control stress levels. Johna Hansen, a licensed clinical social worker in New York City, recommended trying these steps:

Its uncertain how long COVID-19 will keep us in this state of lowered physical activity and heightened stress, but Sawchuk said resilience is key as we navigate the pandemic and the aftermath.

All of us as humans are resilient we really, really are, Sawchuk said. Resilience has this almost rubberized quality to it like bouncing back. But we will bounce back. It may not necessarily be to where we were at pre-COVID-19 because experience changes us; it changes the brain.

To Sawchuk, part of building resilience is learning to accept and adapt, which looks different for everyone. In other words, no one should be beating themselves up because they failed to make a sourdough starter or join an online yoga class that day.

We have to watch out when were making unfair comparisons to people that we think are just doing great, Sawchuk said. Our goal isnt to be perfect. Our goal is to be good enough. Being good enough is being kind to ourselves. There may objectively look like theres more time available, but thats not necessarily a good thing nor does it mean that were going to be more motivated or efficient. Its about adaptation.

A HuffPost Guide To Coronavirus

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