Amy Sapien had prepared for her April 13 surgery as best she could. She dyed her long blond hair a bright pink. She got a tattoo on her right calf of what she jokingly calls her spirit animal Dory, the blue fish from Finding Nemo, whose answer to lifes challenges is to say, over and over, Just keep swimming. Still, she was overwhelmed by dread early that morning as she kissed her husband, Callen, goodbye outside the Moffitt Cancer Center in Tampa, Fla., and walked alone through the bright, empty lobby. Her hands shook as she stepped onto the elevator and pressed the button with her elbow.

Her mind was a jumble. Everyone seemed so eerily expressionless from behind their paper masks that Sapien wondered for a moment whether shed walked onto the set of an alien abduction movie. She had been imagining for weeks what it would be like to leave the hospital without her left breast. Now her mind turned to an even more urgent fear: What if she became infected with the coronavirus during her short stay?

Sapien tried to replace her anxious thoughts with fighting ones. The 40-year-old hospital social worker made Tom Pettys lyrics her mantra: You can stand me up at the gates of hell, she sang to herself as she felt her consciousness give way in the operating room. But I wont back down.

When she came to three hours later, she pushed aside her worries about the treatment and procedures she still faced, nibbled on Saltines, and sipped ginger ale to stave off the nausea she felt from anesthesia. Then she reached for her phone, and recorded separate video messages for her two young boys.

Her blue eyes glazed thick from painkillers, she addressed her 3-year-old son, Corben. Smiling reassuringly, she told him to continue his toilet training with his grandmother, and that shed be home soon. Then she spoke to 7-year-old Landen. Hey. Im OK. Im out of surgery, she said in a near-whisper. With her bandage peeking from her pink surgical robe, she told him that shed be home the next day, and that they would soon be able to watch movies together from the bedroom recliner. I love you, I dont want you to worry about me, Landen, she said. OK? Im doing really good. Bye, honey.

Then she tapped send. Landen watched the video from his own hospital room across town, where he was being treated for leukemia.

Amy and Landen, two generations fighting cancer, are united by something else: They are going through the most frightening and painful moments of their lives without the family warmth and support that was standard practice at the nations medical centers until Covid-19. The pandemics broad impact on cancer care in the U.S. is well-known: non-essential surgeries, biopsies, and scans delayed, and clinical trials disrupted. But its in stories like the Sapien familys that one sees the depth of the harm its causing.

Amy was able to schedule the mastectomy right away only because her cancer was spreading, but she couldnt have her second breast removed at the same time since it was deemed elective. Instead shell have to undergo general anesthesia, surgery, and painful rehab again. While her husband was allowed in the waiting room during her first worrisome mammogram and ultrasound in early March, Amy had to go alone for her biopsy and the MRI that confirmed the diagnosis. Then she went by herself to her surgery, and recovered in isolation.

I didnt see anyone I knew for 36 hours after having a part of my body amputated, she said. Worse, though, was her inability to be with Landen as he lay tethered to a machine delivering a platelet transfusion.

While both parents, and sometimes his grandparents, had been able to reassure him through previous chemotherapy treatments, this time only his father could be present.

Theirs is an experience shared by cancer patients across the country, as Covid-19 separates them from loved ones and family at their time of greatest need.

In the exact moment where we could have reached out for everything our support system could offer, Amy said, we were forced to retract completely into ourselves.

It was last June, a few weeks before Landens seventh birthday, that his grandmother Sandra Sapien noticed a swollen gland on his slender neck. The family had just moved from a nearby town and had not yet met their new doctors, so Amy took Landen to a walk-in clinic to rule out strep. The test was negative, but the doctor suggested following up with a pediatrician and asked if there was a family history of leukemia. No, Amy said, alarmed. None at all.

Days later, at an appointment with Landens new pediatrician, Amy mentioned what the urgent-care doctor had said and asked if he could run some blood tests. Its never cancer, he told her. He diagnosed Landen with tonsillitis, and prescribed antibiotics. Landen seemed fine at his birthday party, and wolfed down pizza and the massive chocolate Minecraft cake his grandmother had made.

The morning of June 29, the family drove to a pet store to pick out a fish for Corben. As he deliberated among the bright blue and red beta fish, Landen turned gray and collapsed. Thinking that hed had a bad reaction to the antibiotics, Callen rushed him to the hospital.

In just a few hours, the couple went from worrying about whether rain would spoil that evenings fireworks to confronting every parents nightmare. After doctors ran a battery of tests, the Sapiens learned that their son was one of 350 to 525 U.S. children diagnosed with a rare form of leukemia each year. Overall, 3,500, or 4.7 out of 100,000, are diagnosed annually with childhood blood cancers.

Leukemia? Amy recalls asking, incredulous. My brain wasnt even linking up what the word was.

As a young woman, Amy had struggled with anxiety, but finally everything had fallen into place. She and Callen, 36, a strategist at a business software company, had solid, steady careers. Together since their first meeting at a college-town coffee shop 17 years ago, they had just purchased their dream home. Id finally convinced myself there were no monsters under my bed, she said.

Now the doctors were hospitalizing their son, and had begun a 3 1/2 year regimen of in- and outpatient chemotherapy treatments that during some stretches required daily infusions.

Callens mother and stepfather, colleagues, and friends rushed to help, providing lunches, dinners, even breakfasts, so the family could focus on Landen and managing his hospital schedule. Amys co-workers donated sick leave.

The couple tried to make life as normal as possible for Corben; both continued working, and resolved never to show their fear to their son. Nobody ever got a trophy for crying on the floor for three years, Amy said.

Early this winter, news of the pandemic began to percolate. Because Landens treatments impaired his immune system, he was at risk for opportunistic infections. The family had initiated a series of precautions: limiting visitors; carrying hand sanitizer; washing every item that came into their house. We were acting as if Covid existed before Covid existed, Callen said. We were already being hypervigilant.

One evening in mid-February, the whole family was gathered on the couples bed watching Ninjago. Amy was leaning against Callens arm, which had fallen asleep. When she wriggled away to release it, her left breast grazed his hand. In that split-second touch, he felt something unusual and hard. Whats that? he asked. Amy padded her breast with her fingertips, immediately detecting a small mass.

Her mother had had breast cancer, and her grandmother had died of the disease. But they had drank and smoked, lifestyle behaviors that increased their risk. Amy had had a baseline mammogram at 33, and had tested negative for the BRCA genes that dramatically increase the risk of breast cancer. I thought I had an insurance policy against having to go through this, she said.

When she turned 40 in October, her doctor had recommended that she get a second mammogram. But she had told herself she would schedule it until after Landen had completed his first year of treatment.

Now she feared the worst. Landens diagnosis had been improbable. Could the universe betray them twice? Im scared, she told Callen.

Landen, hypersensitive to any health news, looked up. Why?

Amy reigned herself in. I couldnt cry in front of him after watching him be poked and prodded hundreds of times and never complaining. Its not fair to expect a 7-year-old to do what I cant.

I couldnt cry in front of him after watching him be poked and prodded hundreds of times and never complaining.

She was sitting at her work desk when a nurse practitioner called her cellphone with the biopsy results: She had invasive lobular cancer. Amy tried to write down the diagnosis on the back of an envelope. The words went into my ears, but they just werent registering, she recalled. How do you spell that? she kept asking. She hung up and burst into tears. Its not fair, she said to her office mate, who was trying to console her. Were good people. It was supposed to be benign.

In those early weeks of the coronavirus, hospitals were just putting in place social distancing rules to protect patients from infection. Family members were prohibited or sharply limited from joining cancer patients as they go from diagnosis to surgery, from chemotherapy to recovery.

Suddenly, the Sapiens could no longer turn to their community for help either. Their kitchen, in disrepair after a massive leak, had only a working hot plate, but they couldnt accept meals. Amy, who has a well of close friends, couldnt see them on weekend lunch dates.

Cancer remains the second-leading cause of death in the U.S., and 1.8 million people are diagnosed annually. Many end up with plans of treatment that last for months, if not years, that require regular surveillance and lifesaving but immune-suppressing drugs.

In her job, Amy has worked with a series of vulnerable populations, from the homeless to veterans to the elderly. As she lurched alone from procedure to procedure at Moffitt, she of course understood that barring patients partners reduced the chance of infections by half. But she also knew that family members play an important role in making decisions about treatment. Its so hard to absorb what youre hearing when youre the patient, she said. That second pair of ears is so important in cancer treatment.

Meanwhile, St. Josephs Childrens Hospital, where Landen was being treated, issued similar restrictions. In the past, we allowed parents, grandparents, even siblings to accompany patients during treatment, said Don Eslin, Landens pediatric hematology oncologist. Now they can only have one parent.

As recently as February, he said, it was common for families whose children were being treated for blood cancers to share stories and encouragement in cafeterias and the waiting room.

Now that support is reduced to a wave from behind a mask down the hallway, Eslin said.

Doctors, too, saw their routines upended in unsettling ways. Eslin must sometimes deliver bad news by phone, something he has always striven to avoid. This is adding complexities to cancer care in a way we never imagined, he said.

Catherine Lee, Amys surgeon, feels most the loss of connection with patients. Since the third week of March, she has only been able to make eye contact with her patients at one of the most terrifying moments of their lives.

A breast cancer diagnosis is so intimate, Lee said. We always want our patients to feel that we are giving as much as we can to them in terms of support and compassion, and to reassure them that were doing as much as we can for them.

From behind her mask, she can only offer supportive words. They cant see my smile. I cant shake their hands, and I certainly cant give them a hug, she said.

In their brief meeting, Lee and Amy discussed Landens situation, and how Amy needed to be back on her feet as soon as possible.

As Lee reflected on the case during a FaceTime call, she paused for a moment: You know something? I dont even know what Amy Sapien looks like.

For the past seven weeks, she said, about the only thing I see of my patients is their breasts.

Amy is recuperating, working from home to help veterans navigate the Covid-19 crisis. She is never far from her sons, and tells them every day how lucky she feels to be their mother. Landen is now in maintenance therapy, and his doctors have replaced his grueling chemo infusions with an oral drug. Some days, his second grade teacher drops by, and they shout to each other through a closed window.

Earlier this month, she got the news that she wont need chemotherapy, but will be on hormone suppression treatments for at least the next decade, and will go into rapid menopause. It is highly likely that she will need a hysterectomy.

Still, she tries to focus on what she can control. She oversees Landens home schooling, which he does by Zoom with his teacher. She watches the boys as they make up imaginary games with their Duplos, and swim in the backyard pool when Landen is well enough. The family just got a new puppy, a brown Bernedoodle named River. The Sapiens had promised a party and a puppy as a way to mark the end of Landens infusions, and what they hoped would be the resumption of a more ordinary life. The puppy adds chaos but also normalcy.

Although Amy and Callen have tried to shield the children from the news, the pandemic is nonetheless a constant backdrop. Sometimes Landen wonders aloud about whether the virus could kill him or everyone in the family. And he worries about his mother, telling her recently that he hoped she wouldnt have to get an infusion port like his. Amy tries to reassure him.

I tell Landen being brave isnt not being scared, she said. Its being scared and doing it anyway.

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Covid-19 isolates patients from loved ones at time of greatest need - STAT

Recommendation and review posted by Bethany Smith

The Blood Testing Market report includes overview, which interprets value chain structure, industrial environment, regional analysis, applications, market size, and forecast. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. The report provides an overall analysis of the market based on types, applications, regions, and for the forecast period from 2020 to 2026. It also offers investment opportunities and probable threats in the market based on an intelligent analysis.

This report focuses on the Global Blood Testing Market trends, future forecasts, growth opportunities, key end-user industries, and market players. The objectives of the study are to present the key developments of the market across the globe.

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Key List Market Participants in the Market:Abbott LaboratoriesBio-Rad LaboratoriesF. Hoffmann La RocheSiemens Healthineers

By Types:GlucoseLipidBUNA1CCRPVitamin DALTASTThyroid Stimulating Hormone

By Applications:HospitalsClinic and Diagnostic CentersOthers

Scope of the Blood Testing Market Report:

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By Regions:North America (The USA, Canada, and Mexico)Europe (Germany, France, the UK, and Rest of Europe)Asia Pacific (China, Japan, India, and Rest of Asia Pacific)Latin America (Brazil and Rest of Latin America.)Middle East &Africa (Saudi Arabia, the UAE, South Africa, and Rest of Middle East & Africa).

Report Answers Following Questions:

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Blood Testing Market Historic Data (2015-2019):

Blood Testing Market Forecast (2020-2026):

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Blood Testing Market 2020 Industry Size, Trends, Global Growth, Insights And Forecast Research Report... - Azizsalon News

Recommendation and review posted by Bethany Smith

Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Endometriosis TherapiesMarket which would mention How the Covid-19 is Affecting the Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Key Regions and Proposal for Endometriosis Therapies Market Players to battle Covid-19 Impact.

The Endometriosis TherapiesMarket report is one of the most comprehensive and important data about business strategies, qualitative and quantitative analysis of Global Market. It offers detailed research and analysis of key aspects of the Endometriosis Therapies market. The market analysts authoring this report have provided in-depth information on leading growth drivers, restraints, challenges, trends, and opportunities to offer a complete analysis of the Endometriosis Therapies market.

Top Leading players covered in the Endometriosis Therapies market report: AbbVie, EliLilly, AstraZeneca, Bayer, AstellasPharma, MeditrinaPharmaceuticals, Pfizer, NeurocrineBiosciences, TakedaPharmaceutical and More

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The report offers clear guidelines for players to cement a position of strength in the global Endometriosis Therapies market. It prepares them to face future challenges and take advantage of lucrative opportunities by providing a broad analysis of market conditions. the global Endometriosis Therapies market will showcase a steadyCAGR in the forecast year 2020 to 2026.

Market Segment by Type covers:HormonalContraceptivesGonadotropin-releasingHormone(Gn-RH)AgonistsProgestinTherapyAromataseInhibitors

Market Segment by Application covers:HospitalClinicOther

Our Complimentary Sample Endometriosis Therapies market Report Accommodate a Brief Introduction of the research report, TOC, List of Tables and Figures, Competitive Landscape and Geographic Segmentation, Innovation and Future Developments Based on Research Methodology.

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Regions Covered in the Global Endometriosis Therapies Market: 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)

Years Considered to Estimate the Endometriosis Therapies Market Size:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year: 2020-2026

Highlights of the Report: Accurate market size and CAGR forecasts for the period 2019-2026 Identification and in-depth assessment of growth opportunities in key segments and regions Detailed company profiling of top players of the global Endometriosis Therapies market Exhaustive research on innovation and other trends of the global Endometriosis Therapies market Reliable industry value chain and supply chain analysis Comprehensive analysis of important growth drivers, restraints, challenges, and growth prospects

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Endometriosis Therapies Market Global Industry Outlook, Share, Growth Analysis, Trends and top manufacture like AbbVie, Eli Lilly, AstraZeneca,...

Recommendation and review posted by Bethany Smith

Doctors warn that taking high doses of Vitamin D has little or no effect on COVID-19, and they urge against taking more of the supplement than is recommended since it can have adverse health effects.

This update comes in the wake of people pounding down the D supplementsas a prophylactic measure, after learning that many patients with the worst symptoms and outcomesafter being diagnosed with COVID-19, have also been vitamin D deficient.

Countries, where COVID-19 cases have resulted in the highest death rates, are also those where more of the population has D deficiencies. Researchers across the globe have found thatthe sickest patients often have the lowest levels of vitamin D.These facts have led individuals who are not sick to start taking large doses of vitamin D.

There is a connection between vitamin D and respiratory illness, but that does not mean that overdosing is a healthy move. Expertsdo say that healthy blood levels ofvitamin Dmay give some protection against the worst symptoms if you do contractCOVID-19. One possible advantageis that vitamin D can help preventthe body from experiencing the so-called "cytokine storm," when the body'simmune systemoverreacts and attacks itsown cells and tissues, much like a histamine response to an allergen. But too much D is not beneficial.

In anew warning by doctors in the UK, researchers at Birmingham Universityare warning people to not overdose themselves with D to gain any potential benefits or edge against the virus. According to The Independent,a steady stream of patients are showing up at hospitalsin theUKhaving takentoxicdoses ofvitamin Dinsupplementsthey bought online. The pills that are poisoning them contain up to 2,250 times the recommended daily dose of D (which is 600 IU according to the Mayo Clinic) and this toxic level of D is putting patients at risk ofheartandkidneyproblems, according to theNHSlab, which said it sees two to three overdose cases every week.

Scientists from the UK, Europe and the US, including experts from the University of Birmingham, have published aconsensus paper warning against taking high doses of vitamin D supplementation.

According to the study,new research shows high levels of vitamin D provides little or no benefit in preventing or treating Covid-19. The study'sauthors advise that the population adhere to Public Health England guidance on supplementation.

Following unverified reports that high doses of vitamin D (higher than 4000IU/d) could reduce the risk of contracting COVID-19 and be used to successfully treat the virus, the new report published in the journal BMJ, Nutrition, Prevention and Health, investigated the current scientific evidence base on the vitamin and its use in treating infections.

Vitamin D is a hormone produced in the skin during exposure to sunlight and helps regulate the amount of calcium and phosphate in the body, which are needed to keep bones, teeth and muscles healthy.

Most of our vitamin D comes from exposure to sunlight, however for many people, particularly those who are self-isolating with limited access to sunlight during the current pandemic, getting enough vitamin D may be a real challenge. Supplementing with vitamin D ... should be done under the current UK guidance," saidProfessor Carolyn Greig, a co-author of the paper, also from the University of Birmingham.

Professor Judy Buttriss, Director General British Nutrition Foundation and a co-author of theresearch said: In line with the latest... guidance on vitamin D, we recommend that people consider taking a vitamin D supplement of 10 micrograms a day during the winter months (from October to March), and all year round if their time outside is limited.

Although there is some evidence that low vitamin D is associated with acute respiratory tract infections, there is currently insufficient evidence for vitamin D as a treatment for COVID-19 and over-supplementing must be avoided as it could be harmful.

Examining previous studies in this field, the scientists found no evidence of a link between high dose supplementation of vitamin D in helping to prevent or successfully treat Covid-19 and cautioned against over-supplementation of the vitamin, without medical supervision, due to health risks. Scientists concluded that assertions about the benefit of the vitamin in treating the virus are not currently supported by adequate human studies and are based on findings from studies that did not specifically examine this area.

Claims of a link between vitamin D levels and respiratory tract infections were also examined by scientists. Previous studies in this area have found that lower vitamin D status is associated with acute respiratory tract infections however limitations of the findings of these studies were identified. Findings from the majority of studies were based on data gathered from population groups in developing countries and cannot be extrapolated to populations from more developed countries due to external factors. Scientists believe that there is currently no firm link between vitamin D intake and resistance to respiratory tract infections.

Vitamin D toxicity, also called hypervitaminosis D, is a rare but potentially serious condition that occurs when you have excessive amounts of vitamin D in your body.

Vitamin D toxicity is usually caused by taking supplements not diet or sun exposure. Your body regulates the amount of vitamin D produced by sun exposure, and even fortified foods don't containenough vitamin D to worry about.

Too much D can lead to a buildup of calcium in your blood (hypercalcemia), which can cause nausea and vomiting, weakness, and frequent urination. Vitamin D toxicity can also leadto bone pain and kidney stones.

Treatment includes stopping vitamin D intake and restricting your calcium intake. Your doctor might also prescribe intravenous fluids and corticosteroids or bisphosphonates.

Doctors warn against taking anything more thanthe U.S. Recommended Dietary Allowance of 600IUof vitamin D per day.

An adequate level of vitamin D in the body is crucial to our overall health, too little can lead to rickets or the development of osteoporosis but too much can lead to an increase in calcium levels in the blood which could be particularly harmful,Professor Sue Lanham-New, Head of the Department of Nutritional Sciences at the University of Surrey and lead author of the study, said.

Levels of the vitamin in the body can also be supplemented through a nutritionally balanced diet including foods that provide the vitamin, such as fortified foods such as breakfast cereals, and safe sunlight exposure to boost vitamin D status.

Most. people can get enough vitamin D with about ten to 15 minutes of direct sunlight a day.

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Doctors: Taking High Doses of Vitamin D Has No Effect on COVID-19 - The Beet

Recommendation and review posted by Bethany Smith

arcognizance.com has added latest research report on Global Osteoporosis Treatment Market, this report helps to analyze top manufacturers, regions, revenue, price, and also covers Industry sales channel, distributors, traders, dealers, research findings, conclusion, appendix and data source.

With the slowdown in world economic growth, the Osteoporosis Treatment industry has also suffered a certain impact, but still maintained a relatively optimistic growth, the past four years, Osteoporosis Treatment market size to maintain the average annual growth rate of 15 from XXX million $ in 2014 to XXX million $ in 2019, Report analysts believe that in the next few years, Osteoporosis Treatment market size will be further expanded, we expect that by 2024, The market size of the Osteoporosis Treatment will reach XXX million $.

Request a sample of Osteoporosis Treatment Market report @ https://www.arcognizance.com/enquiry-sample/878965

This Report covers the manufacturers data, including: shipment, price, revenue, gross profit, interview record, business distribution etc., these data help the consumer know about the competitors better. This report also covers all the regions and countries of the world, which shows a regional development status, including market size, volume and value, as well as price data.

Besides, the report also covers segment data, including: type segment, industry segment, channel segment etc. cover different segment market size, both volume and value. Also cover different industries clients information, which is very important for the manufacturers.

Section 1: Definition

Section (2 3): Manufacturer DetailAllergan PlcAmgen, Inc.Actavis Plc.Eli Lilly and CompanyF. Hoffmann La Roche Ltd.GlaxoSmithKline Pharmaceutical Ltd.Merck & Co AGNovartis AGNovo Nordisk A/SPfizer, Inc.Teva Pharmaceuticals Industries Ltd.

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Section 4: Region SegmentationNorth America Country (United States, Canada)South AmericaAsia Country (China, Japan, India, Korea)Europe Country (Germany, UK, France, Italy)Other Country (Middle East, Africa, GCC)

Section (5 6 7):Product Type SegmentationBisphosphonatesParathyroid Hormone TherapyCalcitoninSelective Estrogen Inhibitors Modulator (SERM)

Industry SegmentationHospitalsClinic

Channel (Direct Sales, Distributor) Segmentation

Section 8: Trend (2019-2024)

Section 9: Product Type Detail

Section 10: Downstream Consumer

Section 11: Cost Structure

Section 12: Conclusion

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Table of Content

Chapter One: Osteoporosis Treatment Product Definition

Chapter Two: Global Osteoporosis Treatment Market Manufacturer Share and Market Overview 2.1 Global Manufacturer Osteoporosis Treatment Shipments2.2 Global Manufacturer Osteoporosis Treatment Business Revenue2.3 Global Osteoporosis Treatment Market Overview

Chapter Three: Manufacturer Osteoporosis Treatment Business Introduction

Chapter Four: Global Osteoporosis Treatment Market Segmentation (Region Level)

Chapter Five: Global Osteoporosis Treatment Market Segmentation (Product Type Level)

Chapter Six: Global Osteoporosis Treatment Market Segmentation (Industry Level)

Chapter Seven: Global Osteoporosis Treatment Market Segmentation (Channel Level)

Chapter Eight: Osteoporosis Treatment Market Forecast 2019-2024

Chapter Nine: Osteoporosis Treatment Segmentation Product Type

Chapter Ten: Osteoporosis Treatment Segmentation Industry

Chart and FigureFigure Osteoporosis Treatment Product Picture from Allergan PlcChart 2014-2019 Global Manufacturer Osteoporosis Treatment Shipments (Units)Chart 2014-2019 Global Manufacturer Osteoporosis Treatment Shipments ShareChart 2014-2019 Global Manufacturer Osteoporosis Treatment Business Revenue (Million USD)Chart 2014-2019 Global Manufacturer Osteoporosis Treatment Business Revenue ShareChart Allergan Plc Osteoporosis Treatment Shipments, Price, Revenue and Gross profit 2014-2019Chart Allergan Plc Osteoporosis Treatment Business DistributionChart Allergan Plc Interview Record (Partly)Figure Allergan Plc Osteoporosis Treatment Product PictureChart Allergan Plc Osteoporosis Treatment Business ProfileTable Allergan Plc Osteoporosis Treatment Product SpecificationChart Amgen, Inc. Osteoporosis Treatment Shipments, Price, Revenue and Gross profit 2014-2019Chart Amgen, Inc. Osteoporosis Treatment Business DistributionChart Amgen, Inc. Interview Record (Partly)Figure Amgen, Inc. Osteoporosis Treatment Product PictureChart Amgen, Inc. Osteoporosis Treatment Business OverviewTable Amgen, Inc. Osteoporosis Treatment Product SpecificationChart Actavis Plc. Osteoporosis Treatment Shipments, Price, Revenue and Gross profit 2014-2019Chart Actavis Plc. Osteoporosis Treatment Business DistributionChart Actavis Plc. Interview Record (Partly)Figure Actavis Plc. Osteoporosis Treatment Product PictureChart Actavis Plc. Osteoporosis Treatment Business OverviewTable Actavis Plc. Osteoporosis Treatment Product Specification3.4 Eli Lilly and Company Osteoporosis Treatment Business Introduction continued

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Due to the ongoing COVID-19 pandemic around the world, the figures in the report study represented in the study might differ along with production capacities and other mentioned aspects. Also, note that there is a possibility of a cooldown period after the pandemic that the data might differ as the world economy aims to catch on.

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Osteoporosis Treatment Market Size, Share, 2020 Emerging-Trends, Services, Applications, Technological-Advancements, Scope, Growth-Analysis,...

Recommendation and review posted by Bethany Smith

Whether youre contemplating using an intrauterine device (IUD) as birth control or to curb the effects of a gynecological issue, you might wonder if the pros outweigh all the cons youve probably heard about. Heres what you need to know about IUDs, according to Ob/Gyn Ashley Brant, DO, MPH.

Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services.Policy

Both types work mainly by preventing egg fertilization, but keep in mind that IUDs dont protect against sexually transmitted infections (STIs).

Despite the fact that modern versions are quite safe, IUDs still tend to get a bad rap. Dr. Brant often hears concerns from patients about migration, when the IUD moves through the uterine wall into the abdominal area. Even though it seems like almost everybody knows somebody to whom thats happened, its actually a pretty rare complication, she says. Migration can happen if the uterus is torn, usually by an instrument during IUD insertion; however, these uterine perforations only occur in 0.01 percent of cases.

Other serious complications from IUDs are rare too. Pelvic inflammatory disease (PID) occurs in just 1 percent of women within the first 20 days after insertion and in 0.5 percent in the first three to six months.

Then there are the uncommon side effects women report from the hormonal IUD like weight gain, hair loss, mood changes and acne. As of now, there isnt enough research to support or refute a definitive link between the two, Dr. Brant says. In fact, the low level of progestin released one-fifth of the amount found in combination birth control pills is tolerated well by the majority of women.

Dr. Brant asks her patients these 3 questions to help them come to a decision thats right for them:

Placing an IUD usually takes less than five minutes. To begin the insertion process, the doctor or nurse will likely feel your uterus to see which way it might be tipping. A speculum is placed, just like youd have for a Pap smear, and the cervix is washed off with soap.

You can expect to experience cramping three times, but only for a few seconds each time, says Dr. Brant.

Read more:
Do the Benefits of an IUD Outweigh the Potential Side Effects? - Health Essentials from Cleveland Clinic

Recommendation and review posted by Bethany Smith

RESEARCH TRIANGLE PARK Theres a new biotech company setting up shop in the Triangle, and its flush with cash and headed up by some big names in the industry.

MeetKriya Therapeutics the brainchild of Dr. Shankar Ramaswamy, former chief business officer for Axovant Gene Therapies; Fraser Wright, co-founder of Sparks Therapeutics; and Roger Jeffs, the former United Therapeutics CEO who has deep rootsinNorth Carolina.

Launched in 2019, the biotech startup has dual headquarters in Durham and Palo Alto, California, and is billing itself as a next-generation gene therapy company focused on designing and developing treatments for highly prevalent and severe chronic conditions, like diabetes and obesity.

Earlier this month, it arrived in a big way after securing $80.5 million in Series A financing during a pandemic.

Its never easy. But itsa really significant pool of capital for us so were thankful to have been able to get it done,Ramaswamy, Kriyas CEO, told NC Biotech in a video interview this week.[Our] investors have a very long term vision of what a next generation gene therapy company could look like, and were very supportive building towards that vision.

Fraser Wright, PhDScientific Co-Founder and Chief Scientific Advisor; Shankar Ramaswamy, MDCo-Founder, Chairman, and CEO; and Nachi Gupta, MD, PhDChief of Staff.

Among the investors: QVT, Dexcel Pharma, Foresite Capital, Bluebird Ventures (associated with Sutter Hill Ventures), Narya Capital, Amplo,Paul Manning, andAsia Alpha. The round followed an initial seed financing led by Transhuman Capital late last year.

Itsis amilestone for the company andsets us up for success to goout and execute on the things that we really want to get done.

Ramaswamy says the company is now ready to scale, and is focused on building out its teams on both coasts.

We expect to grow very quickly both here in the Bay Area and in North Carolina, he said, emphasizing the Triangles importance as its manufacturing hub. That could be dozens of employees [here] in the not so distant future, if not larger over time.

How it will work: co-founders Ramaswamy and Wright will be based in the Bay area along with finance operations and early-stage research.

Meanwhile, in Durham, co-founder Jeffs will lead a team focused on development and manufacturing. It will include Britt Petty, AveXis former head of global manufacturing and Melissa Rhodes, former chief development officer at Altavant Sciences; and Mitch Lower, another Avexis veteran.

I dont view North Carolina as a satellite office.Thats where well be building our internal manufacturing infrastructure to solve for one of the key bottlenecks in gene therapy,which is manufacturing capacity and quality, saidRamaswamy.

Theres a very strong pool of talent in North Carolina, especially in biologics manufacturing. And [our team] has a very strong track record and history of success with biologics manufacturing, and strong experience there as well. So we think its a great place to be, given the past couple of decades, where there have been so many successful products actually manufactured in North Carolina.

Already, Kriyahas a number of gene therapies in the pipeline.

Among them: KT-A112, an investigational gene therapy administered by intramuscular injection that delivers the genes to produce insulin and glucokinase for type 1 and type 2 diabetes;KT-A522, an investigational gene therapy administered by salivary gland injection that delivers the gene to produce a glucagon-like peptide 1 (GLP-1) receptor agonist for type 2 diabetes and severe obesity; andKT-A83, an investigational gene therapy administered by intrapancreatic injection that delivers the gene to produce modified insulin growth factor 1 (IGF-1) for type 1 diabetes.

The team is currently set up in a temporary office in Durham, but plans to move intoamore permanent space somewhere in the Research Triangle in the near future.

Kriya is building a leading team and cutting-edge infrastructure to engineer best-in-class gene therapies for severe chronic conditions and accelerate their advancement into human clinical trials, saidJeffs, its vice chairman. Through its R&D laboratory capabilities in the Bay Area and in-house process development and manufacturing infrastructure inResearch Triangle Park, I believe that Kriya will be uniquely positioned to become a leader in the gene therapy field.

(c) North Carolina Biotechnology Center

Durhams Kriya Therapuetics lands $80M to advance gene therapies for diabetes, severe obesity

Read this article:
Bicoastal startup Kriya Therapeutics to grow gene therapy manufacturing in NC - WRAL Tech Wire

Recommendation and review posted by Bethany Smith

BEIJING, China & CAMBRIDGE, Mass.--(BUSINESS WIRE)--EdiGene, Inc., which develops genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of diseases, and Immunochinaa company dedicated to innovative gene and cellular technology today announced that they have formed a research and development collaboration to develop allogeneic CAR-T therapy for cancer.

Under this partnership, both companies will combine EdiGenes expertise in genome editing and allogeneic T-cell process with Immunochinas expertise in innovative CAR-T technology to develop potentially best-in-class allogeneic CAR-T therapeutics. Terms are not disclosed.

"EdiGene is a leading gene-editing company with cutting edge technology platform. It is our great pleasure to work with this team," said Ting He, Ph.D.founder and CEO of Immunochina, "Make the Incurable Curable, which is Immunochinas vision. We have accumulated considerable experience in late-stage hematological malignancies, with two IND approvals. Although a number of break throughs have been made by autologous T cells lately, allogeneic T cells could also play an important role in the future. The cooperation is a big step for both teams, and I believe we will make exciting discoveries together."

We are excited to collaborate with Immunochina, one of the leading clinical-stage CAR-T companies, said Dong Wei, Ph.D.CEO of EdiGene, We believe that allogeneic T-cell therapeutics has tremendous potential, by offering innovative T-cell therapies off the shelf with more effective quality control and lower cost. By combining the expertise of EdiGene and Immunochina, we will be well positioned to develop such therapeutics and advance to clinics, one step closer to help the cancer patients in need.

About EdiGene, Inc

EdiGene is a biotechnology company focused on leveraging the cutting-edge genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of genetic diseases and cancer. The company has established its proprietary ex vivo genome-editing platforms for hematopoietic stem cells and T cells, in vivo therapeutic platform based on RNA base editing, and high-throughput genome-editing screening to discover novel targeted therapies. Founded in 2015, EdiGene is headquartered in Beijing, with subsidiaries in Guangzhou, China and Cambridge, Massachusetts, USA. More information can be found at http://www.edigene.com.

About Immunochina

Immunochina is committed to the application of innovative gene and cellular technology for treatment of lethal diseases. The company owns integrated CAR-T platform, including core technologies such as large-scale viral vector production and primary immune cell processing. The pipeline includes several CAR-T candidates for treatment of advanced cancer, with two IND approvals. Founded in 2015, Immunochina is headquartered in Beijing. More information can be found at http://www.immunochina.com

Originally posted here:
EdiGene and Immunochina Announce Research and Development Collaboration to Develop Allogeneic CAR-T Therapy for Cancer - Business Wire

Recommendation and review posted by Bethany Smith

Pune, May 27, 2020 (GLOBE NEWSWIRE) -- The global regenerative medicine market size is expected to reach USD 151,949.5 billion by 2026, exhibiting a CAGR of 26.1% during the forecast period. The growing R&D investment by key players for the development of innovative regenerative therapies can be a vital factor enabling the growth of the market during the forecast period, states Fortune Business Insights in a report, titled Regenerative Medicine Market Size, Share and Industry Analysis By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By Application (Orthopaedics, Wound Care, Oncology), By Distribution Channel (Hospitals, Clinics) & Regional Forecast, 2019 2026 the market size stood at USD 23,841.5 Million in 2018. The growing organ transplantation surgeries will spur opportunities for the market during the forecast period.

Request a Sample Copy of the Research Report: https://www.fortunebusinessinsights.com/enquiry/request-sample-pdf/regenerative-medicine-market-100970

Market Driver:

Escalating Cases of Genetic Disorders to Augment Growth

The increasing prevalence of chronic disorders can be an essential factor enabling the growth of the market. Similarly, the growing incidence of genetic disorders will fuel demand for the market. The growing investment in R&D activities by major market players will have a positive impact on the regenerative medicine market growth during the forecast period. For instance, in March 2018, SanBio Group, a leader in regenerative medicine and therapies for neurological disorders announced that it has made a deal with Hitachi Chemical Advanced Therapeutics Solutions, LLC, a cell manufacturing company for the development and manufacturing of innovative regenerative medicines.

Furthermore, the rising cases of neurological disorders will influence the healthy growth of the market. The growing healthcare expenditure in developed and developing countries will boost the market in the forthcoming years. The ongoing clinical trials and robust pipeline products in stem cell andgene therapy will contribute tremendously to the growth of the market. The rising utilization of skin substitutes, grafts, bone matrix, and other tissue-engineered regenerative medicine in orthopedic and neurosurgical applications will augment the growth of the market.

An Overview of the Impact of COVID-19 on this Market:

The emergence of COVID-19 has brought the world to a standstill. We understand that this health crisis has brought an unprecedented impact on businesses across industries. However, this too shall pass. Rising support from governments and several companies can help in the fight against this highly contagious disease. There are some industries that are struggling and some are thriving. Overall, almost every sector is anticipated to be impacted by the pandemic.

We are taking continuous efforts to help your business sustain and grow during COVID-19 pandemics. Based on our experience and expertise, we will offer you an impact analysis of coronavirus outbreak across industries to help you prepare for the future.

To get the short-term and long-term impact of COVID-19 on this Market.

Please visit: https://www.fortunebusinessinsights.com/industry-reports/regenerative-medicine-market-100970

Regional Analysis:

Development of Novel Therapies to Favor Growth in North America

The market in North America generated a revenue of USD 9,128.2 million in 2018 and is predicted to grow rapidly during the forecast period owing to the presence of major pharmaceutical companies. The growing launch of novel therapeutics and the availability of advanced technologies along with clinical trials will support growth in North America. Asia Pacific is expected to witness a high growth rate during the forecast period owing to the

developing healthcare infrastructure and facilities. The increasing stem cell research in developing countries such as India, Japan China will contribute positively to the growth of the market. For instance, In April 2013, the Japan Ministry of Health, Labor, and Welfare approved Regenerative Medicine law. The growing number of clinical developments of regenerative and cell-based therapies will drive the market in the region. The increasing government initiatives for human embryonic stem cell research and development will further encourage growth in the region. The surge in geriatric patients, the evolving lifestyle of people, and the growing need for novel therapies are factors likely to aid the expansion of the market in Asia Pacific.

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Key Development:

2018: Novartis announced that it has received EUs approval for one-time gene therapy Luxturna, to restore vision in people with rare and genetically-associated retinal disease.

List of the Key Companies Operating in the Regenerative Medicine Market are:

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Gene Therapy Market Size, Share and Global Trend By Disease Indication(Cancer, Genetic disorders, Cardiovascular diseases, Ophthalmology, Neurological conditions) By Type of Vectors (Viral vectors, Non-viral vectors), By Type of Cells(Somatic cells, Germline cells) and Geography Forecast till 2026

Induced Pluripotent Stem Cells Market Size, Share and Global Trend By Derived Cell Type (Amniotic cells, Fibroblasts, Keratinocytes, Hepatocytes, Others), By Application (Regenerative medicines, Drug development, Toxicity testing, Reprogramming technology, Academic research, Others), By End-user (Hospitals, Education & research institutes, Biotechnological companies) and Geography Forecast till 2026

Platelet Rich Plasma Market Size, Share And Global Trend By Origin (Allogeneic, Autologous, Homologous), By Type (Pure PRP, Leukocyte rich PRP, Leukocyte rich fibrin), By Application (Orthopaedic surgery, Cosmetic surgery, General surgery, Neurosurgery, Others), And Geography Forecast Till 2026

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Regenerative Medicine Market to Exhibit a CAGR of 26.1% by 2026; Rising Prevalence of Genetic Disorders to Fuel Demand, states Fortune Business...

Recommendation and review posted by Bethany Smith

MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Takara Bio USA, Inc. (TBUSA) announced that its parent company, Takara Bio Inc., has completed the construction of a new facility, the Center for Gene and Cell Therapy Processing II (CGCPII) in Shiga, Japan. The CGCPII has been operational since January 2020.

The CGCPII is an expansion of the Center for Gene and Cell Processing (CGCP), which was established in 2014 and designed specifically for the safe, efficient manufacture of gene and cell therapy products. Both facilities have received ISO 9001 certification. The CGCPII provides additional capacity for Good Manufacturing Practice (GMP) viral vector production, process development, aseptic filling, and quality-testing facilities, as well as room for future expansion.

With the addition of the CGCPII, Takara Bio is able to accommodate the growing demand for gene and cell therapies and will continue to enhance its services for biopharmaceuticals and regenerative medicine products under GMP and Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP).

"Takara Bio is excited to increase our capacity to provide even more support to customers worldwide in the development of their regenerative medicine products. We have a history of developing products like RetroNectin reagent for regenerative medicine research, and we are building on that history with our expanded facility and service offerings," said Junichi Mineno, Chief Operating Officer, Takara Bio Inc.

With our state-of-the-art GMP manufacturing facilities in Japan and Europe, Takara Bio provides services for viral vector production, cell processing, clinical-grade human embryonic stem cell line derivation, quality testing, and cell banking. These gene and cell therapy manufacturing services, carried out by a global team of seasoned experts, provide support throughout the entire process of developing vital regenerative medicine products.

About Takara Bio

Takara Bio USA, Inc. (TBUSA) is a wholly owned subsidiary of Takara Bio Inc. that manufactures and distributes kits, reagents, and instruments for the life sciences, including NGS, PCR, gene delivery, genome editing, stem cell research, nucleic acid and protein purification, and automated sample preparation.

Takara Bio Inc., a world leader in biotechnology research and development, offers a host of life science research solutions, from enzymes and GMP reagents to contracted cell and gene therapy manufacturing services and is the developer of the RetroNectin reagent, a world standard in gene therapy protocols. Takara Bio is committed to preventing disease and improving the quality of life for all people through the use of biotechnology.

See the article here:
Takara Bio Announces the Completion of a New GMP Facility for Manufacturing Gene and Cell Therapy Products - Business Wire

Recommendation and review posted by Bethany Smith

Summary

It turns out that finding driver mutations may be more complicated than previously thought: Nearly a quarter of all tumors have two different mutations in the same gene.

A major effort in cancer research is the search for driver mutations in tumors. These mutations are changes in a genes DNA that play a direct role in the growth of cancer. They are different from passenger mutations, which are genetic changes found in tumors that dont have anything to do with the cancer: Those are just along for the ride.

Figuring out which tumor mutations are drivers is important because they help provide an understanding of how and why tumors grow. Identifying driver mutations also helps researchers design treatments and helps doctors predict how a persons cancer is likely to behave.

But according to a studypublished by Memorial Sloan Kettering researchers in Nature on May 27, the strategy of focusing on driver mutations may be more complicated than previously thought. It turns out that nearly a quarter of all tumors have two different mutations in the same gene that are contributing to the formation of an individual cancer.

Weve seen this phenomenon here and there before, but until now we had no idea how common it was, says MSK computational oncologist Barry Taylor, one of the studys two senior authors. The harder we looked, the more clearly we saw it.

MSK-IMPACT: A Targeted Test for Mutations in Both Rare and Common Cancers

MSK-IMPACT stands for integrated mutation profiling of actionable cancer targets. It is a targeted tumor-sequencing test available to MSK patients.

In every cell of our bodies, we have two copies of each gene. One comes from our mother and the other from our father. When one copy of a gene develops a mutation either by chance or due to exposure to something harmful like UV light, radiation, or tobacco smoke the other copy is there to potentially make up for the loss. If there is a mutation in the second copy, thats when trouble can start: If both copies of a gene are mutated, it can send the cell down the road toward becoming cancerous. These multiple mutations, also called composite mutations,were known to occur with a class of genes called tumor suppressors, where the double mutation effectively cripples the function of both copies of a gene and can lead to cancer.

But it turns out that another type of composite mutation that hasnt been well understood is much more common than expected: It occurs when two different mutations affect the same copy of a gene. Here, the two mutations work together to produce a mutant protein with new, unexpected functions. This situation can lead to the formation of oncogenic proteins those that drive cancer growth.

[MSK-IMPACT data is] well suited to doing this kind of detailed analysis.

In a way, were looking at a phenomenon thats been staring people in the face for a long time, says MSK computational oncologist Ed Reznik, the papers other senior author. I credit graduate student Alex Gorelick, who was working in both my and Barrys labs, with coming up with the idea to look at how common composite mutations are and what they may mean. Mr. Gorelick is first author on the Nature paper.

The team was able to make this discovery thanks to data from MSK-IMPACT, a diagnostic test that helps match people with cancer to the best treatment based on the genetic changes in their tumors. This test, which has been used since 2014, has now analyzed more than 50,000 tumors, giving researchers a lot of data to work with.

One special thing about MSK-IMPACT data is that its very deep and contains a lot more information than other sequencing platforms, Dr. Reznik says. That makes it well suited to doing this kind of detailed analysis.

Now that the researchers know about composite mutations, the next step is to determine what they might mean for individual cancers. One study that came out last year in Science, published by MSK cancer biologist Maurizio Scaltriti and colleagues, found that breast cancers with composite mutations in the gene PIK3CA may respond better to targeted therapy than breast cancers in which only one PIK3CA mutation is present.

However, with other cancers and other mutations, its possible that composite mutations may make them harder to treat.

This gives us a tremendous opportunity to look at the function of these mutations in a different way.

Theres still so much we dont understand about composite mutations. Rather than creating frustration, knowing of their existence leads to new opportunities, concludes Dr. Taylor, who is an Associate Director of the Marie-Jose & Henry R. Kravis Center for Molecular Oncology. This gives us a tremendous opportunity to look at the function of these mutations in a different way and learn something fundamental about cancer genes that we may not have appreciated before.

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Double Trouble: Researchers Find Many Cancers Carry Two Mutations in the Same Gene - On Cancer - Memorial Sloan Kettering

Recommendation and review posted by Bethany Smith

Text size

Sanofi is about to have $11.7 billion burning a hole in its pocket. What might it buy?

Days after the French drug giant announced that it would sell its stake in the biotech company Regeneron Pharmaceuticals (ticker: REGN), speculation is growing on whether the company might pursue an acquisition or two in the coming months.

Sanofi (SNY) has not said what it plans to do with the proceeds of its sale of 21.6 million shares of Regeneron. In a statement, the company said it would use the proceeds to further execute on its strategy to drive innovation and growth.

Still, Sanofis new CEO, Paul Hudson, said in December that the company would consider future deals: We are open-minded and interested, he said at the time. In January, Sanofi completed the acquisition of the cancer drug developer Synthorx for $2.5 billion.

Sanofi appears to be taking advantage of the strong liquidity in biotech equity markets, and in REGN in particular, to accelerate the implementation of their strategy, and we do not expect them to sit on their new capital, SVB Leerink analyst Geoffrey Porges wrote in a note on Tuesday.

Porges suggested that the company could be looking for a gene therapy company to acquire.

We certainly expect a M&A deal of decent size ($5bn) in the coming months for Sanofi, he wrote.

In another note Tuesday, Citi Research analyst Mohit Bansal wrote that the gene therapy company BioMarin Pharmaceutical (BMRN) was an unlikely target for Sanofi. Bansal said that BioMarin does not fit with previous comments from Sanofi about their acquisition interests, noting that the company has indicated a preference toward smaller companies, and away from the crowded hemophilia gene therapy race in which BioMarin is a lead contender. BioMarins market value is $18.8 billion.

Gene therapy companies with market value closer to the $5 billion range include bluebird bio (BLUE), which has a market value of $3.6 billion, and Ultragenyx Pharmaceutical (RARE), which has a market value of $4.4 billion.

Sanofi had some $10.3 billion in cash and cash equivalents on hand as of the end of 2019. The company did not immediately respond to a request for comment.

Shares of Sanofi are down 6.8% so far this year, and on Wednesday morning were trading down 1%. The stock trades at 13.4 times earnings projected over the next 12 months, close to its five-year average of 13.5 times earnings.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

Read the rest here:
What Sanofi Might Buy With Its Regeneron Windfall - Barron's

Recommendation and review posted by Bethany Smith

Gene therapy does more than treat genetic diseases it can cure them. A one-time dose of a non-replicative viral vector, such as commonly used recombinant adeno-associated virus (AAV), delivers a functional gene to replace or compensate for a dysfunctional version that is causing a patients disease (Figure 1). As a cutting-edge biopharmaceutical technology, there are multiple gene therapies now FDA approved; with hundreds more in clinical trials, were likely to see many more of these therapies on the market soon.1 However, to keep up with the rapid pace of clinical research, developers are working to streamline the manufacturing and quality control process to improve quality and lower the cost of bringing these important drugs to market.Developers use a multitude of analytical tests to develop gene therapies and optimize their manufacturing process. When developers get aberrant test results, they must be able to interpret where the problem lies. Did the manufacturing process produce an undesirable product, or is the analytical testing method unreliable? Analytical testing companies that have the infrastructure, personnel, and experience often partner with developers to tighten up analytical variability so that results of tests clearly indicate where there are opportunities to increase efficiency and product quality.

Figure 1. Gene delivery by recombinant viral vector.During gene therapy, viral capsids containing the therapeutic gene are taken up by the patients cells and the genetic material is delivered to the nucleus. There, the gene gets expressed as a protein necessary for the patients health. Credit: Avomeen.

Figure 2. A full AAV capsid and associated capsid impurities. Complete viral capsids have AAV are assembled from 60 capsid proteins, with a defined stoichiometry and shape and contain a therapeutic gene. AAV vector impurities include capsids that contain too many copies of the gene (overfilled), those that contain lower copy numbers or truncations of the gene (partially full), or empty capsids that contain no genetic material. Credit:Avomeen.

There are several ways to measure the empty/full capsid ratio, and as developers are establishing their chemistry, manufacturing and control (CMC) protocol, it is important that they choose an optimized method, as they must use that method for effective quality control from early process development to lot release and stability.3 Gene therapy developers may choose analytical ultracentrifugation to evaluate capsids, but while highly effective, this method is not as quantitative, robust or efficient as some newer methods. High-performance liquid chromatography (HPLC) using AAV full/empty analytical columns have been demonstrated to be highly effective at separating full, empty, and improperly filled capsids for robust quantification. Additionally, this method is higher throughput than ultracentrifugation, and requires less precious AAV sample to run.

Cellular potency is evaluated by transducing cells with the AAV product and then measuring a phenotypic or functional outcome due to the transduction. Developing these tests can be challenging because there is no one-size-fits-all test that will give developers the answers they need. Developers often draw on the experience of analytical labs to determine how to best evaluate their AAV products transduction efficiency.A gene therapy in development must also be tested to ensure that it is free of residual, process-related impurities such as polyethylenimine, iodixanol, poloxamer, and other excipients that must be removed in the final product to ensure safety. Few research and manufacturing facilities have the equipment and expertise necessary to perform this kind of testing, and it is advisable to find one that has experience testing polymers, extractables and leachables to examine if components of the manufacturing equipment or drugs packaging are not contaminating the final product.

As fast-paced as the gene therapy field is now, it stands to become a true race to the finish line to bring new gene therapies to market in the near future. Regulatory bodies are becoming more familiar with reviewing gene therapies, and the road to commercialization will move more quickly. There is no denying that gene therapies will bring incredible benefits to patients, but it will be crucial to improve manufacturing efficiency and lower costs to make gene therapies more accessible to the patients who need them.References

1. Colasante, W., Diesel, P., and Gerlovin, Lev. (2018). New Approaches To Market Access And Reimbursement For Gene And Cell Therapies. Cell & Gene. Retrieved from: https://www.cellandgene.com/doc/new-approaches-to-market-access-and-reimbursement-for-gene-and-cell-therapies-0001

2. Fraser Wright, J. (2014). Product-Related Impurities in Clinical-Grade Recombinant AAV Vectors: Characterization and Risk Assessment. Biomedicines, 2, 80-97; doi:10.3390/biomedicines2010080

3. U.S. Food & Drug Administration (2019). Guidance for Human Somatic Cell Therapy and Gene Therapy. Retrieved from: https://www.fda.gov/animal-veterinary/guidance-industry/chemistry-manufacturing-and-controls-cmc-guidances-industry-gfis

4. Stein, R. (2019). At $2.1 Million, New Gene Therapy Is The Most Expensive Drug Ever. NPR. Retrieved from: https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever

5. Cohen, J.T, Chambers, J. D., Silver, M. C., Lin, P., Neumann, P.J. (2019). Putting The Costs And Benefits Of New Gene Therapies Into Perspective. Health Affairs. Retrieved from: https://www.healthaffairs.org/do/10.1377/hblog20190827.553404/full/

6. ATCC (accessed May, 2020) ATCC Virus Reference Materials. Retrieved from: https://www.atcc.org/en/Standards/Standards_Programs/ATCC_Virus_Reference_Materials.aspx#

7. U.S. FDA (2020). FDA Details Policies on Gene Therapies in Seven Guidances. Retrieved from: https://www.fdanews.com/articles/195767-fda-details-policies-on-gene-therapies-in-seven-guidances

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Troubleshooting the Development of New Gene Therapies - Technology Networks

Recommendation and review posted by Bethany Smith

May 27, 2020 |May featured exciting new, products, and partnerships from around the bio-IT community from innovating companies, organizations, and universities, including Benchling, BERG, Thermo Fisher Scientific, and more.

Benchlingannounced the launch ofBenchling Insights, a new solution that gives life sciences companies the ability to query, visualize and collaborate around high quality, structured data that resides on the platform. While the biotech industry continues to grow, companies are faced with increased competition, patent expirations and increased scrutiny over pricing and efficacy. Biotech companies are under immense pressure to deliver new products into clinical evaluation faster than ever, which requires disciplined execution, a high degree of collaboration and unfettered access to data across the R&D lifecycle, saidSaji Wickramasekara, CEO and Co-Founder of Benchling, in a press release. We launched Benchling Insights so that our customers can make intelligent decisions with a complete view of their experimental and operational data. Analyses and dashboards can be rapidly created and shared across programs, teams, and leadership so companies can reach breakthroughs faster. Benchling Insights extends the Benchling Life Sciences R&D Cloudwith an integrated solution for data querying, visualization, and collaboration. Scientists can tailor advanced queries to visualize scientific and operational metrics, and use these to quickly answer key questions about their programs. For example, they can assess which cell lines generate the best assay performance, or which process variants lead to optimal outputs. R&D leaders can use centralized data to track overall pipeline performance and remove operational bottlenecks, while IT leaders can track product utilization and compliance. Press release

BERGannounced a new collaboration with Boehringer Ingelheimaround understanding the multifaceted nature of the spectrum of inflammatory diseases and seeks to unravel the associated biological drivers. The pilot program with Boehringer Ingelheim will work to reveal novel insights into the complexities of various inflammatory diseases. The potential outcomes of this partnership could lead to a broader understanding of the etiology of potential candidate biomarkers. BERG has previously collaborated with multiple pharmaceutical companies and applied its Interrogative Biologyplatform to diverse datasets to address major clinical unmet needs. Were excited to partner with Boehringer Ingelheim, which will combine Boehringer Ingelheim's translational medicine and biomarker expertise with BERGs next generation AI-driven, patient-biology capability, Niven R. Narain, BERG Co-founder, President and Chief Executive Officer, said in a press release. Our intent is for BERGs Interrogative Biology platform to enable the discoveryofbiomarkersthat willrevolutionize how to diagnose and treat patients with inflammatory diseases. Press release

Thermo Fisher Scientificreleased the Thermo Scientific Helios 5 Laser PFIBsystem, an advanced focused ion beam scanning electron microscope (FIB-SEM) with a fully integrated femtosecond laser that quickly characterizes millimeter-scale volumes of material in 3D with nanometer resolution. The Helios 5 Laser PFIB combines the best-in-class Thermo Scientific Elstar SEM Columnfor ultra-high-resolution imaging and advanced analytical capabilities with a plasma FIB column for top performance at all operating conditions, and a femtosecond laser that enables in-situ ablation at material removal rates not previously obtained by a commercially available product. The Helios 5 Laser PFIB is part of the fifth generation of the industry-leading Helios family. The Helios 5 Laser PFIB dramatically accelerates the pace of research for both academic and industrial users, allowing them to characterize materials in a matter of minutes versus the days it took before,Rosy Lee, vice president of materials science at Thermo Fisher, said in a press release. Not only can researchers quickly and accurately image statistically relevant, site-specific, millimeter-size cross-sections at nanoscale resolution, they can also set up large-volume 3D analyses to be automatically completed overnight, freeing up the microscope for other uses. The Helios 5 Laser PFIB allows researchers to obtain accurate large-volume 3D and sub-surface data up to 15,000 times faster than a typical Gallium ion source focused ion beam (Ga-FIB). For many materials, a large cross-section of hundreds of microns can be milled by the Helios 5 Laser PFIB in less than 5 minutes. Serial-section tomography is now possible with this combination of Laser and Plasma FIB, and when combined with EDS and EBSD detectors, can be extended to 3D elemental and grain orientation analysis at the millimeter scale. Press release

Following the recent launch of NVIDIAs new DGX A100system, NetApp ONTAP AIannounced it will be among the first converged AI stacks to incorporate the DGX A100 and NVIDIA Mellanox networking. NetApp and NVIDIA have been collaborating for several years to deliver AI solutions that help enterprises accelerate AI adoption. Both companies are working on eliminating AI bottlenecks and advancing the realm of possibilities, Kim Stevenson, Sr. Vice President and General Manager, Foundational Data Services Business Unit, NetApp, said in an official statement. NetApps full stack AI/ML/DL platforms delivered at the edge, core and cloud with ONTAP AI complements NVIDIAs rapidly expanding ecosystem of AI hardware, software, and development toolkits. Blog post

Advanced Biological Laboratories (ABL)announced the CE-IVDmarking of its DeepChek-HIVAssays is now available for in-vitro diagnostics. Intended to be used on HIV-1 Group M viruses from patients diagnosed with HIV infection, the assays deliver standardized, open and flexible solution suited to clinical settings performing sequencing through Capillary Electrophoresis and Next Generation Sequencing (NGS) systems. The DeepChek-HIV CE IVD Assays are covering respectively the Protease / Reverse Transcriptase and the Integrase regions of the virus and are intended to be used from input RNA extracted from plasma, serum or whole blood samples. Both assays are highly sensitive and have been validated to process clinical samples as low as 1,000 copies/mL with outstanding performances (100% agreement of analytical reproducibility and repeatability, 100% clinical reproducibility, 99% clinical sensitivity) in all three regions. Open and flexible, the DeepChek-HIV CE IVD Assays is a unique and versatile system that can be used under a large variety of laboratory throughput configurations. Obtaining CE IVD marking for our DeepChek-HIV assays will allow virology labs to access a unique and innovative technology, for HIV genotyping diagnostics. ABL will keep standardizing its entire portfolio of applications in virology and microbiology following European and International guidelines to improve the management of patients suffering from chronic diseases on a worldwide basis, Chalom Sayada, CEO of ABL, said in an official statement. Press release

Cardinal Healthand Vinetiannounced a collaboration to support cell and gene therapy manufacturers with a fully integrated solution that aligns logistics and commercialization services with digital Chain of Identityand Chain of Custodythroughout the treatment journey. Cardinal Healthsupports the cell and gene therapy market with a robust suite of services that includes end-to-end logistics, regulatory strategy, order-to-cash management and patient access and support services. Vineti offers a digital platform of record to integrate logistics, manufacturing and clinical data for cell and gene therapies. The Vineti platform delivers digital Chain of Identity and Chain of Custody, providing essential patient safety and regulatory compliance across the value chain.Together, Cardinal Health and Vineti will develop best-in-class solutions to support the distribution of transformative, personalized therapies for cancer and other serious diseases.Specifically, Cardinal Health and Vineti will focus on integrated solutions that enable cell and gene therapy manufacturers to accelerate the commercialization of their products, while delivering a more simple, seamless and secure experience to hospitals and patients, from initial patient enrollment through delivery of the final dose of therapy and beyond. Press release

Immunailaunched out of stealth to map the entire immune system for better detection, diagnosis, and treatment of disease. Leveraging single-cell technologies and machine learning algorithms, Immunai has mapped out millions of immune cells and their functions, building the largest proprietary data set in the world for clinical immunological data. The company is also announcing $20M in seed funding, which will be used to further the development of its technology and business functions while expanding its team of scientists, engineers, and machine learning experts. Cell therapies and cancer immunotherapies have revolutionized medicine in the last few years and are expected to continue for the near future. However, due to the incredible complexity of the immune systemits trillions of cells partitioned into hundreds of cell types and states and how they interplay with other cells and proteinsit is prohibitively hard to predict how drugs will affect immune cells. For cell therapies with high manufacturing costs, a slight variation in cell therapy products can have a significant influence on a patients response to the therapy.Immunai has developed a vertically-integrated platform for multi-omic single-cell profiling that offers a broader view of the immune system in states of health, disease, and treatment to examine the bodys response to stimulus. With Immunais platform, pharmaceutical companies can identify more subtle nuances in cell abundances and cell function and mechanisms of action and biomarkers for toxicity response to accurately measure the efficacy of immunotherapies. For cell therapies, in particular, Immunai partners with cell therapy companies to understand cellular products sub-populations in unprecedented detail before and after infusion.Press release

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Benchling, BERG, Thermo Fisher Scientific, And More: News From May 2020 - Bio-IT World

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass.--(BUSINESS WIRE)--ElevateBio, LLC, a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies, announced that the company will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 8:30 a.m. ET.

About ElevateBio

ElevateBio, LLC, is a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies. It begins with an environment where scientific inventors can transform their visions for cell and gene therapies into reality for patients with devastating and life-threatening diseases. Working with leading academic researchers, medical centers, and corporate partners, ElevateBios team of scientists, drug developers, and company builders are creating a portfolio of therapeutics companies that are changing the face of cell and gene therapy and regenerative medicine. Core to ElevateBios vision is BaseCamp, a centralized state-of-the-art innovation and manufacturing center, providing fully integrated capabilities, including basic and transitional research, process development, clinical development, cGMP manufacturing, and regulatory affairs across multiple cell and gene therapy and regenerative medicine technology platforms. ElevateBio portfolio companies, as well as select strategic partners are supported by ElevateBio BaseCamp in the advancement of novel cell and gene therapies.

ElevateBios investors include F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, Samsara BioCapital, The Invus Group, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures HC.

ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass. For more information, please visit http://www.elevate.bio.

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ElevateBio to Present at the Jefferies Virtual Healthcare Conference - Business Wire

Recommendation and review posted by Bethany Smith

Gilead CEO Dan ODay has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosens Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. ODay also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. Theres $500 million in potential TIGIT milestones on US regulatory events likely capped by an approval if Gilead partners on it and the stars align on the data. And theres another $150 million opt-in payments for the rest of the Arcus pipeline.

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European regulators accept FibroGen's anemia drug for review; Passage Bio's lead gene therapy gets more love from the FDA - Endpoints News

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CAMBRIDGE, Mass., May 27, 2020 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, today announced an expansion of its leadership team to strengthen expertise in business development and regulatory affairs as the Company advances the development of TRuC-T cells addressing solid tumors and hematological malignancies.

As we position TCR2 for our next phase of growth and value creation, we are pleased to announce the addition of experienced leaders in two key competencies business development and regulatory affairs, said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. Clinical progress and the execution of strategic partnerships are important priorities for the Company and having the right expertise in both domains is critical for our success.

Gregg McConnell brings considerable experience to the business development role after his successful tenures at Pfizer and BlueRock Therapeutics, an engineered cell therapy company purchased by Bayer AG for $1.0 billion. He will lead our effort to deliver significant value from the innovation and progress of our TRuC-T cells through deals with strategic partners, added Dr. Menzel.

Viera Muzithras brings very specific cell therapy experience to TCR2, from leading the development of multiple myeloma assets at Bristol Myers Squibb to the global regulatory strategy for Kymriah while at Novartis, ultimately leading to its approval by the FDA, said Alfonso Quints, M.D., Chief Medical Officer of TCR2 Therapeutics. Her deep expertise will be critical as we advance our two current TRuC-T cell programs in the clinic, TC-210 and TC-110, and file an IND for our third CD70-targeted mono TRuC program.

Gregg McConnell joins TCR2 as Head of Business Development. Most recently, he served as Vice President and Head of Business Development at BlueRock Therapeutics, a leading engineered cell therapy company which was acquired by Bayer AG for an implied value of up to $1.0 billion. At BlueRock, he held numerous responsibilities including leading business development and partnering activities for a pipeline of allogeneic cell therapy programs in neurology, cardiology and immunology. Prior to BlueRock, Gregg held several business development and corporate strategy roles at Pfizer, including Senior Director of Worldwide Business Development, where he led and co-managed the execution of buy- and sell-side transactions across multiple structures, development stages and therapeutic areas, including oncology, immunology and gene therapy.

Viera Muzithras joins TCR2 as Vice President of Regulatory Affairs. With over 25 years of global regulatory experience focusing on cell and gene therapy, oncology and vaccines, she most recently served as Executive Director of Global Regulatory Affairs at Bristol Myers Squibb (formerly Celgene Corporation), where she oversaw the development of novel cell and gene therapy products, biologicals such as T-cell engagers and antibody drug conjugates, and small molecules for hematologic diseases in multiple myeloma. Prior to Bristol Myers Squibb, Viera worked at Novartis Pharmaceuticals as Senior Director of Regulatory Affairs and Global Regulatory Director, where she was responsible for leading the global regulatory strategy and preparation and submission of the New Biologics License Application for Kymriah, a genetically modified autologous T cell immunotherapy targeting CD19. Earlier in her career, Viera served in various regulatory affairs roles at Bayer AG, Sanofi S.A., and Pfizer.

About TCR2 Therapeutics

TCR2Therapeutics Inc.is a clinical-stage immunotherapy company developing the next generation of novel Tcell therapies for patients suffering from cancer.TCR2sproprietary T cell receptor (TCR) Fusion Construct Tcells (TRuC-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent ofhuman leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while exhibiting lower levels of cytokine release. The Companys lead TRuC-T cell product candidate targeting solid tumors, TC-210, is currently being studied in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. The Companys lead TRuC-T cell product candidate targeting hematological malignancies, TC-110, is currently being studied in a Phase 1/2 clinical trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL). For more information about TCR2, please visitwww.tcr2.com.

Forward-looking Statements

This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding the pre-clinical and clinical development of the Companys TRuC-T cells, potential collaborations and strategic partnerships, the future value of the Companys TRuC-T cell platform, the Companys pre-clinical and clinical regulatory strategy and planned IND filings for the Companys third mono TRuC-T cell program.

The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR2s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, whether TCR2's cash resources will be sufficient to fund TCR2's foreseeable and unforeseeable operating expenses and capital expenditure requirements, the impact of the COVID-19 pandemic on TCR2s ongoing operations; and other risks set forth under the caption "Risk Factors" in TCR2s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with theSecurities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR2believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.

Moreover, except as required by law, neither TCR2nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investor and Media Contact:

Carl MauchDirector, Investor Relations and Corporate CommunicationsTCR2 Therapeutics Inc.(617) 949-5667carl.mauch@tcr2.com

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TCR Therapeutics Hires Key Business Development and Regulatory Affairs Cell Therapy Experts to Support Strategic Objectives - GlobeNewswire

Recommendation and review posted by Bethany Smith

Pessac, France Poietis, 4D Bioprinting company, announces formation of Scientific Advisory Board (SAB) and appointment of two first prominent Scientists in Regenerative Medicine. The SAB will serve as a key strategic resource to Poietis as the company expands capabilities of NextGeneration Bioprinting (NGB) platform to therapeutic applications and develops first implantable tissues such as a bioprinted skin substitute in collaboration with the Assistance Publique Hpitaux de Marseille. Poietis appoints Dr. Geoffrey Gurtner, MD, Johnson and Johnson Professor of Surgery, Professor of Materials Science and Engineering at Stanford University and Vice-Chairman of Surgery for Innovation at Stanford University School of Medicine (California, United States) and Dr. Michael H. May, President & CEO of the Center for Commercialization of Regenerative Medicine (CCRM) at Toronto (Canada).

The formation of Poietis SAB is a very important step towards company global deployment in the clinical area says Bruno Brisson, Poietis co-founder and VP Business Development. We are delighted to welcome Dr. Gurtner and Dr. May to our SAB, where they will be key contributors in further enhancing our efforts to bring bioprinting solutions to clinicians and patients with high unmet needs.

To have Dr. Gurtner, a world-renowned expert in tissue-engineering therapies for skin wound healing, join our SAB will enrich our R&D efforts to achieve the first-in-human of a bioprinted skin substitute in the coming years adds Dr. Fabien Guillemot, CEO and Poietis founder. We also believe Dr. May will prove invaluable to Poietis leadership team, and we look forward to his insights and guidance to accelerate the advancement of our bioprinting platform technology to address the key challenges in tissue manufacturing and regenerative medicine.

3D bioprinting is a once-in-a-generation transformative technology. By focusing its 3D printing platform on a clinical application of high unmet need, Poietis is leading the adoption of 3D printing in cell therapy and tissue engineering comments Dr. Michael H. May, PhD, President & CEO of the CCRM.

Dr. Geoffrey Gurtner, MD, is Johnson and Johnson Professor of Surgery and Professor of Materials Science and Engineering at Stanford University, California; USA. He currently serves as the Associate Chairman for Research in the Department of Surgery and is the Executive Director of the Stanford Wound Care Center.

Geoff is a magna cum laude graduate of Dartmouth College and an AOA graduate of the University of California-San Francisco School of Medicine. He completed a general surgery residency at Massachusetts General Hospital, a plastic surgery residency at NYU School of Medicine and received advanced training in microsurgery at the University of Texas-MD Anderson Cancer Center. He is board certified in both general surgery and plastic surgery. He is the author of over 180 peer-reviewed publications in both scientific and surgical literature and editor for two major textbooks in the field: Grabb & Smiths Plastic Surgery and Plastic Surgery. Geoff was awarded the James Barrett Brown Award (for best paper in plastic surgery) in both 2009 and 2010, and has been named Researcher of the Year by the American Society of Plastic Surgeons and the American Association of Plastic Surgeons. His research has led to the development of several novel biomedical technologies. Geoff has co-founded several start-ups focused on wound healing, aesthetics and cardiovascular health.

Dr. Michael May completed his PhD in Chemical Engineering at the University of Toronto in 1998 as an NSERC Scholar and was awarded the Martin Walmsley Fellowship for Technological Entrepreneurship. He is President and Chief Executive Officer of the Center for Commercialization of Regenerative Medicine (CCRM) a Canadian public-private partnership supporting the translation and commercialization of cell & gene therapies and associated enabling technologies through stakeholder networks and with specialized teams, infrastructure and funding. He is also CEO of CCRM Enterprises, the venture creation and investment arm of CCRM.

Prior to CCRM, Michael was the President and co-founder of Rimon Therapeutics Ltd., a Toronto-based tissue engineering company developing novel medical polymers that possess drug-like activity. Rimons initial focus was on advanced wound healing. Michael sits on a number of boards and advisory committees, including: the Entrepreneurship Leadership Council at the University of Toronto; the Commercialization Committee of the International Society for Cell and Gene Therapy, the Alliance for Regenerative Medicine Foundation, CellCan and AgeX Inc. He is Chair of ExcellThera and co-moderates sessions in the health streams of the Creative Destruction Labs.

*****

About Poietis: Bioprinting company specializing in the development of new biomanufacturing solutions, based on Laser-Assisted Bioprinting, for human tissues. Poietis mission is to provide clinicians and patients with tissue engineering therapies thanks to its innovative, proprietary Next-Generation Bioprinting platform (NGB). The multimodal NGB platform is declined in two versions: one for in vitro tissue engineering research (NGB-R) and a clinical version (NGB-C) for the production of implantable bioprinted tissues. This multi-modal, automated biomanufacturing platform enables researchers to achieve superior tissue through high resolution, and enables the fabrication of complex tissues with repeatability and reproducibility. Poietis bioprinting technology is the result of innovative research carried out over ten years at Inserm and the University of Bordeaux. Poietis won the iLab competition in 2014, the World Innovation Challenge Phase II in 2017 and recently the EY Disruptive Strategy Award. The company currently employs 35 people. More information: http://www.poietis.com Contact : bruno.brisson@poietis.com

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Poietis Announces Formation of Scientific Advisory Board and Appoints Two First Prominent Regenerative Medicine Experts - BioSpace

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MARKET INTRODUCTION

Gene therapy is the introduction of DNA into a patient to treat a genetic disease or a disorder. The newly inserted DNA contains a correcting gene to correct the effects of a disease, causing mutations. Gene therapy is a promising treatment for genetic diseases and also includes cystic fibrosis and muscular dystrophy. Gene therapy is a suitable treatment for infectious diseases, inherited disease and cancer.

MARKET DYNAMICSThe growth of the gene therapy market is regulated due to various reason which includes the rapid involvement of synthetically modified gene to treat various diseases, it helps in designing the personalized medicine, rise in the research and development of the gene therapy among the others. The gene therapy requires less doses of medicines and is one time treatment, this factor is likely to show growth opportunity for gene therapy market in coming near future.

The report also includes the profiles of key gene therapy market companies along with their SWOT analysis and market strategies. In addition, the report focuses on leading industry players with information such as company profiles, components and services offered, financial information of last 3 years, key development in past five years.

Key Competitors In Market areSangamo Therapeutics, Inc., bluebird bio, Inc., uniQure N.V., AveXis, Inc., Vineti, Solid Biosciences., Spark Therapeutics, Inc., CHIMERON BIO, RENOVA THERAPEUTICS, HORAMA S.A.

TOC of Market Report Contains:

MARKET SCOPE

The Global Gene Therapy Market Analysis to 2027 is a specialized and in-depth study of the biotechnology industry with a special focus on the global market trend analysis. The report aims to provide an overview of gene therapy market with detailed market segmentation by cell type, application and geography. The global gene therapy market is expected to witness high growth during the forecast period. The report provides key statistics on the market status of the leading gene therapy market players and offers key trends and opportunities in the market.

Market segmentation:

Gene Therapy Market to 2027 Global Analysis and Forecasts by Cell Type (Somatic Gene Therapy, Germline Gene Therapy); By Application (Genetic Disorder, Cancer, Neurological Disorder, and Others)

By Geography North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South & Central America. And 13 countries globally along with current trend and opportunities prevailing in the region.

Points Covered in The Report:

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COVID-19 Impact on GENE THERAPY MARKET EXPECTED 2020 WITNESS A SUSTAINABLE GROWTH OVER 2027 WITH SANGAMO THERAPEUTICS, INC., BLUEBIRD BIO, UNIQURE NV,...

Recommendation and review posted by Bethany Smith

The chapter of global growth trends of this Gene Therapy Products Market business report includes industry tendencies, the growth proportion of major producers, and production analysis while studying market size by application. It covers market consumption analysis by application and studies market size by type, analysis of value, product utility, market percentage & production market share by type. Analysis of profiles of manufacturers or commanding players of the global market is performed based on sales area, key products, gross margin, revenue, price, and production. Market value chain and sales channel analysis of this market document includes details of customer, distributor, market value chain, and sales channel analysis.

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Global gene therapy products market is set to witness a substantial CAGR in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. Rising cancer cases and unused potential for emerging markets are the major factors for the growth of this market.

Few of the major competitors currently working in the globalgene therapy products marketareAdaptimmune., Anchiano Therapeutics, bluebird bio, Inc., CELGENE CORPORATION, GlaxoSmithKline plc., Merck KGaA, Novartis AG, Achieve Life Sciences, Inc., Spark Therapeutics, Inc., Abeona Therapeutics, Inc, Adverum, agtc, Arbutus Biopharma, Audentes Therapeutics, AveXis, Inc., CRISPR Therapeutics, Intellia Therapeutics, Inc and Gilead Sciences,Inc. among others.

Market Definition:Global Gene Therapy Products Market

Gene therapy or human gene therapy is a process which is used to modify gene for the treatment of any disease. Plasmid DNA, bacterial vector, human gene editing technology and viral vectors are some of the most common type of gene therapy products. The main aim of the gene therapy is to replace the dysfunctional genes. Somatic and germline are some of the most common type of the gene therapy.

Complete report on Global Gene Therapy Product Market Research Report 2019-2026 spread across 350 Pages, profiling Top companies and supports with tables and figures

Segmentation: Global Gene Therapy Products Market

Gene Therapy Products Market : By Product

Gene Therapy Products Market : By Application

Gene Therapy Products Market : ByGeography

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Key Developments in the Gene Therapy Products Market:

Gene Therapy Products Market Drivers

Gene Therapy Products Market Restraints

Competitive Analysis: Gene Therapy Products Market

Global gene therapy products market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of gene therapy products market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Key questions answered in the report :-

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Covid-19 Impact On Global Gene Therapy Products Market 2020 : Industry Trends, Size, Growth, Swot Analysis By Top Key Players And Forecast Report To...

Recommendation and review posted by Bethany Smith

Gene Therapy for CNS Disorders Market Insights 2018, is a professional and in-depth study on the current state of the global Gene Therapy for CNS Disorders industry with a focus on the Global market. The report provides key statistics on the market status of the Gene Therapy for CNS Disorders manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry. Overall, the report provides an in-depth insight of 2018-2025 global Gene Therapy for CNS Disorders market covering all important parameters.

The report on the Gene Therapy for CNS Disorders market provides a birds eye view of the current proceeding within the Gene Therapy for CNS Disorders market. Further, the report also takes into account the impact of the novel COVID-19 pandemic on the Gene Therapy for CNS Disorders market and offers a clear assessment of the projected market fluctuations during the forecast period. The different factors that are likely to impact the overall dynamics of the Gene Therapy for CNS Disorders market over the forecast period (2019-2029) including the current trends, growth opportunities, restraining factors, and more are discussed in detail in the market study.

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The key points of the Gene Therapy for CNS Disorders Market report:

The report provides a basic overview of the Gene Therapy for CNS Disorders industry including its definition, applications and manufacturing technology.

The report explores the international and Chinese major industry players in detail. In this part, the report presents the company profile, product specifications, capacity, production value, and 2018-2025 market shares for each company.

Through the statistical analysis, the report depicts the global total market of Gene Therapy for CNS Disorders industry including capacity, production, production value, cost/profit, supply/demand and Chinese import/export.

The total market is further divided by company, by country, and by application/type for the competitive landscape analysis.

The report then estimates 2018-2025 market development trends of Gene Therapy for CNS Disorders industry. Analysis of upstream raw materials, downstream demand, and current market dynamics is also carried out.

The report makes some important proposals for a new project of Gene Therapy for CNS Disorders Industry before evaluating its feasibility.

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There are 3 key segments covered in this report: competitor segment, product type segment, end use/application segment.

For competitor segment, the report includes global key players of Gene Therapy for CNS Disorders are included:

The key players covered in this studyGilead (Kite Pharma)Amgen (BioVex)NovartisRoche (Spark Therapeutics)Bluebird Bio

Market segment by Type, the product can be split intoEx VivoIn VivoMarket segment by Application, split intoHospitalsClinicsOthers

Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaJapanSoutheast AsiaIndiaCentral & South America

The study objectives of this report are:To analyze global Gene Therapy for CNS Disorders status, future forecast, growth opportunity, key market and key players.To present the Gene Therapy for CNS Disorders development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.To strategically profile the key players and comprehensively analyze their development plan and strategies.To define, describe and forecast the market by type, market and key regions.

In this study, the years considered to estimate the market size of Gene Therapy for CNS Disorders are as follows:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year 2020 to 2026For the data information by region, company, type and application, 2019 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.

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* Estimates 2018-2025 Gene Therapy for CNS Disorders market development trends with the recent trends and SWOT analysis

* Market dynamics scenario, along with growth opportunities of the market in the years to come

* Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects

* Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.

* Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years

* Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players

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LONDON--(BUSINESS WIRE)-- MiNA Therapeutics, the pioneer in RNA activation therapeutics, announced today the publication of data from its Phase I liver cancer trial, OUTREACH, in Clinical Cancer Research. It is the first publication in which a small activating RNA treatment (MTL-CEBPA) demonstrated clinical benefit. In addition, the Company provided an update on its ongoing clinical trials for lead program MTL-CEBPA and its drug discovery programs.

This landmark publication in Clinical Cancer Research details for the first time that RNA medicines can activate gene expression, providing clinical benefit to patients, commented Robert Habib, CEO of MiNA Therapeutics. As we enter into the second half of 2020, we continue to advance our clinical development objectives and uncover the vast opportunities inherent in our unique drug discovery pipeline.

Publication and OUTREACH Study Update

The publication in Clinical Cancer Research summarizes the results from MiNAs Phase I, open-label, dose escalation and dose expansion trial of MTL-CEBPA, OUTREACH, in adults with advanced Hepatocellular Carcinoma (HCC). Overall, MTL-CEBPA was well-tolerated and demonstrated pharmacodynamic target engagement, meeting the primary endpoint of the study. Furthermore, a reduction of suppressive immune cells in the tumour microenvironment as well as initial signs of potential synergistic efficacy when combined with standard of care tyrosine kinase inhibitors in HCC could be observed. These encouraging Phase I data validate the targeting of C/EBP- as a novel therapeutic strategy in cancer and prompted a Phase Ib study further evaluating MTL-CEBPA in combination with sorafenib in HCC. Enrolment for the Phase Ib part of the OUTREACH trial was completed in Q1 2020 and initial results will be presented during a poster session at the forthcoming American Society of Clinical Oncology (ASCO) on Friday, May 29, 2020. The framework for a subsequent Phase II clinical trial is currently being designed with the objective of initiating this next stage of clinical development in the second half of 2020.

The full Clinical Cancer Research publication is available on the Publications page of MiNAs website. A similar overview of the Phase I data was most recently presented at the European Society for Medical Oncology (ESMO) in September 2019.

TIMEPOINT Update

In March 2020, TIMEPOINT, a global Phase I/Ib clinical study of MTL-CEBPA in combination with anti-PD1 checkpoint inhibitor pembrolizumab in patients with advanced solid tumours was initiated and the first patient was treated. The study is designed to assess the safety, tolerability, pharmacology and clinical activity of MTL-CEBPA in combination with pembrolizumab in these patients. Recruitment for the study is expected to continue through 2021.

Discovery Programs

In parallel to the clinical trial developments, MiNA is further expanding its drug discovery pipeline with a focus on developing new drug candidates that can address a range of indications including genetic and metabolic diseases. Most recently in January 2020, MiNA validated its metabolic disease capabilities through the entry into a research collaboration with AstraZeneca, a global leader in the discovery and development of prescription medicines to treat metabolic diseases. MiNA remains well-positioned to build out its early-stage pipeline based on its saRNA approach which, through transcriptional activation, enables the modulation of previously undruggable targets.

About MTL-CEBPA

MTL-CEBPA is the first therapy to specifically up-regulate CCAAT/enhancer binding protein alpha (C/EBP-), a transcription factor that acts as a master regulator of myeloid cell lineage determination and differentiation. Dysregulated myeloid cells have been implicated in several diseases and identified as a critical barrier for many therapies to induce clinical responses in solid tumour cancers. In pre-clinical studies MTL-CEBPA has been shown to improve the anti-tumour activity of cancer therapies by targeting dysregulated myeloid cells and reducing their suppression in the tumour microenvironment.

About MiNA Therapeutics

Harnessing an innate mechanism of gene activation, MiNA Therapeutics' platform enables the development of new medicines that restore normal function to patients cells. We are applying our technology and clinical know-how to transform the therapy landscape of cancer and other severe diseases. http://www.minatx.com

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DetailsCategory: AntibodiesPublished on Wednesday, 27 May 2020 10:34Hits: 305

In CheckMate -9LA, Opdivo + Yervoy combined with two cycles of chemotherapy demonstrated superior overall survival versus chemotherapy, regardless of PD-L1 expression or tumor histology1

Approval marks sixth indication for Opdivo + Yervoy-based combinations across five types of cancer

Two Opdivo + Yervoy-based combinations are now approved in first-line lung cancer

PRINCETON, NJ, USA I May 26, 2020 IBristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.1 The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression.1 This application was reviewed under the FDAs Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.2 On May 15, the FDA approved Opdivo + Yervoy as a first-line treatment for certain patients with metastatic NSCLC whose tumors express PD-L11% as determined by an FDA-approved test.

Approval for Opdivo + Yervoy with limited chemotherapy is based on the pre-specified interim analysis from the Phase 3 CheckMate -9LA trial in which Opdivo + Yervoy combined with two cycles of platinum-doublet chemotherapy demonstrated superior overall survival (OS) versus chemotherapy (hazard ratio [HR] 0.69; 96.71% confidence interval [CI]: 0.55 to 0.87; P=0.0006) regardless of PD-L1 expression or tumor histology (minimum 8.1 months follow up).1,3 Median overall survival (mOS) was 14.1 months (95% CI: 13.2 to 16.2) versus 10.7 months (95% CI: 9.5 to 12.5), respectively.1 In a follow-up analysis at 12.7 months, the hazard ratio improved numerically to 0.66 (95% CI: 0.55 to 0.80), with mOS of 15.6 months (95% CI: 13.9 to 20.0) and 10.9 months (95% CI: 9.5 to 12.5).1,3 At one year, 63% of patients treated with Opdivo + Yervoy with limited chemotherapy and 47% of those treated with chemotherapy were still alive.3

Opdivo is associated with the following Warnings and Precautions including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion-related reactions; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1,4 Please see the Important Safety Information section below, including Boxed WARNING for Yervoy regarding immune-mediated adverse reactions.4

We have come a long way in understanding the role of dual immunotherapy-based approaches in cancer and the potential impact on patients long-term outcomes, said David P. Carbone, MD, PhD, CheckMate -9LA investigator and Director of the James Thoracic Oncology Center at The Ohio State University. The positive findings from CheckMate -9LA demonstrate the benefit of combining dual immunotherapy with limited chemotherapy for NSCLC patients regardless of PD-L1 status. With todays approval, more patients now have access to an Opdivo + Yervoy-based option and a chance at a longer life.1

In the trial, the overall response rate (ORR) per Blinded Independent Central Review (BICR) was 38% (95% CI: 33 to 43) for patients treated with Opdivo + Yervoy with limited chemotherapy and 25% (95% CI: 21 to 30) for patients treated with chemotherapy.

Non-small cell lung cancer is a complex disease that requires multiple treatment options to address the needs of different patient populations,5 said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb. This second approval of an Opdivo + Yervoy-based combination for the first-line treatment of advanced NSCLC now gives more patients access to a dual immunotherapy approach that can be administered with or without limited chemotherapy, depending on the patient and their PD-L1 status, and the possibility of a chance to live longer.1

Opdivo + Yervoy is a unique combination of immune checkpoint inhibitors, featuring a potentially synergistic mechanism of action that targets two different checkpoints (PD-1 and CTLA-4) to help destroy tumor cells: Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells discover the tumor.1,4,6 Some of the T cells stimulated by Yervoy can become memory T cells, which may allow for a long-term immune response.6,7,8,9,10,11 Targeting of normal cells can also occur and result in immune-mediated adverse reactions, which can be severe and potentially fatal.1 Please see the Important Safety Information section, including Boxed WARNING for Yervoy (ipilimumab) regarding immune-mediated adverse reactions.4

Receiving a diagnosis of advanced lung cancer is devastating,12 said Andrea Ferris, president and chief executive officer, LUNGevity. Todays announcement is welcome news as it provides a new dual immunotherapy-based option for previously untreated patients searching for a treatment that may help extend their lives.1

This application is part of the FDAs Project Orbis initiative, enabling concurrent review by the FDA and the health authorities in Australia, Canada and Singapore.

About CheckMate -9LA

CheckMate -9LA (NCT03215706) is a Phase 3, randomized open-label, multi-center study evaluating Opdivo + Yervoy combined with two cycles of platinum-doublet chemotherapy versus platinum-doublet chemotherapy (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic or recurrent NSCLC regardless of PD-L1 expression and histology.1 A total of 361 patients were treated with Opdivo + Yervoy with platinum-doublet chemotherapy until disease progression, unacceptable toxicity or for up to two years.1 A total of 358 patients were treated with platinum-doublet chemotherapy for four cycles and optional pemetrexed maintenance for non-squamous patients (if eligible) until disease progression or toxicity.1 The primary efficacy outcome measure of the trial was OS.1 Additional efficacy outcome measures included progression-free survival, ORR and duration of response as assessed by BICR.1

Select Safety Profile from CheckMate -9LA Study

Serious adverse reactions occurred in 57% of patients.1 Opdivo + Yervoy in combination with platinum-doublet chemotherapy were discontinued for adverse reactions in 24% of patients and 56% had at least one treatment withheld for an adverse reaction.1 The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis and respiratory failure.1 Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia and massive hemoptysis in the setting of thrombocytopenia.1 The most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%) and pruritus (21%).1

About Lung Cancer

Lung cancer is the leading cause of cancer death in the United States.12 The two main types of lung cancer are non-small cell and small cell.13 Non-small cell lung cancer is one of the most common types of lung cancer, and accounts for approximately 84% of diagnoses.13 Survival rates vary depending on the stage and type of the cancer when diagnosed.12

INDICATIONS

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. For this indication, OPDIVO 3 mg/kg is administered every 2 weeks with YERVOY 1 mg/kg every 6 weeks.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Bristol Myers Squibbs Patient Access Support

Bristol Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy.

BMS Access Support, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Support at 1-800-861-0048 or by visiting http://www.bmsaccesssupport.com.

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens for patients with cancer in Japan, South Korea and Taiwan.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

References

SOURCE: Bristol-Myers Squibb

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TheGlobal Canavan Disease Marketwas estimated to be valued at USD XX million in 2019 and is projected to reach USD XX million by 2026, at a CAGR of XX% during 2019 to 2026.

Canavan disease is an autosomal recessive degenerative disorder that causes progressive damage to nerve cells in the brain. The market is primarily driven by increasing prevalence of life threatening cerebral diseases. However, lack of awareness and lack of skilled neurologist might impede the market growth.

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Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins.

The key players profiled in the market include:Johnson & Johnson, GlaxoSmithKline plc., Novartis AG, Sanofi, F. Hoffmann-La Roche Ltd., Amgen, Inc., Turing Pharmaceuticals AG, Pfizer Inc., Aspa Therapeutics and BridgeBio

Key Benefits of the Report:

Global Canavan DiseaseMarket is spread across 121 pages

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On the basis of types, the market is split into:

Based on applications, the market is divided into:

Moreover, the market is classified based on regions and countries as follows:

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Target Audience:

Table Of Content

1 Introduction

2 Research Methodology

3 Executive Summary

4 Global Canavan Disease Market Overview

5 Global Canavan Disease Market, by Product Type

6 Global Canavan Disease Market, by Application

7 Global Canavan Disease Market by Region

8 Competitive Landscape

9 Company Profiles

10 Key Insights

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Magarpatta SEZ, Pune, ReportsnReportsprovides in depth study ofHemophilia Gene Therapy Marketusing SWOT analysis i.e. Strength, Weakness, Opportunities and Threat to the organisation. The Hemophilia Gene Therapy Market report also provides an in-depth survey of key players in the market which is based on the various objectives of an organisation such as profiling, the product outline, the quantity of production, required raw material, and the financial health of the organisation.

The global Hemophilia Gene Therapy Market is expected to witness a promising growth in the next few years. The rising level of competition among the leading players and the rising focus on the development of new products are likely to offer promising growth opportunities throughout the forecast period. The research study on the global Hemophilia Gene Therapy Market offers a detailed overview, highlighting the key aspects that are expected to enhance the growth of the market in the near future. The key segmentation and the competitive landscape of the market have also been mentioned at length in the research study.

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The global Hemophilia Gene Therapy Market is highly fragmented. Small market players operating at regional and local levels are challenging the market shares of the leading players (on the basis of cost differentiation and technical support services). In order to maintain their market shares, leading players are continuously developing new technologies and upgrading their existing products and services to enhance their product portfolios. Increasing competition is expected to drive innovation in the market, thereby helping the industry to overcome existing challenges in the field of healthcare mobility and at the same time address user compliance issues and unmet needs of the market.

Analysis on Strategies of Leading Players: Market players can use this evaluation to gain competitive advantage over their competition inside the global Hemophilia Gene Therapy Market.

Summary

Market OverviewThe global Hemophilia Gene Therapy market size is expected to gain market growth in the forecast period of 2020 to 2025, with a CAGR of xx% in the forecast period of 2020 to 2025 and will expected to reach USD xx million by 2025, from USD xx million in 2019.The Hemophilia Gene Therapy market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations.

Market segmentationHemophilia Gene Therapy market is split by Type and by Application. For the period 2015-2025, the growth among segments provide accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.By Type, Hemophilia Gene Therapy market has been segmented into Hemophilia A, Hemophilia B, etc.By Application, Hemophilia Gene Therapy has been segmented into Hemophilia A Gene Therapy, Hemophilia B Gene Therapy, etc.

Regions and Countries Level AnalysisRegional analysis is another highly comprehensive part of the research and analysis study of the global Hemophilia Gene Therapy market presented in the report. This section sheds light on the sales growth of different regional and country-level Hemophilia Gene Therapy markets. For the historical and forecast period 2015 to 2025, it provides detailed and accurate country-wise volume analysis and region-wise market size analysis of the global Hemophilia Gene Therapy market.The report offers in-depth assessment of the growth and other aspects of the Hemophilia Gene Therapy market in important countries (regions), including United States, Canada, Mexico, Germany, France, United Kingdom, Russia, Italy, China, Japan, Korea, India, Southeast Asia, Australia, Brazil and Saudi Arabia, etc. It also throws light on the progress of key regional Hemophilia Gene Therapy markets such as North America, Europe, Asia-Pacific, South America and Middle East & Africa.

Competitive Landscape and Hemophilia Gene Therapy Market Share AnalysisHemophilia Gene Therapy competitive landscape provides details by vendors, including company overview, company total revenue (financials), market potential, global presence, Hemophilia Gene Therapy sales and revenue generated, market share, price, production sites and facilities, SWOT analysis, product launch. For the period 2015-2020, this study provides the Hemophilia Gene Therapy sales, revenue and market share for each player covered in this report.The major players covered in Hemophilia Gene Therapy are: Spark Therapeutics, Freeline Therapeutics, Sangamo Therapeutics, Ultragenyx, uniQure, Shire PLC, BioMarin, Bioverativ, etc. Among other players domestic and global, Hemophilia Gene Therapy market share data is available for global, North America, Europe, Asia-Pacific, Middle East & Africa and South America separately. Global Info Research analysts understand competitive strengths and provide competitive analysis for each competitor separately.

The Hemophilia Gene Therapy Market industry development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed, and overall research conclusions offered.

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This report studies the Hemophilia Gene Therapy Marketstatus and outlook of Global and major regions, from angles of players, countries, product types and end industries; this report analyzes the top players in global market, and splits the Hemophilia Gene Therapy Marketby product type and applications/end industries. These details further contain a basic summary of the company, merchant profile, and the product range of the company in question. The report analyzes data regarding the proceeds accrued, product sales, gross margins, price patterns, and news updates relating to the company.

Other than the aforementioned parameters which Hemophilia Gene Therapy Market report focuses on, another imperative objective of the report is to present the Hemophilia Gene Therapy Market development across the globe especially in North America, Europe, China, Japan, Southeast Asia, India and Central and South America. In the report, the market has been categorized into manufacturers, type, application and regions.

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The report helps to identify the main Hemophilia Gene Therapy Marketplayers. It assists in analyzing Hemophilia Gene Therapy Market competitive environment, including company overview, company total revenue, market opportunities, value, production sites and facilities, SWOT analysis, product details. The study also reveals the sales, revenue and market share for each market player included in this report for the period of 2015-2020. It also helps to ascertain the growth drivers and future prospects for the forecast timeline.

Conclusively, this report is a one stop reference point for the industrial stakeholders to get Hemophilia Gene Therapy Marketforecast of till 2025. This report helps to know the estimated market size, market status, future development, growth opportunity, challenges, growth drivers of by analyzing the historical overall data of the considered market segments.

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