SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced data from the Phase II NOBILITY study, investigating the safety and efficacy of Gazyva (obinutuzumab) for adults with proliferative lupus nephritis. The study met the primary endpoint with Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrating superiority compared to placebo plus standard of care. Patients treated with Gazyva showed increasing rates of complete renal response (CRR) from week 52 to week 76, with 40% of patients in the Gazyva group achieving CRR, compared to 18% of patients in the placebo group at week 76 (p=0.007). Gazyva additionally met key secondary efficacy endpoints showing improved overall renal response (complete or partial renal responses) and serologic markers of disease activity as compared to placebo. No new safety signals were observed with Gazyva in the study at the time of this analysis. Through week 76, serious adverse events (24% vs. 29% in placebo group) and serious infections (6% vs.18% in placebo group) were not increased with Gazyva. These data will be presented at the 2019 American College of Rheumatology (ACR) Annual Meeting in Atlanta, Georgia, on November 10, 2019 (Abstract 939).

We are very encouraged by the positive results from the NOBILITY study, which suggest that Gazyva may provide a clinically meaningful benefit for adults with proliferative lupus nephritis; a condition for which there is a strong need for more effective and targeted treatment options, said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. These results support the continued development of Gazyva for people with lupus nephritis and underscore our longstanding commitment to pursue new treatment options that may benefit the lupus community.

Lupus nephritis is a severe and potentially life-threatening manifestation of systemic lupus erythematosus resulting from inflammation of the kidneys, with proliferative lupus nephritis being the most severe form and associated with high-risk of end-stage renal disease and death. In September 2019, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to Gazyva for adults with lupus nephritis based on the Phase II NOBILITY study data. Genentech will initiate a Phase III study for Gazyva in lupus nephritis in 2020.

Phase II data from the NOBILITY study was also presented as a late-breaking oral presentation at the American Society of Nephrologys (ASN) Kidney Week 2019 in Washington, DC, on November 8, 2019 (Abstract FR-OR136).

An audio webcast for analysts and investors on the Phase II NOBILITY study data will be held on Tuesday, November 12, 2019 from 4:30-5:30 p.m. CET / 10:30-11:30 a.m. ET. Further details are available here.

Lupus nephritis overwhelmingly impacts women, particularly young women of color. About 90% of those diagnosed with lupus are women, and African American, Hispanic, Native American and Asian American women are two to three times more likely than Caucasian women to get lupus. Genentech is committed to addressing barriers to clinical trial participation and advancing inclusive research to create new standards for clinical studies. Genentech is taking action to recruit a broader, more diverse population of participants into clinical trials, including diseases such as lupus nephritis, to ensure clinical trial participants more closely reflect those impacted by the disease for which a medicine is being studied. To learn more about Genentechs efforts in this area, please visit https://www.gene.com/inclusiveresearch.

About the NOBILITY Study

The Phase II, randomized, double-blind, placebo-controlled, multi-center study, NOBILITY (NCT02550652), compared the safety and efficacy of Gazyva, combined with mycophenolate mofetil (MMF) or mycophenolic acid (MPA) and corticosteroids, to placebo, combined with MMF or MPA and corticosteroids, in adult patients with ISN/RPS 2003 class III or IV proliferative lupus nephritis. The study enrolled 125 people who were randomized to receive Gazyva or placebo infusions on days 1, 15, 168, and 182. The primary endpoint was the proportion of participants who achieved a protocol-defined complete renal response (CRR) at 52 weeks. Key secondary endpoints included overall renal responses (complete or partial renal response) and serologic markers of disease activity, as compared to placebo. Patients were followed in a blinded fashion through week 104, and patients with persistent B-cell depletion are being followed for safety and continued B-cell measurements.

About Lupus Nephritis

Lupus nephritis is a severe and potentially life-threatening disorder of the kidneys. Lupus nephritis is one of the most severe manifestations of systemic lupus erythematosus (SLE), an autoimmune disease where a person's own immune system attacks healthy cells and organs, including, in the case of lupus nephritis, the kidneys. This causes kidney inflammation and may lead to blood and/or protein in the urine, high blood pressure, poor kidney function, or kidney failure. An estimated 1.5 million Americans are affected by lupus, with approximately 70% of cases representing SLE. Up to 60% of people with SLE will develop lupus nephritis, and up to 25% of people with the condition develop end-stage renal disease. Lupus overwhelmingly impacts women, particularly young women of color. About 90% of those diagnosed with lupus are women, and African American, Hispanic, Native American and Asian American women are two to three times more likely than Caucasian women to get lupus. Currently, there is no cure for lupus or lupus nephritis.

About Gazyva

Gazyva is an engineered monoclonal antibody designed to attach to CD20, a protein found only on certain types of B-cells. It is thought to work by attacking targeted cells both directly and together with the body's immune system. Gazyva is part of a collaboration between Genentech and Biogen. Combination studies investigating Gazyva with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

Gazyva Indications

Gazyva (obinutuzumab) is a prescription medicine used:

Important Safety Information

The most important safety information patients should know about Gazyva

Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that can become serious or life-threatening, including:

Who should not receive Gazyva:

Patients should NOT receive Gazyva if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to Gazyva. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in Gazyva in the past.

Additional possible serious side effects of Gazyva:

Patients must tell their doctor right away about any side effect they experience. Gazyva can cause side effects that may become severe or life threatening, including:

The most common side effects of Gazyva in CLL were infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.

The safety of Gazyva was evaluated based on 392 patients with relapsed or refractory NHL, including FL (81%), small lymphocytic lymphoma (SLL) and marginal zone lymphoma (MZL) (a disease for which Gazyva is not indicated), who did not respond to or progressed within six months of treatment with rituximab product or a rituximab product-containing regimen. In patients with follicular lymphoma, the profile of side effects that were seen were consistent with the overall population who had NHL. The most common side effects of Gazyva were infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness and urinary tract infection.

A randomized, open-label multicenter trial (GALLIUM) evaluated the safety of Gazyva as compared to rituximab product in 1,385 patients with previously untreated follicular lymphoma (86%) or marginal zone lymphoma (14%). The most common side effects of Gazyva were infusion reactions, low white blood cell count, upper respiratory tract infection, cough, constipation and diarrhea.

Before receiving Gazyva, patients should talk to their doctor about:

Patients should tell their doctor about any side effects.

These are not all of the possible side effects of Gazyva. For more information, patients should ask their doctor or pharmacist.

Gazyva is available by prescription only.

Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit http://www.Gazyva.com for the Gazyva full Prescribing Information, including BOXED WARNINGS, for additional Important Safety Information.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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Genentech's Gazyva (obinutuzumab), in Combination With Standard of Care, More Than Doubles the Percentage of Lupus Nephritis Patients Achieving...

Recommendation and review posted by Bethany Smith

We are lucky to have two of the most knowledgable golf gearheads in our office. And they are sharing their golf equipment knowledge with you. Golf Digest's equipment editors, Mike Stachura and E. Michael Johnson, have covered the golf equipment business for decades, and there are few who know the equipment industry better. We've asked them to answer your questions in a weekly equipment round-up. Tweet them any equipment questions you have, and they might answer your questions next week. (Click here or here to ask them a question.)

Drivers are hit at most 14 times a round while irons are hit 40+ times a round. Plus the average golfer hits less than 20 percent of their greens in regulation. So why not a bigger effort to create more forgiving, longer irons? @TedWilliams2017

Ahh, the Splendid Splinter, back from cryonics, good to hear from you. Perhaps the fact that youve been in the deep freeze for a couple decades might explain your mistaken understanding of the current golf club technology landscape. The good news is the technology in irons is vastly improved over the past 15 years, sort of like how baseball bats are better now that theyre not made of wood anymore. Of course, the primary reason for better iron designs is that much of the same technologies that have made drivers so awesome have found their ways into irons. Super thin faces? Check. Variable face thicknesses? Check. Multiple materials and dramatic weight savings that allow for a lower center of gravity and higher flight? Check and double check. Those technologies came to drivers first, because, well, as has been said, chicks dig the long ball. But secondly, its a lot easier to work within the structure of a hollow, 460-cubic-centimeter, pie-plate-faced driver than it is in the oddly asymmetrical shape of an iron. But that hasnt stopped progress in irons.

We just finished at looking at more than 70 irons for the 2020 Hot List, and wed guess that at least 95 percent of them have faster faces than they did as little as two years ago. Today, there are a whole bunch of irons with springlike effect very near or in some cases exceeding that of drivers. (OK, technically, no face can violate the springlike effect rules. But some irons are getting pretty spicy hot these days.) Heres another key point, not only are irons hotter today, its easier to make them fly higher, too. In one of our recent tests, we found that not only did new 7-irons go farther than 6-irons from a decade ago, they flew as higher or higher than many of those old 7-irons, too. Even comparing 7-irons from just a handful of years ago, we saw sometimes as much as a 20-yard distance advantage and on average a three-yard gain in carry distance on mis-hits and two yards higher flight. In short, today's irons are longer with better stopping power. And we havent even begun to address the advancements in hybrids or even utility irons that make your old long irons not even worth saving, cryonically or any other way you might choose.

Someone explain to me why lofts have been evolving and getting stronger. Or as Brandel Chamblee calls it, "loft creep." Im guessing guys can dial these clubs in and hit all sorts of trajectories high/low/mid even with the stronger lofts and the distance gained is coveted. @WeekendHack_YT

Dear Hack: Some of this is about physics and some of this is about business. First, the latter: If you want to sell clubs these days, particularly irons, you have to have technology that generates ball speed that shows up on a launch monitor. More ball speed means more distance. Of course, the easiest and fastest way to generate ball speed is not some super thin, heat-treated magic steel alloy. Its by making your 7-iron stronger lofted than someone elses. Weve even heard some manufacturers have taken to retool their demo clubs to a stronger loft than their standard just so they can better compete with other companies lower lofts. Messy, of course, when the 7-iron you got fit for in the shop is longer than the 7-iron that you actually buy, but thats why you should ask an extra question or two about the lofts of the irons youre testing. Not all 7-irons are, well, 7-irons.

Still, there also is some serious physics happening here. As club technologies have allowed for the center of gravity to get lower (leading in some cases to higher launch), an iron can then be designed with a stronger loft that takes advantage of that higher launch. Faster ball speed with the same or higher launch means more distance and a better landing trajectory. Thats why when you start seriously testing potential new irons, dont just look at distance. Use the modern technology of a launch monitor to assess those landing angles. Ideally, you want your shots to have a landing angle of more than 45 degrees for best performance coming into a green. The one problem with these stronger lofts in your middle irons: Bad distance gaps in your short irons. If the set youre eyeballing features a pitching wedge with less than 45 degrees of loft, our recommendation is to add another wedge every 4-5 degrees. The more full swings you can make at the short end of the set, the more scoring youll be doing with the scoring clubs.

If Im measured at a D3 swingweight for a driver, should I apply that same weight to all clubs I buy? @NBMH1

Although it certainly would seem logical that you would want all of your clubs to effectively feel the same as you swing them, fact is, from doing dozens of Whats In My Bags with tour pros for Golf Digest, weve seen it both ways. Some players like to keep all their swingweights the same (although sand and lob wedges tend to have a heavier swingweight), while some have numerous different swingweights with their clubs. Tony Finau, for instance, is D-6+ in his driver and D-4 in his fairway wood, although they rarely vary widely. So although consistency is generally a good thing, its not an absolute. If it feels good to you when youre swinging it, theres probably not much need to mess around with it.

RELATED: Golf equipment truths: Do drivers lose their pop?

Have the changes in wedge grooves in the last six years made a significant difference? @cfkuon

Actually, the new regulations on grooves went into effect in 2010, so it has been almost 10 years that wedge designers have been working within the new framework. Its interesting that back then the rule was viewed as spin Armageddon. Phil Mickelson and Padraig Harrington started using original Ping Eye2 lob wedges because its grooves were grandfathered in and Stewart Cink even went so far as to practice with duct tape on the face of his wedges, feeling that would be the equivalent of the new, less-aggressive grooves. But club designers are smart people and as many of them will tell you, while they dont like to have design within a box, a new rule always provides an opportunity to best figure out how to design within it. Thats what has happened here. Today golfers still apply plenty of spin to the ball and can hit pretty much all the shots they need to. Designers have explored areas such as edge radius and surface roughness, making designs with more grooves closer together and ones that even employ a half-groove on the bottom of the face to squeeze out as many revolutions per minute of spin they can. A significant difference? That might actually be an understatement.

RELATED: Golf equipment truths: Is your golf shaft robbing you of yards?

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Golf equipment truths: Iron faces are nearly as fast as a drivers. Here's why - Golf Digest

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MILWAUKEE -- The earlier you catch breast cancer, the better your odds are of beating it. That is the idea behind the FOX6 initiative, Buddy Check 6.

Birthdays are a time to celebrate -- especially the big ones like turning 30 years old -- which is what Antonina Sendik was doing last month.

"I'm one of the lucky ones," Sendik said.

In fact, you might say Sendik is just starting her life.

"It's been a very emotional six months," Sendik said.

Sendik's father has had two brain tumors and was recently diagnosed with a disease called Cowden's Syndrome. It is a red flag that Sendik and her five siblings may have inherited the gene mutation that can cause a host of health problems. Doctors recommended genetic testing. They found Sendik had an 86 percent chance of developing breast cancer.

"I had no symptoms. I felt fine besides what was on the inside," Sendik said. "We started talking then about -- I'm probably going to have a double mastectomy."

Sendik learned that reality just a few months ago.

"You never think this is going to happen to you or this can't happen to me," Sendik said. "I would have loved to have blown it off. Learning that risk, I had no choice.

Sendik's doctor felt the same.

"With the genetic mutation, we knew that the risk was there," Dr. Caitlin Patten said.

"She said my job is to keep you safe -- and that's what I'm going to do," Sendik said.

With that, Sendik decided to go through with the surgery. It was a success. Post-surgery, the breast tissue that was removed was tested.

"So there were cancer cells. But it hadn't broken outside the duct -- it hadn't spread anywhere," Sendik said.

Sendik was relieved.

"She got it, it's gone, it's out of me," Sendik said.

Sendik does not need radiation or chemotherapy because the cancer is gone. She just needs to maintain a healthy lifestyle -- and keep regular appointments with her doctor.

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Genetic testing leads woman to take steps to avoid breast cancer: Im one of the lucky ones - WITI FOX 6 Milwaukee

Recommendation and review posted by Bethany Smith

LUBBOCK, Texas Family trees show where youve been.

But the family tree that genetic counselor Julie Beasley shows her patients at Joe Arrington Cancer Center shows what their future could look like.

Genetics is important for everybody no matter your gender, your race, your age, explained Beasley. Genetic testing and family history can play a vital role in healthcare for any role in any race.

She talks to people who have cancer or family history of cancer and helps them figure out if something is hereditary or can expose them to cancer in their family.

Its important to know your family history to get an idea of whats in your family but not just what they were diagnosed with but how old were they or was it a rare type of cancer, Beasley explained.

This testing can help patients get diagnosed earlier or could prevent it all together.

Interpreters are also available for people who dont speak English so they can also understand what is going on.

I think its very important because sometimes theyre scared to come in because of the diagnosis but if they dont completely understand whats going on then they may not be willing to come back, said Delia Rubio, intake coordinator at Covenant Health. This way theyre informed and they know.

Beasley hopes patients will see the importance of genetic testing and how it can benefit people in the future.

If patients know its there we can help them with managing it so they dont worry as much and they can put that behind them, said Beasley.

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Healthcast: The importance of genetic testing - KLBK | KAMC | EverythingLubbock.com

Recommendation and review posted by Bethany Smith

An Alabama genetic research institute said today it has screened the DNA of 4,200 Alabama men and women for cancer risk and found it in about 150 people or 3 percent.

More than half of that 150 have no strong family history of cancer, researchers at the HudsonAlpha Institute of Biotechnology in Huntsville said today at the institutes annual Tie the Ribbons lunch supporting breast and ovarian cancer research.

The free and low-cost screening program called Information is Power is now entering its fifth year. The test was developed by genetic testing company Kailos Genetics and screens for the well-known BRCA1 and BRCA2 genes plus several others linked to breast, ovarian, colon and other cancers.

Researcher Sara Cooper said the lack of family history in positive test subjects is why this initiative is so important. Testing can fill the gaps in family history with facts, she said.

The screening is available free for men and women between the ages of 28 and 30 living in Madison, Jackson, Limestone, Marshall and Morgan County. Its available for $129 any other person 19 or older wishing to take it.

Cooper said genetic testing can also reveal risk of other medical issues beyond cancer, including cardiovascular disease. It can also help identify medications individuals might want to avoid given their genetic profile and dosage levels that are best for individual patients.

This work is part of a budding initiative at the institute, Cooper said, and it will launch in Alabama within the next year.

It took decades to identify the genes Americans are now tested for as risks, Cooper said. Even when we know what those genes are, we have to develop the technology to efficiently test people and find the changes in their DNA, she said.

There is still work to be done, she said. There are genes researchers havent found that contribute to cancer risk. There are new DNA changes discovered in genes already associated with cancer. These changes have uncertain significance, and HudsonAlpha is developing research techniques to determine whether those changes are meaningful.

The research were doing today lays the foundation for tomorrows success, Cooper said.

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DNA screening of 4,200 Alabamians warns them, helps science - AL.com

Recommendation and review posted by Bethany Smith

The University of Vermont Health Network has begun a pilot project to offer Genomic DNA Testing to patients as part of their clinical care. The pilot program is the beginning of an effort to increase the integration of genetic disease risks into routine medical care, which holds promise for providing Vermonters with valuable information to guide their health decisions.

"Our overall health and longevity are determined about 30 percent by genetics," said Debra Leonard, MD, PhD, Chair, Pathology and Laboratory Medicine. "But until now, most of our clinical health care decisions have been made without understanding the differences in each individual's DNA that could help guide those decisions."

Patients who choose to get the Genomic DNA Test can learn about differences in their DNA that make certain diseases more likely, such as cancer and heart disease. Knowing these genetically-determined disease risks may help patients and health care providers adjust their care to keep people as healthy as possible. While genetic testing to identify the cause of a patient's symptoms to reach a diagnosis is now common in health care, proactive genomic testing to identify health risks across a population is just beginning to be considered, and most projects are being done only in the research setting.

The UVM Health Network is partnering with Invitae and LunaPBC on the pilot project. Invitae will provide information for 147 genes that are well-established indicators of increased risk for certain diseases for which clinical treatment guidelines are established. The test also screens for carrier status for other diseases. Follow-up testing for family members will be provided when appropriate.

"Nearly 1 in 6 healthy individuals exhibits a genetic variant for which instituting or altering medical management is warranted," said Robert Nussbaum, MD, Chief Medical Officer of Invitae. "Genetic screening like the Genomic DNA Test in a population health setting can help identify these risk factors so clinicians can better align disease management and prevention strategies for each patient."

The UVM Health Network is offering the Genomic DNA Test as part of clinical care, but health and genomic data can also help researchers learn more about health and disease. Patients who get the test can consent to securely share their data with researchers through LunaDNA, partner LunaPBC's sharing platform. LunaDNA provides patients with the opportunity to share their genomic and electronic health record information to advance health and disease management research. In the future, patients will also be able to share lifestyle, environment, and nutrition data.Shared data is de-identified and aggregatedduring studiesto protect the privacy of each patient while being used to answer important medical research questions.

"Vermonters who choose to share their genomic data for research will play a leading role in the advancement of precision medicine," said Dawn Barry, LunaPBC President and Co-founder. "This effort puts patients first to create a virtuous cycle for research that doesn't sacrifice patients' control or privacy.We are proud to bring our values as a public benefit corporation and community-owned platform to this partnership."

Dr. Leonard spoke about the project, the UVM Health Network's partnership with LunaPBC and Invitae, and the role of genomics in population health on Monday at the Santa Fe Foundation's Clinical Lab 2.0 Workshop in Chicago, a national conference at which pathologists and healthcare leaders from across the country share ways that pathology can be integral to improving population health.

"Vermont and other states are moving away from 'fee-for-service' health care and toward a system that emphasizes prevention, keeping people healthy and treating illness at its earliest stages," Dr. Leonard said. "Integrating genetic risks into clinical care will help patients and providers in their decision-making."

The pilot project began on Friday, November 1, when the first patient agreed to have the test. During the pilot stage of the project over the next year, the Genomic DNA Test will be offered to approximately 1,000 patients over the next year who: are at least 18 years old; receive their primary care from a participating UVM Health Network Family Medicine provider; are not currently pregnant or the partner of someone who is currently pregnant; and are part of the OneCare Vermont Accountable Care Organization (ACO), a care coordination and quality improvement organization.

Patients do not have to pay for the test or for discussions with the UVM Health Network's Genomic Medicine Resource Center's genetic counselors before and after testing. The test uses a small amount of blood, and focuses on the parts of a patient's DNA that most affect health and health care. Results will go into each patient's medical record, protected like all medical information, and available to the patient and all of their health care providers.

"Much work has gone into getting ready to start this project and it has taken an entire team," Dr. Leonard said. "Providers from Family Medicine, Cardiology, the Familial Cancer Program, Medical Genetics and Pathology, patient and family advisors, ethics and regulatory compliance leaders, Planning, Finance and OneCare Vermont have all worked together to get us across the start line for this initiative."

Patients should be aware that the UVM Health Network will never call them on the phone to ask them to get this test. Testing is arranged through a patient's primary health care provider and only if the patient agrees to have the test.

THE FUTUREIt's understanding technology that gets us an edge to find the "next Apple," or the "next Amazon."

This is what CML Pro does. We are members of Thomson First Call -- our research sits side by side with Goldman Sachs, Morgan Stanley and the rest, but we are the anti-institution and break the information asymmetry.

The precious few thematic top picks, research dossiers, and one-on-one CEO interviews, are available for a limited time.Join Us: Discover the undiscovered companies that will power technology's future.

Thanks for reading, friends. The author is long shares of Invitae at the time of this writing.

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The University of Vermont Initiates Genomic DNA Testing in Partnership With Genomics Leader Invitae (NYSE:NVTA) as Cigna Joins Invitae's Covered Lives...

Recommendation and review posted by Bethany Smith

"Genetics" is a word that is often tossed around in the cannabis industry. Even before the boom in legal cannabis, plant enthusiastsknew the value that gene science could add to the recreational and medical experience.

For the most part, efforts in genetic research surrounding cannabis have been focused on the plantinstead of the user.

Cannabis sativas genetic material has been thoroughly studied and dissected, but the quest to understand how our own genes interact with the plant is still in its early stages. Enough knowledge about human-cannabis interaction has been gathered, however, for companies to leave the realm of academic research and enter the commercial space.

Today, if you have $200 and a mailing address, you can obtain a personalized DNA test that will analyze your unique genetic characteristics and explain what type of cannabis best fits your genetic profile.

After a simple cheek swab, these companies can obtain your entire DNA sequence. Their analysis lets them find out the 1% of DNA that makes you special, and then contrast this data to peer-reviews studies on medical cannabisto recommend a method of consumption; aCBD-to-THC ratio; or a selected terpene profile.

What were doing is, were looking at the genetics in a persons body to determine how the body is going to process and respond to cannabis and the compounds that are in cannabis products, said Dr. Charles Sailey, genetic research partner at MelixGX, a company offering genetic testing.

The company's testing system is basedon certain variants that people have in their DNA that cause each individualto respond differently, such as the gene that encodes an enzyme that processes THC or CBD or a gene that encodes the receptors where cannabinoids and terpenes bind.

After looking at all these variants, MelixGXcomes up with an algorithm that predicts the way a person will respond to a particular cannabis product.

Both companies interviewed we spoke raised the issue of a slewof competitors offering the same service.

A clear rift exists between companies doing the genetic tests themselves and expanding research with in-house scientific teams, and those that lack academic expereience and offer a diluted version of the tests without proper scientific support, the execs said.

Consumers looking to take these tests for themselves are advised to look into the company they hire to ensure the best quality is achieved.

Endocanna Health was one of the first companies in the cannabis space to offer this service.

CEO Len May was focusing his studies on plant genetics when he realized that people have different experiences when they consume the same exact cultivar.

That led him to start the company with the goal of finding out which genes and snips single-nucleotide polymorphisms affect the endocannabinoid system, directly or indirectly, he told Benzinga.

The CEO walked us through the way Endocanna makes recommendations after obtaining a users DNA code.

Every single thing that we say has a reference associated to it. Now, the references are given a different weight. If theres a completed human trial, that gets a grade of a 4. If a study is done on an animal, then it gets a 3. If its done in-vitro, then it gets a 2. And if its an observational study, then it gets a 1. These are all peer-reviewed.

If a study is too specific, Endocanna's scientific team will not accept it.

After having created this database, which is updated as new studies come out,the company came up withthe symptomatic conditions, or traits, that relate back to the use of cannabis and where genetics make a difference. These traits includeanxiety, depression, cognitive function, increased chance of pain, sleep and psychosis.

These are all things that people would use cannabis for, so theres three different variables," May said:

If all these three are positive, Endocanna will make a suggestion to the user, the CEO said.

Dont miss out on the top cannabis stories of the day. Click here to sign up for our daily insider newsletter.

Most people in the cannabis space are aware of the fact that, given the U.S. federal ban on cannabisand the drugs classification as a Schedule 1 narcotic, scientific research licenses are difficult to come by.

This situation widely limits the amount of research done on the plant.Thats why we couldnt help but wonder if the scientific community has obtained enough data for companies like Endocanna and MelixGXto make precise recommendations to patients and customers.

Benzinga raised this question withRob Dhoble, an expert in cannabis science and Managing Director of Havas ECS, a consulting firm focused on cannabis communications that is part of the Havas Group.

The companies face a policy dilemma, he said.

Since these companies work under the principle of cannabis as a medicine, and the DEA is still considersmarijuana to have no medical value federally, their products cannot be approved medical devices, and therefore the algorithms they use are in contradiction withfederal law, Dhoble said.

Endoncanna's May said there will never be enough scientific research to be 100% sure of anything.

The technology behind his company and others is ready to make peoples lives better, the CEO said.

Theres over 15,000 articles alone in pubmed on cannabis, he said.

We dont make any claims, we dont make recommendations, we make suggestions. But people have to be cautious, because the cannabis industry is ever-changing. So, do we need more research? Definitely. We encourage everybody to do research, because that research gets fed into our system, and we will get better.

MelixGX's Sailey saidhis company is solely focusing on anxiety, pain and insomnia at thistime, since these are the three areas in which they were able to secure a reasonable amount of data from over 4,000 publications.

Dr. Susan Trap is a Ph.D. researcher who has done extensive research on terpenes and their therapeutic applications.

In general, these pharmacogenetic tests are useful for the novice user to generalize which strains indica, sativaor hybridbest suit their specific cannabis profile, she told Benzinga.

But in her opinion, thesetests still require much more data sampling in order to increase their accuracy, and Trap said thesewill only come with time.

Dr. Jordan Tishler, a Harvard physician and President of the Association of Cannabis Specialists, said the genetic testing companies are headed in the right direction, but said there are several caveats to the way they operate today.

Tishler is skeptical of any kind of suggestion made outside of a medical context since there may be other illnesses, characteristics, medications or situations that are not apparent simply from the genetic material and need to be factored into any medical recommendation.

No field of medicine would base action solely on one test result, he said.

Genetic testing should be used only at the recommendation or order of a treating clinician, and results should be sent to that clinician for interpretation, communication to the patient,and action as needed.

Dr. Levan Darjania has over 18 years of research experience in the biotech and pharma space and is the chief scientific officer at Vertical Wellness.

"This is just a fresh start that requires way more definitive and specific preclinical and clinical studies and validations before it can be recommended as a 'solution'to patients and users."

Picture byArek SochafromPixabayandNikita Golubevfrom Flaticon.

2019 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Go here to see the original:
The Companies Offering DNA Testing To Find The Best Cannabis For You - Benzinga

Recommendation and review posted by Bethany Smith

The Fulton County Health Department has scheduled the following health clinics and services.

CANTON The Fulton County Health Department has scheduled the following health clinics and services. Please call the number listed with each service for an appointment or more information.

All offices of the Fulton County Health Department will be closed Monday, Nov. 11, 2019 in observance of Veterans Day.

Maternal child health: Health screenings, WIC nutrition education and supplemental food coupons for women, infants and children. To make an appointment or for more information call 647-1134 (ext. 254). For Astoria clinic appointments call 329-2922.

Canton - WIC Nutrition Education - Tuesday, Nov. 12 - 8-4 - Appt needed

Astoria - Clinic, WIC Nutrition Educ. - Wednesday, Nov. 13 - 9-3 - Appt needed

Canton - Clinic - Thursday, Nov. 14 - 8-4 - Appt needed

Adult Health Immunizations: Various vaccines are available. There is a fee for immunization administration. Medicaid cards are accepted. To make an appointment or for more information call 647-1134 (ext. 254).

Canton - Immunizations - Tuesday, Nov 5 - 4-7 - Appt needed

Canton - Immunizations - Wednesday, Nov 6 - 8-4 - Appt needed

Other times available by special arrangement at Canton, Cuba and Astoria.

Blood Lead Screening: Blood lead screenings are available for children ages one to six years. A fee is based on income. To make an appointment or for more information call 647-1134 (ext. 254). For Astoria appointments call 329-2922.

Family Planning: Confidential family planning services are available by appointment at the Canton office for families and males of child-bearing age. Services provided include physical exams, pap smears, sexually transmitted disease testing, contraceptive methods, pregnancy testing, education and counseling. Services are available to individuals of all income levels. Fees are based on a sliding fee scale with services provided at no charge to many clients. Medicaid and many insurances are accepted. After hours appointments are available. To make an appointment or for more information call the 647-1134 (ext. 244). *Program funding includes a grant from the US DHHS Title X.

Pregnancy testing: Confidential urine pregnancy testing is available at the Canton and Astoria offices. This service is available to females of all income levels. A nominal fee is charged. No appointment is needed. A first morning urine specimen should be collected for optimal testing and brought to the health department. Services are provided on a walk-in basis on the following days each week:

Canton: Every Wednesday & Thursday, 8-3:30 (for more information call 647-1134 ext. 244)

Astoria: Every Wednesday, 9-2:30 (for more information call 329-2922)

Womens Health: A womens clinic for pap tests, clinical breast examinations and vaginal examinations is available by appointment. There is a nominal fee for this service. Medicaid cards are accepted. Financial assistance is available for a mammogram. Cardiovascular screenings may be available to age and income eligible women. To make an appointment or for more information call 647-1134 (ext. 244).

Mammograms: Age and income eligible women may receive mammograms at no charge. Speakers are available to provide information to clubs and organizations. For more information or to apply for financial assistance, call 647-1134 (ext. 254).

Mens Health: Prostate specific antigen (PSA) blood tests are available for men for a fee. To make an appointment or for more information call 647-1134 (ext. 224).

Sexually Transmitted Disease (STD) Clinic: Confidential STD and HIV testing services are available by appointment to males and females at the Canton office. Services include physical exams to identify STDs, a variety of STD testing, HIV testing, education, counseling, medications and condoms. There is a nominal fee for services. Services are available to individuals of all income levels. Medicaid cards are accepted. To make an appointment or for more information call 746-1134 (ext. 224).

HIV Testing and Counseling: Confidential HIV testing and counseling services are available by appointment through the sexually transmitted disease (STD) clinic at the Canton office. To make an appointment or for more information call 647-1134 (ext. 224).

Tuberculosis (TB) Testing: TB skin tests are available at no charge by appointment. To make an appointment or for more information call 647-1134 (ext. 254).

Blood Pressure Screenings: The Fulton County Health Department provides blood pressure screenings at no charge on a walk-in basis during the following times:

Astoria - Screening - Wednesday, Nov. 13 - 9-12 - Walk in

Health Watch Wellness Program: The Health Watch Program provides low cost lab services. Through this program adults can obtain venous blood draws for a variety of blood tests. Blood tests offered without a doctors order Comprehensive Metabolic Panel (CMP), Complete Blood Count (CBC), Lipid Panel, Prostate Specific Antigen (PSA) test, Hepatitis C test, and Thyroid Stimulating Hormone (TSH). A wide variety of blood tests are also available with a doctors order. There is a charge at the time of service. To make an appointment or for more information call 647-1134 (ext. 254).

Dental Services: The Dental Center offers a variety of basic dental services to children and adults. An appointment is needed. Medicaid and Kid Care cards are accepted. To make an appointment or for more information call 647-1134 (ext. 292).

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Health Department announces services for the week of Nov 11 - Canton Daily Ledger

Recommendation and review posted by Bethany Smith

(Picture Credit: JOHANNES EISELE/AFP via Getty Images)

Its no surprise that dogs can soothe us when we feel troubled. But research shows bonding with dogs has positive benefits even on a biological level.

Dogs elevate levels of the hormone oxytocin in our bodies, which promotes feelings of trust and well being. Oxytocin also heightens our ability to interpret facial expressions, helps us overcome paranoia, and has positive effects on our social interactions.

These benefits are, in many ways, directly opposite of many of the symptoms returning military veterans experience when they suffer from PTSD.A pet is a medication without side effects that has so many benefits, saysMayo Clinic oncologist Dr. Edward Creagan.

Symptoms of post-traumatic stress disorder, commonly known as PTSD, can appear right away or take years to surface.

Returning soldiers often experience it because they faced danger to their lives or the lives of their fellow soldiers, and they had no control over the situation. They witnessed injuries or death, or they themselves also suffered physical harm.

The shell shock and combat stress symptoms common among those suffering from PTSD are varied; however, many experience suicidal thoughts, recurring memories and nightmares, sleeplessness, a loss of interest in life or feeling numb, anger, irritation, and fear. PTSD can thus impact their everyday life.

A trained PTSD service dog can provide a sense of security and have a calming effect on veterans, help with episodes of depression, anxiety, and PTSD, and they can also be loving companions.

These dogs can sense mood and will know when its a difficult day. Additionally, organizations train them to respond to PTSD episodes and help bring their humans back to a relaxed state.

Furthermore, they give companionship without judgment, bringing joy into lives as they help heal emotional wounds.

As a wonderful bonus, its often a new lease on life for the dogs, as well.

Many service dogs trained to help those suffering from PTSD have been on a difficult journey of their own and are rescues who were mistreated or abandoned, living in shelters.

Organizations train these dogs to alert veterans to potential PTSD triggers and to help them ease their anxieties. Its a win-win situation when a dog is rescued and gains a secure home and purpose, and the veteran gets a companion to help diminish the emotionally destructive feeling of isolation.

If you are a veteran or know one who could benefit from a trained service dog, there are dozens of organizations who can help.

DogTime interviewed K9s For Warriors, an organization that trains service dogs and provides them to veterans free of charge.

Here are a few other organizations that can help veterans find companion animals and service dogs:

As we approach Veterans Day and honor those whove valiantly served and sacrificed for our country, its also a good time to spread the word about the many organizations and non-profits that it possible for veterans with PTSD to be matched with canine companions.

There are many fabulous organizations in cities and towns throughout the countrydedicated to helping returning military rebuild their lives with help from an assistance dog.

Additionally, more information and PTSD resources are available through the US Department of Veterans Affairs website.

You can also help by reaching out to these organizations, donating and volunteering. They need lots of help, and most have a variety of volunteer positions available. Its a beautiful way to show your gratitude to those whove served.

Do you think dogs can help veterans with PTSD return to civilian life? Let us know in the comments below!

Originally posted here:
Dogs Help Veterans With PTSD Heal And Live Their Lives, And You Can Help, Too! - DogTime

Recommendation and review posted by Bethany Smith

When youre ready for an intrauterine device, or IUD, it can feel like an exciting and empowering contraceptive commitment, right? But while youre dreaming of your new life with an IUD (hello, whole entire years of pregnancy prevention), you also have at least one other major choice to make: copper vs. hormonal IUD.

IUDs are small devices inserted into your uterus, and theyre one of the most reliable forms of long-lasting birth control available. And there are two very different kinds. You could opt for a hormonal IUD like Mirena, Skyla, Liletta, or Kyleena, which all use progestin to thin your uterine lining and thicken your cervical mucus so its more difficult for sperm to reach an egg. Or you could go with the copper IUD, manufactured under the name Paragard, instead, which seems a little more mysterious than other forms of birth control. Heres what you need to know about the copper IUD.

It sounds like magic, but its just science. So, how does the copper IUD work, exactly? Paragard is a plastic, T-shaped device that, like other IUDs, fits snugly inside your uterus. The difference is that while hormonal IUDs emit progestin, Paragard has copper wire coiled around it. That copper produces an inflammatory reaction that interferes with sperm movement, thus preventing pregnancy, according to the Mayo Clinic. You can think of it kind of like a long-lasting spermicide, Brett Worly, M.D., an ob/gyn at the Ohio State University Wexner Medical Center, tells SELF.

In terms of longevity, the copper IUD is the epitome of this set it and forget it form of birth control, offering a full decade of pregnancy protection.

By comparison, hormonal IUDs Mirena and Kyleena are recommended for up to five years, Liletta is also recommended for up to five years, and Skyla is recommended for up to three years.

The copper IUD is over 99 percent effective at preventing pregnancy. A 2017 literature review published in Perspectives on Sexual and Reproductive Health looked at birth control failure rates between 2006-2010 and found that IUDs, both hormonal and non-hormonal, have the lowest failure rate of all contraceptive methods. Additionally, earlier research from 2011 shows that the copper IUD fails (meaning people get pregnant while using it) just 0.8 percent of the time. That boils down to fewer than one out of 100 women getting pregnant in the first year of using the copper IUD, which is a pretty excellent success rate.

It makes sense when you think about it. Unlike birth control methods like the pill, you dont actually have to do anything with your copper IUD besides getting it inserted (and then removed when you should), so the opportunities for user error go way down.

When it comes to birth control, only internal and external condoms can prevent the spread of sexually transmitted infections. So, if youre using the copper IUD and are at risk for STIs (like if you have partners whose STI status you dont know), youll still need to use some form of protection like condoms or dental dams. You should also get tested regularly. In fact, the CDC has recommendations for your STI screening schedule depending on your circumstances.

Depending on your insurance provider, the out-of-pocket copper IUD costs can be up to $1,300, which includes the fees for the device itself and any costs associated with insertion (like that of your visit).

Luckily, many insurance companies currently cover these costs in full, though that may change in the future. Call your insurer or discuss the potential costs with your doctors office to be sure.

Some people arent the best candidates for the copper IUD. Those include people who have uterine issues, like large fibroids, that might affect the IUDs placement. Having an infection like pelvic inflammatory disease (a condition in which sexually transmitted bacteria infects the reproductive organs) is also a contraindication, as is abnormal vaginal bleeding that hasnt been diagnosed, along with a few other issues. If you have concerns about how the copper IUD might work with your existing medical condition, be honest about it with your doctor. Theyll either be able to reassure you that it should be just fine or help you find a different birth control method that makes more sense for your situation.

During your IUD insertion, your medical practitioner will insert a speculum into your vagina, clean your vagina and cervix, then place the IUD, according to the Mayo Clinic. They do this by putting the device into an applicator tube, pushing the tube into your vagina and through your cervix, then releasing the IUD into your uterus. Once the IUD is in there, its wings will extend so it can assume its T shape, and it will start its pregnancy-preventing ways. Like all IUDs, the copper version has little fishing wire-esque strings that hang down through your cervix.

People can experience a wide range of sensations during IUD insertion. Some have described the process as [a] few seconds of discomfort, others like sharp, intense, nausea-inducing pain. You can ask your doctor about which pain medication they recommend taking before and after the procedure, since you may experience some residual cramping. Your provider may also be able to offer medications to help your cervix open or to try to numb it instead, although getting those drugs doesnt necessarily mean youll completely bypass any pain or discomfort.

The removal process simply involves your medical practitioner grasping onto your IUDs strings with forceps, then pulling out the device. As the IUD leaves your body, its arms will fold in. You might experience some light bleeding and cramping during this process and afterward, according to the Mayo Clinic. Once the IUD is out, your fertility should get back to normal pretty much immediately, so if youre not ready to get pregnant, youll either need a new IUD or another form of birth control.

So, lets talk about possible copper IUD side effects. The copper IUD might increase your period pain and bleeding or cause bleeding between periods, the American College of Obstetricians and Gynecologists (ACOG) says. Thats why its not recommended for people with conditions like endometriosis that can already cause heavy and painful periods, Taraneh Shirazian, M.D., assistant professor in the department of obstetrics and gynecology at NYU Langone Medical Center, tells SELF.

Some methods of birth control only seem to make your period worse because theyre not improving it, but the copper IUD can actually drive up bleeding and pain in some people. This is because of the local inflammation it causes in your uterus, Dr. Shirazian says, which can lead to extra irritation and blood.

Everyone is different, and if you experience this copper IUD side effect, its hard to predict how long it will last. The good news is that for many people, this issue goes away or at least decreases after using the IUD for a year, ACOG says. If youre at all concerned about how your period might change with the copper IUD, this is definitely something to bring up with your doctor.

Since the copper IUD doesnt contain hormones, you can use it in situations where other kinds of birth control may not be a fit. For instance, it might be a good choice for [breastfeeding people], Dr. Shirazian says. This is because theres a slight chance that estrogen, which is in forms of combined hormonal birth control like the pill, patch, and ring, may impact your milk supply, according to the ACOG.

Due to its lack of estrogen, the copper IUD may also offer an advantage for some people who have health conditions that can get worse when exposed to this hormone, such as people with a history of blood clots, or high blood pressure (estrogen can raise it further), Dr. Shirazian says.

If youre not able to tolerate hormones for some reason, definitely mention that to your doctor when trying to find which type of IUD is right for you.

Usually your partner cannot feel the strings, Dr. Worly says. That doesnt mean this cant happen, though. Its also worth mentioning that, if your partner can feel your strings or they appear longer than usual, this could be a sign that your IUD has moved and needs to be adjusted, according to the Mayo Clinic. If your IUD is firmly in place, you can also talk to your medical practitioner about trimming the strings, Dr. Worly says.

IUDs come with a small risk of expulsion, which is when your body starts to push the IUD out of you. There isnt a ton of research on this out there, but the average expulsion incidence rate is between 2 to 10 percent of users, ACOG says. Risk factors include recently having had the IUD inserted, getting it placed right after childbirth, and history of heavy or prolonged periods, among others. Though you dont really need to stress about this possibility, if it were to happen to you, you might experience symptoms like bleeding and cramping, feel something hard coming from your cervix, or see the IUD somewhere outside of your body; however, it is possible to experience an expulsion without any major symptoms.

IUDs can also cause perforation, which is when the device pushes through the wall of your uterus. It sounds alarming, but again, the risk is really low. According to a 2015 study published in the journal Conception, out of 61,448 people who had an IUD, only 20 with the copper form experienced a perforation. In fact, perforation most often happens due to an error during placement. Much like with expulsion, this isnt something that needs to keep you up at night, but if you were dealing with perforation, you would potentially experience pelvic pain (which can be a symptom of a ton of things), though you might not experience any major symptoms at all.

If you can feel your strings protruding from your cervix, thats a pretty clear sign your IUD is where it should be. But if you cant, its not a reason to immediately assume youre dealing with an IUD complication like perforation or expulsion. Over time, the strings often soften and curl up around your cervix, so you might not be able to feel them. (This is another reason why your IUD may be a non-issue during sex.

Even if your ob/gyn doesnt see the strings when youre looking to remove your IUD, they can use tools like an ultrasound to find the device, so theyre able to take it out.

Many people dont realize this, but the copper IUD is an effective form of emergency contraception as long as its inserted within five days after unprotected sex, according to ACOG. A 2012 meta-analysis of published in the journal Human Reproduction looked at 42 studies and found that the copper IUD had a pregnancy rate of only 0.09 percent when it was used as a form of emergency contraception.

The copper IUD causes inflammation in the uterine lining and may prevent implantation of the developing embryo, Dr. Worly explains.

Of course, this isnt necessarily the most convenient form of emergency contraception. If you werent planning on getting an IUD, pill-based forms may make more sense for you depending on how easily youre able to access them vs. an intrauterine device.

It might feel like theres a lot of information to take in about the copper IUD, not to mention all the other [birth control](https://www.self.com/topic/birth-control options at your disposal. If your head is spinning, you dont have to go it alonethats what doctors are for. Or, if you have nary a question and are just really excited to get that thing in there, well, thats what doctors are for, too.

Related:

Originally Appeared on Self

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13 Things You Absolutely Should Know Before Getting the Paragard Copper IUD - Yahoo Lifestyle

Recommendation and review posted by Bethany Smith

Cleveland Browns safety Jermaine Whitehead, quickly realizing that keeping it real isnt actually applicable in the real world, was released from the team after, among other things, threatening to kill multiple Twitter users after the Browns loss to the Denver Broncos on Sunday. Comedian Tiffany Haddish, bringing an entirely new meaning to streaky shooter, said she once defecated in her boyfriends new Air Jordan shoes after the boyfriend allegedly cheated on Haddish on her birthday. Los Angeles Lakers forward Anthony Davis, who is as likely to leave Hollywood for Chicago as Kim Kardashian-West, said there is a possibility he could sign with his hometown Chicago Bulls this offseason after just one season with the Lakers. Miami Heat forward Jimmy Butler, creating a straw man out of a Texas Straw Hat, said he felt disrespected by the initial reaction to his free agency signing this summer because Mfs act like Im not a good basketball player.

The NBA, hoping fans will fiend so much for an Indiana Pacers-Toronto Raptors opening round playoff series that theyll be willing to pay extra for it, announced an over-the-top streaming subscription for the NBA TV television channel. Atlanta Hawks center John Collins, needing the extra room in his stomach for all the Gladys Knights Chicken & Waffles and Chick-fil-A in Atlanta, was suspended 25 games for testing positive for Growth Hormone Releasing Peptide-2 (GHRP-2), a growth hormone that possibly increases food appetite. Jacksonville Jaguars quarterback Gardner Minshew, who, no doubt in his mind, wouldve won the Super Bowl this season had head coach Doug Marrone kept him as the starter, was replaced by former starter Nick Foles after Foles missed the last eight games. A Washington-area brewery, hoping to get Washington Redskins fans as disoriented as a Gus Frerotte headbutt, is offering a new Sell the Team IPA in reference to Redskins owner Dan Snyder that contains 9.5 percent alcohol by volume.

Weekly water cooler fodder: The Week That Was NewsletterSubscribe

Southern Universitys Dancing Dolls: 50 years of grace, style and beautyRead nowA fear of flying wont stop Isaiah Stewarts dad from showing supportRead nowLike it or not, the Nationals knew what they were in for at the White HouseRead now

Cleveland Browns quarterback Baker Mayfield, who, using this logic, should be as hairless as a competitive swimmer based on how hes played all season, said he shaved off his handlebar mustache immediately following the teams 24-19 loss to the Denver Broncos on Sunday because I didnt deserve it. Chicago Bears quarterback Mitchell Trubisky, like if O.J. Simpson complained about a minimum speed limit being implemented on Southern California highways, said he wants the televisions turned off at the teams headquarters because youve got too many people talking on TV about us and what they think about us what we should do, what we are and what were not. The University of Alabama student government, backpedaling faster than a Crimson Tide defensive back in zone coverage, quickly reversed its warning to student groups that they would risk forfeiture of future home games if the groups demonstrated against President Donald Trump at Saturdays home game against LSU, releasing a statement clarifying that the government body strongly affirms its belief in free speech and the rights of all students to express their opinions.

Multiple NFL teams are reportedly interested in signing free-agent receiver Antonio Brown pending a resolution to the leagues investigation into accusations of Brown sexually assaulting multiple women, though the teams may become less interested if Brown expresses a desire to not stand for the national anthem. Georgia and Ohio State, which will need the financial windfall from this matchup for when they inevitably have to pay their players, scheduled a home-and-home football series for 2030 and 2031. Brown, the first black person in the history of America to actually play the race card, tweeted f the nfl, would never play for the league and accused it of treating black people the worse mere hours after it was reported the league would meet with Brown next week.

Illustrations by Nathan Gelgud.

Martenzie is an associate editor for The Undefeated. His favorite cinematic moment is when Django said "Y'all want to see somethin?"

Continued here:
Antonio Brown said he will never play in the NFL again and other news of the week - The Undefeated

Recommendation and review posted by Bethany Smith

While patients still have to work hard to change their lifestyles, without the constant hormonally-induced cravings for food, attaining and sustaining substantial weight loss becomes a great deal easier.

LOS ANGELES (PRWEB) November 06, 2019

An October 21 article on Yahoo Lifestyle reported on a New York woman who was able to lose 185 pounds through weight loss surgery and who has been able to maintain that loss since 2005. The woman spoke about her past struggle with severe obesity, from experiencing knee pain when she walked to being too large to wear the dress shed always hoped to wear on her wedding day. Fourteen years later and several dress sizes smaller, the article reports that she is finally able to wear a dream dress as she prepares to renew her vows with her husband. Los Angeles-based weight loss surgery specialists Dr. Feiz & Associates notes that bariatric surgery is making these kinds of stories a great deal more common.

Dr. Feiz & Associates comments that, for those struggling with obesity, losing the weight is very hard but thats not the only problem. Its keeping the weight off and maintaining the new weight that is typically even far more challenging. The clinic explains that, while it is sometimes possible to slim down naturally through diet, exercise and strong self-discipline, success is short-lived in the large majority of cases. The clinic says that the body is wired to fight anything it deems a potential threat, including substantial weight loss which it takes as a sign of imminent famine. So, production of the hormone responsible for the nagging feelings of hunger that make weight loss so difficult already present in larger amounts in overweight and obese people goes into overdrive. Plagued by ever-increasing cravings which feel exactly like hunger, the clinic says that its no wonder why the vast majority of people who attempt to defeat obesity on their own eventually backslide and regain all of the weight that they have worked so to get rid of sometimes with a few extra pounds attached.

What a weight loss procedure such as a sleeve gastrectomy does is reduce the size of the stomach, says Dr. Feiz & Associates. By removing a significant portion of the stomach, individuals are discouraged from overeating as it becomes uncomfortable, decreasing their appetite but thats only part of the story. In the process of reducing the size of the stomach, production of the primary hormone associated with hunger, called ghrelin, is also reduced substantially. The clinic notes that patients still have to work hard to change their lifestyles but, without the constant hormonally-induced cravings for food, attaining and sustaining substantial weight loss becomes a great deal easier.

Interested readers who would like to know more about Dr. Feiz & Associates and weight loss offerings can call 310-855-8058 or visit the clinics website at https://www.drfeiz.com.

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Weight Loss Surgery and a Bride Who Can Finally Wear Her Dream Wedding Dress Highlight Long Term Benefits, says Dr. Feiz & Associates - PR Web

Recommendation and review posted by Bethany Smith

(Pregnancy Help News)Ivette had just taken the first dose of the chemical abortion pill protocol when she began to feel the pangs of regret. Sitting in the abortion facility, she felt emotion wash over her.

I knew it was wrong, and as soon and the doctor walked out, I started crying. I asked my boyfriend, Why are we doing this? and he just hugged me, she wrote in a reflection sent to Heartbeat International several months later.

The abortion facility hadnt let Ivette see her unborn baby on the ultrasound screen, but they estimated her child to be about four weeks old. Just a day before, the couple had believed abortion was their only way forward. With an almost-two-year-old daughter at home, they didnt believe that bringing another child into the world was financially feasible.

That belief was about to be challenged in a major way.

On the drive back home from the abortion facility, the full force of Ivettes regret came rushing through her.

I started arguing with my boyfriend, asking him why he had convinced me to do it. That I didnt want to, that I hated him, she wrote. And he was just looking at me, and I was crying and crying.

Struck by her words, her boyfriend pulled the car over.

He started telling me I was right, that he was dumb for even talking me into it, that we shouldve done the right thing, she recalled.

Thats when her boyfriend decided to take action. Grabbing his phone, he began searching the internet for a way to save their unborn baby. He came across Abortion Pill Rescue, a 24/7 helpline (877-558-0333) backed by a network of 800 medical professionals offering Abortion Pill Reversal.

Otherwise known as the abortion pill or RU-486, chemical abortions typically involve two drugs: mifepristone and misoprostol. Mifepristone, the first drug, destabilizes a pregnancy by blocking progesterone, the natural hormone needed to sustain a healthy pregnancy. To finish the abortion, misoprostol induces labor, forcing a womans body to deliver the baby.

The reversal protocol, which was developed by physicians George Delgado and Matt Harrison more than a decade ago, works by giving a woman extra progesterone up to 72 hours after she takes the first chemical abortion drug.

READ:Abortion pill reversal uses the same hormone used to halt miscarriages, so why do some oppose it?

Now operated by Heartbeat International, the Abortion Pill Rescue Network (APRN) has saved more than 900 babies to date.

Women who are facing the immediate regret of abortion call the APRN helpline every day seeking hope and options, said Christa Brown, director of Medical Impact for Heartbeat International. They dont give up the right to other choices when they seek an abortion and we are here to help.

For Brown, a womans courage to call the helpline and try to rescue her baby is nothing short of heroic.

One of APRNs main goals is to help ensure that women like Ivette have the opportunity to choose life for their children every step of the way, she said. We are so thankful for the courage and strength of our clients who choose life often under many pressures to continue the abortion. All of our 900 moms are true heroes.

Despite whatever glimmer of hope the helpline offered, Ivette was convinced it was too late for their baby.

I told (my boyfriend), Hang up. This is ridiculous. Theres nothing we can do. What is done is done, and took away his phone as we drove back home, she wrote. I felt sad. I felt mad. I hated myself. I couldnt stop thinking about my daughter I already had and what a beautiful blessing she was coming into our lives.

Tears overwhelmed Ivette for the rest of the day. She could hardly sleep that night. Early the next morning, she searched the internet once more for the Abortion Pill Rescue number.

A really nice nurse answered, Ivette wrote. I will never forget her. She started asking me questions and told me we were still in time to reverse the abortion.

The nurse connected Ivette to a local doctor who provides the Abortion Pill Reversal protocol and advised her not to take the rest of the chemical abortion regimen. The doctors office set Ivette up with an appointment immediately. Together, she and her boyfriend drove 45 minutes to the pro-life clinic.

I felt so much peace as I entered his clinic, Ivette wrote. It had a really big Virgin Mary and a little place for people to pray. I felt hope.

While waiting to be seen, she slipped into the bathroom. Her hope faltered as she saw how much she was bleeding.

I was bleeding so much, and I said to myself, Im losing the baby, she wrote.

But the doctor was still willing to fight for her and her unborn baby. He administered progesterone to her and prescribed more for her to take over the course of the next two weeks when she was to return to the clinic for a follow-up appointment.

READ:To date, Abortion Pill Reversal has helped save over 900 babies from abortion

Ivettes worries werent gone just yet. The same day she began the reversal treatment, she received a dire voicemail from the abortion facility she had visited. The staff reminded her to take the other four chemical abortion pills the facility had given her and warned that if she continued the pregnancy, her baby would be born with birth defects.

Once more, Ivette turned to the kind nurse from the Abortion Pill Rescue helpline for guidance. Using the research performed by physician George Delgado, the nurse assured her that her baby was at no greater risk of being born with a defect than any other baby.

As the days passed by, Ivette continued to bleed heavily. Nevertheless, she continued to take the progesterone, and after two weeks, she returned to the pro-life clinic.

Ivette nervously watched the screen as the doctor performed the ultrasound. Then, he gave her the news she was longing to hear.

He told me, Theres a heartbeat!!! she said. And there it was on the screen, a little flickering. We couldnt believe it. I looked over at my boyfriend as he smiled and said, We did the right thing.

Ivette continued to take progesterone for the rest of the first trimester. Then, late last year, she met the tiny baby she and her boyfriend rescued all those months ago.

I delivered my baby boy by c-section, and let me tell you, he is the cutest little guy, she wrote. I couldnt imagine my life without my daughter and my son. I love them so much and I know we did the right thing. Thank you, Abortion Pill Reversal, for this second chance.

Editors Note: This article was published at Pregnancy Help News and is reprinted here with permission.

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Parents choose abortion pill reversal, rescue baby: 'I know we did the right thing' - Live Action News

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Conference Call and Webcast Today at 8:30 a.m. ET

MALVERN, Pa., Nov. 08, 2019 (GLOBE NEWSWIRE) -- Ocugen, Inc., (NASDAQ: OCGN), a clinical stage biopharmaceutical company focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases, today reported financial highlights for the third quarter of 2019 and a business update.

This is an exciting time for Ocugen as weve completed our merger and are now a publicly traded company, commented Shankar Musunuri, PhD, MBA, Chairman, CEO and Co-Founder of Ocugen. We are focused on advancing our clinical and preclinical programs, which includes completing enrollment in our Phase 3 clinical trial of OCU300, our product candidate that has received orphan drug designation from the FDA and is being developed for the treatment of ocular graft versus host disease (oGVHD) and furthering our IND-enabling studies for OCU400, our first gene therapy product candidate with two distinct orphan drug designations. We believe our new strategic partnership with CanSinoBIO will be instrumental in accelerating the progress of our modifier gene therapy platform closer to the clinic. We are working to meet several milestones over the course of the next few years that we believe will continue to add value to Ocugen shareholders.

Third Quarter 2019 and Recent Highlights:

Third Quarter 2019 Financial Highlights

Conference Call and Webcast Details

The Company has scheduled a conference call and webcast for8:30 a.m. ETtoday to discuss the financial and recent business highlights. Ocugen's senior management team will host the call, which will be open to all listeners. There will also be a question and answer session following the prepared remarks.

The call can be accessed by dialing (844) 987-9316 (domestic) or (602) 563-8454 (international) and providing the conference ID 9979278. To access a live audio webcast of the call on the Investors section of the Ocugen website, please click here. A replay of the webcast will be archived on Ocugens website for approximately 45 days following the call.

About Ocugen, Inc.Ocugen, Inc. is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing a pipeline of innovative therapies that address rare and underserved eye diseases. The Company offers a robust and diversified ophthalmology portfolio that includes novel gene therapies, biologics, and small molecules and targets a broad range of high-need retinal and ocular surface diseases. Ocugen is leveraging its groundbreaking modifier gene therapy platform to address genetically diverse inherited retinal diseases (IRDs) and dry AMD, based on nuclear hormone receptor genes NR2E3 (OCU400) and RORA (OCU410), respectively. OCU400 has received two orphan drug designations (ODD) targeting two distinct IRDs. Ocugen is also developing novel biologic therapies for wet-AMD, diabetic macular edema and diabetic retinopathy (OCU200), as well as for retinitis pigmentosa (OCU100). The Companys late-stage Phase 3 trial for patients with ocular graft versus host disease (oGVHD)(OCU300) leverages Ocugens patented OcuNanoE Ocugens ONE Platform technology to enhance the efficacy of topical ophthalmic therapeutics. OCU300 is the first and only therapeutic with ODD for oGVHD, providing certain regulatory and economic benefits. For more information, please visit http://www.ocugen.com.

Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as predicts, believes, potential, proposed, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the Companys current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the SEC), including the risk factors described in the section entitled Risk Factors in our Registration Statement on Form S-3 (File No. 333-234127) and our Registration Statement on Form S-4 (Reg. No. 333-232147), as amended, filed with the SEC by Ocugen, Inc. (f/k/a Histogenics Corporation) . Any forward-looking statements that the Company makes in this press release speak only as of the date of this press release. The Company assumes no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

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Corporate Contact:Ocugen, Inc.Kelly Beckkelly.beck@ocugen.com+1 484-328-4698

Media Contact:LaVoieHealthScienceEmmie Twomblyetwombly@lavoiehealthscience.com+1 857-389-6042

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Ocugen Provides Business Update and Third Quarter 2019 Financial Highlights - Yahoo Finance

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Share on PinterestA new U.K. blood test is one of several tests aiming to detect cancer early. Getty Images

Theres a new blood test that aims to detect breast cancer. Its one of many attempts to create an effective early detection method.

The test could pinpoint breast cancer up to 5 years before a person shows clinical signs of the disease, according to researchers from the University of Nottingham in the United Kingdom.

The test evaluates the bodys immune response to the substances tumor cells produce.

Cancer cells make antigens that cause the body to make antibodies known as autoantibodies. The test looks for the presence of autoantibodies against tumor-associated antigens (TAAs).

The team was able to make a panel that looked for autoantibodies against 40 antigens that are known to be associated with breast cancer.

Additionally, they looked at 27 antigens or TAAs that werent known to be linked with breast cancer.

The research was presented at the 2019 National Cancer Research Institute (NCRI) Cancer Conference.

To assess the test, the researchers collected blood samples from 90 people with breast cancer when they received their diagnosis. They then compared those samples with blood samples from 90 people without breast cancer.

We were able to detect cancer with reasonable accuracy by identifying these autoantibodies in the blood, Daniyah Alfattani, a PhD student in the group, said, speaking at the conference.

The results of our study showed that breast cancer does induce autoantibodies against panels of specific tumor-associated antigens, Alfattani said.

Test accuracy improved in the panels that had more TAAs. A panel of five TAAs correctly detected breast cancer in 29 percent of samples.

Additionally, in the control group, researchers detected 84 percent of people as not having cancer. A panel of seven TAAs found cancer in 35 percent of samples and no cancer in 79 percent. The panel of nine TAAs identified cancer in 37 percent of people with cancer and 79 percent in people without cancer.

The researchers are hoping to improve the accuracy of the test. They hope it can evolve into a test that could offer an easy way to detect the disease in an early stage. Next, theyll test the panel with nine TAAs on 800 people.

If funded and evaluated completely, the test could be available in about 4 to 5 years, the researchers said.

Theres been a lot of interest in early cancer detection via blood tests, and more research keeps coming in looking at different approaches, says Dr. Len Lichtenfeld, interim chief medical and scientific officer for the American Cancer Society.

People have known about TAAs for many years. The U.K. test needs more data, but its an example of taking another approach to try to identify cancer through blood, he told Healthline.

Two interesting aspects of the research are that it looked at the bodys response to early stage cancer compared to cancer proteins or DNA shed by a tumor.

It also used a panel that looked at different markers instead of just one, explains Muhammed Murtaza, MD, PhD, assistant professor at Mayo Clinic and TGen, a nonprofit research organization.

These are promising results, but it is still too early to tell how the test will perform across breast cancer subtypes and stages, Murtaza told Healthline.

Stefan H. Bossmann, PhD, is a distinguished professor at Kansas State University and was part of a team that developed blood test technology that looked at cancer-related enzymes in blood.

He told Healthline about some of the ways to detect cancer in blood. These include looking for circulating tumor DNA or RNA, tumor cells, epigenetic markers, TAAs, and proteases and kinases (enzymes).

Another blood test for breast cancer in testing claims to be able to detect 15 different biomarkers (microRNA and methylation markers) in the blood, spotting metastatic and recurring cancers at an early stage, as well as small tumors.

That test may also be used for long-term monitoring to gauge treatment efficacy and is meant to complement other screening methods. It may be out later this year in European markets, according to reports.

Another blood test for early cancer detection, CancerSEEK, is a liquid biopsy test aimed at detecting multiple types of cancer by looking at circulating DNA. It recently obtained venture capital funding.

Early stage cancers shed very small amounts of most biomarkers into blood, making the pursuit for early detection tests fraught with challenges, Murtaza says.

There is not a blood test method yet that is used clinically for early detection, said Dr. Natalie Berger, assistant professor at Icahn School of Medicine at Mount Sinai.

There are multiple subtypes of breast cancer, and to detect these cancers through a blood test may not be a one-size-fits-all approach, Berger said.

Different antigens may be needed to detect hormone receptor-positive breast cancer compared to HER2-positive breast cancer or triple-negative breast cancer, Berger explains.

There are also differences between breast cancer in premenopausal and postmenopausal women as well as differences in people with a familial risk. Those factors may affect the sensitivity and specificity of these tests.

Imaging is superior at this time, but a blood test may be complementary or even the standard of care in the future, Berger said.

Another challenge of detecting cancer in blood is being able to detect enough of a cancer indicator, whatever it may be. Tests have to be accurate. They also need to show that they improve outcomes as well, Lichtenfeld says.

He says more data is needed to see whether the U.K. test will be effective at spotting breast cancers early.

This is an exciting development, but we have to see how it performs in larger studies, Berger added.

Though theres not a blood test for breast cancer thats truly effective and meets the needs of the larger population, developments are moving in that direction, Lichtenfeld says.

We will get there, he added.

More:
How Close Are We to a Blood Test for Breast Cancer? - Healthline

Recommendation and review posted by Bethany Smith

PLAN-LES-OUATES Nov 8, 2019 (Thomson StreetEvents) -- Edited Transcript of Obseva SA earnings conference call or presentation Thursday, November 7, 2019 at 1:00:00pm GMT

* Timothy M. Adams

SVB Leerink LLC, Research Division - MD of Biopharma & Generics and Senior Analyst

* Biren N. Amin

* Edward D. Marks

H.C. Wainwright & Co, LLC, Research Division - Research Analyst

* Kennen B. MacKay

Ladies and gentlemen, thank you for standing by, and welcome to the ObsEva Third Quarter 2019 Financial and Business Update and IMPLANT4 Trial Results Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions)

I would now like to hand the conference over to your speaker, Mr. Mario Corso. You may begin.

Thank you, operator. This is Mario Corso, Senior Director, Investor Relations at ObsEva. Good morning or afternoon to our listeners, and welcome to today's call.

ObsEva issued 2 press releases this morning, one disclosing Phase III results from the IMPLANT4 clinical trials of nolasiban in women undergoing embryo transfer following in-vitro fertilization and the other the disclosure of our third quarter 2019 financial results and business update. On today's call, I'm joined by Ernest Loumaye, our Co-Founder and Chief Executive Officer; Jean-Pierre Gotteland, our Chief Scientific Officer; Wim Souverijns, our Chief Commercial Officer; Tim Adams, our Chief Financial Officer; and Beth Garner, our Chief Medical Officer.

During today's call, ObsEva management will be making forward-looking statements, including, but not limited to, statements relating to financial results and trends; the process and timing of anticipated future development of ObsEva's product candidates; our oxytocin receptor antagonist, nolasiban; our gonadotropin-releasing hormone receptor antagonist, linzagolix; and our prostaglandin F2 alpha receptor antagonist, ObE022.

These forward-looking statements will include comments about expected clinical trial results and regulatory pathways in the U.S., Europe and Asia as well as the therapeutic and commercial potential of ObsEva's products.

These forward-looking statements are based on ObsEva's current expectations and the inherently involve risks and uncertainties. ObsEva's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements. Risks and uncertainties include, without limitation, those related to ObsEva's development programs; clinical trial time lines and results; the uncertain clinical development process including adverse events; the success cost and timing of all development activities in clinical trials; the market potential for ObsEva's product candidates; the accuracy of ObsEva's estimates regarding expenses, capital requirements and the need for financing; and other risks detailed in the Risk Factors and elsewhere in ObsEva's filings with the U.S. Securities and Exchange Commission, including a 6-K report for the 3 months ended September 30, 2019, to be filed on or around November 11, 2019, as well as other reports filed on Form 6-K and 20-F.

ObsEva undertakes no obligation to update any forward-looking statements as a result of new information, future events or changes in expectations, except as required by law.

I will now turn the call over to Ernest Loumaye, our Chief Executive Officer.

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Ernest Loumaye, ObsEva SA - Co-Founder, CEO & Director [3]

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Thank you, Mario. Today, we disclosed results of the Phase III IMPLANT4 trials of nolasiban in women undergoing embryo transfer following in-vitro fertilization. We are surprised and obviously, very disappointed that the trial did not meet its primary end point. The 10 weeks pregnancy rate for women receiving nolasiban was 40.5%. This is a rate of 39.1% for women on placebo with a p-value of 0.745.

As to safety, nolasiban was well tolerated. No difference between placebo and nolasiban were observed. As this result did not confirm the positive results observed in our first Phase III trials of nolasiban, we have decided to discontinue the current development program for nolasiban in IVF. However, we will assess whether there is potential for nolasiban in other indications.

We remain fully committed to continuing the development of our innovative pipeline, focused on addressing unmet needs in women's health and pregnancy. We are focusing our effort and resource on the 4 ongoing Phase III trials of linzagolix for uterine fibroids and endometriosis and our Phase II program for OBE022 for the treatment of acute preterm labor.

We have very important data results for both of this compound this quarter is a PRIMROSE 2 trials of linzagolix in heavy menstrual bleeding due to uterine fibroid and an interim update in 60 patients from the prolonged trial of OBE022 in preterm labor. We consider both of this compound to be potentially best-in-class and look forward to sharing prior results soon.

PRIMROSE 2 recruited approximately 500 women with heavy menstrual bleeding or HMB due to uterine fibroids. It is a standard primary end point of reduction in HMB, as measured by the alkaline hematin method. The trial includes a low dose of linzagolix, 100-milligram without add-back therapy and a high-dose 200 milligram, including add-back therapy. Importantly, we are the only company developing a dose without add-back therapy for the uterine fibroids indication, which we believe is a critical point of differentiation of targeting the large and diverse U.S. patient population.

The 100-milligram dose achieved a response rate in the range of 40% to 50% without clinically significant impact on BMD, bone mineral density. We believe this provides a differentiation needed to be competitive in the market as none of the other generation antagonist under development can offer a way to control symptoms without requiring exogenous hormone through add-back therapy to mitigate bone loss.

Therefore, this could be the de facto first-line dose with our highest dose option, 200-milligram with add-back would be available for patients not responding to the lower dose.

Additionally, we expect a readout of 6 months data for PRIMROSE 1, second Phase III trial in uterine fibroids in the second quarter of next year.

With approximately 5 -- 4 million women in the U.S. diagnosed and treated, we believe that the unmet needs in uterine fibroids is tremendous. Oral contraceptives are often an ineffective treatment option to reduce menstrual bleeding. Generation antagonist are primary used short term as [alternative to] surgery. And surgery is costly and invasive. In addition, as we mentioned in our previous call, the EDELWEISS 2 and 3, the 3 trials assessing the efficacy and safety of linzagolix in women with endometriosis-associated pain are well underway, both in the U.S. and Europe.

Similarly to uterine fibroids, we are developing both a partial suppression, first-line option without add-back therapy as well as a full suppression option with add-back therapy. For the Phase IIa PROLONG study of OBE022 in pregnant women from 24 to 34 weeks of gestation experience in preterm labor, we expect an interim update in 60 patients later this quarter.

Following the open-label Part A of the trial concludes earlier this year, we have seen an acceleration in the randomization [AbbVie] of the trial in recent months, which compared treatment with atosiban alone versus OBE022 added to atosiban. The trial IDMC is scheduled to conduct its second review soon now in 60 patients versus 30 earlier this year.

In addition to safety, we will receive information on any initial efficacy signal that OBE022 may be able to prolong pregnancy compared to atosiban alone, but are not conducting statistical or futility analysis at this interim time point as previously mentioned.

Importantly, the unmet medical needs is likely greater in preterm labor than any other area that we are pursuing with 500,000 annual case in both Europe and in the U.S. and exceedingly high-medical risk to the mother and baby as well as financial cost for neonatal intensive care unit and clinic care that amounts to billions of dollars annually.

In conclusion, we regret not being able to improve outcome with nolasiban for women undergoing IVF. Due to our multi-asset strategy, we have the opportunity to develop 2 potentially best-in-class innovative assets, one of which is in late-stage Phase III. We continue to believe we have the right strategy of building a portfolio of promising assets, addressing significant unmet need in the field of women health.

I will now turn the call over to our CFO, Tim Adams, for a brief financial review. Tim?

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Timothy M. Adams, ObsEva SA - CFO [4]

--------------------------------------------------------------------------------

Thank you, Ernest, and good morning, everyone. I would like to spend a few minutes outlining third quarter results and our updated financial outlook.

Our net loss for the third quarter 2019 was $27.6 million or $0.63 per share. This compares with a net loss of $18.6 million or $0.42 per share for the third quarter of 2018. The year-over-year increase in net loss was largely attributed to increased spending on the clinical development for nolasiban and linzagolix.

Research and development expenses were $21.9 million for the third quarter of 2019 versus $15.9 million for the third quarter of 2018. This increase resulted from the expansion and continued progress with the clinical trial development for nolasiban and linzagolix.

G&A expense in the third quarter of 2019 was $4.9 million as compared to $3.1 million for the third quarter of 2018. This increase is primarily attributed to higher staff costs and precommercial activities for nolasiban.

Our cash balance as of September 30, 2019, was $91 million as compared to $138.6 million at year-end 2018. Of note, the 9/30 cash balance includes the first $25 million loan from our credit facility with Oxford Finance.

Cash used in operations during the third quarter was $26.9 million, reflecting continued spending in support of our pipeline. We also made a $5 million milestone payment to our partner, Kissei, related to the start of the Phase III EDELWEISS trials in endometriosis. Based upon our year-to-date spend and preliminary revisions to our nolasiban and precommercial spend, we now estimate our full year 2019 cash investment to be between $96 million and $99 million. This is less than our previous estimate of $105 million to $110 million cash used for 2019.

And finally, a quick update on the revised cash runway. Based on the $91 million of cash at September 30, our preliminary revised spending plans and assuming we draw another $25 million on the Oxford loan, our updated cash runway can fund our operations into the first quarter of 2021. We remain committed to the continued development of our innovative pipeline, and we will continue to invest appropriately with 4 Phase III trials ongoing for linzagolix and a Phase II trial for OBE022.

With that, operator, we can now take questions.

================================================================================

Questions and Answers

--------------------------------------------------------------------------------

Operator [1]

--------------------------------------------------------------------------------

(Operator Instructions) And our first question comes from Kennen Mackay with RBC Capital Markets.

--------------------------------------------------------------------------------

Kennen B. MacKay, RBC Capital Markets, Research Division - Co-Head of Biotechnology Research [2]

--------------------------------------------------------------------------------

I was hoping, maybe this morning, you could help us understand a little bit around the potential to reduce R&D spend? And how much sort of the current run rate in R&D is coming from IMPLANT4 or spend on the IVF program? I think that would be incredibly helpful going forward. And then I was just wondering on any additional clarity in terms of how much of the -- you have remaining following the quarter or as of today? And again, share the disappointment in the IGF results -- IVF results.

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Timothy M. Adams, ObsEva SA - CFO [3]

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Kennen, it's Tim. Let me start with that. So we will not pursue the IMPLANT3 trial for nolasiban, which was scheduled for the U.S. market. I think we have shared with investors previously that, that trial was much more expensive than what we saw with IMPLANT4 over in Europe. So we will see a significant savings in nolasiban because we're not going forward within IMPLANT3. There are some additional CMC costs and some other things related to the program that we won't incur. So that will be the primary component.

When the financials come out back in the MD&A, you will see the detail of the R&D spend for this quarter was approximately $22 million. The lion's share of that goes to linzagolix. It was a little bit over $14 million. So roughly 2/3 plus, then our additional staff costs. So the run rate in the third quarter for nolasiban was approximately $3 million. But again, that was at the tail end of IMPLANT4 and before IMPLANT3 really got started. So again, our plans for revision are preliminary. This has all come at us very quickly. Certainly, the disappointment of the results.

And then I think your second question related to the Oxford loan. So it's a $75 million facility. And there were 3 tranches. The first tranche of $25 million was drawn back in August when we signed the deal with Oxford. The second tranche was subject to positive results from nolasiban that we will not be drawing. And then the third tranche is available to us mid next year upon the readout of the -- of both PRIMROSE 1 and 2. So we have to wait for that second PRIMROSE to read out before we control that third tranche of $25 million.

--------------------------------------------------------------------------------

Operator [4]

--------------------------------------------------------------------------------

And our next question comes from Ami Fadia with SVB Leerink.

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Ami Fadia, SVB Leerink LLC, Research Division - MD of Biopharma & Generics and Senior Analyst [5]

--------------------------------------------------------------------------------

Obviously, I share your disappointment on the nolasiban data. Can we -- can you help us sort of remind us on the linzagolix data that's expected before the year-end? Maybe remind us what we're looking for in the data? And how confident you are in this study being positive? And secondly, with the discontinuation of the nolasiban program, what are your thoughts around the OBE022 study and your development plans around that?

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Ernest Loumaye, ObsEva SA - Co-Founder, CEO & Director [6]

--------------------------------------------------------------------------------

Yes, Fadia. For the linzagolix PRIMROSE trial, you are well aware that it's a responder rate analysis in terms of heavy menstrual bleeding. That means that -- but it's a proportion of patients achieving a bleeding below 80 milliliter over a period of 28 days at the end of the treatment. So the generation antagonists are usually leading to a responder rate around 70% of the subjects, and we expect with our high dose add-back therapy to be around 70% of responder. For the low dose, we are the only one to have. We have no figure in February, but indirect evidence. It goes in the endometriosis population, the 100-milligram dose led to an amenorrhea rate of 55%. But if you extrapolate that to the fibroid population and there a reason to do that, that means that it should be above 55% because, indeed, amenorrhea, I mean, no bleeding and patient between 80 milliliter and 0 bleeding will still be responder. However -- so I think we are comfortably waiting for this data. Now we are a little bit conservative, and we are setting it as an objective between 40% and 50% because -- and I will ask Wim to justify that, why is it even a 40% is important in this population?

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Wim Souverijns, ObsEva SA - Chief Commercial Officer [7]

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Yes, thanks, Ernest. So Ami, the reason why that number comes up is that we try to assess from what point on would a drug that has an option to control symptoms without the use of add-back become commercially relevant. And as soon as we hit the 40% to 50%, there will be a significant opportunity for us to capture market share because, first of all, there is a segment of women that physiologically is not able to take or should not take add-back therapy, with a high BMI, [vis-a-vis] diabetes, cardiovascular complications, you're supposed not to take hormone replacement therapy. So if you hit a 40% response rate, 40%, 50%, one in two, you would respond. Those women definitely would be a key target for us.

And then on top of that, in terms of market expansion, the second segment are those women that technically could take add-back therapy, but really have expressed a preference of not to take exogenous hormones. And so that is the -- I would say, in the second wave of a commercial launch with the second segment of patients that we could go after. If we are below 30%, it becomes much harder to justify a commercial opportunity there. But as of 40%, 50%, we think there is definitely a value for us.

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Ami Fadia, SVB Leerink LLC, Research Division - MD of Biopharma & Generics and Senior Analyst [8]

--------------------------------------------------------------------------------

And if I could just follow-up, what percent of the target patient population falls within that segment of high BMI, cardiovascular risk, et cetera?

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Ernest Loumaye, ObsEva SA - Co-Founder, CEO & Director [9]

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We don't have a figure on that. But what is clear that, when we compare our EDELWEISS population, which is about 32, the endometriosis versus the fibroids, the fibroids is on average 42 years old, and that's a tranche of age where you have more hypertension, insulin -- glucose intolerance, obesity and so forth. So -- but we cannot give a precise figure. And maybe, Wim, you can help us with that...

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Wim Souverijns, ObsEva SA - Chief Commercial Officer [10]

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Yes, we're actually -- Ami, we're actually running currently research to assess that, to actually get a qualitative number behind that. But as Ernest said, there is definitely a population, significant population in that age group that will fall in that category.

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Elizabeth Ijeoma Onyemelukwe Garner, ObsEva SA - Chief Medical Officer [11]

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The prevalence of fibroid is also much higher in African-American women who are more likely to be having those conditions.

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Ernest Loumaye, ObsEva SA - Co-Founder, CEO & Director [12]

--------------------------------------------------------------------------------

Yes. Thank you, Elizabeth. Yes.

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Ami Fadia, SVB Leerink LLC, Research Division - MD of Biopharma & Generics and Senior Analyst [13]

See original here:
Edited Transcript of OBSV.O earnings conference call or presentation 7-Nov-19 1:00pm GMT - Yahoo Finance

Recommendation and review posted by Bethany Smith

Alex McCall, a trans student from Brighton, hit the headlines in March 2019 when he criticized the NHS for not allowing Trans people equal access to fertility treatment.

Alex wants to freeze his eggs before he undergoes full transition treatment as he fears that hormone treatment may leave him infertile. His application for egg freezing was turned down by the NHS after the Brighton and Hove Clinical Commissioning Group stated that its decision was fair and in-line with other groups.

Currently studying at Newcastle University, 22-year-old Alex is now trying a new route to fulfill his dream of being able to have a family in the future. He said,

Next week, I will go back to my GP to ask them for a new Individual Funding Request. Last year I got my hopes up and I was devastated to hear the result.

Alex has since had a second consultation with Dr James Barrett, lead clinician at the Gender Identity Clinic in London. Alex was delighted to find out that there may be some hope for his request to be accepted by May 2020.

I was told that I could apply for funding again. Apparently by May 2020 the case against the NHS may be withdrawn and a compromise could be reached. If a Trans person was refused funding without good reason, then they may be able to take the matter to court.

If this is the case, then this may affect the future of fertility rights for the Trans community. However Alex is understandably cautious, saying,

Im always feeling in limbo. I went into the clinic last year with the mindset of having to let go of my hopes of having biological children in the future. Sometimes, I dont want to ride that roller-coaster.

Sam Hall, a GP and Chair of The Clare Project, is himself a Trans man and parent of three. He feels that Trans males should not rely on egg freezing as the only way to make a family. He explains,

Taking hormones does not necessarily deprive you of having a family. Many Trans men have already managed to get pregnant and have families by using their own eggs.

Sam, who runs the regular Brighton TMP social night for the Trans community, is concerned that Transgender teenagers are now feeling under extra pressure to choose between egg freezing and start their transitioning treatment, when it not necessarily a choice that they will need to make.

Click here for more information on The Clare Projects regular TNB nights

Photo: Alex with sisters Danielle and Sarah Cornish-Spencer DongPei Yu

If youd like to see more articles like this, please support our Crowdfunder and help us keep community journalism alive.

Read more:
Trans student still hopeful for fertility treatment on the NHS - Brighton Journal

Recommendation and review posted by Bethany Smith

Therapies used to treat endometriosis include: Hormonal contraceptives. Birth control pills, patches and vaginal rings help control the hormones responsible for the buildup of endometrialtissue each month

Access Report Details at: https://www.themarketreports.com/report/global-endometriosis-therapies-market-by-manufacturers-regions-type-and-application-forecast

Market share of global Endometriosis Therapies industry is dominate by companies like AbbVie, Eli Lilly, AstraZeneca, Bayer, Astellas Pharma, Meditrina Pharmaceuticals, Pfizer, Neurocrine Biosciences, Takeda Pharmaceutical and others which are profiled in this report as well in terms of Sales, Price, Revenue, Gross Margin and Market Share (2017-2018).

With the help of 15 chapters spread over 100 pages this report describe Endometriosis Therapies Introduction, product scope, market overview, market opportunities, market risk, and market driving force. Later it provide top manufacturers sales, revenue, and price of Endometriosis Therapies, in 2017 and 2018 followed by regional and country wise analysis of sales, revenue and market share. Added to above, the important forecasting information by regions, type and application, with sales and revenue from 2019 to 2024 is provided in this research report. At last information about Endometriosis Therapies sales channel, distributors, traders, dealers, and research findings completes the global Endometriosis Therapies market research report.

Market Segment by Regions, regional analysis covers:

North America (USA, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, Columbia, etc.)

Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Market Segment by Type, covers:

Hormonal Contraceptives

Gonadotropin-releasing Hormone (Gn-RH) Agonists

Progestin Therapy

Aromatase Inhibitors

Market Segment by Applications, can be divided into

Hospital

Clinic

Other

Purchase this premium research report at: https://www.themarketreports.com/report/buy-now/1501936

Table of Contents

1 Market Overview

2 Manufacturers Profiles

3 Global Endometriosis Therapies Market Competitions, by Manufacturer

4 Global Endometriosis Therapies Market Analysis by Regions

5 North America Endometriosis Therapies by Countries

6 Europe Endometriosis Therapies by Countries

7 Asia-Pacific Endometriosis Therapies by Countries

8 South America Endometriosis Therapies by Countries

9 Middle East and Africa Endometriosis Therapies by Countries

10 Global Endometriosis Therapies Market Segment by Type

11 Global Endometriosis Therapies Market Segment by Application

12 Endometriosis Therapies Market Forecast (2019-2024)

13 Sales Channel, Distributors, Traders and Dealers

14 Research Findings and Conclusion

15 Appendix

Ask your report related queries at: https://www.themarketreports.com/report/ask-your-query/1501936

Continued here:
Global Endometriosis Therapies Market Status and Outlook (2014-2024): Shared in a Latest Research available at TMR - Market Research Writeup

Recommendation and review posted by Bethany Smith

The thought of spaceflight may make the heart skip a beat, but actually travelling beyond Earth could alter the organs cells.

With extended stays aboard the International Space Station (ISS) commonplace, and the likelihood of humans spending longer periods in space increasing, there is a need to better understand the effects of micro-gravity on cardiac function.

New research suggests heart muscle cells derived from stem cells have a remarkable ability to adapt to their environment during and after spaceflight.

Scientists examined cell-level cardiac function and gene expression in human heart cells cultured aboard the International Space Station for five-and-a-half weeks.They found that exposure to micro-gravity changed the expression of thousands of genes, but largely normal patterns reappeared within 10 days after returning to Earth.

Read more about the body in space:

Senior study author, Joseph Wu, of Stanford University School of Medicine, said: Our study is novel because it is the first to use human induced pluripotent stem cells to study the effects of spaceflight on human heart function.

Micro-gravity is an environment that is not very well understood, in terms of its overall effect on the human body, and studies like this could help shed light on how the cells of the body behave in space, especially as the world embarks on more and longer space missions such as going to the Moon and Mars.

Until now, most studies on how the heart reacts to micro-gravity have been conducted in either non-human models or at tissue, organ or systemic level.To address this, the beating cells were launched to the ISS aboard a SpaceX spacecraft as part of a commercial resupply service mission.Simultaneously, they were also cultured on Earth for comparison purposes.

When they returned to the planet, the cells showed normal structure and morphology.However, they did adapt by modifying their beating pattern and calcium recycling patterns.

Immunofluorescence imaging of the cells grown in micro-gravity aboard the International Space Station Joseph Wu lab, Stanford University School of Medicine/PA

Researchers sequenced the cells harvested at four-and-a-half weeks aboard the ISS, and 10 days after returning to Earth.Results showed that 2,635 genes were differentially expressed among flight, post-flight, and ground control samples.

Most notably, gene pathways related to mitochondrial function were expressed more in the space-flown cells, according to the research published in the Stem Cells Reports journal.

A comparison of the samples revealed the space cells adopted a unique gene expression pattern during spaceflight, which reverted to one that is similar to ground-side controls upon return to normal gravity.

Dr Wu added: Were surprised about how quickly human heart muscle cells are able to adapt to the environment in which they are placed, including micro-gravity.

These studies may provide insight into cellular mechanisms that could benefit astronaut health during long-duration spaceflight, or potentially lay the foundation for new insights into improving heart health on Earth.

Read more:
Space travel affects heart cells, but only temporarily - BBC Focus Magazine

Recommendation and review posted by Bethany Smith

CHICAGO, Nov.5, 2019 /PRNewswire/ -- Scientists from Dystrogen Therapeutics Corp. published data supporting cardioprotective effects of the Company's therapy for muscular dystrophy disorders. Cardiomyopathy is the most devastating cause of morbidity and mortality in Duchenne Muscular Dystrophy (DMD) patients and affects 30% of patients by 14years of age and 50% of patients by 18years of age. Heart failure in these patients is the result of cardiac myocyte death and fibrosis, leading to both diastolic and systolic dysfunction. Dystrogen Therapeutics Corp has developed an engineered chimeric cell therapy which has been previously shown to restore muscle function in pre-clinical studies. For Duchenne's muscular dystrophy, the company has developed dystrophin expressing chimeras "DECs." Using the company's proprietary technology, DECs are created by an ex vivo fusion of allogeneic human myoblast from a healthy donor with autologous human myoblast received from DMD patient. DECs have been shown to maintain the ability to express normal dystrophin protein in previously published pre-clinical studies. The new study published in the October 15th, 2019 online edition of the journal Stem Cell Reports and Reviewsconfirmed the protective effect of DEC on cardiac function after intraosseous delivery shown by increased values of both ejection fraction and fractional shortening, which at 90days revealed a rebound effect when compared to the vehicle injected controls and mice receiving not-chimeric cell therapy. Moreover, these functional improvements correlated with restoration of dystrophin expression in cardiac muscle at 90days post-DEC treatment.

"These findings are potentially significant for the treatment of DMD," said Dr. Maria Siemionow, MD, PhD Dystrogen Therapeutics Corp chief scientific officer and the therapy's inventor. "This study establishes DEC as a promising new option for cardiac protection and potential amelioration of DMD related cardiac pathology."

"These data add to the growing body of literature supporting the potential of our chimeric cell platform to restore systemic muscle function, with less potential side effects then gene therapy-based approaches," said Dr. Kris Siemionow, MD, PhD Dystrogen Therapeutics Corp CEO. "We are very pleased to have these data published in a highly relevant journal for the field and look forward to further exploring this opportunity."

About Dystrogen Therapeutics

Dystrogen Therapeutics is a clinical-stage life sciences company committed to developing personalized therapies for rare diseases. The company has developed a chimeric cell therapy platform. Dystrophin expressing chimeras "DEC" are based on ex vivo fusion of allogeneic human myoblast derived from donors with autologous human myoblast received from the DMD patient, where chimeric cells maintain the ability to express normal dystrophin protein. DEC cells increase the number/pool of normal myoblasts and reduce inflammation. DEC cells induce replacement of fibrotic tissue, thus significantly improving muscle strength and function in DMD pre-clinical studies. The therapy minimizes immune response effects and the need for immunosuppression. This new approach will be based on delivery and restoration of dystrophin in affected muscles preventing the premature loss of mobility and early mortality of DMD patients. The company is planning on enrolling patients for its DEC chimeric cell therapy Duchenne muscular dystrophy trial. This therapy offers a unique advantage and allows the patient's body and immune system to accept the chimeric cells without rejection. Pre-clinical results have demonstrated that increased dystrophin levels correlate with improved functional outcomes. First clinical results from DEC therapy are expected in late 2020.

Contact: info@dystrogen.com

View original content:http://www.prnewswire.com/news-releases/dystrogen-therapeutics-announces-that-treatment-with-dystrophin-expressing-chimeric-dec-cells-improves-cardiac-function-in-preclinical-duchennes-study-300951205.html

SOURCE Dystrogen Therapeutics Corp

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Dystrogen Therapeutics Announces That Treatment With Dystrophin Expressing Chimeric (DEC) Cells Improves Cardiac Function in Preclinical Duchenne's...

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVROBIO, Inc. (NASDAQ: AVRO) (the Company), a Phase 2 clinical-stage gene therapy company, today reported financial results for the third quarter ended September 30, 2019 and provided a business update.

We are thrilled with the progress across our pipeline, including the dosing of the first patient in our cystinosis program and receipt of orphan drug designation for our investigational gene therapy for Gaucher disease, commented Geoff MacKay, President and Chief Executive Officer of AVROBIO. In our Fabry program, we have now dosed eight patients across two clinical trials and we are on track to use our optimized lentiviral vector and a conditioning regimen utilizing therapeutic drug monitoring for the first time to dose a patient in our Phase 2 clinical trial for Fabry disease by the end of 2019. While our rapid expansion and early data have been exciting, we are humbled by the needs of the rare disease communities with whom we engage. They impress a sense of urgency on our work to deliver a new paradigm that we believe can supersede current treatment options and potentially provide patients freedom from a lifetime of disease.

Program Updates and Milestones

Third Quarter 2019 Financial Results

AVROBIO reported a net loss of $17.1 million for the third quarter of 2019 as compared to a net loss of $11.6 million for the comparable period in 2018. This increase was due to increased research and development expenses, as well as increased general and administrative expenses.

Research and development expenses were $13.0 million for the third quarter of 2019 as compared to $9.2 million for the comparable period in 2018. This increase was driven by increased program development activities related to the advancement of the Companys pipeline, as well as increased personnel-related costs resulting from an increase in employee headcount.

General and administrative expenses were $5.0 million for the third quarter of 2019 as compared to $3.0 million for the comparable period in 2018. This increase was primarily due to an increase in employee headcount, expenses associated with being a publicly traded company, including consulting expenses, and the impact of non-cash stock-based compensation.

As of September 30, 2019, AVROBIO had $206.4 million in cash and cash equivalents, as compared to $126.3 million in cash and cash equivalents as of December 31, 2018. The cash balance as of September 30, 2019 reflects the receipt of net proceeds of $129.5 million from the Companys July 2019 follow-on equity offering. Based on the Companys current operating plan, AVROBIO expects its cash and cash equivalents as of September 30, 2019 will enable the Company to fund its operating expenses and capital expenditure requirements into the second half of 2021.

About AVROBIO, Inc.

AVROBIO, Inc. is a leading, Phase 2 gene therapy company focused on the development of its investigational gene therapy, AVR-RD-01, in Fabry disease, as well as additional gene therapy programs in other lysosomal storage disorders including Gaucher disease, cystinosis and Pompe disease. The Companys plato platform includes a proprietary vector system, automated cell manufacturing solution and refined conditioning regimen deploying therapeutic drug monitoring. AVROBIO is headquartered in Cambridge, MA and has offices in Toronto, ON. For additional information, visit http://www.avrobio.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as aims, anticipates, believes, could, estimates, expects, forecasts, goal, intends, may, plans, possible, potential, seeks, will, and variations of these words or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy, prospective products and goals, the therapeutic potential of our product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, the intended incentives conferred by orphan-drug designation, potential regulatory approvals and the timing thereof, expected benefits from the appointment of Ms. Verdin to the position of Chief Human Resources Officer and Ms. May to the position of Chief Commercial Officer, anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, timing and likelihood of success, plans and objectives of management for future operations, future results of anticipated products, and the market opportunity for and anticipated commercial activities relating to our product candidates, and statements regarding the Companys financial and cash position and expected cash runway. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIOs current expectations, estimates and projections about our industry as well as managements current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIOs product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIOs product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIOs actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled Risk Factors in AVROBIOs Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, as well as discussions of potential risks, uncertainties and other important factors in AVROBIOs subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

September 30,

December 31,

2019

2018

Cash and cash equivalents

$

206,362

$

126,302

Prepaid expenses and other current assets

7,345

3,718

Property and equipment, net

2,673

2,634

Other assets

825

825

Total assets

$

217,205

$

133,479

Accounts payable

$

1,408

$

2,784

Accrued expenses and other current liabilities

8,502

7,822

Deferred rent, net of current portion

535

689

Total liabilities

10,445

11,295

Total stockholders equity

206,760

122,184

Total liabilities and stockholders equity

$

217,205

$

133,479

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)

(Unaudited)

Three Months Ended September 30,

Nine Months Ended September 30,

2019

2018

2019

2018

Operating expenses:

Research and development

$

13,042

$

9,232

$

37,755

$

22,286

General and administrative

5,022

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AVROBIO, Inc. Reports Third Quarter 2019 Financial Results and Provides Business Update - Business Wire

Recommendation and review posted by Bethany Smith

JERUSALEM & PARSIPPANY, N.J. & INCHEON, South Korea--(BUSINESS WIRE)--Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), Celltrion, Inc., (KRX KRX:068270) and Celltrion Healthcare, Co., Ltd. (KRX KOSDAQ:091990), today announced that TRUXIMA (rituximab-abbs) injection is the first biosimilar to the reference product Rituxan1 (rituximab) now available in the United States with a full oncology label. TRUXIMA is currently indicated for the treatment of adult patients with non-Hodgkins Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL):

We are excited about the first FDA-approved biosimilar to rituximab in the U.S., stated Brendan OGrady, Executive Vice President and Head of North America Commercial at Teva. Tevas commitment to biosimilars is focused on the potential to create lower healthcare costs and increased price competition. This focus is consistent with Tevas mission of making accessible medications to help improve the lives of patients.

TRUXIMA was approved by the U.S. Food and Drug Administration (FDA) as the first rituximab biosimilar. The approval was based on a review of a comprehensive data package inclusive of foundational and extensive analytical characterization, nonclinical data, clinical pharmacology, immunogenicity, clinical efficacy, and safety data. In May 2019, the FDA approved TRUXIMA to match all of the reference products oncology indications for NHL and CLL. In light of a patent settlement with Genentech, Celltrion and Teva have a pending FDA submission for rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA), and microscopic polyangiitis (MPA), and a license from Genentech to expand the TRUXIMA label to include these indications in Q2 2020.

We are pleased to announce the launch of the first rituximab biosimilar, TRUXIMA, with our marketing partner Teva in the U.S. said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. We believe that the introduction of TRUXIMA into the U.S. market will contribute to addressing unmet needs of U.S. patients as well.

The Wholesale Acquisition Cost (WAC or list price) for TRUXIMA will be 10 percent lower than the reference product. TRUXIMA is being made available through primary wholesalers at a WAC of $845.55 for 100mg vial and $4227.75 for 500mg vial. Actual costs to individual patients and providers for TRUXIMA are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patients insurance payer and eligibility for participation in the assistance program.

Dedicated patient support services are also available from Teva through the Comprehensive Oncology Reimbursement Expertise (CORE) program. CORE is available to help eligible patients, caregivers and healthcare professionals navigate the reimbursement process. CORE offers a range of services, including benefits verification and coverage determination, support for precertification and prior authorization, assistance with coverage guidelines and claims investigation, and support through the claims and appeals process. A savings program is also available for eligible commercially insured patients. To learn more, please visit TevaCORE.com. For healthcare professionals seeking additional information, there is also a dedicated site at TRUXIMAhcp.com.

Celltrion and Teva Pharmaceutical Industries Ltd. entered into an exclusive partnership in October 2016 to commercialize TRUXIMA in the U.S. and Canada.

Please see the Important Safety Information below including the Boxed Warning regarding fatal infusion-related reactions, severe mucocutaneous reactions, hepatitis B virus reactivation and progressive multifocal leukoencephalopathy. For more information, please visit the full prescribing information.

Important Safety Information

WARNING: FATAL INFUSION-RELATED REACTIONS, SEVERE MUCOCUTANEOUS REACTIONS, HEPATITIS B VIRUS REACTIVATION and PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY

Infusion-Related Reactions - Administration of rituximab products, including TRUXIMA, can result in serious, including fatal, infusion-related reactions. Deaths within 24 hours of rituximab infusion have occurred. Approximately 80% of fatal infusion-related reactions occurred in association with the first infusion. Monitor patients closely. Discontinue TRUXIMA infusion for severe reactions and provide medical treatment for Grade 3 or 4 infusion-related reactions

Severe Mucocutaneous Reactions - Severe, including fatal, mucocutaneous reactions can occur in patients receiving rituximab products

Hepatitis B Virus (HBV) Reactivation - HBV reactivation can occur in patients treated with rituximab products, in some cases resulting in fulminant hepatitis, hepatic failure, and death. Screen all patients for HBV infection before treatment initiation, and monitor patients during and after treatment with TRUXIMA. Discontinue TRUXIMA and concomitant medications in the event of HBV reactivation

Progressive Multifocal Leukoencephalopathy (PML), including fatal PML, can occur in patients receiving rituximab products

Warnings and Precautions

Infusion-Related Reactions - Rituximab products can cause severe, including fatal, infusion-related reactions. Severe reactions typically occurred during the first infusion with time to onset of 30-120 minutes. Rituximab product-induced infusion-related reactions and sequelae include urticaria, hypotension, angioedema, hypoxia, bronchospasm, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, cardiogenic shock, anaphylactoid events, or death.

Premedicate patients with an antihistamine and acetaminophen prior to dosing. Institute medical management (e.g. glucocorticoids, epinephrine, bronchodilators, or oxygen) for infusion-related reactions as needed. Depending on the severity of the infusion-related reaction and the required interventions, temporarily or permanently discontinue TRUXIMA. Resume infusion at a minimum 50% reduction in rate after symptoms have resolved. Closely monitor the following patients: those with pre-existing cardiac or pulmonary conditions, those who experienced prior cardiopulmonary adverse reactions, and those with high numbers of circulating malignant cells (>25,000/mm3)

Severe Mucocutaneous Reactions - Mucocutaneous reactions, some with fatal outcome, can occur in patients treated with rituximab products. These reactions include paraneoplastic pemphigus, Stevens-Johnson syndrome, lichenoid dermatitis, vesiculobullous dermatitis, and toxic epidermal necrolysis. The onset of these reactions has been variable and includes reports with onset on the first day of rituximab exposure. Discontinue TRUXIMA in patients who experience a severe mucocutaneous reaction. The safety of re-administration of rituximab products to patients with severe mucocutaneous reactions has not been determined.

Hepatitis B Virus Reactivation - Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure and death, can occur in patients treated with drugs classified as CD20-directed cytolytic antibodies, including rituximab products. Cases have been reported in patients who are hepatitis B surface antigen (HBsAg) positive and also in patients who are HBsAg negative but are hepatitis B core antibody (anti-HBc) positive. Reactivation also has occurred in patients who appear to have resolved hepatitis B infection (i.e., HBsAg negative, anti-HBc positive and hepatitis B surface antibody [anti-HBs] positive).

HBV reactivation is defined as an abrupt increase in HBV replication manifesting as a rapid increase in serum HBV DNA levels or detection of HBsAg in a person who was previously HBsAg negative and anti-HBc positive. Reactivation of HBV replication is often followed by hepatitis, i.e., increase in transaminase levels. In severe cases increase in bilirubin levels, liver failure, and death can occur.

Screen all patients for HBV infection by measuring HBsAg and anti-HBc before initiating treatment with TRUXIMA. For patients who show evidence of prior hepatitis B infection (HBsAg positive [regardless of antibody status] or HBsAg negative but anti-HBc positive), consult with physicians with expertise in managing hepatitis B regarding monitoring and consideration for HBV antiviral therapy before and/or during TRUXIMA treatment.

Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following TRUXIMA therapy. HBV reactivation has been reported up to 24 months following completion of rituximab therapy.

In patients who develop reactivation of HBV while on TRUXIMA, immediately discontinue TRUXIMA and any concomitant chemotherapy, and institute appropriate treatment. Insufficient data exist regarding the safety of resuming TRUXIMA treatment in patients who develop HBV reactivation. Resumption of TRUXIMA treatment in patients whose HBV reactivation resolves should be discussed with physicians with expertise in managing HBV.

Progressive Multifocal Leukoencephalopathy (PML) - JC virus infection resulting in PML and death can occur in rituximab product-treated patients with hematologic malignancies. The majority of patients with hematologic malignancies diagnosed with PML received rituximab in combination with chemotherapy or as part of a hematopoietic stem cell transplant. Most cases of PML were diagnosed within 12 months of their last infusion of rituximab.

Consider the diagnosis of PML in any patient presenting with new-onset neurologic manifestations. Evaluation of PML includes, but is not limited to, consultation with a neurologist, brain MRI, and lumbar puncture.

Discontinue TRUXIMA and consider discontinuation or reduction of any concomitant chemotherapy or immunosuppressive therapy in patients who develop PML.

Tumor Lysis Syndrome (TLS) - Acute renal failure, hyperkalemia, hypocalcemia, hyperuricemia, or hyperphosphatemia from tumor lysis, sometimes fatal, can occur within 12-24 hours after the first infusion of rituximab products in patients with NHL. A high number of circulating malignant cells (>25,000/mm3) or high tumor burden, confers a greater risk of TLS.

Administer aggressive intravenous hydration and anti-hyperuricemic therapy in patients at high risk for TLS. Correct electrolyte abnormalities, monitor renal function and fluid balance, and administer supportive care, including dialysis as indicated.

Infections - Serious, including fatal, bacterial, fungal, and new or reactivated viral infections can occur during and following the completion of rituximab product-based therapy. Infections have been reported in some patients with prolonged hypogammaglobulinemia (defined as hypogammaglobulinemia >11 months after rituximab exposure). New or reactivated viral infections included cytomegalovirus, herpes simplex virus, parvovirus B19, varicella zoster virus, West Nile virus, and hepatitis B and C. Discontinue TRUXIMA for serious infections and institute appropriate anti-infective therapy. TRUXIMA is not recommended for use in patients with severe, active infections.

Cardiovascular Adverse Reactions - Cardiac adverse reactions, including ventricular fibrillation, myocardial infarction, and cardiogenic shock may occur in patients receiving rituximab products. Discontinue infusions for serious or life-threatening cardiac arrhythmias. Perform cardiac monitoring during and after all infusions of TRUXIMA for patients who develop clinically significant arrhythmias, or who have a history of arrhythmia or angina.

Renal Toxicity - Severe, including fatal, renal toxicity can occur after rituximab product administration in patients with NHL. Renal toxicity has occurred in patients who experience tumor lysis syndrome and in patients with NHL administered concomitant cisplatin therapy during clinical trials. The combination of cisplatin and TRUXIMA is not an approved treatment regimen. Monitor closely for signs of renal failure and discontinue TRUXIMA in patients with a rising serum creatinine or oliguria.

Bowel Obstruction and Perforation - Abdominal pain, bowel obstruction and perforation, in some cases leading to death, can occur in patients receiving rituximab in combination with chemotherapy. In postmarketing reports, the mean time to documented gastrointestinal perforation was 6 (range 1-77) days in patients with NHL. Evaluate if symptoms of obstruction such as abdominal pain or repeated vomiting occur.

Immunization - The safety of immunization with live viral vaccines following rituximab product therapy has not been studied and vaccination with live virus vaccines is not recommended before or during treatment.

Embryo-Fetal Toxicity - Based on human data, rituximab products can cause fetal harm due to B-cell lymphocytopenia in infants exposed to rituximab in-utero. Advise pregnant women of the risk to a fetus. Females of childbearing potential should use effective contraception while receiving TRUXIMA and for 12 months following the last dose of TRUXIMA.

Most common adverse reactions in clinical trials of NHL (>25%) were: infusion-related reactions, fever, lymphopenia, chills, infection, and asthenia

Most common adverse reactions in clinical trials of CLL (>25%) were: infusion-related reactions and neutropenia

Nursing Mothers - There are no data on the presence of rituximab in human milk, the effect on the breastfed child, or the effect on milk production. Since many drugs including antibodies are present in human milk, advise a lactating woman not to breastfeed during treatment and for at least 6 months after the last dose of TRUXIMA due to the potential for serious adverse reactions in breastfed infants.

About TRUXIMA

TRUXIMA (rituximab-abbs) is a U.S. Food and Drug Administration (FDA)-approved biosimilar to RITUXAN (rituximab) for the treatment of adult patients with CD20-positive, B-cell NHL to be used as a single agent or in combination with chemotherapy or CLL in combination with fludarabine and cyclophosphamide (FC).

TRUXIMA has the same mechanism of action as Rituxan and has demonstrated biosimilarity to Rituxan through a totality of evidence.

About Celltrion Healthcare, Co. Ltd.

Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcares products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines.

About Celltrion, Inc.

Headquartered in Incheon, Korea, Celltrion is a leading biopharmaceutical company, specializing in research, development and manufacturing of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion received FDA approval for TRUXIMA (rituximab-abbs) and HERZUMA (trastuzumab-pkrb) in 2018.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve peoples lives for more than a century. We are a global leader in generic and specialty medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products. Learn more at http://www.tevapharm.com.

Teva's Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding TRUXIMA, which are based on managements current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to:

and other factors discussed in our Quarterly Reports on Form 10-Q for the first and second quarter of 2019 and in our Annual Report on Form 10-K for the year ended December 31, 2018, including in the sections captioned "Risk Factors and Forward Looking Statements. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

1 RITUXAN is a registered trademark of Genentech and Biogen.

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Teva and Celltrion Announce the Availability of TRUXIMA (rituximab-abbs) Injection, the First Biosimilar to Rituxan (rituximab) in the United States -...

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE:TAK) today announced that it will present a total of 29 company-sponsored abstracts at the 61st American Society of Hematology (ASH) Annual Meeting on December 7-10, 2019 in Orlando, FL, highlighting the companys commitment to advancing the treatment of hematologic cancers and bleeding disorders.

Pursuing Breakthrough, Patient-Centric Innovation in Oncology and Bleeding Disorders

Takeda will present 29 scientific updates on the companys investigational and early-stage therapies, which demonstrates its investment in new compounds to address patient needs, as well as data from Phase 3 trials and real-world evidence findings, in disease states including multiple myeloma, lymphoma and leukemia.

We are presenting notable data on several clinical programs at ASH, highlighting our deep oncology pipeline and our commitment to developing innovative therapies that may address unmet needs for blood cancer patients, said Phil Rowlands, Ph.D., Head, Oncology Therapeutic Area Unit, Takeda. In particular we look forward to sharing data from the Phase 3 clinical trial of ixazomib in amyloidosis patients, data from the US MM-6 study, which evaluates an in-class transition from parenteral bortezomib to oral ixazomib in multiple myeloma, further analyses from the Phase 3 ECHELON-2 trial of ADCETRIS in peripheral T-cell lymphoma, as well as early stage data from several of our pipeline programs.

In hematology, Takeda will present real-world evidence from studies of its portfolio of treatments across bleeding disorders, including hemophilia A, hemophilia B and von Willebrand disease. The company will also present scientific updates related to its hemophilia A and hemophilia B gene therapy programs and adeno-associated virus (AAV) gene therapy platform.

Understanding real-world evidence is critical as Takeda continues to provide patients with innovative therapies for hemophilia A and hemophilia B while broadening our research and development efforts in von Willebrand disease and other bleeding disorders, said Daniel Curran, M.D., Head, Rare Diseases Therapeutic Area Unit, Takeda. Also at ASH, we look forward to providing an update on our gene therapy programs in hemophilia and the optimization of Takedas AAV gene therapy platform, particularly for patients with pre-existing immunity to AAV serotypes.

Accepted oncology abstracts include:

Note: all times listed are in Eastern Standard Time

NINLARO (ixazomib) and Multiple Myeloma

ADCETRIS (brentuximab vedotin) and Lymphoma

ICLUSIG (ponatinib)

Pipeline (multiple myeloma, lymphoma, chronic lymphocytic leukemia, acute myeloid leukemia)

Accepted hematology abstracts include:

Note: all times listed are in Eastern Standard Time

ADYNOVATE (Antihemophilic Factor (Recombinant), PEGylated) and Hemophilia A

FEIBA (Anti-Inhibitor Coagulant Complex)

von Willebrand Disease

Pipeline (hemophilia A, hemophilia B and gene therapies)

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

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, and for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD.

ADCETRIS has received marketing authorization by regulatory authorities in more than 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

ADCETRIS (brentuximab vedotin) Important Safety Information (European Union)Please refer to Summary of Product Characteristics (SmPC) before prescribing.

CONTRAINDICATIONS

ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. In addition, combined use of ADCETRIS with bleomycin causes pulmonary toxicity.

SPECIAL WARNINGS & PRECAUTIONS

Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients treated with ADCETRIS. PML has been reported in patients who received ADCETRIS after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.

Closely monitor patients for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. A negative JCV PCR does not exclude PML. Additional follow up and evaluation may be warranted if no alternative diagnosis can be established Hold dosing for any suspected case of PML and permanently discontinue ADCETRIS if a diagnosis of PML is confirmed.

Be alert to PML symptoms that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).

Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Closely monitor patients for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. Hold ADCETRIS for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.

Pulmonary Toxicity: Cases of pulmonary toxicity, some with fatal outcomes, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. Promptly evaluate and treat new or worsening pulmonary symptoms (e.g., cough, dyspnoea) appropriately. Consider holding dosing during evaluation and until symptomatic improvement.

Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Carefully monitor patients during treatment for emergence of possible serious and opportunistic infections.

Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have been reported with ADCETRIS. Carefully monitor patients during and after an infusion. If anaphylaxis occurs, immediately and permanently discontinue administration of ADCETRIS and administer appropriate medical therapy. If an IRR occurs, interrupt the infusion and institute appropriate medical management. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. IRRs are more frequent and more severe in patients with antibodies to ADCETRIS.

Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS. Monitor these patients closely and manage according to best medical practice.

Peripheral neuropathy (PN): ADCETRIS treatment may cause PN, both sensory and motor. ADCETRIS-induced PN is typically an effect of cumulative exposure to ADCETRIS and is reversible in most cases. Monitor patients for symptoms of neuropathy, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay and a dose reduction or discontinuation of ADCETRIS.

Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Monitor complete blood counts prior to administration of each dose.

Febrile neutropenia: Febrile neutropenia has been reported with ADCETRIS. Complete blood counts should be monitored prior to administration of each dose of treatment. Closely monitor patients for fever and manage according to best medical practice if febrile neutropenia develops.

When ADCETRIS is administered in combination with AVD, primary prophylaxis with G-CSF is recommended for all patients beginning with the first dose.

Stevens-Johnson syndrome (SJS): SJS and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. Fatal outcomes have been reported. Discontinue treatment with ADCETRIS if SJS or TEN occurs and administer appropriate medical therapy.

Gastrointestinal (GI) Complications: GI complications, some with fatal outcomes, including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorrhage, have been reported with ADCETRIS. Promptly evaluate and treat patients if new or worsening GI symptoms occur.

Hepatotoxicity: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported with ADCETRIS. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Pre-existing liver disease, comorbidities, and concomitant medications may also increase the risk. Test liver function prior to treatment initiation and routinely monitor during treatment. Patients experiencing hepatotoxicity may require a delay, dose modification, or discontinuation of ADCETRIS.

Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. Closely monitor serum glucose for patients who experiences an event of hyperglycemia. Administer anti-diabetic treatment as appropriate.

Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations.

CD30+ CTCL: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence. In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Szary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology. These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes. Carefully consider the benefit-risk per patient and use with caution in other CD30+ CTCL patient types.

Sodium content in excipients: This medicinal product contains 13.2 mg sodium per vial, equivalent to 0.7% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

INTERACTIONSPatients who are receiving a strong CYP3A4 and P-gp inhibitor, concomitantly with ADCETRIS may have an increased risk of neutropenia. If neutropenia develops, refer to dosing recommendations for neutropenia (see SmPC section 4.2). Co-administration of ADCETRIS with a CYP3A4 inducer did not alter the plasma exposure of ADCETRIS, but it appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. ADCETRIS is not expected to alter the exposure to drugs that are metabolized by CYP3A4 enzymes.

PREGNANCY: Advise women of childbearing potential to use two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. There are no data from the use of ADCETRIS in pregnant women, although studies in animals have shown reproductive toxicity. Do not use ADCETRIS during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus.

LACTATION (breast-feeding): There are no data as to whether ADCETRIS or its metabolites are excreted in human milk, therefore a risk to the newborn/infant cannot be excluded. With the potential risk, a decision should be made whether to discontinue breast-feeding or discontinue/abstain from therapy with ADCETRIS.

FERTILITY: In nonclinical studies, ADCETRIS treatment has resulted in testicular toxicity, and may alter male fertility. Advise men being treated with ADCETRIS not to father a child during treatment and for up to 6 months following the last dose.

Effects on ability to drive and use machines: ADCETRIS may have a moderate influence on the ability to drive and use machines.

UNDESIRABLE EFFECTS

Monotherapy: The most frequent adverse reactions (10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain. Serious adverse drug reactions occurred in 12% of patients. The frequency of unique serious adverse drug reactions was 1%. Adverse events led to treatment discontinuation in 24% of patients.

Combination Therapy: In the study of ADCETRIS as combination therapy with AVD in 662 patients with previously untreated advanced HL, the most common adverse reactions ( 10%) were: neutropenia, nausea, constipation, vomiting, fatigue, peripheral sensory neuropathy, diarrhoea, pyrexia, alopecia, peripheral motor neuropathy, decreased weight, abdominal pain, anaemia, stomatitis, febrile neutropenia, bone pain, insomnia, decreased appetite, cough, headache, arthralgia, back pain, dyspnoea, myalgia, upper respiratory tract infection, alanine aminotransferase increased. Serious adverse reactions occurred in 36% of patients. Serious adverse reactions occurring in 3% of patients included febrile neutropenia (17%), pyrexia (6%), and neutropenia (3%). Adverse events led to treatment discontinuation in 13% of patients.

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

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

Contraindication

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

Warnings and Precautions

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

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

Most Common (20% in any study) Adverse ReactionsPeripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia, and mucositis.

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

Use in Specific PopulationsModerate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

For additional Important Safety Information, including BOXED WARNING, please see the full Prescribing Information for ADCETRIS at http://www.seattlegenetics.com or http://www.ADCETRIS.com.

ADYNOVATE Professional Important Information

ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] Important Information

Indications and Limitation of UseADYNOVATE is a human antihemophilic factor indicated in children and adults with hemophilia A (congenital factor VIII deficiency) for:

ADYNOVATE is not indicated for the treatment of von Willebrand disease.

DETAILED IMPORTANT RISK INFORMATION

CONTRAINDICATIONSPrior anaphylactic reaction to ADYNOVATE, to the parent molecule (ADVATE [Antihemophilic Factor (Recombinant)]), mouse or hamster protein, or excipients of ADYNOVATE (e.g. Tris, mannitol, trehalose, glutathione, and/or polysorbate 80).

WARNINGS & PRECAUTIONSHypersensitivity ReactionsHypersensitivity reactions are possible with ADYNOVATE. Allergic-type hypersensitivity reactions, including anaphylaxis, have been reported with other recombinant antihemophilic factor VIII products, including the parent molecule, ADVATE. Early signs of hypersensitivity reactions that can progress to anaphylaxis may include angioedema, chest tightness, dyspnea, wheezing, urticaria, and pruritus. Immediately discontinue administration and initiate appropriate treatment if hypersensitivity reactions occur.

Neutralizing AntibodiesFormation of neutralizing antibodies (inhibitors) to factor VIII can occur following administration of ADYNOVATE. Monitor patients regularly for the development of factor VIII inhibitors by appropriate clinical observations and laboratory tests. Perform an assay that measures factor VIII inhibitor concentration if the plasma factor VIII level fails to increase as expected, or if bleeding is not controlled with expected dose.

ADVERSE REACTIONSThe most common adverse reactions (1% of subjects) reported in the clinical studies were headache and nausea.

Click here for Full Prescribing Informationhttps://www.shirecontent.com/PI/PDFs/ADYNOVATE_USA_ENG.pdf

FEIBA [Anti-Inhibitor Coagulant Complex] Indications and Detailed Important Risk Information

Indications for FEIBA

FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia A and B patients with inhibitors for:

FEIBA is not indicated for the treatment of bleeding episodes resulting from coagulation factor deficiencies in the absence of inhibitors to coagulation factor VIII or coagulation factor IX.

Detailed Important Risk Information for FEIBA

WARNING: EMBOLIC AND THROMBOTIC EVENTS

CONTRAINDICATIONS

FEIBA is contraindicated in patients with:

WARNINGS AND PRECAUTIONS

Thromboembolic events (including venous thrombosis, pulmonary embolism, myocardial infarction, and stroke) can occur, particularly following the administration of high doses (>200 units/kg/day) and/or in patients with thrombotic risk factors.

Patients with DIC, advanced atherosclerotic disease, crush injury, septicemia, or concomitant treatment with recombinant factor VIIa have an increased risk of developing thrombotic events due to circulating tissue factor or predisposing coagulopathy. Potential benefit of treatment should be weighed against potential risk of these thromboembolic events.

Infusion should not exceed a single dose of 100 units/kg and daily doses of 200 units/kg. Maximum injection or infusion rate must not exceed 2 units/kg/minute. Monitor patients receiving >100 units/kg for the development of DIC, acute coronary ischemia and signs and symptoms of other thromboembolic events. If clinical signs or symptoms occur, such as chest pain or pressure, shortness of breath, altered consciousness, vision, or speech, limb or abdomen swelling and/or pain, discontinue FEIBA and initiate appropriate diagnostic and therapeutic measures.

Safety and efficacy of FEIBA for breakthrough bleeding in patients receiving emicizumab has not been established. Cases of thrombotic microangiopathy (TMA) were reported in a clinical trial where subjects received FEIBA as part of a treatment regimen for breakthrough bleeding following emicizumab treatment. Consider the benefits and risks with FEIBA if considered required for patients receiving emicizumab prophylaxis. If treatment with FEIBA is required for patients receiving emicizumab, the hemophilia treating physician should closely monitor for signs and symptoms of TMA. In FEIBA clinical studies TMA has not been reported.

Hypersensitivity and allergic reactions, including severe anaphylactoid reactions, can occur. Symptoms include urticaria, angioedema, gastrointestinal manifestations, bronchospasm, and hypotension. Reactions can be severe and systemic (e.g., anaphylaxis with urticaria and angioedema, bronchospasm, and circulatory shock). Other infusion reactions, such as chills, pyrexia, and hypertension have also been reported. If signs and symptoms of severe allergic reactions occur, immediately discontinue FEIBA and provide appropriate supportive care.

Because FEIBA is made from human plasma it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

FEIBA contains blood group isohemagglutinins (anti-A and anti-B). Passive transmission of antibodies to erythrocyte antigens, e.g., A, B, D, may interfere with some serological tests for red cell antibodies, such as antiglobulin test (Coombs test).

ADVERSE REACTIONS

Most frequently reported adverse reactions observed in >5% of subjects in the prophylaxis trial were anemia, diarrhea, hemarthrosis, hepatitis B surface antibody positive, nausea, and vomiting.

Serious adverse reactions seen are hypersensitivity reactions and thromboembolic events, including stroke, pulmonary embolism and deep vein thrombosis.

DRUG INTERACTIONS

Continued here:
Takeda to Highlight Expanded Portfolio of Products Across Oncology and Hematology at 61st American Society of Hematology (ASH) Annual Meeting -...

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Science Foundation Ireland 2019 Science Awards recognise key leaders in the Irish Research Community

Associate Professor Dr Eilish McLoughlin has been honoured with a prestigious 2019 Science Foundation (SFI) award announced today at the annual SFI Science Summit in Athlone attended by over 300 leading members of Irelands research community who gathered to celebrate the significant contributions made over the past year to Science, Technology, Engineering and Maths (STEM) in Ireland.

Dr McLoughlin was presented with the SFI Outstanding Contribution to STEM Communication in recognition of her incredible contribution to the popularisation of science and her sterling efforts in raising public awareness of the value of science to human progress.

Dr McLoughlin is Director of the Research Centre for the Advancement of STEM Teaching and learning (CASTeL) at DCU. She obtained her BSc in Applied Physics and PhD in Surface Physics from DCU.

A firm believer in the mantra that science is for all, she has led several large-scale national initiatives to widen participation in STEM including Physics Busking, Science on Stage, Improving Gender Balance (all 3 have been funded by SFI) and the STEM Teacher Internship.

Her significant contributions to STEM engagement have resulted in many awards, especially the prestigious Institute of Physics Lise Meitner Medal in 2018 and the DCU President's Award for Engagement in 2017.

She has led several EU collaborations in STEM Education including coordinator of ESTABLISH, Co-Coordinator SAILS and is currently National Coordinator of the H2020 Open Schools for Open Societies project.

Speaking about her award Dr McLoughlin said:

I would like to thank Science Foundation Ireland for presenting me with this award.

I really appreciate their on-going support for STEM education and public engagement activities that allow me to engage with members of the public and teachers and students in schools across Ireland and share my passion for physics.

I hope that my interaction with young people and their parents will encourage more students to choose physics and follow a career in STEM.

Young girls need role models to encourage them to follow their interests and achieve their potential in physics. I hope by winning this award, more young people will realise that physics is a rewarding pathway to follow.

Dr McLoughlin was among ten award winners including a new award for Mentorship which was introduced to celebrate the important role mentors play in providing guidance, motivation and emotional support in our research system.

Acknowledging the award winners, Minister for Training, Skills, Innovation and Research and Development, John Halligan TD, said:

The Science Foundation Ireland Awards recognise the breadth and depth that research encompasses from industry collaborations to public engagement and the innovative breakthroughs that are leading research globally in the areas of Immunology, Biomaterials, Cancer research and much more.

I would like to congratulate each awardee on their achievements, which illustrate the invaluable knowledge and resource that Irelands research community offers.

I am also pleased to see mentorship amongst the awards this year, highlighting the importance of supporting the next generation of researchers and enriching our growing research community.

Professor Mark Ferguson, Director General of Science Foundation Ireland and Chief Scientific Adviser to the Government of Ireland, also congratulated the award winners, saying:

On behalf of Science Foundation Ireland, I would like to congratulate the award winners on their success and recognise their dedication in realising their ambitions and in doing so, building Irelands reputation as a global research leader.

We are very proud of the excellent quality of research that our funding enables, and the SFI Awards are an important acknowledgement of the collective achievements of the Irish research community, which continue to be impactful, inspirational and world-leading.

The 2019 Recipients are as follows:

SFI Researcher of the Year 2019

The SFI Researcher of the Year Award recognises the accomplishments of an SFI funded researcher who has contributed significantly to the Irish research community in the year of the award and/or throughout their career.

The successful researcher has achieved exceptional scientific and engineering research outputs combined with a clear demonstration of the ability to communicate their research.

Recipient: Professor Kevin OConnor, Director of the BEACON SFI Bioeconomy Research Centre, University College Dublin

Professor Kevin OConnor received his BSc degree and PhD from University College Cork.

He is a Professor of Microbial biotechnology in the School of Biomolecular and Biomedical Science at UCD and an investigator in the UCD Earth Institute.

As Director of the BEACON SFI Bioeconomy Research Centre, Professor OConnor is leading blue skies and industry focused research to build and support the development of Irelands bioeconomy.

He is shaping the European Bioeconomy Strategy through his chairmanship of the Scientific Committee for the Bio-based Industries Joint Undertaking (BBIJU), a 3.7 billion Public-Private Partnership.

His research work is seminal in the area of circular economy (plastics to biodegradable plastics), circular bioeconomy (dairy processing by-product to value-added chemical) and biotechnology (hydroxytyrosol production by a biocatalyst).

Collaborating with industry, Professor OConnor developed technology to convert a dairy by-product into an organic acid, which was patented and licensed to industry.

It is now being scaled and implemented in a world first second generation dairy biorefinery, which has received over 30 million in EU funding.

He has published extensively and patented technologies on the conversion of waste plastics to biodegradable plastic and the biotechnological production of hydroxytyrosol (a health promoting molecule) and founded two spin-out companies Bioplastech and Nova Mentis.

Commenting on receiving the Award Professor Kevin OConnor stated:

I am delighted and honoured to receive this prestigious SFI award.

It is a recognition of the dedication of the many researchers and industry partners with whom I work and collaborate with, across multiple scientific fields and sectors, at UCD, across Ireland and internationally.

Through these collaborations we are creating knowledge and translating this knowledge into innovative technological solutions to address global and societal bioeconomy challenges.

I would especially like to acknowledge and thank SFI for their funding, and UCD, BEACON centre members and my wife and family for all their support.

SFI Early Career Researcher of the Year

The SFI Early Career Researcher Award recognises outstanding early career research talent and in recognition of the high calibre of nominations in 2019, there are two individual recipients of the Early Career Researcher of the Year Award:

Recipient: Associate Professor Lydia Lynch, Trinity College Dublin

An Associate Professor at Trinity College Dublin (TCD), in the School of Biochemistry and Immunology, Dr Lydia Lynch established and runs the Lynch Laboratory.

She graduated from University College Dublin with a BSc in Cell Biology and Genetics and a PhD in Immunology and went onto receive a Newman Fellowship for her early post-doctoral studies in St. Vincents University Hospital, where she helped establish the Immunology and Obesity Lab.

Here she discovered adipose iNKT cells and demonstrated that their activation could help manage obesity and metabolic disease.

Dr Lynch is also the recipient of the prestigious LOreal-UNESCO International Women in Science Award and a Marie Curie International Fellowship, which allowed her to move to Harvard Medical School in 2013 and continue studying immunometabolism.

Whilst at Harvard, she was a recipient of the inaugural Innovation Evergreen Fund award. She is also the holder of an American Diabetes Association Award and a Cancer Research Institute Award as well as a European Research Council (ERC) Starting grant and SFI President of Ireland Future Research Leader Award and currently leads an international team in immunometabolism at TCD.

Recipient: Dr Orla OSullivan, APC Microbiome Ireland SFI Research Centre and Vistamilk SFI Research Centre, Teagasc

Dr Orla OSullivan completed her degree in Biochemistry and PhD in Bioinformatics in UCC. She went on to complete a postdoctoral fellowship at the Conway Institute UCD and then joined Teagasc, where she focuses on profiling the microbiome and where she has worked on the ELDERMET project amongst many others.

Dr OSullivan is a funded investigator within the APC Microbiome Ireland SFI Research Centre and Vistamilk SFI Research Centre.

In 2014, Dr OSullivan was awarded an SFI Starting Investigator Research Grant to allow her to establish herself as an independent scientist.

In the same year she was awarded the APC Junior Scientist of the Year.

She is committed to communicating science to all and actively participates in a number of outreach programmes such as BIG STEM communicators, BT Young Scientist, Fota Mad Scientist and World Microbiome Day.

Her research focuses on the microbiome and her studies have established that healthy and protein-rich athlete diets result in a more diverse gut microbiota than standard diets.

She aims to utilise outputs from this research to holistically manage chronic illnesses associated with the gut microbiome, thereby addressing a number of critical societal health challenges.

In 2018, Dr OSullivan was named by Clarivate Analytics as a Highly Cited Researcher placing her in the top 1% of researchers worldwide.

SFI Industry Partnership Award

The SFI Industry Partnership Award celebrates a collaboration between an SFI-funded academic research group and industry.

Recipient: Professor Danny Kelly, AMBER SFI Research Centre for Advanced Materials and BioEngineering Research, Trinity College Dublin, for collaboration with Johnson & Johnson Services, Inc.

Professor Danny Kelly is a Professor of Biomedical Engineering and is Director of the Trinity Centre for Biomedical Engineering where he leads a large multidisciplinary orthopaedic tissue engineering group.

He holds the Chair of Tissue Engineering at TCD and has received three prestigious European Research Council (ERC) awards. Professor Kelly is at the forefront of tissue regeneration using 3D bioprinting strategies.

Through his position at AMBER he has led the Johnson & Johnson partnership on the TRANSITION programme, funded under SFIs Spokes programme to develop a new class of 3D-printed biological implants that will regenerate, rather than replace, diseased joints.

TRANSITION is a shared vision and expands upon AMBERs long-standing collaboration with DePuy Ireland Unlimited Company.

TRANSITION, led by Professor Danny Kelly, brings together Principal Investigators and researchers from four AMBER partners (DCU, RCSI, TCD & UCD) and scientists and engineers from Johnson & Johnsons 3D Printing Centre of Excellence and DePuy Synthes.

A significant milestone was realised earlier this year with the establishment of the Collaborative Bioprinting Laboratory in TCDs Trinity Biomedical Sciences Institute, which co-locates researchers from both sides of the partnership.

SFI Best International Engagement Award

This award recognises the accomplishments of a Science Foundation Ireland-funded researcher/group specifically in the context of their international activities.

Recipient: Professor Abhay Pandit, Scientific Director, CRAM SFI Research Centre for Medical Devices, NUI Galway

Professor Abhay Pandit is Professor of Biomaterials at NUI Galway and Scientific Director of CRAM SFI Research Centre for Medical Devices.

Professor Pandit has been an elected member on the Council for both the Tissue Engineering and Regenerative Medicine International Society and European Society for Biomaterials Society.

He was the first Irish academic to be inducted as an International Fellow in Biomaterials Science and Engineering by the International Union of Societies for Biomaterials Science and Engineering and elected as a Fellow of the Tissue Engineering and Regenerative International Society.

He was also elected to the American Institute of Medical and Biological Engineering (AIMBE) College of Fellows.

Professor Pandit has published more than 250 papers in peer-reviewed journals, filed numerous patent applications and has licensed four technologies to medical device companies.

He has coordinated four EU grants to date and has generated research contracts from industry and government funding agencies totalling 90 million.

Throughout his career, his work has been outward facing, from engaging in international collaborations and hosting international conferences, to supporting trade missions and championing residency programs for leaders in the community (artists, filmmakers, teachers) to empower them with the STEM message.

SFI Entrepreneurship Award

The SFI Entrepreneurship Award celebrates an entrepreneurial achievement by SFI supported researchers.

Recipient: Professor William Gallagher, University College Dublin

Professor William Gallagher is Director of the UCD Conway Institute of Biomolecular and Biomedical Research and Professor of Cancer Biology in the UCD School of Biomolecular & Biomedical Science at University College Dublin.

He was also the Director of the first Irish Cancer Society Collaborative Cancer Research Centre, BREAST-PREDICT, which completed its ground-breaking six year programme in September 2019. Professor Gallagher co-founded the molecular diagnostics company OncoMark in 2007 and is currently its Chief Scientific Officer.

OncoMark focuses on the development and application of biomarker panels which address critical unmet needs for cancer patients.

A major focus of Professor Gallaghers research work is the identification and validation of candidate biomarkers of breast and other cancers, particularly those which guide treatment decision making.

He has received a number of awards to date, including the BACR/AstraZeneca Young Scientist Frank Rose Award in 2004, the St. Luke's Silver Medal Award in 2008, the NovaUCD Innovation Award in 2011 and the inaugural IACR Award for 'Outstanding Contribution to Cancer Medicine and Research' in 2017.

Professor Gallagher has led multiple EU networks under EU programmes, he has had many collaborations with a variety of industrial partners throughout his research, and has filed multiple patents.

SFI Outstanding Contribution to STEM Communication (There are two recipients of this award, including Dr McLoughlin)

Recipient: Dr Muriel Grenon, NUI Galway

Dr Muriel Grenon is a lecturer in Biochemistry, School of Natural Sciences, NUI Galway and the founding Director of the Cell EXPLORERS science outreach programme.

Dr Grenon started out the programme in 2012 with a team of 10 undergraduate science students in NUI Galway and has built Cell EXPLORERS into a national network comprising 13 partner teams with members from 15 Higher Education Institutions in Ireland.

Between 2012 and 2018 Cell EXPLORERS involved 1,187 team members, visited 471 classrooms in 280 schools and reached 32,000 members of the public.

Cell EXPLORERS has also successfully integrated science outreach projects into the final year of the Biochemistry undergraduate course at NUI Galway allowing the creation of potential novel science outreach resources each semester.

Dr Grenon is also involved in driving science communication internationally: Cell EXPLORERS is part of Scientix, the community for Science Education in Europe.

The programme has also started a collaboration with the University of Kwatzulu-Natal in South Africa, where a team is currently piloting the Fantastic DNA school visits.

Dr Grenons contribution and dedication to the popularisation of STEM has been recognised by the Outstanding Contribution to STEM award at the 2013 Galway Science and Technology Festival, the 2017 NUI Galway President Award for Societal Impact and being made Knight of the Order of the Palmes Acadmiques by the French Ministry of Education in 2019.

SFI Mentorship Award

This inaugural award recognises outstanding mentorship provided by a researcher funded by Science Foundation Ireland.

Recipient: Dr Fatima Gunning, IPIC SFI Research Centre and Tyndall National Institute

Dr Fatima Gunning completed her BSc in Physics and PhD in Optoelectronics from Pontifcia Universidade Catlica do Rio de Janeiro (PUC-Rio), Brazil before joining IPIC SFI Research Centre, hosted by Tyndall National Institute after a brief two year period at Corning.

Currently serving as Head of Graduate Studies at Tyndall National Institute and a PI at IPIC SFI Research Centre, she is looking at novel photonics technologies for the Internet of the future.

She has also led many diversity and inclusion programmes that are directly targeted at improving the deficit of diverse talent and gender balance in the field including Empowering Women@Tyndall and being a key advocate for Tyndall to apply for Athena SWAN by 2020.

Dr Gunning has been selected to become Vice President of Membership and Outreach of the IEEE Photonics Society starting January 2020 to expand the diversity, inclusion and mentorship efforts to an international scale.

Dr Gunning believes that all students are different, are driven by different motivations and develop their research in different ways.

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Dr Eilish McLoughlin honoured by SFI for Outstanding Contribution to STEM Communication - Dublin City University

Recommendation and review posted by Bethany Smith

BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (NASDAQ:LVGO) are both medical companies, but which is the superior business? We will contrast the two companies based on the strength of their risk, valuation, institutional ownership, earnings, dividends, profitability and analyst recommendations.

Valuation & Earnings

This table compares BioRestorative Therapies and Livongo Healths revenue, earnings per share (EPS) and valuation.

BioRestorative Therapies has higher earnings, but lower revenue than Livongo Health.

Insider & Institutional Ownership

0.1% of Livongo Health shares are held by institutional investors. 17.9% of BioRestorative Therapies shares are held by company insiders. Strong institutional ownership is an indication that endowments, hedge funds and large money managers believe a stock will outperform the market over the long term.

Profitability

This table compares BioRestorative Therapies and Livongo Healths net margins, return on equity and return on assets.

Analyst Recommendations

This is a breakdown of recent ratings for BioRestorative Therapies and Livongo Health, as provided by MarketBeat.

Livongo Health has a consensus target price of $44.30, indicating a potential upside of 81.33%. Given Livongo Healths higher possible upside, analysts plainly believe Livongo Health is more favorable than BioRestorative Therapies.

Summary

Livongo Health beats BioRestorative Therapies on 7 of the 9 factors compared between the two stocks.

BioRestorative Therapies Company Profile

BioRestorative Therapies, Inc. develops therapeutic products and medical therapies using cell and tissue protocols, primarily involving adult stem cells for the treatment of disc/spine disease and metabolic disorders. The company's lead cell therapy candidate is the BRTX-100, which focuses on providing non-surgical treatment for protruding and bulging lumbar discs in patients suffering from chronic lumbar disc disease. It also develops the ThermoStem program, a pre-clinical program for the treatment of metabolic diseases, such as type 2 diabetes, obesity, hypertension, and other metabolic disorders, as well as cardiac deficiencies. In addition, the company provides curved needle device, a needle system with a curved inner cannula that allows access to difficult-to-locate regions for the delivery or removal of fluids and other substances. Further, it offers skin care products under the Stem Pearls brand name. BioRestorative Therapies, Inc. has a research and development agreement with Rohto Pharmaceutical Co., Ltd.; and a research agreement with Pfizer, Inc. and the University of Pennsylvania. The company was formerly known as Stem Cell Assurance, Inc. and changed its name to BioRestorative Therapies, Inc. in August 2011. BioRestorative Therapies, Inc. was incorporated in 1997 and is headquartered in Melville, New York.

Livongo Health Company Profile

Livongo Health, Inc. provides an integrated suite of solutions for the healthcare industry in North America. It solutions promote health behavior change based on real-time data capture supported by intuitive devices and insights driven by data science. The company offers a platform that provides cellular-connected devices, supplies, informed coaching, data science-enabled insights, and facilitates access to medications. Its products include Livongo for Diabetes, Livongo for Hypertension, Livongo for Prediabetes and Weight Management, and Livongo for Behavioral Health by myStrength. The company was formerly known as EosHealth, Inc. and changed its name to Livongo Health, Inc. in 2014. Livongo Health, Inc. was incorporated in 2008 and is headquartered in Mountain View, California.

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Comparing BioRestorative Therapies (OTCMKTS:BRTX) and Livongo Health (OTCMKTS:LVGO) - Darby News

Recommendation and review posted by Bethany Smith