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Wednesday, October 3, 2018

BrainStorm Data Support Platform as Best-In-Class Strategy in ALS


BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of innovative adult stem cell therapeutics for debilitating neurodegenerative diseases, announced today that members of its executive team will present at the Northeast Amyotrophic Lateral Sclerosis (NEALS) Conference in Clearwater, Florida and the Cell & Gene Meeting on the Mesa 2018 Conference in La Jolla, California, both taking place today, October 3, 2018.
Chaim Lebovits, President & Chief Executive Officer, will also be attending the MidCap Investor Event® sponsored by CF&B Communication in Europe on October 8-9, 2018 in Paris, France, and will be available for one-on-one meetings with potential institutional investors. To schedule a meeting, please use the Contact link on BrainStorm’s website at www.brainstorm-cell.com. 
NEALS Annual 2018 Conference  
Poster entitled, “MicroRNA Changes in the NurOwn® Phase 2 ALS Randomized Clinical Trial: Relationship to Neuroprotection and Innate Immunity.”
  • Date: Wednesday, October 3, 2018
  • Time: 3:45 pm to 5:45 pm Eastern Time (Clearwater, Florida)
  • Location: Opal Foyer in the Opal Sands Resort, Clearwater, Florida
  • Presenter: Ralph Kern, M.D., MHSc, Chief Operating Officer & Chief Medical Officer
  • Key Academic Collaborators:
    • Massachusetts General Hospital: James Berry, M.D. and Merit Cudkowicz, M.D.
    • University of Massachusetts Medical School: Robert Brown, M.D. and Margaret Ayo Owegi, D.O.
    • Mayo Clinic: Anthony Windebank, M.D. and Nathan Staff, M.D., Ph.D.
  • For more information: https://goo.gl/zikHA2
Cell & Gene Meeting on the Mesa 2018 Conference   
Scientific Workshop entitled, “Successful Strategies in the Design and Delivery of Cell & Gene Therapy Clinical Programs.”
  • Date: Wednesday, October 3, 2018
  • Time:  7:15 am to 8:45 am Pacific Time (La Jolla, CA)
  • Location: Estancia La Jolla Hotel, La Jolla, CA
  • Workshop Panel Speakers:
    • Peter Altman, Ph.D., President and CEO, BioCardia
    • Blake Anson, Ph.D., Director, Strategic Alliances, Fujifilm Cellular Dynamics
    • Robert Deans, Ph.D., Chief Technology Officer, BlueRock Therapeutics
    • Gisèle Deblandre, Ph.D., Scientific and Project Management Director, MaSTherCell
    • Felix Hsu, SVP and Head, Advanced Therapies Unit, WuXi AppTec
    • Hardy Kagimoto, M.D., Chairman and CEO, Healios
    • Dan Kaufman, M.D., Ph.D., Professor of Medicine, Division of Regenerative Medicine; Director of Cell Therapy, UC San Diego
    • María Pascual, VP Regulatory Affairs and Corporate Quality, TiGenix
    • Joseph Petroziello, VP, Scientific and Corporate Communications, BrainStorm Cell Therapeutics
    • Edward Wirth, M.D., Ph.D., Chief Medical Officer, Asterias Biotherapeutics
  • For more information: https://goo.gl/3M4L8b
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ObsEva SA reports additional positive Phase 3 results of IMPLANT 2 trial


  • Phase 3 IMPLANT 2 trial results showed Live Birth Rate increased by up to 35% with Nolasiban treatment
  • Nolasiban safety profile not different from placebo in IMPLANT 2
  • European MAA submission confirmed to be targeted for 4Q:19, commercial planning underway
  • Nolasiban is a novel therapy and the first therapy of its kind to improve clinical pregnancy and live birth rates in women undergoing IVF
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Novartis licenses 3 anti-infective programs to Boston Pharmaceuticals


Novartis International AG / Novartis licenses three novel anti-infective programs to Boston Pharmaceuticals . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.
  • Clinical and pre-clinical stage programs focused on addressing growing need for new treatments against drug resistant Gram-negative bacteria
  • Agreement is part of Novartis strategy to partner with like-minded innovators to further develop new medicines to address global health challenges
  • Research and development for new medicines to treat tropical diseases continues through the Novartis Institute for Tropical Diseases
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Gilead announces approval of Biktarvy in Hong Kong


Gilead Sciences announced that the Hong Kong Department of Health has approved Biktarvy, a once-daily single tablet regimen, or STR, for the treatment of HIV-1 infection in adults. Hong Kong is the first market in Asia to approve Biktarvy. The triple-combination, single-tablet therapy combines the potency of the novel integrase strand transfer inhibitor, or INSTI, bictegravir, with the demonstrated safety and efficacy profile of a guideline recommended dual nucleoside reverse transcriptase inhibitor backbone – Descovy. BIC/FTC/TAF provides a convenient once-daily dosing STR without regards of food. Furthermore, BIC/FTC/TAF’s use is not restricted by the patient’s baseline viral load, CD4 cell count or HLA-B 5701 status.
https://thefly.com/landingPageNews.php?id=2798881
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Tuesday, October 2, 2018

Raymond James Starts Vertex (VRTX) at Outperform



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Common Diabetes Meds May Raise Odds of Amputation


People with type 2 diabetes who are taking common drugs called diuretics may be at a significantly increased risk of losing a foot or leg, according to a new French study.
Researchers found that taking a diuretic raised the odds of having an amputation, or requiring an angioplasty or bypass, by 75 percent or more, compared with those not using the medicines.
Based on the findings, “diuretics should be used cautiously in patients with type 2 diabetes at risk of amputations,” concluded a team led by diabetes specialist Dr. Louis Potier, of Bichat Hospital in Paris.
But one U.S. expert said that restricting the use of diuretics puts diabetic patients “between a rock and a hard place.”
As Dr. Gerald Bernstein explained, diuretics are used to help “get rid of extra salt and water” in the blood, thereby helping patients control blood sugar and blood pressure.
In turn, that could help ward off a major killer: congestive heart failure.
So, the challenge is to “select the right drugs to prevent worsening of heart failure in order to prevent increased risk for amputations,” said Bernstein, coordinator for the Friedman Diabetes Program at Lenox Hill Hospital in New York City.
As Bernstein explained, “type 2 diabetes is a disease heavily associated with cardiovascular complications, in particular the big arteries from the heart to the rest of the body. When these arteries and the heart are diseased there is abnormal blood flow to all the organs but the lower extremities can be affected most because of how long that artery is.”
When circulation issues to the leg and foot become severe, amputation is often the only option.
How much might particular diabetes medicines affect the odds of needing an amputation?
To help find out, Potier’s team tracked outcomes for nearly 1,500 people with type 2 diabetes. The study specifically focused on amputations, as well as procedures such as angioplasty or the bypassing of blocked or damaged blood vessels. Those procedures are used to improve circulation and prevent leg or foot amputations.
Participants were followed until they had a leg procedure or died. Nearly 700 of the study participants were taking a diuretic drug.
Over a follow-up of about seven years, 13 percent of those taking a diuretic had an amputation or other procedure on their lower leg, compared with just 7 percent of those not taking a diuretic.
Said another way, this meant that taking a diuretic increased the risk of having an amputation or an angioplasty/bypass by 75 percent or more, compared with those not using one.
Most of this increase involved amputations, which nearly doubled for those taking a diuretic.
The results of the study were presented Monday at the meeting of the European Association for the Study of Diabetes, in Berlin.
It’s important to note the study was observational in nature, meaning that while it could point to an association between diuretics and amputation rates, it could not prove cause and effect, and other factors might be at play. Furthermore, research presented at medical meetings is typically considered preliminary until published in a peer-reviewed journal.
According to Bernstein, the take-home message here is not to immediately discontinue the use of diuretics, but to keep in mind that “the patient and physician must be very careful not to overtreat and be very selective” in which drugs are used to fight diabetes.
Diabetes specialist Dr. Robert Courgi agreed. Reviewing the findings, he said that while more study is needed to confirm the results, “if a patient is at risk for amputation then perhaps diuretics should be avoided for other equally effective options.” Courgi is an endocrinologist at Southside Hospital in Bay Shore, N.Y.
More information
For more on type 2 diabetes, visit the American Diabetes Association.
SOURCES: Gerald Bernstein, M.D., endocrinologist and coordinator, Friedman Diabetes Program, Lenox Hill Hospital, New York City; Robert Courgi, M.D., endocrinologist, Southside Hospital, Bay Shore, N.Y.; Oct. 1, 2018, press release, European Association for the Study of Diabetes
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J&J California Talc Cancer Trial Ends With Deadlocked Jury


A Los Angeles jury weighing claims by a retired computer salesman that Johnson & Johnson’s iconic baby powder is laced with cancer-causing asbestos failed to reach a verdict, resulting in a mistrial.
Kirk Von Salzen said J&J was responsible for causing his mesothelioma, a cancer linked to asbestos exposure. He sought more than $12 million in damages. The jury deliberated for several days before a state judge decided the panel was hopelessly deadlocked.
The mistrial is the second straight in lawsuits attempting to link the company’s talc products to cancer. A Pasadena, California, jury also deadlocked a little over a week ago, in a lawsuit brought by a school counselor who blamed her mesothelioma on asbestos in J&J talc.
In the last case to end conclusively, a jury in Missouri awarded $4.69 billion in July to more than 20 women with ovarian cancer who alleged asbestos in the company’s baby powder and Shower to Shower products caused their illnesses.
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