FDA panel votes to relax Avandia restrictions Print E-mail
By Mary Davila   
Friday, 07 June 2013 07:37
Below is a look at some of the headlines for companies that made news in the healthcare sector on June 6, 2013.

U.S. health advisers voted on Thursday to recommend relaxing market restrictions on GlaxoSmithKline's diabetes drug Avandia, the former blockbuster at the center of one of the biggest drug controversies in recent years.

The vote, by a divided Food and Drug Administration advisory committee of outside health experts, could modestly enlarge the market for Avandia in the United States and lay the groundwork for further research into the drug's health risks. FDA will now take the vote into consideration for a final decision on how the pill also known by the generic name rosiglitazone can be used.

The committee did not consider a specific change in protocol. But 13 experts on the 26-member panel who backed modification said current restrictions that require prescribing physicians and pharmacists to be certified should be relaxed or eliminated after a reexamination of Glaxo safety data settled longstanding concerns about the danger of death from cardiovascular disease.

"In general, this drug doesn't look any different than any other diabetes drug," said Dr. William Hiatt, a cardiologist from the University of Colorado, who was among seven experts who backed lifting restrictions altogether.

Five committee members favored keeping the current sales restrictions, while one voted to withdraw Avandia from the market altogether.

Glaxo, which no longer plans to promote Avandia, issued a statement saying the company would work with FDA as it considers its decision. "We continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labeling," Dr. James Shannon, Glaxo's chief medical officer, said in a statement.

The British drugmaker's stock closed nearly 1.5 percent lower in London trading before the committee voted.

Avandia was once the world's best-selling treatment for type 2 diabetes, with annual sales of $3.2 billion.

In 2010 its use in the United States was heavily restricted and it was withdrawn from the market in Europe because of the possibility of increased risk of heart attack and stroke. Only 3,000 people in the United States take it today, down from about 120,000 just before the restrictions were put in place.

Much of the advisory committee's two-day meeting focused on a Duke University reexamination of a Glaxo safety study known as Record that confirmed initial findings of no significant increased heart risk from the drug. That reassured some experts that earlier concerns with the quality of the research had been unwarranted and encouraged support for the restrictive protocols, while retaining continued guidance on potential dangers for patients and care providers.

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Astro-Med, Inc. (NASDAQ: ALOT)
announced that it has been awarded the flight deck printer contract for the new Embraer KC-390 military transport aircraft by the Embraer Defense and Security division of Embraer SA (NYSE: ERJ).

BioLineRx (NASDAQ: BLRX; TASE: BLRX)
, a biopharmaceutical development company, announced today enrollment of the first patient in a Phase 2 trial for BL-8040, for the treatment of acute myeloid leukemia (AML).

Emergent BioSolutions Inc. (NYSE: EBS)
announced today that a member of the company’s senior management team will participate in investor conferences during June and July 2013.

Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT)
today announced two presentations showing the strengths of AE37 as a viable and promising treatment option for patients who have had breast cancer.

Hadasit Bio-Holdings Ltd. (TASE: HDST, OTC: HADSY)
, a publicly traded portfolio of biotech companies, based on intellectual property developed and owned by Hadassah University Hospital, Israel's foremost medical research center, today announced that Mr. Ophir Shahaf, Chief Executive Officer, will be presenting at the third annual Connecticut-Israel Technology Summit on June 12th at The Oakdale Theater in Wallingford, CT.

Medicago Inc. (TSX: MDG; OTCQX: MDCGF)
, a biopharmaceutical company focused on developing highly effective and competitive vaccines based on proprietary manufacturing technologies and Virus-Like Particles (VLPs), today reported positive interim results from a preclinical trial for an H7N9 Avian Influenza VLP vaccine candidate ("H7 vaccine").

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN)
and Bayer HealthCare today announced positive top-line results for EYLEA® (aflibercept) Injection from the Phase 3 MYRROR study in myopic choroidal neovascularization (mCNV).

Royalty Pharma announced today that on Tuesday, June 4, 2013, Elan (NYSE: ELN) withdrew a lawsuit it had filed on an emergency basis only the previous day.

RXi Pharmaceuticals Corporation (OTCQB: RXII)
, a biotechnology company focused on discovering, developing and commercializing innovative therapies addressing major unmet medical needs using RNA-targeted technologies, today  announced the unblinded results of the first of their 2 placebo-controlled double blind studies in volunteers with their anti-scarring agent RXI-109, a proprietary sd-rxRNA® compound that has been shown in vitro and in animals to reduce mRNA for connective tissue growth factor (CTGF).

Sorrento Therapeutics, Inc. (OTCBB: SRNE)
today announced that it has been awarded the 2013 Frost & Sullivan Global Investment Opportunity Award in Oncology.

Spectrum Pharmaceuticals (NasdaqGS: SPPI)
, a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today announced that an overview of the Company's business strategy and commercial and development-stage programs will be given at the Goldman Sachs 34th Annual Global Healthcare Conference being held at Terranea Resort in Rancho Palos Verdes, CA.

Verastem, Inc., (NASDAQ: VSTM)
focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, today announced that Robert Forrester, President and Chief Operating Officer, will be named President, Chief Executive Officer and a Director, and that Christoph Westphal, M.D., Ph.D., Chairman and Chief Executive Officer, will be transitioning to Executive Chairman.

Where Food Comes From, Inc. (d.b.a. IMI Global) (OTCQB: WFCF)
, a leading provider of verification and Internet solutions for the agricultural and food industry, today announced it has signed an exclusive relationship with Colorado State University's Center for Meat Safety & Quality (CMSQ) for the use of their newly acquired Randox Evidence Investigator, a unique testing system allowing rapid screening for the presence of a wide array of residues in mediums such as food products, feedstuffs and urine.



"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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