In questioning by members of the House Energy and Commerce Committee, FDA Commissioner Margaret A. Hamburg was hammered for more than four hours Wednesday about the agency's failure to communicate proactively with the Massachusetts Department of Public Health or to provide adequate oversight of the New England Compounding Center, which has been implicated in 32 deaths and more than 400 additional illnesses from a fungal meningitis outbreak across 19 states. Read More
Multiple sclerosis is perhaps the best known of the demyelinating disorders, where loss of the insulating sheath surrounding neurons makes high-speed communication impossible. Read More
One-by-one, big pharmaceutical firms are plunging off patent cliffs. They're scrambling to fill pipelines and reinforce bottom lines. The door is open wider than ever for biotechnology companies and their coffers of innovative therapeutic candidates to negotiate lucrative licensing deals with a focus on royalty rates. Read More
Amarantus BioSciences Inc., of Sunnyvale, Calif., said it secured more than $1.1 million in funding through two separate transactions. The firm issued a convertible promissory note to an undisclosed investor in the principal amount of $600,000 and, in an unrelated equity financing deal with an institutional fund, settled more than $500,000 in accounts payable. Read More
• GenVec Inc., of Gaithersburg, Md., presented data related to its malaria vaccine program at the American Society of Tropical Medicine and Hygiene meeting in Atlanta. The data showed that the new antigens are as protective as circumsporozoite protein (CSP) in a mouse model of malaria. Read More
• OncoSec Medical Inc., of San Diego, reported interim results from a Phase IV trial of NeoPulse in skin cancer at the World Meeting of Interdisciplinary Melanoma and Skin Care Centres and EADO Congress in Barcelona, Spain, showing a complete response greater than 90 percent in basal cell carcinoma patients and 70 percent in squamous cell carcinoma patients at six months. Read More
• Fedora Pharmaceuticals Inc., of Edmonton, Alberta, appointed Ronald W. Odynski and Leonard E. Post to its newly created board, and named Christopher Micetich board chairman. Read More
• Bristol-Myers Squibb Co., of New York, and AstraZeneca plc, of London, said the European Commission approved Forxiga (dapaglifozin) tablets for Type II diabetes in the European Union. Read More
• Merck & Co. Inc., of Whitehouse Station, N.J., presented data from a post-hoc subgroup analysis of three studies, which found that integrase inhibitor Isentress (raltegravir) demonstrated consistent long-term viral suppression and a well-established safety profile in adults co-infected with HIV-1 and hepatitis C virus and/or hepatitis B virus, compared to adults with HIV-1, at 240 weeks. Read More
