• Isis Pharmaceuticals Inc., of Carlsbad, Calif., and Genzyme Corp., of Cambridge, Mass., a unit of Sanofi SA, reported two-year data from a Phase III long-term extension study showing that Kynamro (mipomersen) maintained robust reductions in LDL-C in patients, as well as reductions in all other Apo B-containing atherogenic lipoproteins measured, with a safety profile consistent with the Phase III studies. Read More
• Forest Laboratories Inc., of New York, and Almirall SA, of Barcelona, Spain, said the FDA will require a three-month extension to complete its review of the new drug application for aclidinium bromide, a long-acting antimuscarinic drug, for the maintenance treatment of chronic obstructive pulmonary disease. Read More
• Derma Sciences Inc., of Princeton, N.J., said it signed a definitive agreement to acquire device manufacturer MedEfficiency Inc., of Wheat Ridge, Colo., for $14.5 million. MedEfficiency had revenues of $5.3 million in 2011. Read More
Oncothyreon Inc. raised $47 million through a public offering of 11.75 million shares priced at $4 apiece. The price represents an 8 percent discount to Wednesday's closing price of $4.35, and shares of Seattle-based Oncothyreon (NASDAQ:ONTY) dipped 10 cents to close at $4.25 on Thursday. Read More
Optimer Pharmaceuticals Inc. has earned analyst and investor kudos for its successful launch of Dificid (fidaxomicin). The macrolide antibiotic for Clostridium difficile Infection (CDI) had fourth quarter 2011 net sales of about $11 million and has bucked the biotech trend of underperforming analyst launch estimates. Read More
Merrimack Pharmaceuticals Inc., which has initiated six new clinical trials since August 2011, priced an initial public offering (IPO) of 14.3 million shares of common stock at $7 per share, for a total anticipated raise of about $100 million. Read More
Ten days after inking a potential $494 million deal with eye care specialist Alcon Inc. for the ex-U.S. rights to vitreous macular adhesion (VMA) candidate ocriplasmin, ThromboGenics NV raised €77.8 million (US$103.2 million) in a private placement of 3,244,677 new shares with domestic and international investors. Read More
Cardiovascular safety won out over all other risk factors and the need to encourage the development of innovative weight-loss drugs Thursday as the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 17-6 that cardiovascular outcome trials (CVOTs) should be required for all obesity drugs, even those that have no theoretic cardiovascular risk or signal. Read More
• Eli Lilly and Co. Inc., of Indianapolis, published new Phase II data in The New England Journal of Medicine showing that ixekizumab (LY2439821), an anti-IL-17 monoclonal antibody, met its primary endpoint of achieving at least a 75 percent improvement in psoriasis area and severity index (PASI) scores from baseline. The study enrolled 142 subjects, and significantly more patients achieved a PASI response in the 150-mg, 75-mg and 25-mg group (82 percent, 83 percent and 77 percent) than the placebo group (8 percent). The 10-mg dose group did not separate from placebo. Read More
