Sernova Corp., of London, Ontario, is taking islet cell transplantation to the next level by combining transplanted insulin-producing islet cells with its Cell Pouch device in a Phase I/II trial in patients with Type I diabetes.
Regulus Therapeutics Inc., of La Jolla, Calif., inked another two deals related to its microRNA technology. Its agreement with London's AstraZeneca plc calls for a $28 million up-front cash and equity payment, plus milestones, for development of three microRNA targets.
A post-market study by Acorda Therapeutics Inc. designed to compare a lower 5-mg dose of Ampyra (dalfampridine) to the approved 10-mg dose failed to show any benefit for the 5-mg dose and missed its primary endpoint altogether at both doses. The drug is approved for use in patients with multiple sclerosis.
The FDA approved Lucentis (ranibizumab injection) for diabetic macular edema (DME), offering patients the first improvement on the standard-of-care in 25 years.
Following a decision to terminate development of saridegib under its alliance with Mundipharma International Corp., and subsequent 20 percent headcount reduction, Infinity Pharmaceuticals Inc. said Thursday it would raise about $76.85 million through a public offering of 5.3 million shares of common stock at $14.50 per share. Net proceeds from the offering will be funneled into clinical development of cancer candidates IPI-145 and retaspimycin.
K-V Pharmaceutical Co. filed for Chapter 11 bankruptcy protection in the U.S. Bankruptcy Court for the Southern District of New York, in order to restructure its financial obligations, principally a milestone payment to Bedford, Mass.-based Hologic Inc.
In its second quarterly earnings report for 2012, Aveo Pharmaceuticals Inc., of Cambridge, Mass., said the FDA is concerned about overall survival trends in its ongoing TIVO-1 trial of tivozanib compared to sorafenib (Nexavar, Onyx Pharmaceuticals Inc.) in 517 patients with advanced renal cell carcinoma.
Incyte Corp.'s launch of Jakafi (ruxolitinib) for myelofibrosis continues to gather momentum as physicians gradually expand its use to less severely ill patients. The Wilmington, Del.-based company reported Jakafi sales of $31.9 million for the second quarter of 2012, and $53.1 million for the first six months of the year.
Array BioPharma Inc.'s p38-alpha kinase inhibitor, ARRY-797, hit its primary endpoint of reducing pain more than placebo in a Phase II proof-of-concept trial in 157 patients with knee pain due to osteoarthritis. Enrolled patients suffered moderate-to-severe pain in spite of the use of nonsteroidal anti-inflammatory drugs (NSAIDs).
Mersana Therapeutics Inc. attracted $27 million in Series A-1 financing for its Fleximer-based antibody-drug conjugate (ADC) pipeline. Riding the coattails of Adcetris' success, Mersana is hoping to develop the next generation of ADCs, addressing limitations of earlier iterations of the technology.
