Hedgehog has been a household name in biotech circles for decades – both because the Sonic Hedgehog protein owes its whimsical name to a Sega video game character and because scientists have long pursued ways to target the Hedgehog pathway. Now Roche AG's Genentech unit has succeeded – with a little help from Curis Inc. – winning FDA approval of Erivedge (vismodegib) for advanced basal cell carcinoma. Read More
WASHINGTON – After coming under fire for delaying rulemaking on prescription drug reimbursement, the Centers for Medicare & Medicaid Services (CMS) has proposed a rule to implement provisions of the 2010 Affordable Care Act (ACA) relating to manufacturer rebates and alignment of pharmacy reimbursement rates for covered outpatient prescription drugs. Read More
La Jolla Pharmaceutical Co. is anything but new – founded in 1989, the biotech is best known for its rollercoaster ride with lupus drug Riquent (abetimus sodium). Read More
• Ziopharm Oncology Inc., of New York, said an independent data monitoring committee unanimously recommended continuation of its international, randomized, double-blind, placebo-controlled Phase III trial of palifosfamide (Zymafos, or ZIO-201), dubbed PICASSO 3, in front-line metastatic soft tissue sarcoma – the third such review and recommendation by the committee. Read More
• Cephalon Inc., a unit of Jerusalem-based Teva Pharmaceutical Industries Ltd., is recalling one lot of Treanda (bendamustine HCL) for injection 25mg/8mL due to glass fragments found in a single vial of the leukemia drug. To date, no adverse events have been associated with the problem. Read More
• Trius Therapeutics Inc., of San Diego, said underwriters of its previously announced public offering exercised in full their option to purchase an additional 1.29 million shares to cover overallotments. Including the overallotment, the company grossed $51.9 million from the sale of 9.89 million shares priced at $5.25 apiece. Read More
