Shares of Sarepta Therapeutics Inc. (NASDAQ:SRPT) plunged 44 percent in heavy trading Thursday after the FDA posted revised briefing documents for Monday's re-scheduled meeting of the Peripheral and Central Nervous System Drugs (PCNS) Advisory Committee (adcom) to discuss the new drug application (NDA) for its Duchenne muscular dystrophy (DMD) candidate, eteplirsen. Read More

CEO George Scangos said Biogen Inc. has "deliberately brought in a series of compounds and [is] conducting late-stage trials and things that are outside" of multiple sclerosis (MS) in order to keep the business growing. Thursday's reaction to first quarter earnings by the Cambridge, Mass.-based firm varied from "a solid start to the year and biotech earnings season" (Cowen and Co. analyst Eric Schmidt) to "good enough is the theme right now" (RBC Capital Markets' Michael Yee). Piper Jaffray's Joshua Schimmer observed drily: "Lower spending, otherwise same Biogen." Read More

HONG KONG – Elucidation of the molecular structure of nonstructural protein 1 (NS1) from the Zika virus by Chinese Academy of Sciences (CAS) researchers shows that NS1 is involved in viral pathogenesis, a finding that could lead to new diagnostic technologies and treatments, including for related pathogens such as dengue and West Nile viruses. Read More

BOGOTA, Colombia – Novartis AG is working against the clock in Colombia in a bid to prevent the Colombian government from issuing a mandatory license for the blockbuster cancer drug Glivec (imatinib). Read More

SAN FRANCISCO – Large cap medtech companies, fueled by a growing wave of M&A and recognizing the importance of clinical data in building value, are following the biotech's sector's lead as they look to fill product pipelines, speakers at the Cooley Medical Technology Growth Conference said. Read More

The U.S. Department of Veterans Affairs issued notice of a policy change regarding covered drugs not compliant with the Trade Agreements Act (TAA) of 1979. Previously, the VA required that all products offered on the Federal Supply Schedule (FSS) contract be U.S.-made or substantially transformed designated country end products. Read More

Living Cell Technologies Ltd., of Melbourne, Australia, and Auckland, New Zealand, completed the placement of 8.35 million shares at 5.17 cents to wholesale investors in New Zealand. Read More

Camurus AB, of Lund, Sweden, said it granted R-Pharm U.S., of Princeton, N.J., the exclusive license and distribution rights for Episil oral liquid for mucositis in the U.S. Terms were not disclosed. Read More

Inotek Pharmaceuticals Corp., of Lexington, Mass., said the Journal of Ocular Pharmacology and Therapeutics published results from its phase I dose-escalation trial of lead candidate trabodenoson, showing that doses up to 3,200 mcg per eye were safe and well tolerated, both in the eye and systemically, in healthy adult volunteers. Read More