When it comes to making biotechs toe the line on drug promotion, public guilt and humiliation aren’t working. Neither are multimillion-dollar corporate fines. They’re just the cost of doing business these days. And yanking an offending company’s Medicare participation hurts the patients whose health depends on the firm’s drugs. So how’s the government to keep biopharma on the straight and narrow? Make CEOs pay for the sins of their companies. In recent months, the FDA and the Departments of Justice and Health and Human Services have held corporate officers to the fire, banning them from the industry, imposing hefty personal...
WASHINGTON – In a split decision, a federal appellate court lifted a preliminary injunction Friday intended to keep the National Institutes of Health (NIH) from funding research involving human embryonic stem cells (hESCs).
The unanimous support of the FDA's Antiviral Drugs Advisory Committee Thursday for telaprevir as a treatment for hepatitis C virus (HCV) genotype 1 is good news for Vertex Pharmaceutical Inc., but it could change the game for HCV clinical trials that are ongoing or just getting started.
An FDA advisory committee began priming the pipeline Wednesday for new hepatitis C virus (HCV) treatments, voting unanimously to recommend approval of Merck & Co. Inc.'s boceprevir in conjunction with the current standard of care (SOC), pegylated interferon and ribavirin, to treat chronic HCV genotype 1.
WASHINGTON – After discussing it for the past two years, the FDA has set a due date, Aug. 17, for makers of extended-release and long-acting opioids to come up with a risk evaluation and mitigation strategy (REMS) for their products.
With a new road map in hand, Durata Therapeutics Inc. has its lead candidate, dalbavancin, back on course for what it hopes is the final lap to FDA approval for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
While they could have the answers in hand to the serious health issues facing workers at Japan's crippled Fukushima reactors, several biotechs may have to be content with learning the lessons of the ongoing disaster – and being ready for similar emergencies.