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.

Although no protease inhibitor has yet to be approved for hepatitis C, the new class of drugs is already changing the landscape for hepatitis C virus (HCV) therapies.

WASHINGTON – The FDA is counting on a fistful of strategies to prepare it for the regulatory and public health challenges of the future.

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.

WASHINGTON – The biopharmaceutical industry could be one of the casualties as Congress and the president prepare the field for the battle of the 2012 budget.

WASHINGTON – Flexing its enforcement muscle, the Department of Health and Human Services (HHS) is threatening to exclude Forest Laboratories Inc.'s founder, CEO and president from participation in federal health care programs.

WASHINGTON – Caught in a vicious circle of spiraling drug imports, the FDA is scrambling to develop the tools and get the authority it needs to ensure the safety of the nation's medicine chest.