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.
SILVER SPRING, MD – Hope overrode the FDA's concerns about clinical trial conduct when an advisory committee gave a thumbs up Tuesday to Novartis Pharmaceuticals Corp.'s Afinitor and Pfizer Inc.'s Sutent as treatments for pancreatic neuroendocrine tumors (pNET).
Like thousands of other federal workers, folks at the FDA and SEC kept their fingers crossed Friday, hoping the House and Senate would come to terms on a spending bill in time to keep the government from shutting down.
WASHINGTON – Everybody's doing it, even the FDA. Using social media, that is. But the online community can be hostile territory for biopharma as the FDA has provided little guidance on where drugmakers can go and what they can do in this 21st century neighborhood.
WASHINGTON – Optimism, and eight years of hard work, paid off for Optimer Pharmaceuticals Inc. Tuesday when an FDA advisory committee unanimously recommended approval of Dificid (fidaxomicin) as a treatment for Clostridium difficile infection (CDI).
WASHINGTON – Instead of making all DNA patents vanish or asking judges to pull rabbits out of their hats every time they have to rule on genomic patents, the Department of Justice (DOJ) recommended they use a "magic microscope" as the legal patent test for clarifying when genetic material is a product of nature.
Intercept Pharmaceuticals Inc. is soaring, now that it has an expanded runway and a flight plan to Asia via its first strategic partner worth a potential $315 million.
