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.
WASHINGTON – Things should be a little quieter at the FDA this week as new safety reporting requirements go into effect to reduce the "noise" from the overreporting of individual serious adverse events in clinical trials
Tekmira Pharmaceuticals Corp. filing a complaint alleging misappropriation of information and seeking potentially more than $1 billion in damages from RNAi partner Alnylam Pharmaceuticals Inc. might seem like a bad dream. After all, the horror stories of partnerships gone bad are the stuff of nightmares for biopharmaceutical companies looking for the right mate to advance a product.