In determining that the Affordable Care Act (ACA) was constitutional, the Supreme Court last week blew away a cloud of uncertainty that has been hanging over the biopharma industry for the past two years. But other clouds are gathering.
Stop waiting and start implementing. That's the message the Supreme Court sent to drugmakers Thursday when it ruled the Affordable Care Act (ACA) meets constitutional muster.
WASHINGTON – A week ahead of its self-imposed July 4 deadline, the Senate overwhelmingly passed the FDA Safety and Innovation Act (FDASIA) Tuesday, reauthorizing PDUFA for another five years. Now all the user-fee package needs is the president's signature so it can go into effect Oct. 1.
Two days ahead of Wednesday's PDUFA date for obesity drug lorcaserin, shares of Arena Pharmaceuticals Inc. continued to slide after a roller coaster of a ride last week.
Anticipation is making a lot of Supreme Court watchers wait a few more days to see if the court will release its opinion on the Affordable Care Act (ACA) this term.
On their way to the European market with Elelyso, Pfizer Inc. and Protalix BioTherapeutics Inc. tripped over Shire plc's marketing exclusivity for Vpriv.
WASHINGTON – Drug researchers counting on National Institutes of Health (NIH) support could be in for a bit of a drought next year, as a federal budget sequester, set to go into effect Jan. 1, 2013, would dry up funding for about 2,300 grants – one-fourth of the grants the NIH typically awards.
Recognizing myeloma patients' need for options, the FDA's Oncologic Drugs Advisory Committee (ODAC) voted 11-0 Wednesday, with one abstention, that the benefits of Onyx Pharmaceuticals Inc.'s Kyprolis outweigh its risks as a third-line treatment for relapsed and refractory multiple myeloma.
WASHINGTON – Trying to increase the risks of making and peddling counterfeit drugs so they outweigh the potential financial gain, the House passed a bill Monday that puts drug counterfeiting on par with fake military products.
