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.
While the Supreme Court narrowly ruled that pharma sales representatives are "outside" salespeople not subject to overtime pay, the court sent a unanimous message to all federal agencies that they can't reinterpret laws and regulations without going through the proper rulemaking process.
WASHINGTON – Reconciliation of the House and Senate versions of the PDUFA package could turn into a battle pitting brand drugmakers against generics as both sides fight for a little more market time.
WASHINGTON – As economic woes continue to rattle Europe, many advocacy groups are looking to the U.S. to increase its funding of global R&D for HIV/AIDS, malaria and tuberculosis (TB).
