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).
WASHINGTON – As a congressional conference committee knits together the Senate and House versions of a PDUFA package, pressure is mounting for it to darn a few holes – such as the lack of an effective track-and-trace system to reinforce the drug supply chain.
The biotech industry is hoping the Supreme Court will do what Congress hasn't been able to do – give companies a fighting chance against class-action shareholder lawsuits claiming "fraud on the market."
WASHINGTON – The Small Business Innovation Research (SBIR) program is about to get a lot more competitive. And that should improve the quality of proposals and spur innovation in a program that provides much-needed funding to small biotechs, the Small Business Administration (SBA) said.
WASHINGTON – Whether a biosimilar by any other name would be prescribed as readily as the brand biologic it mimics is the budding debate as the FDA moves forward on the biosimilar pathway.
