WASHINGTON – Drugmakers are keeping their fingers crossed as two separate bills to reauthorize PDUFA roll through Congress well ahead of its Sept. 30 expiration.
The second time proved to be a charm for Arena Pharmaceuticals Inc.'s lorcaserin as it sought a vote of confidence from the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) in its benefit-risk profile as a weight-loss drug.
In a bit of a déjà vu, the FDA's Arthritis Advisory Committee (AAC) once again overwhelmingly rejected a sponsor's quest to expand the label of its IL-1 blocker to include the prevention of gout flares.
Whether Pfizer Inc. cleared the efficacy bar with tofacitinib, its first-in-class JAK inhibitor for rheumatoid arthritis (RA), will be open for debate at Wednesday's meeting of the FDA's Arthritis Advisory Committee (AAC).
WASHINGTON – Regeneron Pharmaceuticals Inc. is hoping Arcalyst can do what another IL-1 blocker couldn't do last year – wow the Arthritis Advisory Committee (AAC).
WASHINGTON – When it comes to discovering new uses for failed drugs, serendipity is about to be replaced by translational science in what National Institutes of Health (NIH) Director Francis Collins is calling a "win-win-win" pilot program for researchers, industry and patients.
WASHINGTON – Does the U.S. government's funding of early drug research entitle it to a say in drug pricing discussions? That question is at the center of a debate over whether the current government-academia-industry research model is out of balance.
WASHINGTON – The PDUFA package that's been cruising through Congress on its way toward reauthorization hit its first speed bump this week when a House subcommittee delayed marking up its version of the user fee bill.
