Tag Archives: PDUFA
By Clark Herman | Published: January 8, 2013
30 years ago last week, the US Orphan Drug Act came into being, and with it, a door of possibilities opened up for patients with literally thousands of untreated diseases. The anniversary marks the beginning of a journey where medicines for rare diseases have gained a foothold in the portfolios of drug companies large and [...]
By Jill Wechsler | Published: June 20, 2012
Legislation fails to establish a national track-and-trace system, but tackles shortages, orphans. House and Senate leaders announced final agreement June 18, 2012 on legislation that authorizes industry user fees to support Food and Drug Administration regulatory programs. The bipartisan measure moved through Congress quickly with an eye to avoid getting tangled up in fallout from the [...]
By Ben Comer | Published: February 3, 2012
Allergan CEO David Pyott is bullish on Botox’s potential as a salve for chronic migraine. He’s also betting on a next-gen dihydroergotamine (DHE) – Levadex – from MAP Pharmaceuticals.