Orange Book Blog

At the intersection of Patent and FDA Law

Pharma News Briefs

Pharmalot had this post Friday about a new bipartisan follow-on biologics bill in the Senate.
MarketWatch reported Friday that European regulators have moved a step closer to approving Sandoz’s follow-on version of J&J’s blockbuster Eprex, sold in the U.S. as Procrit.
On Thursday, a House committee marked up the PDUFA reauthorization legislation (Pharmalot). PhRMA reacted positively in this press release.
FDA Law Blog had this post Tuesday reporting that the Senate-passed version of FDARA would open the door to 5-year New Chemical Entity exclusivity for enantiomers of previously-approved racemic drug compounds.