- 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.
Recent Posts
- Hikma v. Vanda: Oral Argument Recap
- Teva v. Lilly should not be read as creating a new 112 rule for method of use claims
- Should ANDA filers be using the PTAB to mount early challenges to OB patents?
- Switching to WordPress
- Judge Hughes concurrence highlights post grant review appeal standing issue for pharma cases
Orange Book Blog 
Leave a comment