In rare loss for FDA, appeals court reverses district court decision tossing Catalyst’s suit over Orphan Drug Act, saying deference should not have been granted to agency’s interpretation. District court finds it is too early to rule on one Pfizer charity co-pay program but backs broad reading of Anti-Kickback Statute.

A cap set at $2,000 would help nearly 1 million more seniors than a cap set at $3,100, according to new study by Kaiser Family Foundation. Either competing legislative proposal would probably be welcomed by pharma industry as way to defuse pricing debate.

As its acquisition by AstraZeneca moves toward closure, Alexion plans to file the Soliris follow-on for generalized myasthenia gravis in the US, EU and Japan. But potential competition awaits in the C5 inhibitor and FcRn antagonist classes.

Plus deals involving Y-Biologics/Pierre Fabre, Contera/Abzu, Chugai/Alebund, Catalyst/DyDo, Spergogenix/Abbiska, Nippon Gene/ERS Genomics, Simcere/Vivoryon, Dr. Reddy’s/Journey Medical and Innovent/Synaffix.