Plus transactions involving Nissan Chemical/Sanwa Kagaku, Memel/Therabest, Chugai/Alnylam, Takeda/Kumquat, Nxera/Handok, 3SBio/CStone and deals in brief.

As sponsors explore development in autoimmune and infectious diseases, plus a range of hematologic and solid tumors, manufacturing processes can be centralized or decentralized, but Marks says the FDA is ‘neutral’ on that decision.

The FDA would only withdraw a rare disease gene therapy for “pretty clear” reasons, such as when there is minimal benefit with extensive side effects. The one-and-done nature of administration also makes withdrawal easier, CBER Director Peter Marks says.

Teva reported positive Phase III data for a long-acting version of olanzapine for schizophrenia, coinciding with its first quarter sales and earnings release.