AMAG’s decision to fight US FDA’s decision to pull the preterm birth product seems unlikely to result in victory, but Makena will get to stay on the market during the appeal process, which is expected to be protracted and will likely include accusations that the agency is being insensitive to affected patients.

CBER’s Peter Marks says agency assesses the importance of durability of effect differently for a gene therapy that treats a disease that has no other available therapies versus a condition for which there are multiple approved treatments. Marks’ comments shed more light on the complete response letter for BioMarin’s hemophilia gene therapy Roctavian.

Also, deals between Boehringer Ingelheim/Oxford BioTherapeutics, Bausch/Eyenovia, Ligand/HitGen, Moderna/Merck & Co., Vincera/Bayer, Genentech/Kineta, Selecta/IGAN, RedHill/AstraZeneca, Urovant/Sunovion, Biogen/Scribe, BridgeBio/Eidos, Elevar/Taiba

Avenue’s two-stage deal with an arm of Cipla faces uncertainty following a US Complete Response Letter for its intravenous tramadol. The US firm says it is "very surprised" with the potential safety concern raised and plans to seek a meeting with the agency at the earliest to resolve the issue.