The biomanufacturing firm National Resilience has raised more than $2bn in venture capital and millions more in fees from government and industry contracts since 2020. Also, Code Biotherapeutics raised $75m in series A cash, Concert grossed $66.4m and Amarin is cutting US jobs. 

Taiho will pay Cullinan Oncology up to $405m for their joint venture and lead candidate for a form of lung cancer. Plus deals involving Zhaoke/Visus, AnGes/Eiger, Juniper/Helsinn, Peak Bio and more.

Rep. Matsui withdrew amendment on FDA’s use of patient experience data during health subcommittee markup of user fee reauthorization legislation, but it may be considered in full committee markup following agency input. Chair Eshoo says the provision specifying contrast agents must be regulated as drugs needs to be reworked to include ophthalmic products.

Draft legislation would undo the Catalyst decision prohibiting FDA from providing separate orphan exclusivity periods for different subpopulations and alter the Genus ruling by requiring FDA to treat contrast agents, radioactive drugs and OTC monograph drugs as drugs.