Dec. 16 Quick Takes: At long last, FDA approves Ferring’s Adstiladrin 

Adstiladrin nadofaragene firadenovec from Ferring Pharmaceuticals A/S will be commercially available in the U.S. in 2H23 following its approval by on Friday, more than two years after CMC issues led the agency to issue a complete response letter (CRL). The approval comes two months after Ferring assumed control of FerGene Inc, the entity it set up in 2019 with Blackstone Life Sciences to commercialize the non-muscle invasive bladder cancer (NMIBC) treatment. Adstiladrin comprises an intravesically administered, non-replicating adenovirus, which engages the biosynthesis of interferon alfa-2b protein in the bladder. 

A few months after Eli Lilly and Co. (NYSE:LLY) Chair and CEO David Ricks told BioCentury the Inflation Reduction Act will halve the values of small molecule drugs, his company entered into a discovery collaboration with Sosei Group Corp. (Tokyo:4565) for small molecules targeting GPCR targets associated with diabetes and metabolic diseases. Sosei received an upfront payment of $37 million and is eligible for up to $694 million in development and commercial milestone payments, plus tiered royalties on global sales. The agreement will leverage Sosei’s StaR technology and structure-based drug design platform, which was also the basis of the company’s small molecule GPCR deal with AbbVie Inc. (NYSE:ABBV) in 2020. ...