Action Required: Password Reset on Next Login

As part of our recent security and system improvements, a password reset will be required the next time you log in. This applies to username/password users only; SSO users are not affected.

To reset your password, please visit the Reset Password page.

We appreciate your patience during this transition and are available to assist with any questions. For support, please call us at +1 650-552-4224 or email us at support@biocentury.com.

BioCentury
ARTICLE | Regulation

Nov. 8 Quick Takes: FDA request could extend review of BioMarin’s hemophilia therapy

Plus Sanofi’s latest AI deal taps Insilico and updates from Kronos, Marinus and more  

November 9, 2022 12:48 AM UTC

FDA has asked BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) to submit three-year data from the Phase III GENEr8-1 trial as part of the agency’s review of gene therapy valoctocogene roxaparvovec to treat hemophilia A. The biotech said the submission could result in a major amendment that may extend FDA’s review beyond the treatment’s PDUFA date of March 31, 2023. The agency has also scheduled an inspection of BioMarin’s manufacturing facility. The company resubmitted its BLA for the therapy in October following a 2020 complete response letter; EMA has approved valoctocogene roxaparvovec as Roctavian.

Sanofi (Euronext:SAN; NASDAQ:SNY) continues to build out its AI capabilities, this time in a deal with Insilico Medicine Inc. to discover drugs against six targets at the pharma’s China R&D center. Insilico will receive $21.5 million in an upfront payment and target nomination fees and is eligible for R&D and sales milestones of up to $1.2 billion, plus tiered royalties. Sanofi struck a discovery deal of similar size and scope with AI company Atomwise Inc. in August, covering up to five targets for $20 million up front and up to $1 billion total, and the pharma partnered with Owkin Inc. last November in a multi-cancer discovery deal...

Get Unlimited Access
Continue reading with a free trial.
Or Purchase This Article