The FDA has finalized a more detailed “leapfrog guidance” on additive manufactured, or 3D-printed, medical technologies outlining some of its initial thoughts on technical considerations. Source: The GMP Letter
The FDA released final guidance on requirements for direct marking of devices with unique device identifiers. The final document closely resembles the draft version issued in June 2015. Source: The…
argenx increased the Offering from the initially filed offering size of $150 million. Source: BioSpace
Regeneron shares have made little headway since the disappointing launch of Praluent in 2015. Source: BioSpace
Ginkgo Bioworks, recently recognized by Forbes as one of 25 U.S. companies likely to hit a valuation of $1B or more, is well on its way. Source: BioSpace
As part of the licence agreement, Takeda has taken a strategic equity stake in Izana. Source: BioSpace
reMYND's pre-clinical diabetes therapy ReS39 will get a significant boost after the company entered a licensing agreement with noted European diabetes company Novo Nordisk. Source: BioSpace
Reportedly, Raze Therapeutics, a biotech launched in 2014, has closed its doors. Source: BioSpace
The round was led by BVF Partners, with new investors GV, Casdin Capital, EcoR1 Capital and Section 32. Source: BioSpace
The companies will also collaborate on discovery efforts to identify additional compounds from Ono’s PGE2 receptor antagonist programs. Source: BioSpace