Protocols

China regulators launch a review for BeiGene’s PD-1; PureTech co-founder hops to Longwood Fund

→ Beijing-based BeiGene says that China’s regulatory group — the National Medical Products Administration of China — has accepted its NDA for their PD-1 checkpoint tislelizumab for classical Hodgkin’s lymphoma. There are currently 6 PD-1s approved in the US, with another on the way from Regeneron/Sanofi and others on the way.

→  Bausch Health — formerly Valeant — is getting its FDA pitch for Duobrii back on track. The agency hit the biotech with a rejection notice for the psoriasis drug a couple of months ago. Meant to help the turnaround, Valeant’s stock took another hit as regulators queried the PK data available. This week the newly redubbed Bausch said that the FDA had accepted the resubmitted application, giving them a PDUFA date of February 15, 2019.

→ PureTech co-founder and Chief Innovation Officer David Steinberg is leaving to join Christoph Westphal’s Longwood Fund. He made the announcement in a Tweet Thursday.


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