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Latest From ImClone Systems, Inc.
Private Company Edition: VC mega-rounds boosted the Q1 2021 total. Also, new funds from Versant, The Column Group and Rapha Capital keep cash flowing into biopharma; up to $525m is invested in Exscientia; and Arch Oncology and Boundless Bio raised $105m each, while Forge brought in $120m.
PD-1 Inhibitor Market Poised For A New Round Of Expansion: After GSK’s Jemperli Approval, US FDA Still Has Three Novel Candidates Under Review
Agenus’ recent submission of balstilimab joins novel checkpoint inhibitors from Incyte expecting FDA action this year; Junshi and Coherus’ ongoing rolling BLA for toripalimab is the first from the multiple PD-1/L1 inhibitor candidates developed in China that are vying to enter the US market.
Off-label use of cancer drugs in China is legal and even common in certain cases. But a line has been crossed in cases of active promotion and even conflicts of interest for some high-priced products and unproven cell therapies, unveiled by a Chinese physician whistleblower, regulatory observers say.
After an earlier frenzy around local production and supply, policies to encourage generics, and fast-evolving procedural streamlining, Pfizer’s $350m ambition to develop and make cheaper biologics in China has come to an abrupt halt with the sale of its manufacturing site in a deal with services heavyweight WuXi Apptec.