Ironwood Pharmaceuticals, Inc.
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Latest From Ironwood Pharmaceuticals, Inc.
Chinese domestic firms have gained a flurry of novel drug approvals at home, including the first globally for an anti-PD-1 antibody for nasopharyngeal carcinoma.
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.
Oncology partnership with Swiss major follows late 2020 pact with Merck KGaA. Pfizer divests Phase Ib breast cancer candidate to Celcuity.
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