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Ironwood Pharmaceuticals, Inc.

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Latest From Ironwood Pharmaceuticals, Inc.

China Inc. Shines In Latest Batch Of Approvals

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.

China Approvals

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.

Approvals Drug Review

China Cancer Drug Off-Label Use: A Crossed Line?

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.

China Regulation

Deal Watch: Artios Links Up With Novartis On DNA Damage Response Modifiers

Oncology partnership with Swiss major follows late 2020 pact with Merck KGaA. Pfizer divests Phase Ib breast cancer candidate to Celcuity.

Deals Business Strategies
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