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Europe's CHMP reverses endorsement of Amgen's Tavneos as FDA hearing looms
As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators recommending that the ANCA-associated vasculitis drug lose its author | As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators recommending that the ANCA-associated vasculitis drug lose its authorization in the European Union after a new review led to the conclusion that its benefits are “no longer proven to outweigh its risks.”
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biopharmadive.com
On second try, Acadia drug gets nod from European regulators
The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.
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fiercepharma.com
Fierce Pharma Asia—Historic solid tumor CAR-T nod; Inside Pfizer, Innovent’s $10B pact; More China deals
In the past two weeks, CARsgen Therapeutics won the world's first regulatory approval for a solid tumor CAR-T, a behind-the-scenes look at Pfizer and Innovent Biologics' $10.5…
