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Latest From Mylan N.V.
Pfizer CEO says that an EUA request for its COVID-19 vaccine is unlikely before late November. Analyst calls Pfizer’s development pace an encouraging sign it could be a more nimble company.
Mylan is taking aim at a lucrative oral solid formulation in Europe, with the European Medicines Agency’s Committee for Medicinal Products for Human Use recommending approval for the company’s generic version of Revlimid (lenalidomide) capsules.
In October, the period during which Mylan may complete its merger with Upjohn will begin, while the FDA will begin holding monthly stakeholder meetings ahead of the third iteration of the Generic Drug User Fee Amendments program, also known as GDUFA III.
Tildrakizumab debuts in Japan, marking a key milestone for Sun Pharma, though heavyweight competitors including same class rival Skyrizi are already available on the market there.
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