Advanced Therapies From Orchard & Kite Win EMA Thumbs Up
Novartis’s siRNA for lowering cholesterol was also among the 10 new medicines that the European Medicines Agency this week said should be approved in the EU.
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Pfizer’s abrocitinib and Biogen/Eisai’s aducanumab are among a host of new investigational products that are under review by the European Medicines Agency.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Novartis has failed to reach a reimbursement agreement to keep its first-in-class advanced breast cancer drug on the German market, but it is pressing on with plans to expand market access for the product across Europe. It is also working on securing regulatory approval to use Piqray in a broader patient population that would carve out a more meaningful place in the relevant treatment pathway.