The orphan drug designation by the EC is issued for drugs which are intended to treat diseases that affect fewer than five in 10,000 people in the European Union
This product has sales of about US$ 20 million in Europe
TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union
The brands Aarne in Germany and Nalcrom in Canada and the Netherlands are being acquired
Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial
Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries
The centralized marketing authorization granted by the EC is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway
Reinforces Henkel commitment to supporting customers and ecosystem in medical healthcare
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KEYTRUDA is the first immunotherapy approved in the EU for the first-line treatment of this patient population
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