Shilpa Medicare updates on Europe GMP inspection at Unit 4, Jadcherla, Telangana

The company intends to respond to the two minor observations within the stipulated time

European Commission grants ODD to NS-229 for treatment of Eosinophilic Granulomatosis

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

Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg

This product has sales of about US$ 20 million in Europe

European Commission approves Pfizer’s Talzenna in combination with Xtandi for treatment of metastatic castration-resistant prostate cancer

TALZENNA is the first and only PARP inhibitor approved in combination with standard of care XTANDI for mCRPC patients in the European Union

Lupin Atlantis Holdings to acquire accretive established products in Europe and Canada from Sanofi

The brands Aarne in Germany and Nalcrom in Canada and the Netherlands are being acquired

European Commission approves Pfizer’s Elrexfio for multiple myeloma

Conditional marketing authorization is based on clinically meaningful response rates, duration of response, and safety from the Phase 2 MagnetisMM-3 trial

Cosmo and Glenmark sign distribution and license agreements for Winlevi in Europe and South Africa

Glenmark will receive from Cassiopea, a subsidiary of Cosmo, the exclusive right to commercialize Winlevi in 15 EU countries

Biocon Biologics receives European Commission approval for biosimilar of Aflibercept ‘Yesafili’

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

Henkel joins MedTech Europe to drive innovation in the medical technology industry

Reinforces Henkel commitment to supporting customers and ecosystem in medical healthcare

Takara Bio Europe launches high-quality enzymes suitable for pre-clinical mRNA vaccine