EU Approval Nod Possible For Novartis, Gilead/Galapagos, and Janssen
CHMP Marketing Opinions Are Due On Alpelisib, Filgotinib, Ebola Vaccines
The May meeting of the European Medicines Agency’s drug evaluation committee, the CHMP, is under way. Decisions are due on whether eight marketing approval applications should be approved for marketing in the EU.
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Moment Of Truth For Belantamab Mafodotin, Trikafta And Turalio At EMA
A number of drug companies are set to learn the fate of their marketing authorization applications in the EU this week.
Roche Seeks Speedy EMA Review For SMA Drug Risdiplam
Applications to market Roche’s spinal muscular atrophy drug have already been submitted in eight countries including the US, where a decision is due in August.
Biocon’s Bengaluru Biosimilars Plant Cleared For EU
Biocon is actively expanding its biosimilars manufacturing capacity with an aim to further penetrate EU markets after receiving a GMP approval for a key manufacturing site. The company has ramped up production for trastuzumab and pegfilgrastim, while awaiting approval for bevacizumab.