Roche Gets UK Early Access OK For New Hemophilia Drug
The UK regulator is allowing patients to be treated with Roche’s as yet unlicensed hemophilia drug, emicizumab, under the country’s early access scheme. Hemlibra is already approved in the US and is in the final stages of review in the EU, where it is undergoing accelerated assessment.
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Seven Green Lights From EU’s CHMP, Including Drugs For Hemophilia, Diabetes, Alpha Mannosidosis And Hyperkalemia
The European Medicines Agency’s CHMP has OKd seven new products, including drugs for hemophilia A, diabetes, alpha mannosidosis, hyperkalemia and herpes zoster. But it again rejected Santhera’s filing for Raxone in the new indication of Duchenne muscular dystrophy, and also turned down Repros’ Encyzix for hypogonadism.
Roche’s Hemlibra Looking For CHMP Green Light, Crunch Time for Santhera DMD Hopeful
The first meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London, with a number of new drugs up for a marketing authorization recommendation.
‘Outstanding Issues’ Near For Products Approaching EU Review End – Including Neulasta Biosimilar
Ammtek, Pfizer, Portola and Roche are among the companies that are likely to find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are nearing the end of the review pathway. Questions are likely to be in store for the sponsor of a biosimilar version of pegfilgrastim.