EU Approval In Sight For New ATMP, Products For XLH And Diabetes, And 2nd Biosimilar Herceptin
A new ATMP, two generics and a biosimilar got the thumbs up this week from the European Medicines Agency’s drug evaluation committee, the CHMP. The committee also recommended one product for conditional authorization and another for a pediatric use authorization, But it turned down a potential multiple myeloma therapy derived from sea squirts.
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Think Positive: Clovis Confident Of CHMP Okay For Rubraca
The US biotech expects to finally get its PARP inhibitor for ovarian cancer onto the European market in the next few months to compete with rivals AstraZeneca and Tesaro after the CHMP "communicated a positive trend vote" ahead of an opinion being issued next month.
Decision Time At CHMP: Portola and Aegerion In Spotlight
Nine marketing authorization applications, 15 variation of therapeutic indication requests, two requests for accelerated assessment and a re-examination procedure. These are some of items on the agenda at the latest meeting of the EMA’s key advisory panel, the CHMP, which is under way in London.
Bumper Number Of 'Oral Explanations' Due At CHMP Meeting
An unusually large number of companies are due to appear this week before the European Medicines Agency’s key advisory panel, the CHMP, to answer questions about initial marketing authorization applications or indication extension requests. The CHMP has questions regarding nine different products.