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Latest From Approvals
A monthly-updated listing of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
Roche has once again failed to convince the EMA’s key advisory panel, the CHMP, that the company’s novel multiple sclerosis treatment, Ocrevus (ocrelizumab), should be approved for marketing throughout Europe. The CHMP was considering an unusually low number of products for an opinion this month – just three – and only Teva’s generic tacrolimus got a positive recommendation. As with Ocrevus, no opinion was taken on the third product – carmustine, another generic.
Original new drugs and biologics recently approved by US FDA.
Colombia’s health ministry has accused the R&D-based pharmaceutical industry association of prioritizing monopolies over patients after its attempts to suspend legislation that promises a faster route to market for biosimilars.
Baxter, Ariad, Diurnal. Kyowa Kirin and AB Science are among the companies that will shortly find out what remaining concerns the European Medicines Agency’s key advisory panel, the CHMP, has regarding products of theirs that are under review.
Just three initial marketing authorization applications are up for an opinion this week on whether they should be approved for sale across the EU. Roche’s new multiple sclerosis treatment, Ocrevus (ocrelizumab), is one, after failing to secure a positive opinion earlier. The October meeting of the panel that will decide, the European Medicines Agency’s CHMP, is under way in London.
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