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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.
Helsinn and AB Science plan to conduct additional studies with their products the CHMP turned down this month, in an effort to secure eventual EU approval in the rejected indications. A third company, XBiotech, hasn’t ruled out similar action. New MAAs would be required.
New treatments for plaque psoriasis and ovarian and prostate cancer join the first Herceptin biosimilar and several other products in garnering recommendations for EU marketing approval at September's meeting of EMA's key scientific committee, the CHMP. No decision was taken on Roche’s new MS drug, Ocrevus, and earlier negative opinions of three other products were upheld.
The European Medicines Agency’s key scientific committee, the CHMP, is deciding this week whether a dozen or so new medicines that are in the final stages of the evaluation process should be approved for marketing across the EU. The committee will discuss 13 initial marketing authorization applications.
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