AB Science Asks For Re-examination After EMA Rejects Masitinib For Mastocytosis
The EMA’s main scientific committee, the CHMP, has rejected AB Science’s potential mastocytosis drug masitinib, but the company has asked for a re-examination of the decision on a number of grounds, including the fact that it has implemented GCP corrective actions and that updated information shows the product to have “acceptable” long-term safety.
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After two years on clinical hold, the French biotech has resolved quality and pharmacovigilance problems that forced it to suspend studies of masitinib, moving it a step closer to restarting trials in its home country.
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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.