France Lifts Clinical Hold From AB Science’s Masitinib
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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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.
Entries for the Scrip Awards are now open. Now in their 17th year, the Awards seek to reward the outstanding achievements of the pharmaceutical, biotech and allied industries in improving human health and will take place in London on 2 December.