April CHMP Meeting: Disappointment In Advance For AB Science, Gilead Hopeful On Biktarvy
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The sponsors of Alsitek and quizartinib are hoping that new data generated for the drugs will resolve the concerns raised by the European Medicines Agency when it previously rejected the products for marketing in the EU.
Plagued by concerns on the integrity of data and compliance issues with its clinical practices, the French firm still believes masitinib could be effective for ALS, multiple sclerosis, cancers, asthma and even Alzheimer's.
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.