April CHMP Meeting: Disappointment In Advance For AB Science, Gilead Hopeful On Biktarvy
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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.
The European Medicines Agency is this week deciding whether it will fast track its review of orphan drugs from two companies, one of which has previously tried but failed to get the same product approved for sale in the EU.