Keyword: European Medicines Agency
Trials for cancer drugs undertaken in Europe in the mid-2010s were flawed to such a degree as to “raise questions” over their true benefit to patients.
Sanofi’s isatuximab extended patients’ lives and nearly doubled the number of patients for whom the standard of care worked.
Three weeks after filing luspatercept for FDA approval, Celgene has submitted the anemia drug for consideration by the European Medicines Agency.
Staff will move into the offices throughout the coming week having left the U.K. as it enters a critical moment in the Brexit process.
The submission comes a year after Celgene received an embarrassing refuse-to-file letter for ozanimod from the FDA.
The biotech took the action after learning that the CHMP was likely to advise against approving the oral kinase inhibitor.
The biotech said it withdrew the submission for C5aR antagonist avacopan as it now expects to have the data to file for a full approval next year.
CMO Sean Bohen and I-O head David Berman are leaving AstraZeneca, while Roche's Omar Khwaja and Pearl Huang land at new biotechs.
More than 900 days have passed since the U.K. voted to leave the EU, but the outlook today is more uncertain than on any of the preceding 900 days.
Xenon Pharmaceuticals is taking a stab at repurposing GlaxoSmithKline's ezogabine for a rare, difficult-to-treat form of pediatric epilepsy.