Keyword: European Medicines Agency
Novartis unveiled more data showing how its asthma combo QMF149 fared against the standard of care: a combination of the same types of drugs.
Intercept already sells obeticholic acid as Ocaliva for the treatment of primary biliary cholangitis; it earned the FDA nod for that liver disease back in 2016. Intercept submitted OCA for FDA approval in NASH in September and plans to follow up with a European Medicines Agency filing by the end of the year.
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.