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The authorization from the UK’s Medicines and Healthcare products Regulatory Agency followed a positive recommendation from the European Medicines Agency in November 2020. Read More
The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has begun a rolling review of Regeneron’s REGN-COV2 antibody combination (casirivimab/imdevimab) for treating and preventing COVID-19. Read More
Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last year, but — as it warned it would — the agency struggled to meet its inspection goals. Read More
The FDA has delayed its review of Biogen and Eisai’s highly anticipated Alzheimer’s treatment candidate aducanumab, pushing back its action date to June 7 after deciding it needs more time to review additional analyses and clinical data from the drugmakers. Read More
MeiraGTx and Janssen Pharmaceuticals are collaborating on the development of AAV-CNGA3 as part of a partnership to produce gene therapies for inherited retinal diseases. Read More
Despite the COVID-19 pandemic making manufacturing site inspections difficult in 2020, the FDA’s Center for Drug Evaluation and Research (CDER) met most of its drug and biologic review goals last year, but — as it warned it would — the agency struggled to meet its inspection goals. Read More
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