UK Early Access For BioCryst’s Hereditary Angioedema Drug
Berotralstat Could Overcome ‘Serious Limitations’ Of Existing Therapies
The HAE product, which meets the four criteria for pre-licensing use under the UK’s early access scheme, is currently undergoing regulatory evaluation in the EU, the US and Japan, with approval decisions expected in the last two countries next month.
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Orladeyo is the first oral prophylactic approved in the US for hereditary angioedema, with Japan and EU approvals expected to follow. Pricing of $485,000 a year undercuts segment leader.
Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
Coronavirus Notebook: South Africa To Build mRNA Vaccine Tech Transfer Hub, EMA OKs More Comirnaty Production Capacity
MSF is pressuring Moderna and Pfizer/BioNTech to share their vaccine know-how with manufacturers in developing countries, and companies have just a few days to answer the European Commission's questions about COVID-19 therapies they have in development.