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Latest From BioMarin Pharmaceutical Inc.
As COVID Public Health Emergency Winds Down, US FDA Employs Flexibility For Rx EUA Transitions
Biden administration sets May 11 as end date for public health emergency. CDER has said it will work with sponsors to help them gain approval of COVID therapeutics cleared under emergency use authorizations, but agency will likely not issue a formal transition framework.
Deal Watch: Sol-Gel To Tackle Gorlin Syndrome In Pact With BridgeBio’s PellePharm
Shoreline picks up technology platform rights and access from Editas, which recently reduced staff. Hyloris out-licenses commercial rights to Maxigesic in nine EU markets to Salus.
Five Big Pharma Products That Saw Action In India; There’s More To Come
Scrip spotlights the action around five key big pharma products in India. We track the gains made by Rybelsus and Keytruda, the wave of Januvia and Ibrance generics and on-market and court action for blockbuster Entresto.
Requests For EMA PRIME Designation Fall But Improvements Are On The Way
While the European Medicines Agency and industry speculate as to why 2022 saw far fewer applications for a place on the priority medicines scheme for drugs for unmet medical needs, they are enthusiastic about improvements to the initiative that are set to be trialed soon.
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Biotechnology
- Liposomes
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- Huxley Pharmaceuticals, Inc.
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