BioMarin Pharmaceutical Inc.
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Latest From BioMarin Pharmaceutical Inc.
Biocon Pumps Up For Adalimumab US Debut Amid Payer ‘Steady State’
Biocon is confident of its “four channel strategy” for the upcoming debut of biosimilar Humira in the US and also asserts it’s well positioned to compete when price cuts come into play for Sanofi’s Lantus next year.
US FDA Looks To Assure Advisory Committees' Subject Expertise With More Temporary Members
Reform efforts in CDER include ensuring expertise is specific to the issues being discussed, which may mean more temporary voting members on advisory committees.
Keeping Track: Entasis’ Antibiotic Xacduro, Two Opioid Misuse Therapies Clear US FDA; Pfizer’s Paxlovid Makes It Official
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
Intercept’s Ocaliva: ‘Dangling’ PBC Indication At Risk As Near-Term NASH Approval Looks Unlikely
Accelerated approval for primary biliary cholangitis in 2016 came with three postmarketing requirements, but studies were terminated early; firm working toward sNDA submission in 2023 for regular approval, but US FDA says reports already are overdue and it expects to take PBC indication back to an adcomm.
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