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Brenda Sandburg
Latest From Brenda Sandburg
Keeping Track: Tauvid, Oriahnn, Artesunate Clear US FDA, Along With Trio Of Pediatric Approvals
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
REMS In The Time Of COVID-19: ACLU Sues FDA Over Abortion Pill Access
Medical and advocacy groups claim FDA is requiring women to fill prescriptions for Mifeprex in person while waiving REMS requirement for in-person visits for other drugs.
Patent Owners Would Get Better Shot At Quashing IPR Petitions Under USPTO Rule
Proposed rule would eliminate petitioner advantage when patent board is deciding whether to institute inter partes review of patent claims.
USPTO Allows Accelerated Path For COVID-19 Products Across Medical, Health Care Sectors
USPTO pilot program aims to examine applications for COVID-19 products subject to approval by FDA within 6 to 12 months. Prioritized examination is available solely for small entities and would save them $2,000.
Keeping Track: Approvals For Phexxi, Kynombi; New Claims For Lynparza, Alunbrig, Tecentriq; Intercept May Miss NASH User Fee Date
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
Small Biotech Companies Could Get Faster USPTO Review Of COVID-19 Patent Applications
Pilot program aims to examine applications for COVID-19 products subject to approval by FDA within 6 to 12 months; the prioritized examination is available solely for small entities and would save them $2,000.