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Latest From Braeburn Inc.
Scrip Asks…What Does 2024 Hold For Biopharma? Part 6: Therapeutic Area Advances
More than 100 biopharma executives and experts told Scrip their predictions for therapeutic area advances in the coming year. The recent commercial success of GLP-1s in diabetes and obesity and their potential in further disease areas fuelled excitement around the metabolic space. Expectations were also positive in neurology following the launch of Leqembi for Alzheimer’s disease in 2023, while the multiple opportunities to improve cancer treatment kept oncology top of the pile overall.
FDA Staff ‘Literally’ Up At Night Deciding 3-Year Exclusivity Requests
More sponsors are submitting applications around the same time requiring the agency to make complicated decisions about exclusivity and whether approval of subsequent applications is barred, FDA attorney says.
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
Keeping Track: Immunology Drives US FDA Action, With Approvals For AZ/Amgen’s Tezspire, Argenx’s Vyvgart, And New JAK Uses
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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