Orexo AB
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Latest From Orexo AB
US FDA's Delay In Acting On Moderna RSV Vaccine Adds To Growing List of User Fee Goal Misses
Administrative constraints adds Moderna’s mRNA-1345 to the recently increasing number of US FDA user fee goal date misses.
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.
Gene And Cell Therapy Clinical Holds Decline While Those For Drugs Hit 12-Year High
FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.
Asia Deal Watch: Lotus Brings Corium’s Donepezil Patch To 10 Markets
Plus deals from Huadong/Arcutis, SK Bioscience/Novavax, NeuroBio/MThera, CASI/Mundipharma/Acrotech, Amarin/Lotus and Synergy/Livzon.
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