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Latest From Day One Biopharmaceuticals, LLC
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.
As 2024 Begins, US FDA’s Novel Agent Prospects Look A Lot Like 2023
Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
Breakthrough Bounceback Looks Unlikely At US FDA’s CDER, But CBER Is Riding Wave Of RMATs
Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.
Deal Watch: Leo Pharma Adds Rare Dermatology Disorder Candidate In Timber Buyout
Plus deals involving SK Biopharmaceuticals, Hikma and Proteovant, Day One/Sprint, Eyenovia/Formosa, Clinigen/CNX, Ikena/Pionyr and more.
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- DOT Therapeutics-1, Inc.
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