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Latest From F2G Ltd
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.
Breakdowns In The Breakthrough Lane: When Recipients Of FDA Expedited Designation Fall Short
Safety signals were the most common cause of discontinued candidates in the breakthrough therapy designation program in 2023.
Cool Down: US FDA’s July User Fee Calendar Suggests Slower Pace After Torrid June
FDA action is expected on a handful of novel agents, including Daiichi Sankyo’s quizartinib, and conversion to full approval for Eisai/Biogen’s Leqembi.
FDA Turns Down F2G’s Antifungal, But Firm Plots Comeback As Trial Completes Accrual
The US regulatory agency asked for more data and analyses for olorofim, which F2G hopes to provide from an ongoing Phase IIb study.
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