FDA
The small molecule, vatiquinone, had already flunked a Phase III trial, but the company pushed ahead with an approval bid anyway.
A draft copy of the Make America Healthy Again Commission’s latest report, obtained by Politico, focuses on vaccine-related injuries and expediting access to investigational medicines for children—even though the FDA has recently rejected several of them.
In Phase III studies, Tonmya showed significantly superior analgesic effects in patients with fibromyalgia versus placebo. The sublingual pill also led to better clinical outcomes.
Papzimeos is the first immunotherapy approved for recurrent respiratory papillomatosis, a rare lung disorder involving the development of benign tumors in the airways.
Prasad Returns, Delany Departs, Lilly’s Weight Loss Pill Disappoints and Sarepta’s Fallout Continues
CBER Chief Vinay Prasad reclaimed his job less than two weeks after his mysterious exit; MAHA implementor Gray Delany is out after reportedly sparring with other agency officials over communications strategy; Eli Lilly’s first Phase III readout for oral obesity drug orforglipron missed analyst expectations; and Arrowhead Pharmaceuticals addresses the recent woes of its of partner Sarepta.
Insmed’s Brinsupri is the first DPP1 inhibitor approved by the FDA and the first treatment for bronchiectasis to reach the market.
Phase Ib data show Hernexeos can elicit a confirmed objective response rate of 44% in patients with HER2-mutated NSCLC who had previously been treated with a directed antibody-drug conjugate.
Skysona can now only be used in patients with cerebral adrenoleukodystrophy who have no available treatment alternatives or stem cell donors.
Arguably the FDA’s most anticipated decision this month is for a subcutaneous induction formulation of Biogen and Eisai’s Alzheimer’s drug Leqembi, which, according to Eisai, could “help reduce the burden on healthcare professionals and patients.”
After exiting the FDA less than two weeks ago for unclear reasons, Vinay Prasad is once again director of the Center for Biologics Evaluation and Research, HHS confirmed to several outlets Saturday.
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