Regulatory
In the Phase 3 TEMPO program, AbbVie’s Juvmo elicited significant improvements in motor symptoms and prolonged periods with good symptom control.
Merck and Daiichi Sankyo’s withdrawal of an accelerated approval request for the antibody-drug conjugate ifinatamab deruxtecan is a “net positive” for rivals like GSK and Roche, according to RBC Capital Markets.
Stem cell therapies vary widely yet many physicians still treat them as interchangeable. A more credible model requires diagnostics, product characterization and conventional medical context to determine who and when should receive regenerative treatment.
In Thursday’s Senate committee meeting, FDA commissioner nominee Heidi Overton was repeatedly questioned about her ability to retain the FDA’s independence under President Donald Trump, as well as about her views on vaccines and abortion drugs.
A late-stage test of Roche and Ionis Pharmaceuticals’ sefaxersen showed that the drug reduced protein in the urine, which suggests the RNA-targeting therapy could improve kidney function and delay transplant.
Novo plans to hit $23B in revenue by 2035, has further reduced its workforce by 4,000 and is boosting manufacturing capacity for its Wegovy pill, but investors are unconvinced it will be enough to turn things around; Viking Therapeutics and Roche report positive results for their weight loss assets; Ultragenyx snags FDA approval for its Sanfilippo syndrome gene therapy; IPOs keep on coming.
Citing the urgent unmet need for patients with advanced biliary tract cancer, Compass Therapeutics will continue to seek an approval path for its drug after the FDA recommended the biotech conduct a new clinical study.
The FDA held a public forum on Monday to discuss the future of psychedelic therapeutics, followed by a meeting on Wednesday regarding recommendations for reauthorizing the Prescription Drug User Fee Act the day after launching its TrialBlazer initiative. Meanwhile, Definium Therapeutics notched another late-stage trial win for its LSD drug, and Novartis continues to reel from the company’s triple asset stumble.
The FDA aims to leverage the expertise of qualified research institutions paired with drug sponsors to lessen the risk of clinical holds during the investigational new drug review process and expedite the path to first-in-human development in the U.S. The initial application period will close on Oct. 30.
The FDA gathers Wednesday to hear what industry stakeholders and the public want included in the latest iteration of the Prescription Drug User Fee Act that sets the agency’s priorities for fiscal years 2028–2032.
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