Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).
Withings SA received U.S. FDA clearance for Beamo, its health check-up tool designed to monitor heart and lung function. Described as the ‘thermometer of the future’, Beamo combines the sensors of an electrocardiogram, a stethoscope and a thermometer into a hand-held device to allow users to check their body temperature, cardiac and pulmonary health in less than a minute.
The U.S. FDA gave the thumbs up to Kura Oncology Inc./Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, to treat relapsed, refractory (r/r) nucleophosmin1 (NMP1)-mutant acute myeloid leukemia (AML). The approval of the drug, branded Komzifti, came more than two weeks ahead of the Nov. 30 PDUFA date.
In an article that reads like informal guidance, U.S. FDA Commissioner Marty Makary and CBER Director Vinay Prasad discussed the criteria for using the agency’s novel plausible mechanism pathway for personalized treatments when a randomized trial isn’t feasible, as well as future uses of the approval path that could expand beyond gene and cell therapies to other biologics and even small molecules.
A team of five members of the U.S. FDA staff published a review of the use of AI in health care and concluded that while hallucinations in AI systems can be minimized, the trade-off is that efforts to minimize hallucinations tend to diminish the AI’s performance.
In reaching within to name 26-year FDA veteran Richard Pazdur as the next CDER director, FDA Commissioner Marty Makary likely chose the best possible person to helm the drug evaluation center at a time marked by uncertainty, morale issues and upheaval, according to several agency watchers.
The U.S. House is expected to vote late Nov. 12 on an amended continuing resolution (CR) to end the historic 43-day partial government shutdown. Already passed by the Senate, the CR would fully reopen the government and fund it through Jan. 30. President Donald Trump has said he will sign the CR, which ensures federal employees furloughed during the shutdown will receive back pay and will not be terminated.
Magstim Co. Ltd. reported that the U.S. FDA cleared its Magstim Rapid magnetic stimulation system for the treatment of chronic pain. The clearance provides a clinically validated therapy that directly targets neural pathways involved in pain processing to deliver a non-invasive, drug-free treatment for chronic pain.
Evotec SE has received a $5 million milestone payment from Bristol Myers Squibb Co. (BMS), following the acceptance of an IND application by the FDA in the companies’ strategic protein degradation partnership.
The U.S. FDA is turning the clock back more than 20 years to advance women’s health by narrowing the boxed warning on hormone replacement therapies (HRTs) for menopause. The agency announced at a Nov. 10 news conference that it’s working with companies to update their HRT labeling to remove references to risks of cardiovascular disease, breast cancer and probable dementia.
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