The U.S. FDA issued a handful of warning letters to device makers in the month of April 2024, one of which is for the Waukegan, Il., plant operated by Cardinal Health Inc., of Dublin, Ohio. While the Waukegan plant escaped citations for most routine Quality System Regulation deviations, the FDA said Cardinal’s handling of contract manufactured luer locks and syringes fell well short of the agency’s expectations given that these issues led to a massive recall, a product removal and an FDA advisory.
Medtronic plc said it secured U.S. FDA approval for its first closed-loop spinal cord stimulator (SCS), designed to take in signals from the body and adjust its therapy automatically.
Epitel Inc. received U.S. FDA clearances for two epilepsy-focused technologies that simplify detection and analysis of seizures in patients with suspected epilepsy. The Remi remote electroencephalogram monitoring system is a wearable device that allows patients to continue with their daily activities for extended periods without the restrictions of wires, while still capturing intermittent seizures. The Remi Vigilenz artificial intelligence system uses machine learning to identify and note seizure events in the Remi EEG records.
The U.S. FDA’s senior managers often lament the lack of routine increases in taxpayer funding, a concern that Michael Rogers, the associate FDA commissioner for regulatory affairs, reiterated during a May 1 webinar. Rogers said the agency’s field inspectorate will be working through a large number of retirements over the next few years, a predicament he said will continue to be “a huge challenge” to overcome.
The U.S. government chalked up another win April 29 against the constitutional challenges to the Inflation Reduction Act’s provision mandating direct Medicare price negotiations for selected prescription drugs.
Three people have agreed to pay more than $170,000 to settle U.S. SEC insider trading charges related to UCB SA’s $1.9 billion acquisition of Zogenix Inc.
Ten days early, the U.S. FDA granted full approval under priority review to Pfizer Inc. and Genmab A/S’s antibody-drug conjugate Tivdak (tisotumab vedotin) to treat cervical cancer.
It’s been a year since U.S. FDA Commissioner Robert Califf first started talking about reforming the agency’s advisory committee process. Now the FDA is moving beyond talking about it to listening. The agency has scheduled an all-day listening session June 13 to get feedback on optimizing the use of adcoms and the processes involved.
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them.
Amidst a slew of end-of-week, positive EMA Committee for Medicinal Products for Human Use (CHMP) opinions is Takeda Pharmaceutical Co. Ltd.’s Fruzaqla (fruquintinib). The selective inhibitor of vascular endothelial growth factor receptors-1, -2 and -3 is for adults with previously treated metastatic colorectal cancer.
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