Some U.S. FDA inspections go better than other ones, but the agency’s inspection of the Boston plant operated by a subsidiary of Princeton, N.J.-based Integra Lifesiences Holding Corp. was not one of those with a quick resolution. The agency said in a July 17 warning letter that Integra will have to obtain certification for the site in each of the next three years after finding considerable fault with operations, including one citation the agency said is a carryover from a warning letter issued in 2019.
Cathvision ApS received U.S. FDA clearance for two artificial intelligence (AI) models, the PVI Analyzer, and Signal Complexity, which are part of a suite of algorithms designed to help electrophysiologists improve the diagnosis and treatment of complex atrial arrhythmias, including atrial fibrillation. The two algorithms are part of Cathvision’s Cardialytics suite of AI-powered analytics integrated into its Ecgenius system, an electrophysiology recording system that helps with electrogram interpretation.
The U.S. FDA granted the de novo marketing request for Bluewind Medical Ltd.’s Revi system for the treatment of urgency incontinence with or without urinary urgency, the company reported on August 17. Unlike other neuromodulation devices approved in recent years, Revi stimulates the tibial nerve instead of the sacral nerves.
Novarock Biotherapeutics Ltd., a subsidiary of CSPC Pharmaceutical Group Ltd., has received FDA approval of its IND application for NBL-028, a CLDN6-CD137 bispecific antibody.
It’s been 25 years since the U.S. FDA issued a final guidance on informed consent and nine years since it asked for comments on a draft guidance to supersede that 1998 guide.
As a U.S. appeals court ruling that restores the original restrictions the FDA imposed on the abortion drug mifepristone in 2000 heads to the Supreme Court for what will likely be full argument, the Biden administration continues to insist that the courts have no business overriding the FDA’s “scientific, evidence-based decisions.” Commenting on the Aug. 16 opinion from the U.S. Court of Appeals for the Fifth Circuit, which reinstated the original use restrictions, Vice President Kamala Harris said, “It endangers our entire system of drug approval and regulation by undermining the independent, expert judgment of the FDA.”
China’s National Medical Products Administration has approved Innovent Biologics Inc.’s proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitor, Sintbilo (tafolecimab), making it the first first locally developed PCSK9 monoclonal antibody to be approved in China. The approval is for treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia (abnormal lipid levels). Tafolecimab marks Innovent's first cardiovascular drug as well as the company’s 10th approval.
There are plenty of companies chasing the first U.S. FDA-approved treatment for the ultra-rare disease fibrodysplasia ossificans progressiva (FOP), but Ipsen SA stayed the course longer and won that approval Aug. 16 with Sohonos (palovarotene). Other companies have struggled to develop a treatment for FOP, which affects about 400 people in the U.S. and about 900 people worldwide. Some potential competitors are still in the clinic, trying to catch up.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Bluewind Medical, Nemaura Medical, Icad.
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