The U.S. FDA’s latest draft guidance on discussions of off-label uses with doctors revisits a controversial subject that has previously migrated into the courts, and by some accounts, may do so yet again. In comments to the docket, the Washington Legal Foundation (WLF) argued that this latest attempt to regulate commercial speech is another example of the agency’s “flagrant disregard for drug and device manufacturers’ free speech rights,” which WLF seemed to suggest is an actionable violation of the First Amendment.
Orchestra Biomed Holdings Inc. randomized the first patient in the BACKBEAT pivotal study investigating the use of its atrioventricular interval modulation (AVIM) therapy as a treatment for patients with uncontrolled hypertension implanted with a Medtronic plc pacemaker. AVIM therapy is an investigational patented bioelectronic therapy designed to immediately and durably reduce blood pressure.
When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices.
The U.S. FDA granted breakthrough device designation to CG Bio Co. Ltd.’s spine implantation device, Novosis putty, making it the first bone substitute material developed in South Korea to gain the agency’s priority support. Novosis putty, successor to CG Bio’s first generation Novosis Ortho, combines a bone-forming protein called recombinant human bone morphogenetic protein 2 (rhBMP-2; Nebotermin) with ceramic scaffolds to accelerate bone growth.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biosense, Medtronic, Robocath.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Cook Biotech, Deepcell, Fresenius, Icardio.ai, Labcorp, Medtronic, Nowdiagnostics, Nvidia, Orchestra, Quest, RTI Surgical, Teal Health, Techcyte, Ultima Genomics, Ultralinq.
Vaxess Technologies Inc. seeks patent protection for devices that enable the reliable application of silk fibroin-based microneedle medicament patches used for delivering small molecule drugs, vaccines, peptides, biologics, antibodies, hormones or other materials into or through the skin.
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