U.S. Sen. Bernie Sanders (I-Vt.) sent letters to Sanofi SA and Novo Nordisk A/S executives on March 1, urging them to follow Eli Lilly and Co.’s example in cutting prices for their insulin products, offering more affordable access for Americans with diabetes. Industry leaders, however, have long argued that the problem goes far beyond list price, as pharmacy benefit managers and health plans have simply not passed their rebates onto consumers.
The U.S. development path for rare disease treatments is strewn with numerous challenges, not least of which are the regulatory hurdles. For companies developing promising candidates to treat ultra-rare diseases and the patients who are running out of time, the regulatory obstacles in the U.S. may seem almost insurmountable. And new concerns about drug development in general could make those barriers even higher.
Boomerang Medical Inc. knocked out its first target with a U.S. FDA breakthrough device designation for its bioelectronic device for treatment of inflammatory bowel disease (IBD). The technology stimulates the parasympathetic nervous system to reduce inflammation for individuals with both types of IBD, Crohn’s disease and ulcerative colitis.
Eko Devices Inc. launched a new platform designed to easily identify heart and vascular problems. The artificial intelligence (AI)-driven Sensora cardiac disease detection platform currently features an algorithm that detects structural murmurs and another to guide patient care through the health care system.
Although the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously, 12-0, March 1 that the data GSK plc presented was adequate to support the safety of its respiratory syncytial virus vaccine, several panelists cautioned the FDA against viewing the vote as a recommendation to license the vaccine before more data are available.
Abbott Laboratories continues to push its presence in the cardiovascular market with offerings for the left atrial appendage (LAA) closure and transcatheter aortic valve implant (TAVI) markets, both of which generated affirmative data presented at this year’s edition of the annual meeting of Cardiovascular Research Technologies (CRT 2023) in Washington.
Manufacturers of contact lenses may or may not want prescribers to be agnostic as to brand, but the U.S. Federal Trade Commission’s (FTC) contact lens rule requires that prescribers give the prescription to the customer when the eye exam is complete.
Ra Medical Systems Inc. launched a simple device that holds sutures more securely in place for closure of percutaneous wound sites during cardiac electrophysiology, structural heart and vascular surgical procedures.
The SEC and the U.S. Attorney’s Office for the Southern District of New York charged a former pharmaceutical executive and his cousin Feb. 23 with the insider trading of Eastman Kodak Co. stock prior to a COVID-19 partnership with the U.S. government to support the launch of Kodak Pharmaceuticals.
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