Just a day after the U.S. FTC released an interim report on harmful pharmacy benefit manager (PBM) practices and appeared before a House subcommittee that encouraged the commissioners to take enforcement action, the agency reportedly was preparing to file suit against the country’s three largest PBMs over their practices in negotiating insulin and other drug prices.
Following an advisory committee’s recommendation in May against approval, the U.S. FDA issued a complete response letter (CRL) to Novo Nordisk A/S for its once-weekly insulin icodec injection for diabetes, which is on the market as Awiqli in several other countries.
The U.S. Medicare physician fee schedule for 2025 appears set to reduce the number of services that can be provided via telehealth, but the proposed rate cut of 2.8% for physician services triggered a backlash from specialty medical societies, which seem destined to lobby Capitol Hill for a reversal of these cuts.
Know Labs Inc.’s radiofrequency sensor accurately classified blood glucose levels more than 93% of the time, a study published in Diabetes Technology & Therapeutics found. That’s good news for people with diabetes, who may be able to use the non-invasive technology to avoid not just the needle sticks that used to be the hallmark of diabetes management, but even the microneedles used in current continuous glucose systems.
Researchers from Arizona State University and Mayo Clinic have filed for protection of wireless, battery-free brain implants which may be used in the monitoring, stimulation, and treatment of epilepsy, tumors, neurodegenerative disorders, neuroinflammatory conditions and trauma.
The industry is looking, with renewed hope, to the “promise” of messenger RNA (mRNA) therapeutics for a wide range of diseases beyond COVID-19, and not only in vaccine form but also for gene and cell therapies.
In the recently cast shadow of the U.S. Supreme Court’s Loper Bright decision that unraveled Chevron deference for federal agencies, the FTC’s broad rule banning noncompete employment clauses is on shaky ground. The first tremor hit July 3 when the U.S. District Court for the Northern District of Texas temporarily enjoined the FTC Noncompete Rule that is scheduled to go into effect Sept. 4 on the grounds that the agency overstepped its authority.
Illumina Inc. wasted no time in returning to the M&A front, closing the acquisition of Fluent Biosciences Inc. on July 9 with cash on hand, just a fortnight after freeing itself of Grail Inc. Fluent’s single-cell analysis technology expands Illumina’s presence in the life sciences, possibly marking a turn away from the diagnostics focus that led to the Grail debacle. The acquisition price was not disclosed.
The draft version of the U.S. Medicare hospital outpatient rule for 2025 carries more than a dozen applications for a new technology pass-through payment next year, but Boston Scientific Corp.’s Agent balloon for treatment of in-stent restenosis might not be eligible for NTPT payment because of a debate over whether the device can be assigned to an existing Healthcare Common Procedure Coding System code.
Setpoint Medical Corp. reported positive topline results from its landmark RESET-RA study. The study evaluated the Setpoint system as a potential new neuroimmune modulation treatment for adults living with moderate-to-severe rheumatoid arthritis who are incomplete responders or are intolerant to biologic or targeted synthetic disease-modifying anti-rheumatic drugs.
RSS
