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Home » Topics » Regulatory

Regulatory
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US FDA nixes Novo’s once-weekly insulin Awiqli with CRL

July 11, 2024
By Karen Carey
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.
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Medicare puzzle

Physicians slam US Medicare doc fee schedule for rate cuts

July 11, 2024
By Mark McCarty
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.
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Microscope with laptop displaying histology image.
Cancer

Rgenta’s RGT-61159 cleared by FDA for first-in-human trial in adenoid cystic carcinoma and colorectal cancer

July 11, 2024
Rgenta Therapeutics Inc. has received IND clearance by the FDA for RGT-61159, which is being developed for adenoid cystic carcinoma, colorectal cancer and other solid tumors, as well as acute myeloid leukemia.
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South Africa drops anticompetition complaint against J&J

July 10, 2024
By Mari Serebrov
Having secured a 40% price cut and a commitment to not enforce a patent protecting a tuberculosis drug, South Africa’s Competition Commission decided not to prosecute a complaint accusing Johnson & Johnson (J&J) and its subsidiary, Janssen Pharmaceutica (Pty) Ltd., of anticompetitive conduct.
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Gavel and FTC logo

US FTC’s Noncompete Rule on shaky ground

July 10, 2024
By Mari Serebrov
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.
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CMS logo and website

US CMS dubious of pass-through standing of Boston Sci’s Agent

July 10, 2024
By Mark McCarty
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.
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Accu-Chek glucose monitor by Roche

Roche receives CE mark for its AI-enabled CGM solution

July 10, 2024
By Shani Alexander
Roche Holdings AG received CE mark for its artificial intelligence (AI)-enabled continuous glucose monitoring (CGM) system, Accu-Chek Smartguide. The company said the solution addresses the unmet need around diabetes management and glycemic control as it offers critical predictions to people living with type 1 and type 2 diabetes.
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Setpoint Medical - vagus nerve stimulation device

Setpoint reports results of RA neuroimmune modulation treatment study

July 10, 2024
By Holland Johnson
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.
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Product recall concept image

Medtronic withdraws endotracheal tubes after 2 years

July 10, 2024
By Mark McCarty
In an action two years in the making, Dublin-based Medtronic plc withdrew a series of endotracheal tubes because of complaints of lost functionality that carries the risk of respiratory and/or cardiac arrest.
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Multiple sclerosis, neurons concept art.
Neurology/psychiatric

Abata obtains IND clearance for autologous TCR-Treg therapy for progressive MS

July 10, 2024
Abata Therapeutics Inc. has obtained FDA clearance for its IND application enabling initiation of a first-in-human study of ABA-101 in patients with progressive multiple sclerosis (MS). A phase I study will open later this year.
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