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Regulatory
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tissium

Tissium’s polymer solution set to transform nerve repair after FDA nod

June 30, 2025
By Shani Alexander
Could the U.S. FDA’s de novo marketing authorization for Tissium SA’s Coaptium Connect, an atraumatic sutureless solution for peripheral nerve repair, signal a transformative shift away from sutures in nerve surgery? Only time will tell.
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Cyber security padlock

FDA retains non-statutory definition of cyber device in final guidance

June 30, 2025
By Mark McCarty
The U.S. FDA finalized the latest edition of its premarket cybersecurity guidance, but the agency is of the view that any device with software is subject to the terms of the guidance even though the statute would seem to exempt device software that lacks connectivity.
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Hourglass on glowing circuit board, symbolizing time and technology

UK’s MHRA first regulatory to join Health AI’s global regulator network

June 30, 2025
By Mark McCarty
The U.K. Medicines and Healthcare Products Regulatory Agency reported June 24 it joined a global regulatory network for AI that is part of the Health AI regulatory initiative – a program that will invite another nine regulatory agencies to take part in the initiative in the months ahead.
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Mazdutide injection device and product packaging

China clears mazdutide as first dual GCG/GLP-1RA for weight loss

June 30, 2025
By Marian (YoonJee) Chu
No Comments
Innovent Biologics Inc. announced June 27 that it gained National Medical Products Administration’s (NMPA) approval of mazdutide as a new weight loss therapy for obese or overweight patients in China. Mazdutide is a dual glucagon/glucagon-like peptide-1 (GCG/GLP-1) receptor agonist originally discovered by Eli Lilly and Co., of Indianapolis.
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Appeals court refuses to sing Jazz tune

June 30, 2025
By Mari Serebrov
No Comments
Weighing in on the marketing exclusivity provided by the Orphan Drug Act, the U.S. Court of Appeals for the District of Columbia Circuit said the FDA didn’t act beyond its statutory authority when it approved Avadel CNS Pharmaceuticals plc’s narcolepsy drug, Lumryz, for marketing during the exclusivity period granted to Jazz Pharmaceuticals plc’s Xywav, even though both drugs contained the same active ingredient, sodium oxybate, and were approved for the same disease or condition.
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UK launches pharmacogenomics project targeting GLP-1s

June 30, 2025
By Nuala Moran
No Comments
The increased use of GLP-1 receptor agonists has led on to an increase in reports of acute pancreatitis in people taking these weight loss drugs in the U.K. That has prompted the launch of a pharmacogenomics project to investigate if there are any genetic links underlying the occurrence of this adverse event.
Read More
Mazdutide injection device and product packaging

China clears mazdutide as first dual GCG/GLP-1RA for weight loss

June 30, 2025
By Marian (YoonJee) Chu
No Comments
Innovent Biologics Inc. announced June 27 that it gained National Medical Products Administration’s (NMPA) approval of mazdutide as a new weight loss therapy for obese or overweight patients in China. Mazdutide is a dual glucagon/glucagon-like peptide-1 (GCG/GLP-1) receptor agonist originally discovered by Eli Lilly and Co., of Indianapolis.
Read More
Heart and DNA
Cardiovascular

FDA clears Rocket Pharmaceuticals’ IND for gene therapy candidate

June 30, 2025
No Comments
The U.S. FDA has cleared Rocket Pharmaceuticals Inc.’s IND application for RP-A701, an AAVrh.74-based gene therapy candidate for the treatment of BAG3-associated dilated cardiomyopathy (BAG3-DCM), a severe form of heart failure.
Read More
U.S. Supreme Court

Supreme Court upholds ACA’s preventive care coverage

June 27, 2025
By Annette Boyle
The U.S. Supreme Court preserved the U.S. Preventative Services Task Force coverage mandate that requires payers to cover certain preventive services at no cost to patients in a 6-3 ruling. That’s very good news for many diagnostics companies including Exact Sciences Corp. and Guardant Health Inc. as well as companies that manufacture HIV pre-exposure prophylaxis (PReP) medications such as Gilead Sciences Inc.
Read More
Illustration of TAVR device

NICE still wary of TAVR in moderate and low risk patients

June 27, 2025
By Mark McCarty
The U.K. National Health Service may or may not deploy transcatheter aortic valve replacement devices as widely as in the U.S., but the National Institute for Health and Care Excellence officially staked out the position the data are not yet compelling for anyone other than high risk patients.
Read More
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