The U.S. FDA announced Dec. 15 that it will take a more relaxed approach regarding the use of real-world evidence (RWE) in drug and device application reviews. Specifically, new guidance for device premarket applications will not require identifiable individual patient data collected from real-world data sources, and the agency indicated it intends to consider similarly updating guidance regarding submissions for drugs and biologics.

The European Union’s struggles with regulations for devices and in vitro diagnostics seem virtually endless, but the European Commission floated a series of changes that would present a significant reset of both regulations. One of the more sweeping changes would be to exempt medical technologies from much of the text of the Artificial Intelligence Act, a move that would ease the drag on AI-based technologies in the EU.

Much has been made of the recent skyrocketing of Medicare spending on skin substitutes, but a new enforcement action by the U.S. Department of Justice might help to explain some of those spending increases.

Sanegenebio has obtained clinical trial clearance in China for SGB-7342, an siRNA medicine targeting inhibin β E (INHBE) for the treatment of obesity. A phase I trial is scheduled to begin early next year.

Nchroma Bio Inc. has received a certificate for clinical trial in Hong Kong to initiate a first-in-human phase I/II trial of CRMA-1001 for the treatment of chronic hepatitis B virus (HBV) infection. Dosing is expected to begin early next year.

Recludix Pharma Inc. has obtained IND clearance from the FDA to advance REX-8756 (SAR-448755), an oral STAT6 inhibitor for inflammatory diseases, into phase I testing. REX-8756 is an oral, selective STAT6 inhibitor that employs a novel therapeutic approach by targeting STAT6’s SH2 domain.

Edwards Lifesciences Corp., of Irvine, Calif., petitioned the Centers for Medicare & Medicaid Services to revise the Medicare coverage policy for transcatheter aortic valve replacement (TAVR) devices on two points, the combination of which would make a big difference for TAVR devices across manufacturers. Edwards requested that CMS explicitly cover TAVR for asymptomatic aortic stenosis patients, a notion well supported by recent data, and bring an end to the coverage with evidence development mandate.

Companion Spine SAS received premarket approval from the U.S. FDA for its DIAM spinal stabilization system, for treatment of degenerative disc disease. The approval comes as the company recently completed the acquisition of a number of assets from Xtant Medical Holdings Inc., including Paradigm Spine GmbH, as it continues to strengthen its position in providing solutions to treat spinal degenerative conditions.

The U.S. FDA announced Dec. 15 that it will take a more relaxed approach to device premarket applications using real-world evidence from data sources that lack individual patient-level data, a switch that might ease manufacturers’ efforts to expand a device’s labeled indication for use.