Partly focused on delivery challenges that have limited the reach of RNA medicines, new biotech company Axelyf Inc. closed a $2.6 million seed round to support development of its AXL technology and to advance lead autoimmune candidate AXL-003.

Amid the increasingly competitive myasthenia gravis drug development space, siRNA candidate cemdisiran met phase III endpoints, with the monotherapy showing numerically higher results than a combination product. Regeneron Pharmaceuticals Inc., which has a worldwide license to cemdisiran from Alnylam Pharmaceuticals Inc., plans to file for U.S. approval in generalized myasthenia gravis, a rare and chronic autoimmune disease leading to life-threatening muscle weakness, in the first quarter of 2026.

After making a significant strategic investment in Oxganox Ltd. earlier this year, Terumo Corp. quickly returned to buy the organ preservation company. On Aug. 25, the companies announced that Terumo would acquire Organox for $1.5 billion, marking Terumo’s entry into the organ transplant sector. The transaction is one of the largest exits ever for the U.K. med-tech sector.

The U.S. and the EU have signed off on a trade deal, which makes some important provisions for generic pharmaceuticals. However, Medtech Europe said in an Aug. 21 statement that it is concerned about the exclusion of medical technology, given the potential for negative effects on patient care.

The U.S. FDA has announced a class I recall for the Wallstent Monorail system by Boston Scientific Corp. of Marlborough, Mass, a device for treatment of carotid artery stenosis. The company advised customers in early July to return any unused inventory because the inner diameter of the stent is narrower than intended, which may lead to difficulties in extracting the delivery device after placement of the stent.

Partly focused on delivery challenges that have limited the reach of RNA medicines, new biotech company Axelyf Inc. closed a $2.6 million seed round to support development of its AXL technology and to advance lead autoimmune candidate AXL-003.

Worrisome new signals caused the U.S. FDA – which earlier this month OK’d revised labeling for Valneva SE’s chikungunya virus vaccine Ixchiq – to suspend the product’s license altogether. Regulators pointed to four added reports of serious adverse events consistent with chikungunya-like illness, and told Valneva, of Saint Herblain, France, that the company must stop U.S. shipping and sales of the product. Shares (NASDAQ:VALN) closed Aug. 25 at $9.43, down $2.21, or 19%.

On Thursday, the Supreme Court handed the Trump administration another significant victory in its attempts to defund NIH-sponsored research. In a 5-4 decision, the justices paused the June 16 order of U.S. District Judge William Young to restore funding for hundreds of canceled NIH research grants focusing on gender and diversity, equity and inclusion (DEI). The funding had first been cut through a series of executive orders shortly after President Donald Trump resumed power in January.

Aclarion Inc.'s Nociscan, an AI-augmented platform that leverages MR spectroscopy to noninvasively identify the discs causing low-back pain, enables precise targeting of surgical intervention, resulting in 97% success. That’s roughly double the rate of 48% to 54% seen in conventional procedures for discogenic lower back pain, Aclarion CEO Brent Ness told BioWorld.

Medtronic plc expects its Hugo robotic-assisted surgery system to be a key growth driver, especially when it receives U.S. FDA approval. Already approved for use in Europe, Medtronic recently received CE mark for the Ligasure technology to be used with the Hugo RAS system, expanding its capabilities for gynecologic, general and urologic procedures, across the region.