The saga of the EU's Medical Device Regulation (MDR) is far from over, but stakeholders were treated to another related dose of reality in a session at this year's Med Tech Conference here in Toronto. Several panelists pointed to a lack of harmonization regarding notified bodies' interpretation of the regulation, but Stryker Inc.'s Michel Marboeuf said this problem flows to some extent from a lack of harmonization among the member states' competent authorities, a condition that is likely to resist treatment in the near term.

Inventiva SA is back on course to complete phase III development of its metabolic dysfunction-associated steatohepatitis (MASH) drug, lanifibranor, after putting in place new financing of up to €348 million (US$379.4 million), including an immediate cash injection of €94.1 million.

In an effort to shore up its position in a rapidly developing market for brain-computer interface (BCI) technologies, Onward Medical NV signed an exclusive license with France’s CEA-Clinatec to use its BCI chip as part the Arc-BCI system, which restores direct communication from the brain to the spinal cord.

H. Lundbeck A/S is to acquire Longboard Pharmaceuticals Inc. in an all-cash deal valuing the epilepsy specialist at $2.6 billion. The agreed price of $60 per share is a 54% premium to the closing price of Longboard stock (NASDAQ:LBPH) on Oct. 11 and represents the biggest deal in Lundbeck’s 110-year history. The acquisition will give the Copenhagen, Denmark-based pharma company ownership of bexicaserin, which in September entered phase III development in Dravet syndrome. The 5-HT2C agonist has the potential to treat this and other rare developmental and epileptic encephalopathies, for most of which there are no approved therapies.

The $15.3 million Mindpeak GmbH recently raised in its series A funding round will allow the company to be able to accelerate the development and deployment of its AI-based solutions, Felix Faber, CEO of Mindpeak, told BioWorld.

Endostart s.r.l obtained CE marking for the expanded use of its magnetic balloon system for use in endoscopic procedures, Endorail, to enteroscopy. The company believes that Endorail, which helps resolve intestinal looping, will make the procedure more accessible and improve patient care.

Booster Therapeutics is ready to open up a new arm of the proteasome after raising $15 million in seed funding to advance small molecules it says can degrade multiple types of harmful proteins. Rather than tagging single disease proteins with a ubiquitin marker for degrading via 26S proteasomes, these compounds directly activate 20S proteasomes that naturally recognize disordered proteins without the need for ubiquitin tagging.

Booster Therapeutics is ready to open up a new arm of the proteasome after raising $15 million in seed funding to advance small molecules it says can degrade multiple types of harmful proteins. Rather than tagging single disease proteins with a ubiquitin marker for degrading via 26S proteasomes, these compounds directly activate 20S proteasomes that naturally recognize disordered proteins without the need for ubiquitin tagging.

The U.K. government recently unveiled £148.4 million (US$193.7 million) in funding for a raft of initiatives to tackle cancer. Backed by public and private sector investment, the projects will deliver new technologies to speed up cancer diagnosis and new methods to transform treatment.