For once, the EMA appears to have pipped the U.S. FDA to the post, with Pfizer Inc.’s hemophilia A and B therapy Hympavzi (marstacimab) recommended for approval in Europe on Sept. 20, while the U.S. PDUFA date is set for the fourth quarter of the year.
Onward Medical NV successfully implanted its Arc-BCI system, which restores direct communication from the brain to the spinal cord enabling lower limb mobility, into a third patient.
Creo Medical Group plc entered into an agreement to sell a 51% stake in its European consumable business to Chinese medical device distributor, Micro-Tech Co. Ltd. for approximately €36.7 million (US$41 million) in cash on a cash free, debt free basis.
As med-tech startups look to raise capital without diluting the valuation of their company, many may look to sell distribution rights in certain geographies to interested companies.
Strategics tend to invest in med-tech companies they are looking to acquire or could be acquired. Furthermore, companies like Medtronic plc and Royal Philips NV, which have venture arms, will continue to invest even through challenging times.
Capricor Therapeutics Inc. has expanded its commercialization and distribution deal with Nippon Shinyaku Co. Ltd. to include the EU and the U.K. for deramiocel, Capricor’s lead asset, in treating Duchenne muscular dystrophy (DMD). In the new agreement, Capricor will receive an up-front payment of $20 million. Capricor will handle development and manufacturing duties for deramiocel while Nippon Shinyaku will be responsible for the sales and distribution.
As Novo Nordisk A/S and Eli Lilly and Co. go head-to-head in the U.S. and Chinese glucagon-like peptide-1 receptor agonists (GLP-1RA) market for diabetes and obesity, Novo Nordisk is in innovator gear once more with leading studies of GLP-1s in Alzheimer’s disease.
This is a very exciting time for med-tech in Europe despite companies facing regulatory and funding challenges, Todd Brinton, corporate vice president, advanced technology, and chief scientific officer at Edwards Lifesciences Corp. told BioWorld.
Imcheck Therapeutics SAS’s gamma-delta T-cell activating antibody has become a poster child for the French government’s plan to reduce dependence on imports of biopharmaceuticals by directly supporting domestic development and manufacture of 20 novel products by 2030. The Marseille-based company has been awarded nondilutive public funding of €20.18 million (US$22.4 million) as part of the €54 billion France 2030 strategy, which aims to restore the country’s industrial competitiveness.
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