Less than four months after company officials said they would explore options to find ways of maximizing shareholder value, Sensei Biotherapeutics Inc. disclosed the buyout of Faeth Therapeutics Inc. by way of a stock-for-stock deal – news that sent shares (NASDAQ:SNSE) to a closing price Feb. 18 of $26.25, up $17.12, or 187.5%. Read More
A week after catching Moderna Inc. and its investors off guard with a refuse-to-file letter, the U.S. FDA has reversed course on the company’s BLA submission seeking approval of seasonal influenza vaccine mRNA-1010, now agreeing to review the application and setting an assigned PDUFA date of Aug. 5, 2026. Read More
Med-tech companies with an AI component in their solutions will certainly find investors willing to back them. AI after all, is being used to develop more effective, smarter technologies. However, investors will only deploy capital into innovations that address genuine clinical needs. The aging population is driving interest in devices targeting cardiovascular and musculoskeletal disorders, and other solutions geared toward neurological conditions, women’s health and diagnostics are also attracting investor attention. Read More
With CE-marked products accounting for about 90% of medical devices currently used in Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) is considering proposals for a path forward that would help the U.K. achieve its goal of becoming a leading country for med-tech access by 2030. Read More
After 118 years as a private company, dermatology specialist Leo Pharma A/S is poised to complete an IPO after reporting a full-year net profit for the first time since 2018. Read More
In a deal worth up to $1.8 billion for oral macrocyclic peptide developer Unnatural Products Inc., Novartis AG has signed a research collaboration and licensing agreement for an undisclosed program. Read More
Gilead Sciences is stepping deeper into synthetic lethality, licensing a clinic-ready MAT2A (methionine adenosyltransferase 2a) inhibitor from Suzhou, China-based Genhouse Bio Co. Ltd. in a deal worth up to $1.53 billion. Read More
U.S. NIH Director Jay Bhattacharya will be a lot busier in the days and weeks ahead. As if helming the NIH isn’t enough, Bhattacharya has been tapped to also serve as acting director of the CDC, an administration official confirmed to BioWorld. Read More
Parkinson’s disease is a neurodegenerative disorder that affects movement, and tremor is one of its signatures. But it is a much more wide-ranging disorder, and patients experience problems with cognitive and emotional processes as well. SCAN, the somato-cognitive action network identified in 2023, could reshape the definition of PD. Treating this circuit can improve outcomes. Read More
New hires and promotions in the biopharma and med-tech industries, including: AMT, CNS, Cyclerion, Galderma, Harness, Integra, Longeveron, Naya, Nucleome, Oculis, Palisade, Ray, Roche, Sana, Sanofi, Sensorion, Turn. Read More
Biopharma and med-tech companies raising money in public or private financings, including: Bioventrix, Cingulate, Gelmedix, Levee, Liminatus, Mainz, Newron, Q32. Read More
Clinical updates for biopharma and med tech, including data readouts and publications: Briacell, Compass, Cyrano, Diakonos, Eli Lilly, Entrada, Helus, Ocular, Pfizer, Rallybio, Roche, Sanofi, Teva, TG. Read More
Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Accord, Bio-Techne, Bio-Thera, BMS, Cytokinetics, Deciphera, Disc, Eisai, GSK, Harmony, Johnson & Johnson, Kane, Lex, Moderna, Nicox, Novo Nordisk, Nrx, Ono, Retia Medical, Stada, Valneva. Read More
