The American Academy of Pediatrics (AAP) and a few other medical professional groups were no-shows at the Sept. 18 meeting of the U.S. CDC’s Advisory Committee for Immunization Practices. The absence of the liaison groups was noted, especially that of the AAP. In opening the two-day meeting, ACIP Chair Martin Kulldorff said he lamented that the AAP has ended its association with the committee.
Shape Therapeutics Inc. could bring in as much as $1.2 billion in a new option and license deal with Vectory Therapeutics BV. It’s another collaboration for both companies that are known for working with large and small pharmas. Vectory is getting the exclusive option to evaluate Shape’s brain-penetrating adeno-associated virus capsid, SHP-DB1, against three targets, including mHTT, TDP-43 for Huntington’s disease and phosphorylated tau for Alzheimer’s disease.
The dash for MASH is gaining momentum, with Roche AG acquiring 89bio Inc. and its phase III FGF21 analogue, pegozafermin, for treating metabolic dysfunction-associated steatohepatitis, in a deal worth up to $3.5 billion. The Swiss pharma is to pay $14.50 per share, valuing San Francisco-based 89Bio at $2.4 billion, a premium of approximately 52% to 89bio’s 60-day average price on Sept. 17, 2025. Shares of 89bio (NASDAQ:ETNB) gained $6.88, or 85%, to close Sept. 18 at $14.96.
After a five-year partnership, Senseonics Holdings Inc. and Ascensia Diabetes Care Holdings AG, a unit of Tokyo-based PHC Holdings Corp., agreed to transition worldwide commercialization and distribution of Senseonics’ Eversense 365 implantable continuous glucose monitor back to Senseonics beginning on Jan. 1, 2026.
For enquiring minds that want to know, Susan Monarez laid out the details Sept. 17 of how she was fired as CDC director for the Senate Health, Education, Labor and Pensions Committee.
With positive phase III results in hand, Roivant Sciences Ltd. and Priovant Therapeutics Inc. anticipate an NDA filing in the first half of 2026, seeking approval for brepocitinib, a dual inhibitor of tyrosine kinase 2 and JAK1, in dermatomyositis, a rare autoimmune disease with limited treatment options.
The Sept. 17 U.S. Senate Health, Education, Labor and Pensions Committee hearing on the CDC is throwing even more shade on the upcoming meeting of the agency’s reconstituted Advisory Committee for Immunization Practices (ACIP), which is expected to recommend changes to the childhood vaccine schedule.
To say the team at Ollin Biosciences Inc. has some experience in ophthalmology would be an understatement. The company, which emerged from stealth with $100 million in venture capital and two in-licensed assets with plans to add more, brings to the table years of expertise from work on blockbuster retinal disease drugs Lucentis (ranibizumab, Roche AG) and Vabysmo (faricimab, Roche AG).
On the heels of the announcement of German bionics developer Ottobock SE KGaA's pending IPO and more than 20 med-tech IPOs completed to date in 2025, four other med-tech companies spanning three continents queued up to go public on four exchanges, potentially signaling an active fall for med techs worldwide.
Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment.
RSS
