Regulatory snapshots for biopharma and med tech, including global submissions and approvals, and other regulatory decisions and designations: Biocon, Bridgebio, BVI, Clearpoint, Cristcot, Humacyte, Hyalex, Moderna, Polaryx, Roche, Star, TCM, Xeltis.
Biopharma and med-tech happenings, including deals and partnerships, and other news in brief: Bioaegis, BMS, Celularity, Efemoral, Foundation, Implantica, Jona, Microbiome, Nexgel, Prenosis, Replimune.
Clinical updates for biopharma and med tech, including data readouts and publications: AB Science, Astrazeneca, Bioage, Eisai, Eupraxia, Invera, Ionis, Livanova, Lytix, Merck, Reva, Scandinavian Real Heart.
Biopharma and med-tech companies raising money in public or private financings, including: Alesi Surgical, Deep Blue Medical, Flagship, Kailera, Pulmatrix, Ray, Serif, Spruce, Trevi.
Akeso Pharmaceuticals Inc. has raised the bar for next-generation immuno-oncology, reporting more than 23 months median overall survival in pancreatic cancer with its PD-1/CTLA-4 bispecific antibody cadonilimab, as emerging competitors begin to post earlier signals across solid tumors at the American Association for Cancer Research annual meeting in San Diego April 17 to 22.
Netris Pharma SA has delivered positive phase Ib data showing its first-in-class netrin-1 inhibitor NP-137 alleviates resistance to chemotherapy in pancreatic cancer. This could represent an important advance in treating these tumors, which are notoriously resistant to chemotherapy.
Boston Scientific Corp.'s CEO Mike Mahoney said that the year is turning out to be “more challenging” than the company anticipated, prompting a cut to its organic sales growth guidance to 6.5% to 8%, from 10% to 11%. The company also lowered its adjusted earnings-per-share guidance to $3.34 to $3.41, from $3.43 to $3.49 previously. Analysts welcomed the lower guidance seeing it as somewhat of a relief and an opportunity to reset on the back of the company’s share price, which has fallen sharply over the last year.
When the U.S. CMS didn’t get takers for its voluntary Better Approaches to Lifestyle and Nutrition for Comprehensive Health (BALANCE) model to cover obesity drugs under Medicare Part D, the agency punted. It announced late April 21 that it will indefinitely delay the BALANCE model in Medicare but extend its temporary Medicare GLP-1 Bridge demonstration model through the end of 2027. (The Medicaid BALANCE model will still kick in this year in states that choose to participate in it.)
And the positive news continues to flow for Revolution Medicines Inc. On the heels of a successful phase III trial for RAS inhibitor daraxonrasib in previously treated patients with metastatic pancreatic ductal adenocarcinoma (PDAC) – not to mention the firm pricing the largest follow-on offering in biopharma history – Revolution presented updated phase I/II data at the American Association for Cancer Research (AACR) meeting detailing impressive findings in first-line PDAC patients.
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