Biopharma deal activity closed out the year strong in December, reaching a total value of $29.02 billion – the second highest monthly figure of 2024, just shy of November's $29.34 billion. For the full year, deals amounted to $230.37 billion, marking a nearly 6% increase from $217.69 billion in 2023 and making 2024 the highest value year in in BioWorld’s records.
Data from two out of three positive studies faced the U.S. FDA’s Anesthetic and Analgesic Drug Products Advisory Committee as members examined the package submitted by Seikagaku Corp., of Tokyo, for SI-6603 (condoliase), a chemonucleolytic drug for radicular leg pain associated with lumbar disc hernia.
Dyne Therapeutics Inc. is eyeing accelerated approval for its myotonic dystrophy type 1 treatment after reviewing new results from a phase I/II study. DYNE-101, an oligonucleotide antisense and DMPK gene modulator, produced results on disease biomarkers that included DMPK and splicing correction, disease progression reversal on several functional endpoints and a favorable safety profile. The accelerated approval submission could come in the first half of 2026.
Though Pfizer Inc.’s work on a PD-1-targeting antibody has trailed far behind that of its fellow big pharmas, the company could be the first to market in treatment-naïve, high-risk non-muscle invasive bladder cancer on the back of solid phase III data showing subcutaneously administered sasanlimab hit its endpoint of event-free survival. Pfizer anticipates meeting with regulatory agencies to discuss potential filings for what could be the first new treatment for that NMIBC population in decades.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Affinia, Astellas, Bridgebio, Exelixis,Grifols,Johnson & Johnson, Neurocrine, Puretech, Rigel, RQ, Stallergenes, Zentalis.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alchemab, Biocytogen, Boehringer Ingelheim, Climb Bio, Cyrus, Eli Lilly, Frontier Medicines, Mabworks, Oxford Biotherapeutics, Pfizer, Sotio.
The PD-1 receptor, a major immune checkpoint inhibitor whose signaling is the target of multiple blockbuster anticancer drugs, differs functionally between rodents and humans in previously unknown ways. Researchers from the University of California, San Diego, and co-authors at the Chinese Academy of Sciences and the National Cancer Institute reported these findings in the Jan. 3, 2025, online issue of Science Immunology.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alentis, Bayer, DBV, Karolinska, Genascence, Inmagene, Maat Pharma, Rapport , Sanofi, Seres.