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. Read More
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. Read More
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. Read More
Windward Bio AG was established with plans to both license a drug and establish wet labs to create an internal pipeline of drug candidates. SR One, Omega Funds, RTW Investments, Qiming Venture Partners, Quan Capital and Pivotal Bioventure Partners funded the Basel, Switzerland-based company’s $200 million series A financing round. Read More
Fourteen global pharma companies are getting together to conduct the largest proteomics study to date, analyzing 600,000 blood samples held in the UK Biobank to assess the levels of 5,400 different proteins. Read More
Biopharma stocks saw a year of ups and downs in 2024, with the BioWorld Stock Index rising as much as 21% before dipping below 2% and ultimately closing the year up 5.16%. This performance follows a 33.59% gain in 2023 and a sharp 32.75% decline in 2022. Among the 509 stocks analyzed in the index, 169 companies (33%) ended the year with gains, while 340 (67%) saw their shares decline. Read More
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. Read More
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. Read More
BioWorld’s staff recaps the therapeutic trends and breakthroughs of 2024, the economic highs and lows facing the industry throughout the past year and the regulatory actions that are likely to have implications as biopharma forges ahead in 2025. Read More
BioWorld MedTech’s staff recaps the med-tech and diagnostic trends and breakthroughs of 2024, the financing trends of the past year and the regulatory actions likely to affect med-tech into 2025. Read More
New hires and promotions in the biopharma industry, including: Achieve, Ariceum, Artbio, Belharra, Catalym, Chemify, Enveda, Spero, Terremoto, Totus, Tourmaline, Y-mabs. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alentis, Bayer, DBV, Karolinska, Genascence, Inmagene, Maat Pharma, Rapport , Sanofi, Seres. Read More
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. Read More
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. Read More
