Sana Biotechnology Inc. CEO Steve Harr said “cool and transformative science” led to his firm’s latest strides in type 1 diabetes, and the “very generalizable [clinical] result” cheered Wall Street, which led shares of the Seattle-based firm (NASDAQ:SANA) to close Jan. 8 at $4.30 up $2.65, or 160.6%. “I believe we now have all of the pieces in place to move forward rapidly,” Harr said. Read More
Vir Biotechnology Inc.’s 2024 deal with Sanofi SA is starting to look like a pretty savvy move. The company, which picked up three clinical-stage dual-masked T-cell engagers (TCEs) and rights to the platform technology as part of a pipeline overhaul, reported phase I data for TCE programs targeting HER2 and PSMA that indicated promising efficacy with a low prevalence of the cytokine toxicity that has hampered other TCE programs. Read More
With obesity drugs taking the U.S. and global markets by storm and more than 100 clinical programs currently in progress for the drugs, the U.S. FDA released a draft guidance Jan. 7 to help sponsors develop drugs and biologics for weight reduction and long-term maintenance of body weight. Read More
Despite positive preliminary data from its early stage study of treating hives, Jasper Therapeutics Inc. saw its stock drop dramatically on Jan. 8. Results were from the ongoing phase Ib/IIa study of the monoclonal antibody and lead candidate briquilimab in treating chronic spontaneous urticaria, often referred to as hives. The results showed clinical responses across several of the dosing cohorts. The treatment also displayed a favorable safety profile. Read More
The wheels of the antibody-drug conjugate (ADC) juggernaut keep on turning, with Araris Biotech AG announcing a deal with a headline value of $780 million to apply its multi-payload linker technology to generate novel ADCs for Chugai Pharmaceutical Co. Ltd. Read More
Yuhan Corp., Oscotec Inc. and Genosco Inc. were three companies with Asian ties to reap benefit from Johnson & Johnson’s stellar top-line Mariposa study results, wherein J&J’s Rybrevant (amivantamab-vmjw) and Lazcluze (lazertinib) combo regimen beat out Astrazeneca plc’s standard of care in non-small-cell lung cancer (NSCLC). Read More
Wuxi Biologics Co. Ltd. is licensing a preclinical trispecific T-cell engager to Candid Therapeutics Inc. in a deal worth up to $925 million plus royalties. Read More
Artificial intelligence (AI)-based models developed by a team of international researchers were able to identify ovarian cancer in ultrasound images more accurately than humans. Results from a study published in Nature Medicine showed that the AI models achieved an accuracy rate of 86.3%, compared to 82.6% for the experts and 77.7% for the non-expert examiners. Read More
The 2025 edition of Clarivate’s Drugs to Watch features 11 candidates or approved therapeutics that may well revolutionize treatments or become blockbusters. The 12th annual report has a strong track record. Twelve of the 13 drugs from the 2024 Drugs to Watch report have been approved and launched. 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: Actio, Aicuris, Alltrna, Antag, Avidity, Cardurion, Centessa, Commit, Corrixr, Eyepoint, Gain, Kailera, Noema, Odyssey, Sionna, Tarsier, Trisalus, Unnatural Products, Vor. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acelyrin, Achieve, Brainchild, Denali, Hoth, Imbrium, Immuneering, Johnson & Johnson, MBX, Metsera, Pharmaessentia, Raphael. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acellera, Abbvie, Capsida, Cytomx, Generation Bio, Glycotope, Hummingbird, Immunome, Inverna, Kuros, Mitocarex, Merck, Neuraxpharm, Novo Nordisk, Pentixapharm, Quris, Rycarma, Sanofi, Scisparc, TG, Variant. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: 4SC, Alivegen, Bayer, Calico, Dizal, GSK, Interius, Orion, Restem, Vergent. Read More