Sangamo Therapeutics Inc.’s stock sank sharply on the last day of 2025 as Pfizer Inc. handed back the rights to their collaborative gene therapy hemophilia A program. While it was another big loss to Sangamo, which had seen two other major deals fall through in the past two years, the company still has two large collaborations in development. Read More
Daiichi Sankyo Co. Ltd.’s trophoblast cell surface antigen 2 (Trop2)-directed antibody-drug conjugate (ADC), datopotamab deruxtecan (dato-dxd), has been approved in Japan for treating adults with hormone receptor (HR)-positive, HER2-negative unresectable or recurrent breast cancer after prior chemotherapy. Read More
Driven by declining competitiveness, the new European Commission will start 2025 by getting to work on an EU-wide industrial strategy, proposing a number of policies with direct and indirect implications for the biopharmaceutical sector. Read More
Intriguing scientific data continue to roll out in the head and neck cancer space, where the need for therapies has spurred a number of drug firms to try new approaches, which BioWorld examines in part two of a series that began in the Dec. 30 issue. Read More
At Bio Japan 2024, policymakers and industry leaders pledged to make Japan a land of drug discovery to attract native and foreign drug developers. Like many Asian countries, Japan is harnessing and prioritizing the bio sector to drive economic growth, throwing its weight behind its 10-year Bioeconomy initiative to create bioclusters and increase investment. Read More
Zhongzhi Pharmaceutical Holdings Ltd. made a $3 million investment in a series A financing round of stem cell therapy developer Gabaeron Inc. Dec. 21, expected to help propel Gabaeron’s preclinical Alzheimer’s disease (AD) candidate into phase I testing. Read More
The U.S. FDA’s draft guidance for reporting of deviations from clinical study protocols lends some insight as to the definition of a deviation, but the agency highlights some concerns about related compliance activities. Read More
Rounding out a year of insider trading charges involving biopharma companies, the U.S. SEC reported Dec. 30 that it had filed a complaint against two top Humanigen Inc. executives, Cameron Durrant, CEO, and Dale Chappell, chief science officer,
for trades based on insider knowledge of FDA actions. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biora, Huadong, Immedica, Kadimastem, Lantheus, Marinus, NLS, Oqory, Radiopharm, Synerk, Vincerx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: BMS, Chimerix, Janssen-Cilag, Nrx, Telix. Read More
