GSK plc is plunking down $1 billion cash to take over Aiolos Bio Inc., with the promise of as much as $400 million in regulatory milestone payments along with tiered royalties. The deal gives London-based GSK asthma candidate AIO-001, a phase II-ready, long-acting antibody that binds to the human thymic stromal lymphopoietin (TSLP) ligand to inhibit TSLP signaling and relieve inflammation. GSK said AIO-001 could redefine the standard of care in asthma via the prospect of dosing every six months. Read More
Blueprint Medicines Corp. shifted away from two early clinical therapies for EGFR-mutant non-small-cell lung cancer and dropped development and commercialization of lung and thyroid cancer drug Gavreto (pralsetinib) for areas outside of the U.S. and greater China, reducing its operating expenses, as it prepares for increasing Ayvakit sales and prioritizes development of other assets. Read More
The U.S. FDA is promising to make 2024 a “breakout” 12 months for gene therapies, with a number of initiatives to promote clinical development, approvals and uptake. “This is a great year to focus on gene therapy,” said Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA. “I just want to focus on moving ahead gene therapy,” he told attendees of the J. P. Morgan Healthcare Conference on Jan. 8. Read More
Cell and gene therapy companies continue moving away from traditional treatment modalities into a future that’s often unclear. A panel of CEOs said at the Biotech Showcase in San Francisco that, instead of aiming for developing silver bullet therapies that knock out indications in a single blow, they tend to only be able to take incremental steps in development. Read More
Innovent Biologics Inc. said its glucagon-like peptide-1 receptor and glucagon receptor dual agonist, mazdutide, met the primary endpoints and all key secondary endpoints in its first phase III trial in Chinese adults who were overweight or obese. The company plans to submit the first mazdutide NDA for weight management to China's NMPA shortly. Read More
The U.S. FDA issued Astellas Pharma Inc. a complete response letter for its BLA for zolbetuximab, citing unresolved deficiencies following its pre-license inspection of a third-party manufacturing facility for claudin 18.2-targeting drug, which was recently listed in the 2024 edition of Clarivate’s Drugs to Watch. Read More
Boston-based Praxis Precision Medicines Inc.’s shares rose nearly 25% on Jan. 8 after it announced a pipeline update and licensing deal for its tremor drug, ulixacaltamide (PRAX-944), with Shanghai’s Tenacia Biotechnology Co. Ltd. Read More
When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices. Read More
Boehringer Ingelheim GmbH partnered with Newcastle University and the University of Edinburgh to fund a £30 million (US$38 million) study into liver cirrhosis in a bid to provide scientists with new insights into liver health. The partners hope that the study will not only enhance the understanding of nonalcoholic or metabolic dysfunction-associated steatohepatitis (NASH/MASH) cirrhosis, but also help identify translational biomarkers using a cutting-edge approach called single-cell RNA sequencing to accelerate the development of future therapies. Read More
New hires and promotions in the biopharma industry, including: Abionyx, Biocorrx, Cellular Origins, Futura Medical, Nutcracker, Oncolytics, Sanofi, Shield. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acelrx, Affimed, Aicuris, Athersys, Chiesi Farmaceutici, Danaher, Healios, J&J, Menarini, Merck & Co., Nec, Novabay, Oak Hill, Precision, Predicine, Sonoma, Talphera, TG, Transgene, Venatorx. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accord, Caliway, Inotrem, Ligand, Medexus, Shuttle, Soligenix, Veru, Zevra. Read More
