Redx Pharma plc has closed its biggest transaction to date, selling a preclinical KRAS inhibitor program to Jazz Pharmaceuticals plc in a potential $880 million deal. Of that, $10 million will be paid up front, with the balance to come in development and commercialization milestones. For any product that makes it to market, Redx will in addition receive tiered mid-single digit percentage royalties. Read More
Amgen Inc. reported its latest financial numbers but much of the conversation on the Feb. 6 conference call was about obesity. The same was true with Eli Lilly and Co. as weight loss drove the narrative. Read More
Immunome Inc. gained renewed attention for its pipeline by way of the Feb. 6 deal to buy from Ayala Pharmaceuticals Inc. the phase III-stage small-molecule gamma secretase inhibitor AL-102 (plus related drug candidate AL-101). Read More
Gilead Sciences Inc. has officially discontinued work on anti-CD47 antibody magrolimab in hematologic cancers, nearly four years after shelling out $4.9 billion to acquire its developer, Forty Seven Inc. The company announced in its full-year 2023 earnings Feb. 6 call that the phase III Enhance-3 study testing magrolimab as a first-line treatment in unfit acute myeloid leukemia patients was discontinued following a futility analysis and higher incidence of grade 5 adverse events. Read More
Shadowed by prescription drug shortages at their highest level since 2014, the FDA issued a slightly revised version Feb. 6 of a draft guidance it released a year ago to give it more visibility into the U.S. drug supply chain. Read More
Hong Kong’s Hutchmed (China) Ltd. reported mixed phase III results of fruquintinib as a second-line combination therapy for advanced gastric cancer on Feb. 6, with the oral vascular endothelial growth factor receptor inhibitor hitting just one co-primary endpoint. Read More
The U.S. Department of Health and Human Services (HHS) has released a sweeping plan that is designed to help manage vector-borne pathogens, such as the Zika virus, with the ultimate goal of reducing the related disease burden to zero. Read More
In a first, the U.S. FDA accepted an artificial intelligence (AI)/machine learning-model into its Innovative Science and Technology Approaches for New Drugs (ISTAND) pilot program for drug development. The program will support use of Deliberate AI Inc.’s anxiety and depression assessment tool, called the AI-generated Clinical Outcome Assessment, as a qualified drug development tool. Read More
New hires and promotions in the biopharma industry, including: Abivax, Artios, Astellas, Atai, Cartography, Cervomed, Corvus, Disc Medicine, Lapix, Phoreus, Sail, Terns, Tris. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alterity, Avencell, Bayer, Bioxcel, Eli Lilly, Geovax, GSK, Irlab, Kancera, Kyowa Kirin, Lipocine, Mink, Sangamo, Sanofi, Thermosome, Ultragenyx, Vertex, Vividion. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, Arkuda, Astrazeneca, Blujay, Bridgebio, C21 Genomics, Dr. Falk, Evogene, Exicure, I-Mab, Janssen, Kyowa Kirin, Manhattan Biosolutions, Nascent, PT Etana, Recce, Renexxion, Veracyte, Verb Biotics, Yiviva. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: prea, Arvinas, Encoded, GSK, Pfizer, Ultragenyx, Veru. Read More
