Kura Oncology Inc. and Kyowa Kirin Co. Ltd.’s selective oral menin inhibitor, ziftomenib, met the primary endpoints in the phase II registrational Komet-001 trial in patients with relapsed/refractory NPM1-mutant acute myeloid leukemia (AML), and Kura expects to submit its NDA to the U.S. FDA in the second quarter of 2025. Read More
The U.K. is continuing to shape up regulation, adding reform of its accelerated drug approval process and its draft guidance on personalized mRNA cancer vaccines to new clinical trial regulations that will come into force early in 2026. The Innovative Licensing and Access Pathway has been relaunched following a review of the industry’s experience of the scheme since its introduction in January 2021, and it will be open for applications from next month. Read More
BioWorld’s three-part analysis of M&As sought to discover successful transactions and to understand the trend of multibillion-dollar deals that have become commonplace in the last decade. Instead, more than 80% of the acquisitions explored simply indicate that buyers are paying too much, suggesting that transactions meant to restore pipelines and revenues with innovative and marketed products are sometimes akin to high-stakes gambling. In part three, the final part of this series, we examine four more disappointments in which the return on investment (ROI) remains well behind the price paid in acquiring the company. Read More
The European Commission on Feb. 5 cleared Shanghai Henlius Biotech Inc.’s serplulimab (HLX-02) under the brand name of Hetronifly as a first-line combination therapy with carboplatin and etoposide to treat extensive-stage small-cell lung cancer. Read More
Eli Lilly and Co.’s end last year to its PI3Kα inhibitor program didn’t mean the pharma player was giving up on the target – far from it, as signaled by the potential $2.5 billion deal signed recently to take over Scorpion Therapeutics Inc. and gain rights to phase I/II-stage STX-478 for breast cancer and other solid tumors. The list of developers at work in the space includes Roche AG plus smaller entities such as Celcuity Inc., Menarini Group, Onkure Therapeutics Inc., Relay Therapeutics Inc. and Totus Medicines Inc. Read More
With the first company in the world announcing more than $1 billion in annual revenue from pulsed field ablation on Feb. 5, Clarivate plc and BioWorld MedTech’s latest report provides well-timed insight into the stunning growth and bright future of this new medical technology for the treatment of atrial fibrillation. Read More
Biopharmas raising money in public or private financings, including: 60 Degrees, Algernon, Azitra, Cytoimmune, GH Research, Iveena, Nuvectis. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ensysce, Eyepoint, Pasithea, Qlaris, Ultragenyx. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Actinogen, Aqilion, Creative Medical, Greenstone, Klinge, Lotus. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Adicet, Amgen, Arbor, Astellas, Gradalis, Helius, Genentech, Serac, Valneva. Read More
