Xenon Pharmaceuticals Inc. is delaying the phase III data readout from the X-tole2 trial with azetukalner in focal onset seizures (FOS) from the second half of 2025 to early 2026 but remains busy with NDA plans. Read More
TIGITs took another tumble with GSK plc’s decision to end a development program and a collaboration with Iteos Therapeutics Inc. New top-line results from a phase II study in non-small-cell lung cancer using belrestotug, an anti-TIGIT monoclonal antibody, were disappointing so the companies are calling it a day. Read More
Lysosomal storage disorder specialist Azafaros NV has raised €132 million (US$146.7 million) in a series B to fund two phase III studies of its lead product, a small-molecule glycosidase inhibitor that the company says has shown disease-modifying effects. Read More
A number of biopharma and med-tech companies are committing to expand manufacturing and other facilities in the U.S. Some shifts could be driven by the tariffs imposed by President Trump in 2025, signaling a strategic move to mitigate costs and ensure continued growth Read More
China’s National Medical Products Administration has approved Remegen Co. Ltd.’s antibody-drug conjugate (ADC), disitamab vedotin (RC-48), for treatment of HER2-positive advanced breast cancer in patients with liver metastasis. Read More
Korean pharmaceutical stocks rose across the board May 13, a day after U.S. President Donald Trump signed off on the most favored nation executive order, a drug pricing policy expected to benefit biosimilar makers in the U.S., according to Celltrion Inc. Read More
In a continuing déjà vu, the Senate Judiciary Committee held yet another hearing May 13 on pharmacy benefit managers (PBMs), focusing on a lack of transparency. Read More
Tilt Biotherapeutics Ltd. has raised $25.6 million in a series B round that will fund phase II development of the lead oncolytic virus in the treatment of platinum-resistant ovarian cancer. Read More
As the U.S. Department of Health and Human Services (HHS) and its agencies begin weeding out old regulations, the department is requesting public input to help identify and eliminate outdated or unnecessary regulations. Read More
The U.S. FDA’s decision to phase out animal testing for INDs is driving a new market of alternative, nonanimal testing technologies like organoids and organs-on-a-chip, speakers at Bio Korea 2025 said. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aavantgarde, Alterity, Amylyx, Apogee, Biomarin, Cantargia, Carsgen, Cytomx, Eli Lilly, Faron, Genescence, Innovo, Maat, Madrigal, Novo, Radiopharm, Remegen, Theravance. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abeona, Actinium, Casi, Genentech, Kaixin, Lexeo, Roche. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biodexa, Innocare, Thermosome, Valneva. Read More
