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.
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
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.
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.
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.
Shionogi & Co. said it plans to acquire Japan Tobacco Inc. (JT) subsidiaries Torii Pharmaceutical Co. and Akros Pharma Inc. for ¥160 billion (US$1.1 billion) to expand its global R&D business. The two companies have been negotiating since early 2024, and the deal is structured such that a tender offer will begin on May 8 and end on June 18 with an offer price of ¥6,350 per share to buy at least 11.89% of the minority stake, JT told BioWorld.
After a week of hype, the most-favored nation (MFN) drug pricing executive order (EO) U.S. President Donald Trump signed May 12 has a lot of bark but little bite, as one analyst put it. Brian Abrahams, head of global healthcare research at RBC Capital Markets LLC, said the EO is unlikely to rattle the biopharma sector, even though it lacked the certainty to completely remove the MFN overhang. “We see reason for relief and, alongside improving FDA clarity and limited tariff risk, expect biopharma to be viewed as increasingly investable,” Abrahams said.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Iaso, Meiragtx, UTR, Verastem.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Garuda, IGM, Kymera, Roche, Sanofi, Stratus, Zealand.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Akero, Artax, Astrazeneca, Corvus, Johnson, Leo, Palatin, Volixibat, Vir.
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