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Home » Newsletters » BioWorld

BioWorld

May 13, 2025

View Archived Issues
Illustration of brain and brain waves, concept of focal seizure

FOS-tering patience: Xenon moves azetukalner data to next year

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

More TIGIT trouble: GSK and Iteos part ways

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
3D Euro symbol

Azafaros raises €132M in series B for parallel phase III trials

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

Trump tariffs trigger US capital commitments

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
Disitamab vedotin

China’s NMPA gives thumbs up to Remegen’s ADC targeting HER2

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
Illustration of Won currency, graph, up arrows

Korea pharma stocks rally; Celltrion welcomes US drug pricing

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

US lawmakers call for action in addressing PBM practices

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’s $25.6M series B advances TILT-123 for ovarian cancer

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
Speech-bubble-pic.png

HHS asks for input on which regs to kill

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
Koreabio Humanase KOH Sungho

FDA shift from animal testing fuels organoid, organ-on-chip demand

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

Appointments and advancements for May 13, 2025

New hires and promotions in the biopharma industry, including: Aera, Agenus, Elevatebio, Entera, Fortrea. Read More

Financings for May 13, 2025

Biopharmas raising money in public or private financings, including: Cytomx. Read More

In the clinic for May 13, 2025

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

Other news to note for May 13, 2025

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abeona, Actinium, Casi, Genentech, Kaixin, Lexeo, Roche. Read More

Regulatory actions for May 13, 2025

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Biodexa, Innocare, Thermosome, Valneva. Read More

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