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Home » Newsletters » BioWorld

BioWorld

Jan. 22, 2025

View Archived Issues
FDA approved icons and medical professional

FDA clears Medexus’ HSCT conditioning agent treosulfan – finally

Medexus Pharmaceuticals Inc. looks set for its U.S. launch of bifunctional alkylating agent treosulfan in the first half of 2025 following a long-awaited FDA approval of the drug, branded Grafapex, for use in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) in adults and pediatric patients, 1 and older, with acute myeloid leukemia or myelodysplastic syndrome. Read More

More China ADCs: Arrivent gets GI cancer drug in $1.2B Lepu deal

A year after its $175 million IPO in 2024, Arrivent Biopharma Inc. picked up rights to develop and commercialize Lepu Biopharma Co. Ltd.’s antibody-drug conjugate (ADC) candidate, MRG-007, worldwide excluding the greater China region. Read More
Generic drugs

Drugsplaining: Teva details price negotiation impact on generics

With more than five dozen generics already tentatively approved for 10 of the drugs selected for the next round of the Medicare Price Negotiation Program, the impact of the negotiations won’t be limited to just the brand drugs. Read More

Pain relief in a phase III has Tris considering an NDA

Tris Pharma Inc.’s positive top-line data from a pivotal phase III study of cebranopadol in pain relief has the company thinking about an NDA submission later in the year. The company’s goal is to avoid the problems opioids have brought to treating pain. Read More
Colorectal cancer 3D illustration

Vilastobart set apart? Xilio phase II combo performs in CRC

“The [colorectal cancer field is moving, and thankfully it’s moving quickly,” said Marwan Fakih, gastrointestinal specialist at City of Hope, speaking about initial phase II data from Xilio Therapeutics Inc.’s ongoing trial with vilastobart (XTX-101) when paired with PD-L1-blocking antibody Tecentriq (atezolizumab, Roche AG) in metastatic microsatellite stable disease. Read More
Illustration of cobra in front of protein structures

An antidote to cobra venom designed with AI

Following Nobel Prize-winning chemist David Baker’s recipe for cooking an antidote to cobra venom using artificial intelligence (AI) could be faster and more effective than currently available methods. The ingredients and steps can be found in a new study published by the University of Washington scientist in collaboration with the Technical University of Denmark. They are ready for the next steps in preclinical trials. Read More

Arctic Therapeutics explores Alzheimer’s with $28M series A

Icelandic genomics company Arctic Therapeutics has closed a €26.5 million (US$27.6 million) series A, enabling it to assess if its lead drug AT-001, designed to treat a rare inherited amyloid disease, also could be used to treat more common forms of dementia, including Alzheimer’s disease. The program is currently in a phase IIb/III European trial in cystatin C amyloid angiopathy, an ultra-rare disease found only in Iceland that is caused by the L68Q mutation in the cystatin C gene. Read More

Appointments and advancements for Jan. 22, 2025

New hires and promotions in the biopharma industry, including: ALX Oncology, Arcus, Biodexa, Edgewise, IGC, Kyverna, Maxwell, Nurix, Pliant, Tenax, Vividion. Read More

Financings for Jan. 22, 2025

Biopharmas raising money in public or private financings, including: Ascentage, Immunovia, Kane Biotech, Odyssey, Quantum, Sionna. Read More

In the clinic for Jan. 22, 2025

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascletis, Cytonics, Kiromic, Verrica, Valneva. Read More

Other news to note for Jan. 22, 2025

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: 4basebio, Circio, Catalyst, Cormedix, Coya, Crown, Dydo, Fermion, Immunoprecise, Junshi, Keros, Leo, Poxel, Revance, Sandoz, Simcere, Sumitomo, Takeda, Teva, Topalliance. Read More

Regulatory actions for Jan. 22, 2025

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Arrowhead, Astrazeneca, Atara, Bluejay, Daiichi Sankyo, Disc Medicine, Dyne, Formycon, GSK, Janssen-Cilag, Johnson & Johnson, Klinge Biopharma, Kalvista, Nacuity, Replimune, Solid Biosciences. Read More

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