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
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
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
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
“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
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
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
New hires and promotions in the biopharma industry, including: ALX Oncology, Arcus, Biodexa, Edgewise, IGC, Kyverna, Maxwell, Nurix, Pliant, Tenax, Vividion. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Ascletis, Cytonics, Kiromic, Verrica, Valneva. Read More
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
