Hansa Biopharma files for FDA approval of imlifidase to enable kidney transplants in highly sensitized patients. Find out what changes next.
Rubraca’s FDA approval before chemo in BRCA-mutated prostate cancer could reshape precision treatment. See what this changes for mCRPC strategy.
Mercury Bio Inc., a biotechnology company focused on large-molecule therapeutics, has announced a strategic collaboration with Meta-Flux, a disease simulation company that leverages artificial intelligence, to advance drug discovery programs for Parkinson’s disease and Alzheimer’s disease. The partnership combines Mercury Bio’s proprietary yeast extracellular vesicle (yEV) delivery technology with Meta-Flux’s disease-scale computational modeling platform, with
Tolmar Inc. has received expanded approval from the U.S. Food and Drug Administration for Rubraca (rucaparib), enabling its use before chemotherapy in patients with metastatic castration-resistant prostate cancer who carry BRCA mutations. The decision was based on results from the TRITON3 Phase 3 trial, which showed Rubraca to be the first and only PARP inhibitor
Amgen has expanded its direct-to-patient program, AmgenNow, to include Aimovig (erenumab-aooe) and Amjevita (adalimumab-atto), each now available at a flat monthly price of $299 for eligible U.S. patients. This development forms part of Amgen’s broader agreement with the Trump Administration, satisfying conditions laid out in the President’s July 31 policy letter and positioning the company
Boehringer Ingelheim’s $10B U.S. investment and TrumpRx.gov deal may redefine drug pricing and supply chains. Find out what this changes for pharma now.
Hansa Biopharma AB has submitted a Biologics License Application to the U.S. Food and Drug Administration for imlifidase as a desensitization treatment in highly sensitized adult patients awaiting deceased donor kidney transplants. The submission is supported by the pivotal Phase 3 ConfIdeS trial, and the company is seeking a priority review that could lead to
Meiji Seika Pharma Co., Ltd. has announced a strategic partnership with MBC BioLabs, a leading biotech incubator based in California’s San Francisco Bay Area, to expand its global drug discovery initiatives. The Tokyo-headquartered pharmaceutical firm aims to deepen its open innovation approach by tapping into early-stage biotech talent in the United States, with a focus
Takeda Pharmaceutical Company Limited has reported positive topline results from two pivotal Phase 3 studies of its investigational drug zasocitinib (TAK-279), a once-daily oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis. The trials met all primary and secondary endpoints, with more than 50 percent of participants achieving near-complete skin clearance (PASI
Astellas Pharma Inc. and Pfizer Inc. have announced that their antibody-drug conjugate PADCEV (enfortumab vedotin), in combination with the PD-1 inhibitor pembrolizumab (marketed as Keytruda by Merck), met key survival endpoints in the Phase 3 EV-304 trial. In cisplatin-eligible patients with muscle-invasive bladder cancer (MIBC), the combination significantly improved both event-free survival and overall survival