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
Wasatch BioLabs has announced a co-marketing agreement with Agilent Technologies to expand access to its Direct Targeted Methylation Sequencing (dTMS) platform. The partnership integrates Agilent’s SureSelect and Avida enrichment chemistries with Wasatch BioLabs’ Oxford Nanopore-based native-read workflow, aiming to streamline high-throughput targeted sequencing for research use only (RUO) and translational settings. The announcement marks a
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
Hardy Diagnostics has announced an exclusive partnership with NEMIS Technologies to introduce the N-Light rapid pathogen detection platform across North America. The move brings chemiluminescent-based hygiene monitoring—already validated in several European food manufacturing segments—into the U.S. market at a time when regulatory focus on proactive food safety and decentralized diagnostics is accelerating. The announcement positions
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
The U.S. Food and Drug Administration has approved Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), the first subcutaneous version of its bispecific EGFR-MET antibody therapy, for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval spans all current RYBREVANT indications and is based on the Phase 3 PALOMA-3 study, which demonstrated comparable pharmacokinetics