Press Releases

The Biologics License Application (BLA) seeking accelerated approval in the U.S. for Daiichi Sankyo (TSE: 4568) and Merck’s (NYSE: MRK), known as MSD outside of the United States and Canada, patritumab deruxtecan (HER3-DXd), based on the HERTHENA-Lung01 Phase 2 trial for the treatment of adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies, has been voluntarily withdrawn. The d

Moderna, Inc. today announced positive interim data from a Phase 1/2 clinical study (NCT05972174) evaluating the safety and immunogenicity of its investigational pandemic influenza vaccine, mRNA-1018, in approximately 300 healthy adults aged 18 years and older. The interim results focus on a vaccine candidate targeting the H5 avian influenza virus subtype. The Company had previously expected to advance the program to late-stage development with the U.S. Department of Health and

Eton Pharmaceuticals, Inc, an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, today announced the U.S. Food and Drug Administration (FDA) approval of a New Drug Application (NDA) for KHINDIVI™ (hydrocortisone) Oral Solution as a replacement therapy in pediatric patients five years of age and older with adrenocortical insufficiency. KHINDIVI is the only FDA-approved oral solution formulation of hydrocortisone. It comes i

Bristol Myers Squibb today announced that the European Commission (EC) has approved a new Opdivo® (nivolumab) formulation associated with a new route of administration (subcutaneous use [SC]), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Opdivo SC, or nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), has been approved for use across multiple adult solid tumors as monotherapy, monotherapy maintenance followi

TQ Therapeutics GmbH (“TQx”), a biotechnology company dedicated to advancing the field of cellular therapies through innovative technologies, today announced the acquisition of Juno Therapeutics GmbH (“Juno GmbH”), a cell therapy company, through a share purchase agreement. Juno GmbH is a German subsidiary of Juno Therapeutics, Inc., which is a wholly owned subsidiary of the global biopharmaceutical company, Bristol Myers Squibb. The financial terms of the agreement we

Teva Pharmaceutical Industries, Ltd. today announced that the US Food and Drug Administration (FDA) granted Fast Track designation for investigational TEV-53408, an anti-IL-15 antibody, for the treatment of people with celiac disease on a gluten-free diet. TEV-53408 is currently being evaluated in a Phase 2a trial to assess the efficacy and safety in adults with celiac disease. Fast Track is an FDA process designed to facilitate development and expedite review of drugs to treat

Eli Lilly and Company and SiteOne Therapeutics, Inc. a private biotechnology company developing small molecule inhibitors of sodium channels to treat pain and other neuronal hyperexcitability disorders, today announced a definitive agreement for Lilly to acquire SiteOne. The transaction includes STC-004, a Phase 2 ready Nav1.8 inhibitor being studied for the treatment of pain. STC-004 may represent a next-generation, non-opioid treatment for patients suffering from chronic pain.

Biogen Inc. and City Therapeutics, Inc., a privately held biopharmaceutical company leading the future of RNA interference (RNAi)-based medicine, today announced a strategic collaboration to develop select novel RNAi therapies. Through the collaboration, City Therapeutics will leverage its next-generation RNAi engineering technologies to develop an RNAi trigger molecule combined with proprietary drug delivery technology from Biogen. The collaboration will initially focus on a s

Hansa Biopharma AB, “Hansa” today announced that it plans to restructure the organization to optimize resource allocation and improve operational efficiency. The planned restructuring would result in an approximately 20% reduction in the current workforce and will result in projected annual savings of 40-50 MSEK in annual savings. The restructuring is subject to negotiation with relevant trade unions. Renée Aguiar-Lucander, CEO, Hansa Biopharma said: “T

Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that it will present latest clinical study results of its investigational drugs DZD8586 and DZD6008 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The studies focus on B-cell non-Hodgkin lymphomas (B-NHLs) and non-small cell lung cancer (NSCLC) two disease areas Dizal has approved drugs and strong clinical pipeline.