Press Releases

VGXI, Inc., a leading contract developer and manufacturer (CDMO) specializing in nucleic acid biopharmaceuticals, including gene therapies, DNA vaccines, and RNA medicines, is honored to announce its acceptance into the Biopharmaceutical Manufacturing Preparedness (BioMap) Consortium. The BioMap Consortium is focused on expanding the United States' biopharmaceutical industrial capabilities and bio-manufacturing output, including funding requisite capabilities, enhancing supply chain flexi

Astellas Pharma Inc. today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration  has approved PADCEV™ (enfortumab vedotin) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) after prior treatment with platinum-containing chemotherapy and programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitors. Urothelial cancer is a debilitating and often aggre

Pharmaceutical Manufacturing and Packaging Congress (PHARMAP) invites industry professionals to find new business partners, showcase equipment and services to potential customers, as well as enjoy networking and celebrate the 5th anniversary. The Congress takes place in Berlin, Germany, on 14-15 April 2025. PHARMAP is a networking event organised by BGS Group that annually unites over 350 key players of the pharmaceutical sector. Among regular participants are executives of pharmace

RNA Therapeutics, a clinical-stage biotechnology company focused on innovative applications of mRNA-based delivery systems for therapeutic proteins and vaccines, announced that it has received a written response to its Pre-Investigational New Drug Application (pre-IND) questions submitted to the U.S. Food and Drug Administration (FDA) regarding the development of its lead asset, RNAT-89 (BLA-761423), an mRNA LNP formulation to express darbepoetin, as the first such product presented to the FD

TuHURA Biosciences, Inc. a Phase 3 registration-stage immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, and Kintara Therapeutics, Inc. a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that Kineta, Inc a clinical-stage biotechnology company focused on the development of novel immunotherapies in oncology that address cancer immune resistance, has reopened enrollment in its ongoing

Personalis, Inc. and Tempus AI, Inc. announced today that the companies have expanded their commercial relationship. The companies agreed in November 2023 to collaborate and bring ultra-sensitive MRD testing to market and launched their efforts at the recent ASCO meeting. Tempus is serving as exclusive commercial partner for Personalis’ ultra-sensitive tumor-informed MRD product for broad patient adoption in breast and lung cancers, and for immunotherapy monitoring across all solid tumo

Bavarian Nordic A/S has submitted clinical data to the European Medicines Agency to support the extension of the IMVANEX® smallpox and mpox vaccine indication to include adolescents 12 to 17 years of age. While currently only indicated for adults 18 years and older, the vaccine was granted an Emergency Use Authorization for use in adolescents by the FDA during the 2022 global mpox outbreak. It remains the only FDA and EMA-approved mpox vaccine. The submission is b

Pfizer Inc. and BioNTech SE today announced top-line results from their Phase 3 clinical trial to evaluate the companies’ combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age. The combination candidate consists of Pfizer’s mRNA-based influenza vaccine candidate with the companies’ licensed COVID-19 vaccine. The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against SARS-CoV-2 as well as im

Pathos AI, Inc., a biotechnology company focused on revolutionizing precision medicine in cancer by harnessing the power of machine learning to transform drug development, announced today the world-wide license of PRT811, a potent, selective, and orally bioavailable brain penetrant SAM-competitive PRMT5 inhibitor from Prelude Therapeutics. PRT811 (renamed P-500) was developed by Prelude Therapeutics and completed a Phase 1 trial in March 2023. The trial enrolled patients with solid

osteolabs GmbH, an innovative diagnostic company applying its proprietary CIM (Calcium isotope marker) technology for the early detection of Calcium-related metabolic bone diseases affecting over 1 billion patients worldwide, announced today the publication of real-world evidence data from close to 3,000 OsteoTest patient samples in the prestigious journal Bone. The publication, accessible online (DOI: https://doi.org/10.1016/j.bone.2024.117210) marks the first report on the real-wo