NOVARTIS

FDA reviews Sanofi and Regeneron’s Dupixent for chronic spontaneous urticaria, targeting decision by April 2025. Dupixent, a monoclonal antibody, inhibits IL-4 and IL-13 pathways, showing significant itch and urticaria reduction in Study C. Already approved in Japan and UAE, Dupixent seeks EU approval and has potential revenue of $23.6bn by 2030.

The FDA approved nilotinib tablets (Danziten) by Azurity Pharmaceuticals, the first nilotinib without mealtime restrictions for adults with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. This new formulation offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose and no food-related restrictions, potentially enhancing patient adherence.

DelveInsight's 'Glioblastoma Pipeline Insight, 2024' report details 190+ companies developing 200+ therapies, including Enzastaurin, Marizomib, VT1021, and ONC201, with insights on mechanism of action, route of administration, and market dynamics.

Article lists affiliations and funding sources for researchers in nephrology and critical care from various institutions, including University of Minnesota, University of Chicago, King’s College London, and University of Washington. Funding sources include Novartis, Bioporto, Biomerieux, NIH, and others.

IgGenix announced the first patient dosed with IGNX001, a monoclonal antibody therapeutic for peanut allergy, in the ACCELERATE Peanut phase 1 clinical trial. The trial aims to assess safety, tolerability, and proof of mechanism in patients aged 15 years and older. IGNX001 attaches to peanut proteins to neutralize them, differing from other immunotherapies like Palforzia and Xolair. The trial is ongoing in Australia, with recruitment targeting older adolescents and adults, and initial results expected mid-2025.

The OCT DACH 2024 conference in Zurich discussed EU regulations, digitalisation, AI, and ethics in clinical trials, with concerns over MDR hindering innovation and the need for inclusive trial designs. Experts emphasized the importance of partnerships and patient-centric approaches, while WHO guidance aimed at reducing research waste through better trial design and inclusivity.

Amgen's MariTide linked to bone density loss, Lexeo Therapeutics gains FDA agreement for Friedreich ataxia gene therapy, AstraZeneca to invest $3.5B in U.S. facilities, Roche pays Flare Therapeutics $70M for oncology drug development, Novartis collaborates with Schrödinger for drug discovery, Centessa halts hemophilia B treatment development.

Novartis and Schrödinger form $2.4bn research collaboration to advance drug candidates in cardiovascular, renal, metabolic, immunology, neuroscience, and oncology. Schrödinger receives $150m upfront and potential $2.272bn in milestones and royalties. Expanded software agreement enhances Novartis' access to Schrödinger's computational platform.

The North America RNA Therapeutics Market is projected to grow from USD 12.95 billion in 2023 to USD 17.79 billion by 2029, driven by advancements in RNA technology and personalized medicine. Key players include Moderna, Alnylam Pharmaceuticals, and Pfizer Inc.