NOVARTIS

The FDA approved nilotinib (Danziten) without mealtime restrictions for adults with newly diagnosed or resistant/intolerant Philadelphia chromosome-positive chronic myeloid leukemia (CML). Danziten, a re-engineered nilotinib, offers equivalent efficacy to Tasigna but without fasting requirements, addressing Tasigna's bioavailability issues and QT interval prolongation when taken with food.

The FDA accepted Sanofi and Regeneron's resubmitted sBLA for Dupixent in treating CSU in patients aged 12+ with inadequate H1 antihistamine control, supported by LIBERTY-CUPID Phase III data. Study C results showed Dupixent reduced itch severity and urticaria activity scores, with safety consistent with known profiles. The FDA decision target date is April 18, 2025.

Halozyme proposes €2 billion acquisition of Evotec, offering €11.00 per share in cash, a 109% premium to Evotec's Oct. 15 stock price. Evotec, with 4,000 employees, faces recent setbacks including a cyberattack and restructuring. Halozyme, with 373 employees, offers Enhanze drug delivery tech used by Roche, Takeda, Eli Lilly, Pfizer, and AbbVie.

C3G is a rare kidney disease with limited long-term treatments; Spherix studies reveal nephrologists' interest in new therapies targeting complement system pathways. Novartis' Fabhalta and Apellis' Empaveli show promise in Phase III trials, with significant reductions in proteinuria. Spherix continues to track market developments and patient treatment patterns.

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.