NOVARTIS

Sarilumab more effective than methotrexate in enabling steroid taper in polymyalgia rheumatica patients, according to ACR Convergence 2024 data.

Inclisiran, a twice-yearly dosed therapy, significantly reduces LDL-C and improves adherence in ASCVD patients, with 84% achieving LDL-C <70 mg/dL in ORION-10 trial. Its unique RNA interference mechanism and long-term efficacy in ORION-8 support its real-world use, showing higher adherence than LCSK9 monoclonal antibodies.

Canadian researchers are part of global efforts to test targeted alpha therapy, a new cancer treatment using radioactive alpha particles to kill cancer cells more effectively and with less damage to healthy tissue. Several therapies are in final stages of testing and could be approved by Health Canada within a few years. Potential applications include pancreatic, prostate, breast, and neuroendocrine cancers. Challenges include production of rare radioactive isotopes and high costs, with treatments expected to cost tens of thousands of dollars per dose.

Roche's Evrysdi leads SMA market with 16,000+ patients; Biogen's Spinraza faces revenue decline but sees growth potential; higher-dose Spinraza shows efficacy; Novartis' Zolgensma grows 3%; Roche explores combo therapy for Evrysdi.

C3G is a rare, progressive 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.

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.

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.