Johnson & Johnson

The global Generative AI in healthcare market was USD 1.4B in 2023, expected to grow to USD 34.61B by 2034 with a CAGR of 34.4%. Advantages include accurate diagnostics, drug discovery, and personalized medicine. Key drivers are chronic disease prevalence and telehealth adoption. Major companies include IBM Watson, Google, Microsoft, and NVIDIA.

The FDA approved Steqeyma (ustekinumab-stba), the seventh biosimilar to Stelara, for inflammatory conditions including plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Steqeyma demonstrated comparable efficacy and safety to Stelara in trials, with a PASI score improvement of 77.93% vs. 75.89%. It will be available as a subcutaneous injection or intravenous infusion, expected on the market in February 2025.

Sorriso Pharmaceuticals' Phase Ib trial of SOR102, an oral drug for ulcerative colitis, met its endpoints, showing safety, tolerability, and significant clinical improvements. The company plans to advance to Phase II trials in 2025.

Applied Therapeutics announces leadership changes: John H. Johnson named Executive Chairman, Shoshana Shendelman steps down as CEO, and Les Funtleyder appointed Interim CEO. Business updates include evaluating response to FDA Complete Response Letter for govorestat, withdrawal of MAA to EMA, and ongoing SORD Deficiency clinical program. Inducement awards approved for Johnson.

Hemolytic anemias include PNH, aHUS, and wAIHA. Anti-C5 therapy is key for PNH and aHUS. New treatments target upstream complement cascade components. Novel therapies for wAIHA include fostamatinib and sovleplenib.

The Pediatric Clinical Trials Market is projected to grow from US$ 20.1 Billion in 2023 to US$ 33.0 Billion by 2033, with a CAGR of 5.0%. North America led in 2023 with a 39.10% share. Challenges include ethical concerns, limited recruitment, and high costs. Innovations like adaptive trials and digital technologies are enhancing efficiency.

Sanofi and Teva announced positive phase IIb RELIEVE UCCD study results for duvakitug, an anti-TL1A therapy for Ulcerative Colitis and Crohn's disease, meeting primary endpoints. Plans for a late-stage study and detailed results presentation are underway. Shares of both companies surged post-announcement.

Merck announced FDA acceptance of its BLA for clesrovimab, an RSV prevention antibody for infants, with a PDUFA date of June 10, 2025. Johnson & Johnson submitted a BLA to expand Simponi's indication for pediatric ulcerative colitis.

The FDA issued a CRL to Johnson & Johnson's BLA for subcutaneous amivantamab due to manufacturing inspection issues, not efficacy or safety. The CRL does not affect current IV amivantamab approvals. The PALOMA-3 study showed SC amivantamab's comparable efficacy to IV, with shorter administration time and fewer reactions.