Johnson & Johnson

Tremfya (guselkumab) receives FDA approval for adults with moderately to severely active ulcerative colitis, offering significant improvement in symptoms and endoscopic remission.

Janssen-Cilag International NV submits MAA to EMA for nipocalimab, an FcRn blocker, based on Phase 3 Vivacity-MG3 study results showing sustained disease control in antibody-positive gMG patients over 24 weeks.

India's 'BioE3' policy aims to drive biotech innovation through biomanufacturing, bio-AI hubs, and bio-foundries, focusing on precision therapeutics and biologics. Organ-on-chip technology, valued at $1.4 billion by 2032, offers a more accurate drug testing platform, reducing animal use and speeding up drug development. Investments and collaborations globally highlight the technology's potential, while India faces challenges in interdisciplinary collaboration and regulatory navigation to fully utilize this technology.

The FDA expanded guselkumab (Tremfya) indications for adults with moderately to severely active ulcerative colitis, based on QUASAR phase IIb/III findings showing higher rates of clinical and endoscopic remission. Guselkumab, an IL-23 inhibitor, also binds to CD64, entering a crowded field of ulcerative colitis treatments. Recommended dosing includes 200 mg IV at weeks 0, 4, and 8, with maintenance options of 100 mg every 8 weeks or 200 mg every 4 weeks. Adverse events include respiratory infections and injection site reactions. Guselkumab is also approved for plaque psoriasis and active psoriatic arthritis, with Crohn's disease evaluation ongoing.

Aristotle's early animal dissections evolved into standard drug development practices by the late 1930s, leading to the 1938 Federal Food, Drug, and Cosmetic Act. Despite animal testing's contributions to medicine, 95% of drugs fail post-testing. Thomas Hartung's research at Johns Hopkins Center for Alternatives to Animal Testing advocates for AI and organoid cultures to replace animal tests, with some success. The FDA Modernization Act of 2023 no longer requires animal testing before clinical trials, and collaborations like CAAT's with the FDA aim to advance nonanimal testing methods. However, challenges remain in replacing animal models entirely due to technological limitations and systemic resistance.

FDA approves Johnson & Johnson's Tremfya for adults with moderately to severely active ulcerative colitis. Tremfya, a dual-acting monoclonal antibody, blocks IL-23 and binds to CD64, improving chronic symptoms and normalizing intestinal lining. The drug is also approved for plaque psoriasis and psoriatic arthritis, with a cost of $14,618 per 100 mg/mL solution. Tremfya generated $3.1 billion in worldwide revenue in 2023, up 18% from 2022. J&J offers $5 per injection and $0 copay programs for eligible patients. The ulcerative colitis approval was based on the QUASAR study, showing significant clinical and endoscopic remission rates. J&J has also submitted an application for Tremfya to treat Crohn's disease, based on the GALAXI program results.

Johnson & Johnson presented a large-scale proteomics analysis at AAIC 2024, identifying 3 distinct Alzheimer’s subtypes based on protein dysregulation, suggesting more personalized treatment strategies.

FDA approves Johnson & Johnson's Tremfya for ulcerative colitis, adding to its existing approvals for plaque psoriasis and psoriatic arthritis. Tremfya's potential to generate $5B in revenue is significant, especially as J&J's Stelara faces market exclusivity loss and price cuts. Competitors like AbbVie and Eli Lilly also have strong IBD treatments, intensifying the market competition.

The FDA approves Johnson & Johnson's Tremfya, an IL-23 inhibitor, for treating moderately to severely active ulcerative colitis, marking its third indication. Tremfya competes with AbbVie's Skyrizi in the UC market. The approval is based on the QUASAR trial, showing 50% of patients achieved clinical remission with Tremfya 200 mg every 4 weeks.

The FDA approved Johnson & Johnson’s Tremfya for treating adults with moderately to severely active ulcerative colitis, marking the first fully-human, dual-acting monoclonal antibody targeting IL-23 and CD64. Tremfya showed significant clinical and endoscopic improvements, with 50% and 45% of patients achieving clinical remission at 200 mg and 100 mg doses, respectively, compared to 19% in the placebo group. Common adverse events included respiratory tract infections, injection site reactions, and arthralgia.