Amgen, Inc.

A Mass General Brigham study found inebilizumab reduced IgG4-RD symptoms by 87%, published in the New England Journal of Medicine.

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.

Merck licenses a new cancer drug from LaNova Medicines for $588 million upfront and up to $2.7 billion in milestone payments. GOP-controlled Congress gives Trump broad power over health care policies. Vertex Pharmaceuticals plans to announce results from a mid-stage trial for sciatica treatment by year-end. CDC and FDA officials warn of anti-vaccine consequences. Tune Therapeutics to begin human testing of a gene-editing therapy for hepatitis B. Amgen defends its obesity drug amid bone concerns. Neurogene criticized for not conducting randomized, placebo-controlled trials for its Rett syndrome gene therapy.

Amgen states no association between MariTide and bone mineral density changes, affirming its promise. Phase 2 data is expected later in 2024.

FDA expands DUPIXENT use for COPD, offering new treatment options for patients. COPD affects 44 million in 7MM, with cases expected to rise. DUPIXENT targets IL-4 and IL-13 pathways, reducing exacerbations and improving lung function.

Unverified data on Amgen’s obesity drug MariTide, showing potential side effects, led to a $12 billion market value loss after being discovered in hidden tabs of a publication.

NK cell therapy, a promising cancer treatment, sees robust R&D with 140+ companies developing 160+ therapies. Key players include Amgen, Innate Pharma, Nektar Therapeutics, and others. Promising therapies like Bemarituzumab, Monalizumab, and NKTR-225 are in various clinical phases. Recent milestones include Immunitybio's CAR-NK cell therapy for NHL, Nkarta's NKX019 for AAV, and KGen Biotech's SNK01 advancing to Phase II.

Biopharma layoffs continue into 4Q 2024, affecting companies like Thermo Fisher, Charles River, Pfizer, Evonik, Johnson & Johnson, Bayer, Bristol Myers Squibb, AGC Biologics, and others. These layoffs are part of restructuring initiatives, site closures, and focus shifts in strategic core growth areas.

Climb Bio appoints Douglas E. Williams, Ph.D., as Chair of its Board of Directors, succeeding Andrew Levin, who remains a director. Dr. Williams brings over 30 years of biotech leadership experience, including roles at Sana Biotechnology, Codiak BioSciences, and Biogen.