MERCK KGAA

Merck KGaA announced that the Phase III MANEUVER trial of pimicotinib, developed by Abbisko Therapeutics, met its primary endpoint, showing a 54.0% objective response rate in tenosynovial giant cell tumor (TGCT) patients at week 25, compared to 3.2% for placebo. The study also demonstrated significant improvements in secondary endpoints, including stiffness and pain, with pimicotinib well-tolerated and showing no evidence of cholestatic hepatotoxicity.

Pimicotinib showed significant improvements in TGCT symptoms, with safety data consistent from previous reports. The MANEUVER study, involving both Asian and Western patients, aims to establish pimicotinib as a new treatment option for TGCT, addressing the unmet need for systemic therapy.

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.

The Asia Pacific mRNA therapeutics contract development & manufacturing market is rapidly growing due to increased R&D investments, disease prevalence, and technological advancements. Infectious diseases dominate the market, with mRNA technology expected to be a 'game-changer' in vaccine manufacturing. Key markets include Japan, Singapore, Australia, Indonesia, China, South Korea, and India. Horizon Databook offers comprehensive data, insights, and customizable reports to aid informed decision-making and strategic advantage.

PDS Biotech is preparing a Phase 3 trial for Versamune HPV + pembrolizumab as a first-line treatment for recurrent or metastatic HPV16-positive HNSCC. CEO Frank Bedu-Addo discusses the company's history, technology, and clinical successes, including Versamune HPV's potential in HPV-positive cancers with a TAM exceeding $6B in the U.S.

The Biotechnology Market is projected to grow at a CAGR of 15.4% from 2024 to 2031, driven by key players like F. Hoffmann-La Roche Ltd, Pfizer, and Merck KGaA. The market leverages biological systems for applications in medicine, agriculture, and environmental management, addressing health, food security, and sustainability challenges.

The global induced pluripotent stem cells (iPSCs) market, valued at USD 1.88 billion in 2023, is projected to grow to USD 4.48 billion by 2032, driven by advancements in regenerative and personalized medicine, drug discovery, and increased investments in stem cell research. Key market participants focus on improving iPSC generation methods, while challenges include high production costs, ethical issues, and regulatory complexities. North America leads the market, with Asia-Pacific showing rapid growth.

The global Head and Neck Cancer Diagnostics market is expected to grow from $6.8B in 2023 to $15.2B by 2030, driven by advancements in liquid biopsy, NGS, AI, and molecular testing. Rising cancer incidence, personalized medicine, and healthcare policies are key factors. The report offers detailed market analysis, competitive insights, and future trends.

Authors from various institutions collaborated on a project, with A.R.M.B. and M.F.E. as originators. Experimental work was conducted by C.L.L. and F.F., and data processing by M.F.E. and L.S. Additional contributors participated in experiments and manuscript editing.