Amgen
- Country
- Ownership
- -
- Employees
- 26.7K
- Market Cap
- -
- Introduction
Amgen, Inc. is a biotechnology company, which engages in the discovery, development, manufacture, and marketing of human therapeutics. It operates through Human Therapeutics segment. The company was founded by William K. Bowes, Jr., Franklin Pitcher Johnson, Jr., George B. Rathmann, and Joseph Rubinfeld on April 8, 1980 and is headquartered in Thousand Oaks, CA.
Global Thrombocytopenia Clinical Trials Market Sees Significant Growth in 2025
• The global thrombocytopenia clinical trials landscape is expanding rapidly with over 25 pharmaceutical companies developing 25+ treatment therapies, according to recent market analysis.
• Key industry players including GSK, Novartis, Amgen, and Sanofi are leading clinical development efforts, with several promising candidates in late-stage trials showing efficacy in reducing thrombocytopenia events.
• Recent advances include Takeda's TAK-755 demonstrating 60% reduction in thrombocytopenia events compared to standard of care, and HUTCHMED completing enrollment for its pivotal Phase III ESLIM-01 trial of sovleplenib for immune thrombocytopenia.
Global Clinical Trials for Myelodysplastic Syndrome Show Significant Industry Investment in 2025
• A comprehensive review of global Myelodysplastic Syndrome clinical trials reveals extensive research activity across G7 and E7 countries, with major pharmaceutical companies leading development efforts.
• The analysis highlights significant participation from industry leaders including Bristol-Myers Squibb, Novartis, and Sanofi, demonstrating strong commercial interest in MDS therapeutics.
• The report indicates evolving clinical trial landscapes across multiple regions, with detailed tracking of trial phases, enrollment trends, and success rates over the past five years.
Clinical Trial Diversity Crisis: Black Patients Severely Underrepresented in Multiple Myeloma Studies
• Recent phase 3 trials IMROZ and PERSEUS for multiple myeloma treatments showed alarming diversity gaps, with Black patients comprising only 0.9% and 1.3% of participants despite representing 20% of new myeloma cases.
• FDA study of 32,000 clinical trial participants reveals significant racial disparities, with non-Hispanic Whites overrepresented at 75% while Hispanic and Black populations remain underrepresented relative to US demographics.
• Real-world multiple myeloma patients show 44% worse progression-free survival compared to clinical trial participants, highlighting the consequences of non-representative trial populations.
FDA Approves Sotorasib Plus Panitumumab for KRAS G12C-Mutated Metastatic Colorectal Cancer
• The FDA has approved sotorasib (Lumakras) in combination with panitumumab (Vectibix) for treating KRAS G12C-mutated metastatic colorectal cancer in adults who have received prior chemotherapy.
• This approval is based on the Phase 3 CodeBreaK 300 trial, which demonstrated a significant improvement in progression-free survival compared to standard of care.
• The combination therapy led to a median progression-free survival of 5.6 months, a substantial increase compared to the 2 months observed with standard treatments.
• The FDA also approved the therascreen KRAS RGQ PCR Kit as a companion diagnostic to identify patients eligible for this targeted treatment approach.
Axsome's AXS-05 Shows Promise in Alzheimer's Agitation Trials, NDA Submission Planned for 2025
• Axsome Therapeutics' AXS-05 demonstrated a statistically significant delay in agitation relapse in Alzheimer's patients in the ACCORD-2 Phase 3 trial.
• The ADVANCE-2 trial did not meet its primary endpoint, but results numerically favored AXS-05, with a good safety profile across trials.
• Axsome plans to submit an NDA to the FDA in the second half of 2025, supported by data from four Phase 3 trials.
• AXS-05 has Breakthrough Therapy designation, potentially expediting its review for Alzheimer's disease agitation, a condition with limited options.
Dupixent Approval by FDA: A New Era in COPD Treatment for Smokers
• The FDA has approved Dupixent (dupilumab) for COPD, marking the first targeted therapy for this progressive lung condition, particularly benefiting smokers.
• Clinical trials demonstrated that Dupixent reduces moderate-to-severe COPD exacerbations by 30% and improves lung function significantly.
• Dupixent targets type 2 inflammation pathways (IL-4 and IL-13), offering a novel approach for COPD patients with elevated eosinophils.
• Several mid-stage drugs are in development, promising more options to transform COPD management, enhancing the treatment landscape.
Clinical Trials Market to Reach $85.37 Billion by 2033, Driven by Globalization and Precision Medicine
• The clinical trials market is projected to reach USD 85.37 billion by 2033, driven by the increasing globalization of clinical trials and the need to access diverse patient populations.
• The expansion of precision medicine is creating significant opportunities for clinical trials focused on validating targeted therapies and identifying relevant biomarkers.
• North America currently dominates the clinical trials market due to its robust healthcare infrastructure and favorable regulatory environment, with Europe showing strong growth.
• Recent developments include FDA approval of Spinogenix's ALS trial and the NHS launch of a platform to accelerate personalized cancer vaccine clinical trials.
EMA Accepts Alvotech's Biosimilar AVT03 for Prolia and Xgeva
• The European Medicines Agency (EMA) has accepted Alvotech's Marketing Authorization Application for AVT03, a biosimilar candidate to Prolia and Xgeva.
• AVT03 demonstrated clinical similarity to Prolia in terms of efficacy, safety, immunogenicity, and pharmacokinetics in clinical studies.
• Alvotech has partnered with STADA Arzneimittel AG and Dr. Reddy’s Laboratories SA for commercialization of AVT03 in Europe.
• The European denosumab market is valued at approximately US$1 billion, and AVT03 could expand patient access at lower costs.
Verastem Oncology Announces Positive Interim Results and FDA Submission for Cancer Therapies
• Verastem Oncology reported an 83% overall response rate in a Phase 1/2 trial of avutometinib plus defactinib with chemotherapy for metastatic pancreatic cancer.
• The company initiated a rolling NDA submission to the FDA for avutometinib and defactinib in recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC).
• A Phase 3 trial is underway comparing the combination therapy to standard chemotherapy or hormonal therapy for recurrent LGSOC.
Next-Generation RNA Technologies Promise Longer-Lasting Therapeutics Beyond mRNA
• Biotech companies are developing novel RNA technologies, including circular RNA and transfer RNA, to overcome the rapid degradation limitations of current mRNA therapeutics.
• At least nine biotechnology startups have secured hundreds of millions in funding, with companies like Orna Therapeutics and Laronde leading circular RNA development with over $800M combined funding.
• These next-generation RNA platforms aim to enable longer-lasting protein expression, reduced dosing frequency, and expanded therapeutic applications across cancer, rare diseases, and chronic conditions.
© Copyright 2025. All Rights Reserved by MedPath