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Amgen
NovaPharmaNews editorial coverage mentioning Amgen — regulatory, clinical, and market analysis.
Company details
- Status
- Public
- HQ
- One Amgen Center Drive, Thousand Oaks, CA 91320, US
- Founded
- 1980
- Employees
- 40,212
- Programs
- 2
- Drugs
- 86
- Patents
- 1
News & analysis
NovaPharmaNews articles mentioning Amgen — regulatory, clinical, and market coverage.
NovaPharmaNews editorial coverage mentioning Amgen — regulatory, clinical, and market analysis.
EMA Tightens Liver Safety Checks for Tavneos After Fatal Cases
EMA's PRAC has tightened monitoring and stopping rules for Tavneos (avacopan) after reviewing serious liver injury cases, including fatal outcomes. The update adds liver injury as a rare side effect and creates a new regulatory watchpoint for Amgen and ANCA-associated vasculitis teams.
MariTide Phase 2 obesity data show up to 20% weight loss at one year
Amgen’s MariTide phase 2 obesity data showed up to 20% average weight loss at 52 weeks in participants without type 2 diabetes. The trial also reported up to 17% average weight loss in participants with type 2 diabetes, with placebo results provided in the published data.
MariTide Phase 2: Amgen reports up to 20% weight loss at one year
Amgen’s MariTide Phase 2 obesity study reported up to ~20% average weight loss at one year in participants without type 2 diabetes and up to ~17% in those with type 2 diabetes. The plan below focuses only on the trial facts, the placebo comparisons, and the clinical-trial readouts already supported by source material.
FDA Shakeup: Høeg's Departure and Amgen Drug Controversy
The FDA's dismissal of acting CDER director Tracy Høeg and the revelation of 20 patient deaths linked to Amgen's Tavneos in Japan create a dual crisis of regulatory leadership and drug safety. This analysis provides key takeaways, a timeline of events, and strategic implications for pharmaceutical BD and regulatory teams.
Amgen and Zai Lab Leadership Shifts: Strategic Implications for Pharma BD and Investors
Recent leadership transitions at Amgen and Zai Lab signal potential shifts in strategic direction and operational focus. Understanding these changes is crucial for pharmaceutical business development, investment, and regulatory teams.
Amgen's Expanded Crackdown on 340B Program Misuse
Amgen has intensified its efforts to address what it claims is the misuse of the 340B program. This article explores the implications for the pharmaceutical sector.
Amgen Inc Stock: Lung Cancer Setback Meets Steady Cash Flow
Amgen Inc faces a setback in lung cancer trials but maintains strong cash flow. This article explores its implications for investors and pharma teams.