Worldwide: Life Sciences, Biotechnology & Nanotechnology

Biocon Limited has commercially launched YESAFILI (aflibercept-jbvf), a biosimilar to Regeneron's EYLEA, in the United States following settlement agreements that lifted previous injunction barriers. This marks the second aflibercept biosimilar available in the U.S. market, entering a competitive landscape where patent litigation continues to shape biosimilar entry strategies. The launch follows a complex legal journey involving multiple jurisdictions and settlement negotiations that ultimately permitted ea

The Centers for Medicare and Medicaid Services has issued a final rule prohibiting federal Medicaid and CHIP funding for gender-affirming care for minors, effective October 2026. This comprehensive analysis examines the rule's scope, legal framework, state-by-state implications, and operational impacts on healthcare providers, insurers, and families navigating coverage restrictions.

Ankura's comprehensive insights hub showcases cutting-edge analysis across cybersecurity threats, life sciences transactions, regulatory compliance, and corporate governance. Explore how emerging malware campaigns, building envelope litigation patterns, and evolving valuation landscapes are reshaping risk management and strategic decision-making for enterprises worldwide.

Meitheal Pharmaceuticals has secured FDA approval for GARZULYS, a biosimilar to Novo Nordisk's NOVOLOG for diabetes treatment, marking the third insulin biosimilar approved in the United States. The approval follows Meitheal's 2023 exclusive licensing agreement with Tonghua Dongbao Pharmaceutical to commercialize multiple insulin biosimilars across the U.S. market.

The Patent Eligibility Restoration Act of 2025 seeks to fundamentally restructure U.S. patent law by replacing the controversial Alice/Mayo framework with a statutory regime that explicitly defines what can and cannot be patented. This proposed legislation has ignited fierce debate between those who believe current eligibility doctrine stifles innovation in fields like AI and biotechnology, and critics who warn it could enable patent trolls and monopolize fundamental research tools.

The U.S. Government Accountability Office has released a comprehensive report examining the potential and pitfalls of using genetically engineered microbes to clean up waste. The analysis identifies critical obstacles including insufficient testing infrastructure, regulatory uncertainties, and public acceptance challenges that currently hinder the development and deployment of this biotechnology. GAO presents thirteen policy options for policymakers to consider, addressing goals ranging from demonstrating s

On June 26, 2026, in Huey v. Anavex Life Sciences Corporation, No. 25-1752, the United States Court of Appeals for the Second Circuit affirmed the district court’s dismissal of a putative class action asserting securities fraud claims where the plaintiff-shareholder failed to plead a plausible causal link between the alleged misrepresentations and the loss in share price, as was necessary to plead loss causation.

The U.S. Senate Committee on the Judiciary recently held a hearing examining the Patent Eligibility Restoration Act of 2025, legislation designed to clarify Section 101 of the Patent Act and restore patent...

Representative Rich McCormick introduces legislation to establish a dedicated biotechnology leadership position within the U.S. Department of State, responding to recommendations from the National Security Commission on Emerging Biotechnology. The bill aims to coordinate America's international biotechnology strategy and counter strategic rivals in this critical arena of global competition.