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Hogan Lovells

New FDA approval process promotes development of rare disease gene therapies

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known genetic defects will...more

Bergeson & Campbell, P.C.

APHIS Withdraws Notices of Intent to Prepare EISs for Two Petitions Seeking Determinations of Nonregulated Status for Organisms...

Bergeson & Campbell, P.C. on

On August 18, 2025, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) advised the public that it is withdrawing notices of intent to prepare environmental impact statements (EIS)...more

Bergeson & Campbell, P.C.

Call for Evidence for Impact Assessment of the European Biotech Act Will Close June 11, 2025

Bergeson & Campbell, P.C. on

The European Commission (EC) began a call for evidence on May 14, 2025, for an impact assessment of the European Biotech Act. The EC states that the overall objective is to improve the size and competitiveness of the...more

Hogan Lovells

FDA animal testing phaseout urges AI-based trial alternatives, organoids, other “NAMs”

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently announced it plans to phase out animal testing in the development of monoclonal antibody therapies and other drugs and biological products “with more effective,...more

Bergeson & Campbell, P.C.

National Biotechnology Initiative Act Would Implement Recommendations from NSCEB’s Final Report

Bergeson & Campbell, P.C. on

As reported in our April 25, 2025, blog item, the National Security Commission on Emerging Biotechnology (NSCEB) announced on April 8, 2025, the availability of its final report and action plan, “urging Congressional action...more

Morgan Lewis

FDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug Developers

Morgan Lewis on

The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to optimize interactions with the...more

Paul Hastings LLP

FDA Funding Changes Could Impact Biotech M&A

Paul Hastings LLP on

With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment often leads to mergers and acquisitions (M&A) as a vehicle for larger companies to...more

Morrison & Foerster LLP - Class Dismissed

APHIS Reinstates Legacy Biotechnology Regulations: Implications for CRISPR-Edited Plants

Morrison & Foerster LLP - Class Dismissed on

USDA Animal and Plant Health Inspection Service (APHIS) announced on January 23, 2025, that it is reinstating its legacy notification procedure as of February 7, 2025, providing a streamlined alternative to permits for...more

Ropes & Gray LLP

Adapting to the IRA: Early Lessons Learned on the IRA’s Impact on Deal-Making, Drug Economics, and Business Strategy

Ropes & Gray LLP on

More than two years after the passage of the Inflation Reduction Act (“IRA”) and the Centers for Medicare and Medicaid Services’ (“CMS’”) rapid implementation of the drug price negotiation program, the life sciences industry...more

Vinson & Elkins LLP

BIS Expands Export Controls over Biotechnology Software with Implications for CFIUS Mandatory Filing Requirements

Vinson & Elkins LLP on

On October 5, 2021, the Bureau of Industry and Security (“BIS”) issued a final rule formally expanding its controls over the export of biotechnology software. ...more

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