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Biotechnology › Regulatory Reform › Life Sciences

Hogan Lovells

New FDA approval process promotes development of rare disease gene therapies

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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

Morgan Lewis

UK Life Sciences Sector Plan: What In-House Legal and Compliance Teams Need to Know

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The UK government recently unveiled its 10-year Life Sciences Sector Plan, putting forward a comprehensive strategy for transforming the UK into a global leader in life sciences by 2035. This LawFlash outlines key areas of...more

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

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The biotechnology and life science sectors underpin breakthroughs in health care, agriculture, and environmental sustainability by leveraging living systems to create next-generation medicines, diagnostics, and bio-based...more

Bergeson & Campbell, P.C.

NSCEB Seeks Input to Modernize Biotechnology Product Regulation

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The National Security Commission on Emerging Biotechnology (NSCEB) announced on July 1, 2025, that it is gathering input to modernize U.S. biotechnology product regulation and create simpler, faster, science-based pathways to...more

Bergeson & Campbell, P.C.

BIOTech Caucus Will Advance Domestic Bioeconomy and Competitive Posture

Bergeson & Campbell, P.C. on

On June 26, 2025, Representatives Chrissy Houlahan (D-PA) and Stephanie Bice (R-OK) announced the formation of the BIOTech Caucus. According to Houlahan’s June 26, 2025, press release, the Caucus’ mission “is to advance...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

Knobbe Martens

Bipartisan Law Introduced to Clarify Patent Eligibility

Knobbe Martens on

For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...more

Bergeson & Campbell, P.C.

National Security Commission on Emerging Biotechnology’s Final Report Includes Recommendations to Boost Economy and Protect...

Bergeson & Campbell, P.C. on

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 to bring the full weight of American innovation...more

Morgan Lewis - As Prescribed

FDA's Recent Release of a Roadmap to Reduce Animal Testing

Morgan Lewis - As Prescribed on

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more

Bergeson & Campbell, P.C.

President Trump Revokes 2022 EO on Advancing Biotechnology and Biomanufacturing

Bergeson & Campbell, P.C. on

On March 14, 2025, President Trump signed Executive Order (EO) 14236, rescinding 19 executive actions, including former President Biden’s September 2022 EO 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a...more

Morrison & Foerster LLP - Class Dismissed

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

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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

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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

Alston & Bird

Feds Continue to Reform Approach to Regulation of Biotech Products

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Our Food & Beverage and FDA teams explore a plan from a trio of federal agencies that seeks to implement regulatory reform and update the Coordinated Framework for the Regulation of Biotechnology....more

Jones Day

Ban on European Patents for Plants Engineered by "New Genomic Techniques" Nearing Reality

Jones Day on

The European Parliament has adopted an amended European Commission proposal to regulate plants engineered using techniques such as CRISPR/Cas and ban any patenting of plants, plant parts, material, genetic information, or...more

Hogan Lovells

FDA proposes clarification in long-running tussle over “intended use” rules for drugs and devices

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On September 23, the U.S. Food and Drug Administration (FDA) published a proposed rule to modify its intended use regulations to clarify the types of evidence FDA will consider when determining the “intended use” of a medical...more

Hogan Lovells

A new right for American patients: The Right to Try

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On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients with life-threatening conditions the right to...more

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