News & Analysis as of

Artificial Intelligence Pharmaceutical Industry

Cozen O'Connor

The State AG Report – 05.29.2025

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Here are curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: • NY Fights FAIR to Expand State Consumer Protection Law - ...more

McDermott Will & Emery

McDermott HealthEx 2025: McKinsey Key Takeaways

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McDermott HealthEx convened more than 1,300 of the most influential leaders in healthcare and life sciences. The event emphasized creativity, transformation, and growth, with sessions dedicated to innovation, AI-powered...more

Gardner Law

FDA Goes All In on AI: What It Means for Your Submissions

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The FDA is moving quickly to bring artificial intelligence (AI) into the heart of its regulatory review process. On May 8, 2025, the agency announced the successful completion of its first AI-assisted scientific review—and...more

Hogan Lovells

AI Summit panelists weigh emerging data & privacy risks for novel technology

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Hogan Lovells and the AI Health Care Coalition recently hosted their fourth annual AI Health Law & Policy Summit, where thought leaders and policymakers gathered to discuss a variety of topics including data and privacy...more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

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The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

McCarter & English, LLP

Economic and Clean Energy Leadership in New Jersey—FY 2026 Budget Testimony Highlights

Last week, Tim Sullivan, CEO of the New Jersey Economic Development Authority (NJEDA), and Christine Guhl-Sadovy, president of the New Jersey Board of Public Utilities (BPU), presented their fiscal year (FY) 2026 budget...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

White & Case LLP on

Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Hogan Lovells

EMA’S NEW WORK PLAN: Leveraging data and AI to encourage innovation and research

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The European Medicines Agency (EMA) published a workplan on its ambition to leverage high volumes of data and artificial intelligence (AI). On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with...more

King & Spalding

FDA Announces Completion of AI-Assisted Scientific Review Pilot and Deployment of Agency-Wide AI-Assisted Review

King & Spalding on

On May 8, 2025, the Food and Drug Administration (FDA) announced the completion of its generative artificial intelligence (AI) pilot program for scientific reviewers. FDA Commissioner Marty Makary was quoted in the...more

Hogan Lovells

FDA advances AI-powered review of medical product applications

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If the initiative proceeds as planned, it will mark a pivotal shift in the regulatory landscape, introducing both efficiencies and novel questions related to the reliability and validity of the AI reviews, as well as...more

McDermott Will & Emery

Investment Opportunities in TechBio and Pharma Services - European Health & Life Sciences Symposium 2025

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In April 2025, McDermott once again hosted its annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

Ropes & Gray LLP

Insights from the Third Annual Ropes & Gray Rare Disease Forum

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Ropes & Gray recently hosted its Third Annual Ropes & Gray Rare Disease Forum on May 1, 2025 in Cambridge, Massachusetts. The event gathered legal, commercial, and patient advocacy experts in the rare disease community to...more

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – OpenAI and FDA discussing AI for drug approval, AI chatbots fuel wave of cheating at U.S. colleges, AI bots...

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....more

McDermott Will & Emery

Quit Monkeying Around: FDA Offers Faster Approval Times in Bid to Phase Out Animal Testing

On April 10, 2025, the US Food and Drug Administration (FDA) announced its intent to phase out the use of animal testing in the development of certain drugs and biologics. To help bring this “paradigm shift in drug...more

Hogan Lovells

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

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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

McDermott Will & Emery

European Health & Life Sciences Symposium 2025: Key Takeaways

In April 2025, we were proud to host the annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - April 2025 #5

News Briefs - March Healthcare Data Breaches Declined 46% to Lowest Since 2022 - Healthcare data breaches appear to be on the decline for now. The HIPAA Journal reported just 58 breaches in March -- the lowest total for the...more

American Conference Institute (ACI)

[Event] 23rd Advanced Summit on Life Sciences Patents - May 19th - 20th, New York, NY

At ACI’s 23rd Advanced Summit on Life Sciences Patents, you can expect informational overviews and thorough discussion of every facet of the industry. In a time of major legislative, regulatory, and judicial change, you can't...more

Sheppard Mullin Richter & Hampton LLP

Navigating the Evolving Pharmacy Landscape in 2025: Challenges, Opportunities and Innovations

As we stride further into 2025, the pharmacy industry faces a landscape teeming with challenges and opportunities. From tackling drug price transparency to juggling implementation of artificial intelligence, the industry is...more

Hogan Lovells

Life Sciences & Health Care Horizons 2025

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Our 2025 Life Sciences and Health Care Horizons edition is now live! Explore the latest global insights from the U.S., Asia-Pacific, Europe, Latin America, and the Middle East on the key issues and emerging trends shaping the...more

Holland & Knight LLP

Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More

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In this episode of Holland & Knight's "The Eyes on Washington" podcast series, attorneys Rachel Gartner, Sara Klock, John Vaughan and Michael Werner discuss the evolving landscape of U.S. Food and Drug Administration (FDA)...more

Proskauer Rose LLP

Question of the Week: How are expiring patents fueling M&A in the life sciences industry?

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Expiring patents can be a catalyst for M&A in the life sciences industry as pharmaceutical and biotechnology companies seek to maintain revenue streams and competitive advantages. In this edition of Beyond the Deal, our...more

McDermott+

An MA Extravaganza: Overview of the Final Rule and Rate Announcement

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This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...more

Hogan Lovells

AI Health Law & Policy: FDA’s rapidly evolving regulatory paradigms

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Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more

Holland & Knight LLP

Holland & Knight Health Dose: April 8, 2025

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Looking Ahead: House to Vote on Compromise Budget Resolution On the heels of the U.S. Senate's passage of a compromise budget resolution, the U.S. House of Representatives is expected to consider the budget resolution on the...more

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