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Mintz - Venture Capital & Emerging Companies...

Mintz Venture Watch — Volume 8: A Report on Deal Trends from 2024 and H1 2025

Despite continued macroeconomic headwinds and a cautious investment climate, Mintz’s Venture Capital and Emerging Companies practice remained highly active throughout 2024 and into the first half of 2025. Our team advised on...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more

McDermott Will & Schulte

FDA teases faster approval times with new agency-wide AI tool

The US Food and Drug Administration (FDA) launched Elsa, a generative artificial intelligence (AI) tool designed to assist FDA employees with tasks such as reading, writing, and summarizing. The press release on the tool’s...more

Foley & Lardner LLP

Navigating FDA’s Proposed Guidance on AI and Non-Animal Models: Safeguarding Innovation in Drug Development

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In April 2025, the U.S. Food and Drug Administration (FDA) released a landmark guidance titled “Roadmap to Reducing Animal Testing in Preclinical Safety Studies,” outlining its commitment to advancing New Approach...more

Fenwick & West LLP

The Buzz Around Femtech at New York Tech Week 2025

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The femtech sector's evolution presents opportunities for tech, healthcare, and life sciences companies that are both vast and largely untapped. What began as a narrow focus on period-tracking applications has blossomed into...more

Fenwick & West LLP

NY Tech Week 2025: The Future of Femtech

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Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more

Hogan Lovells

FDA launches “Elsa” AI tool to aid drug approvals

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The U.S. Food and Drug Administration (FDA) has introduced “Elsa,” a generative AI tool designed to enhance the efficiency of its regulatory operations. Elsa's deployment comes nearly a month ahead of the agency’s original...more

Fenwick & West LLP

What We’re Watching Ahead of BIO 2025: Trends Shaping the Future of Biotech

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As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 3 - International Clinical Trials Country Requirements-...

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From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 2 - AI In Real Life (Science): Exploring Real World...

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From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Woodruff Sawyer

[Ongoing Program] Risk Management for Your Life Sciences Company: Webinar 1 - Navigating Risk from Lab to IPO: A Guide to...

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From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more

Jones Day

Vital Signs: Digital Health Law Update | Spring 2025

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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more

Holland & Knight LLP

Food and Chemical Regulatory Update: The Make Our Children Healthy Again Assessment

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The Make America Healthy Again (MAHA) Commission, as established by President Donald Trump's Feb. 13, 2025, Executive Order (EO) 14212, released its inaugural report on May 22, 2025, titled "The MAHA Report: Making Our...more

Morrison & Foerster LLP

MAHA Commission Publishes Report to Highlight Childhood Chronic Disease Drivers

On May 22, 2025, President Trump’s Make America Healthy Again (MAHA) Commission released an assessment titled “The MAHA Report: Make Our Children Healthy Again Assessment.” The report—framed as a “call to action”—stems from a...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

Arnall Golden Gregory LLP

Wind of Change: FDA Commissioner Makary Outlines His Vision for FDA

In his first major public remarks as commissioner of the U.S. Food and Drug Administration, Dr. Marty Makary laid out a comprehensive, reform-oriented vision for the agency during a fireside chat at the 2025 Food & Drug Law...more

White & Case LLP

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

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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

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

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 & Schulte

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

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

Two Days, Two Hearings: NIH and FDA Nominees Go Before the HELP Committee

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Dr. Jayanta (Jay) Bhattacharya, nominated to be Director of the National Institutes of Health (NIH), and Dr. Martin Makary, nominated to be the Commissioner of the U.S. Food and Drug Administration (FDA), appeared before the...more

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

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In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

Foley & Lardner LLP

Unlocking the Future of Medicine: The Role of AI in Drug Discovery

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Since 1995, Nature Medicine has been chronicling advances in medical technology and health care. To mark the journal’s 30th anniversary, each month an issue of critical importance for the future of medicine will be...more

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