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Clinical Trials Medical Research

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - September 8th - 11th, Scottsdale, AZ

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals....more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with...

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Ming-Wei Chen and Fanheng Zhou, the scientists behind RephImmune, join hosts Lynnsey and Matthew to discuss how their biotech startup is developing a next-generation cell therapy platform designed to overcome the limitations...more

Ropes & Gray LLP

HALT Fentanyl Act: Unpacking its Significant Reforms for Controlled Substance Research

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On July 16, 2025, President Trump signed the Halt All Lethal Trafficking of Fentanyl (“HALT Fentanyl”) Act into law. The law permanently reclassifies “fentanyl-related substances” into Schedule I of the Controlled Substances...more

Health Care Compliance Association (HCCA)

Their Terms Ended by Trump, SACHRP Members Form New Committee, Vow to Continue ‘Mission’

Reflecting thwarted desires to continue their terms, while answering calls from trial administrators and oversight leaders, seven former members of the highest-ranking federal advisory panel on human research...more

Knobbe Martens

Johnson & Johnson Study Shows Promise for the Treatment and Potential Cure of Multiple Myeloma

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On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated with CARVYKTI®...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

Maynard Nexsen

Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of...

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Recorded at SCbio’s 2025 annual conference, Heather and Lauren welcome Eric Perrault, the CEO of Kiyatec, which focuses on functional precision oncology. Eric discusses their exciting process, which aims to predict how...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences...

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Recorded at SCBio’s 2025 annual conference, hosts Heather and Matthew welcome keynote speaker John Crowley, President and CEO of the Biotechnology Innovation Organization (BIO), the world’s leading advocacy group for the life...more

Latham & Watkins LLP

Preparing for the European Health Data Space - Opportunities and Challenges for Europe’s Digital Future

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The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more

Downs Rachlin Martin PLLC

Mass General Brigham study offers promise that nasal spray targeting neuroinflammation could become an effective treatment for TBI

The secondary cascade, although a normal physiological response, can contribute to ongoing neuroinflammation, oxidative stress and axonal injury, continuing in some cases years after the initial insult.  There is no clearly...more

Maynard Nexsen

Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center

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Recorded at SCbio’s 2025 annual conference, Heather and Lauren welcome Dr. Ray DuBois, a physician and researcher who has dedicated his life to cancer research and patient-centered care. Dr. DuBois, Director of MUSC’s...more

Knobbe Martens

FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers

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Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and Education to...more

Health Care Compliance Association (HCCA)

[Event] Healthcare Research Compliance Academy - March 24th - 27th, Chicago, IL

HCCA's Healthcare Research Compliance Academy is a three-and-a-half-day interactive educational program with a focus on the highly specialized and complex regulations and issues that affect research compliance professionals....more

Benesch

Dialysis & Nephrology Digest - February 2025

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A New Hope in Kidney Transplants: The Promise of Xenotransplantation - Joe’s struggle for a kidney transplant highlights a dire reality: donor shortages are leaving countless patients in limbo. Enter Dr. PK, a pioneering...more

Holland & Knight LLP

NIH Cuts Research Funding for Indirect Costs

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The National Institutes of Health (NIH) published guidance late on Feb. 7, 2025, setting the indirect cost rate for NIH grants at 15 percent, replacing the negotiated indirect cost rates at many universities, which typically...more

Health Care Compliance Association (HCCA)

[Event] Research Compliance Conference - June 2nd - 4th, Orlando, FL

Get the latest insights in research compliance - The risks and challenges that come with clinical research are unique, as are the abundance of government regulations and enforcers that oversee them. HCCA’s Research...more

Foley & Lardner LLP

FDA & OHRP Draft Guidance: Including Tissue Biopsies in Clinical Trials

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The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more

A&O Shearman

Key regulatory changes impacting the healthcare industry in the EU and Germany in 2025

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The regulatory frameworks in the life sciences and healthcare sector keep evolving rapidly and dynamically. Several important legislative reforms have been adopted over the last years, which are set to impact players in the...more

Health Care Compliance Association (HCCA)

Tackling Review of ‘Uninformative’ Studies, SACHRP Joins Quest to Boost Research Caliber

In 2023, after two years of study, an NIH task force proposed a series of recommendations to improve stewardship of research it funds, including that the agency adopt “stopping rules” that would allow poorly designed or low...more

Ropes & Gray LLP

Clinical Trial Protocol Deviations: A New FDA Draft Guidance to Ring in the New Year

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As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting protocol deviations in...more

Fenwick & West LLP

Clinical Data FAQs: How to Approach Fundraising and Investor Relations

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For publicly traded biotech companies, disclosing clinical trial data can be an exciting milestone as you build towards an exit or public offering—but disclosure is a double-edged sword....more

Hogan Lovells

Research wrapped: Key developments for academic research institutions in 2024 and looking ahead to 2025

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In 2024, the federal government continued to shape the research compliance landscape with significant developments for research institutions across several areas. Key updates included the continued implementation of research...more

Ropes & Gray LLP

[Podcast] Non-binding Guidance: Clinical Trial Diversity in Focus

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On this episode of Ropes & Gray’s podcast series Non-binding Guidance, health care partner David Peloquin and life sciences regulatory and compliance counsel Sarah Blankstein discuss the FDA's recent draft guidance on...more

Holland & Knight LLP

HHS OHRP Amends Protections of Human Research Subjects Rule for Specified Populations

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The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services on Oct. 25, 2024, issued nonsubstantive amendments to subparts B, C and D of 45 CFR Part 46, which provide additional...more

Knobbe Martens

Nobel Prize in Medicine Awarded to American Scientists for Discovery of microRNA

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On October 7, 2024, the 2024 Nobel Prize in Physiology or Medicine was jointly awarded to two American scientists, Victor Ambros (of UMass Medical School) and Gary Ruvkun (of Harvard Medical School), for their discovery of...more

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