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Gardner Law

The Value of MDUFA

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Anyone who has submitted a medical device for pre-market review knows the financial investment it takes to for FDA to conduct its review. Under the Medical Device User Fee Amendments (MDUFA), certain submissions, including...more

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

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In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...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

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - July 2025

With 10,000 baby boomers turning 65 each day, it’s not hard to see why aging well — even spectacularly well — has become a leading obsession of our era. The good news is that yes, there are practical ways to extend life,...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

BCLP

IARC Classifies Automotive Gasoline as Carcinogenic to Humans

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The International Agency for Research on Cancer (IARC)—a branch of the World Health Organization mandated to investigate potential causes of cancer—conducts its own hazard evaluations of suspected carcinogens and publishes...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 240: Independent Practice In Dermatology with Dr....

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The heat wave is here - is your skin ready? This week on the podcast, Heather and Matthew are joined by Dr. Charles Darragh and Dr. Marshall Shuler of Carolina Dermatology, one of the largest dermatology practices in upstate...more

Holland & Knight LLP

Another Change to NIH Grant Civil Rights Terms and Conditions

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The National Institutes of Health (NIH) issued a notice on June 12, 2025, rescinding recent civil rights–related changes to the terms and conditions governing federally funded research (the Rescission). Effective immediately,...more

Holland & Knight LLP

Holland & Knight Health Dose: June 17, 2025

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The U.S. Senate is in session for three days this week while the U.S. House of Representatives is in recess all week. Both chambers will return for a week before breaking for the July 4 recess. Negotiations on the...more

Knobbe Martens

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

Knobbe Martens on

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

Benesch

Dialysis & Nephrology Digest - June 2025

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Byonyks, a medical device company focused on advancing dialysis care, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Byonyks X1 APD Cycler, an automated peritoneal...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 237: Tackling Cancer with Cellular Immunotherapy with...

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In this episode, Heather and Matthew welcome Dr. Leonardo Ferreira, Assistant Professor at the Medical University of South Carolina and cofounder of Torpedo Bio. Leo shares how his team at Torpedo Bio is working to develop...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney...

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In this powerful episode, hosts Heather and Matthew are joined by Sydney Severance, a young woman and former competitive athlete whose life changed dramatically when she unexpectedly became wheelchair-bound. After a...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

Holland & Knight LLP

Holland & Knight Health Dose: May 13, 2025

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U.S. House of Representatives committees are scheduled to begin markups on additional portions of the budget reconciliation package on May 13, 2025. Both the House Committee on Ways and Means and the House Committee on Energy...more

Dorsey & Whitney LLP

The Next Front in the Administration’s Sponsored Research Crackdown: What Recipients of Federal Funding - Particularly Grantees -...

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The Trump Administration’s effort to remake the Federal government’s relationship with Higher Ed and research grantees continues to gather steam, and an unprecedented recent letter to Harvard presages a potentially new front:...more

Benesch

Dialysis & Nephrology Digest - May 2025

Benesch on

DOJ scores first victory in criminal antitrust labor market trial - A federal jury convicted a former home healthcare staffing executive in Las Vegas for orchestrating a three-year wage-fixing conspiracy targeting...more

Maynard Nexsen

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

Maynard Nexsen on

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

Patrick Malone & Associates P.C. | DC Injury...

Better Health Care Newsletter - May 2025

Great thinkers have sought for centuries to convey a crucial truth about humanity’s interconnection. As the poet John Donne wrote: “No man is an island, entire of itself; every man is a piece of the continent, a part of the...more

Holland & Knight LLP

Holland & Knight Health Dose: April 29, 2025

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U.S. Congress returns from a two-week recess this week and has lofty goals to draft, mark up and pass a reconciliation bill by Memorial Day 2025. The U.S. House of Representatives Committee on Energy and Commerce, which was...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

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle...

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Recorded at SCbio’s 2025 annual conference, Matthew and Lauren welcome Kendalle O’Connell, President & CEO of MassBio, a powerhouse life sciences organization and the driving force behind Massachusetts’ thriving life sciences...more

Goodwin

FDA to Phase Out Animal Testing for Monoclonal Antibodies and other Drugs

Goodwin on

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced it will be phasing out the current requirements for animal testing in the development of monoclonal antibody therapies and other drugs, replacing them...more

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