News & Analysis as of

Medical Research

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

Stark & Stark

Making the Invisible Visible: How Diffusion Tensor Imaging Sheds Light on Mild Traumatic Brain Injury

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Mild traumatic brain injury (mTBI), often called a concussion, is one of the most misunderstood injuries in medicine and law. Doctors, insurers, and defense experts frequently point to “normal” CT or MRI scans as proof that...more

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

Downs Rachlin Martin PLLC

Systematic review endorses integration of DTI imaging in clinical assessment of “mild” traumatic brain injury

The use of diffusion tensor imaging (“DTI”) to assess mild Traumatic Brain Injury (mTBI) has been discussed in several prior posts. Also as discussed in prior posts, DTI evidence has been challenged in dozens of cases (the...more

MG+M The Law Firm

PFAS and Diabetes: Association Without Causation

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Given ongoing concerns surrounding exposure to per- and polyfluoroalkyl substances (PFAS) and potential adverse human health effects, researchers recently examined whether PFAS exposure could contribute to an increased risk...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's...

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Lynnsey and Matthew are joined by Neal Goodwin and Pawel Krysiak of Jaya Bio, a preclinical life sciences company developing gene therapies for genetically defined neurodegenerative diseases. They share how their team is...more

Fenwick & West LLP

The Gates Foundation’s $2.5B Investment Signals a Boost for Women’s Health

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In one of the largest philanthropic initiatives ever dedicated to women’s health, the Gates Foundation announced a $2.5 billion commitment to close long-standing gaps in care, research, investments and data collection focused...more

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

Better Health Care Newsletter - August 2025

Has this ever happened to you? Misplacing your reading glasses, almost daily? Forgetting names, even of good friends and colleagues? Puzzling over why you just walked into the kitchen? Spending a big part of each day...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

Bass, Berry & Sims PLC

Healthcare Trends & Transactions Q2 2025

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The healthcare mergers and acquisitions (M&A) market remained active in Q2 2025, with several sectors including physician practice management (PPM), clinical research, and digital health experiencing continued investment and...more

Venable LLP

FDA and USDA Call for a Definition of Ultra-Processed Foods

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On July 23, 2025, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) announced a joint Request for Information (RFI) to gather information and data to help establish a federally recognized...more

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

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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

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

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