News & Analysis as of

Biotechnology 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

Maynard Nexsen

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

Maynard Nexsen on

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

Maynard Nexsen

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

Maynard Nexsen on

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

Foley & Lardner LLP

The Patent Eligibility Restoration Act and Life Sciences Innovation

Foley & Lardner LLP on

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

Fenwick & West LLP

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

Fenwick & West LLP on

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 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

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...

Maynard Nexsen on

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

Goodwin

Goodwin’s 2025 Rare Disease Symposium: Momentum Builds for Addressing Critical Diagnosis and Treatment Gaps

Goodwin on

Goodwin’s 2025 Rare Disease Symposium, held on February 5 in Boston and virtually, gathered patient advocates and caregivers, providers, researchers, biotech and medtech leaders, investors, and policy experts to discuss the...more

Wilson Sonsini Goodrich & Rosati

FDA Issues Multiple Guidances Supporting Clinical Trial Innovation

In September 2024, the U.S. Food and Drug Administration (FDA) issued three guidance documents to support different clinical trial approaches, including trials that implement decentralized elements, trials that allow...more

Faegre Drinker Biddle & Reath LLP

Recap of the FDA and CTTI Public Workshop on AI in Drug Development

On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...more

Maynard Nexsen

Episode 185: America’s Bioeconomy with Sarah Glaven, White House Research Biologist

Maynard Nexsen on

Recorded at SCbio’s 2024 annual conference, hosts Heather and Matthew welcome Sarah Glaven, a research biologist and the Assistant Director of Biotechnology and Biomanufacturing for The White House Office of Science and...more

BakerHostetler

Healthcare Industry Team 2023 Year in Review

BakerHostetler on

As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...more

Maynard Nexsen

Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy &...

Maynard Nexsen on

Recorded at NC Life Sciences Organization’s 2023 annual meeting, hosts Heather and Matthew welcome Christine Harhaj, the Senior Director for Pharmaceutical Research and Manufacturers of America (PhRMA). They have an...more

Goodwin

Common FDA Bioresearch Monitoring Violations: Updates from FY 2022 to Now

Goodwin on

The Bioresearch Monitoring (BIMO) Program, operated by the U.S. Food and Drug Administration (FDA), conducts on-site inspections and data audits in order to effectively monitor the compliance of all FDA-regulated research....more

McDermott Will & Schulte

FDA Issues Draft Guidance on Decentralized Clinical Trials for Drugs, Biological Products and Devices

Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more

Nelson Mullins Riley & Scarborough LLP

Minimizing the Fallout from Increasing FDA Clinical Holds

With medical and scientific advances progressing at an exponential pace, FDA appears to be taking a more aggressive stance in imposing clinical holds on studies where adverse events are reported. Over the last several years,...more

Hogan Lovells

FDA explains how to use secondary endpoints in clinical trials to show efficacy

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently finalized the guidance “Multiple Endpoints in Clinical Trials,” which advises drug sponsors on how to separate analyses of primary endpoints – which are critical to showing...more

Morgan Lewis - As Prescribed

Executive Order Outlines New Federal Biotechnology/Manufacturing Goals

President Joseph Biden issued an “Executive Order on Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy” (EO) on September 12. Under this EO, the president aims to...more

White & Case LLP

Healthcare M&A on track to set new record in 2021

White & Case LLP on

Heightened interest in medical suppliers, contract research organizations and biotech firms resulted in an impressive year for healthcare dealmaking- Dealmaking within the pharma, medical and biotech sector continued from...more

Sunstein LLP

The Estate of Henrietta Lacks Sues Thermo Fisher Scientific

Sunstein LLP on

In a one-count complaint for unjust enrichment filed on October 4, 2021—the 70-year anniversary of Henrietta Lacks’ death—the estate of Henrietta Lacks sued Thermo Fisher Scientific, a multibillion-dollar corporation...more

McDonnell Boehnen Hulbert & Berghoff LLP

Ticked Tabby Cats and Their Genetic Bases Elucidated

The domestic cat has been the subject of much study, recently involving its genetic structure, genomic DNA sequence, and comparisons with other felines.  The first such study was published in 2014, when an international...more

Spilman Thomas & Battle, PLLC

The Story of Henrietta Lacks and the Biotechnology Company Accused of Selling Her Cells for Profit

Two articles (Newsweek and Fierce Biotech) describe the new lawsuit by the Henrietta Lacks Estate surrounding the HeLa cell line. The claim is "unjust enrichment," a difficult claim to win, but one that seems to fit this...more

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