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Research and Development Pharmaceutical Industry Healthcare

ArentFox Schiff

RFK Jr., HHS Pull the Plug on Federal Funding for mRNA Vaccine Research and Development

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On August 5, the US Department of Health and Human Services (HHS) announced a significant change in its vaccine development strategy, ending its support for mRNA vaccine projects under the Biomedical Advanced Research and...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

A&O Shearman

A new European strategy to foster life sciences innovation and market access

A&O Shearman on

On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more

Troutman Pepper Locke

Exclusive Licensing May Offer Biotechs a Financial Lifeline

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With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more

Troutman Pepper Locke

Embattled Biotechs Facing Uncertainty at the FDA Look to Collaborative Deal Structures

Troutman Pepper Locke on

Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more

Sheppard Mullin Richter & Hampton LLP

Reflections on the FDLI 2025 Annual Conference – Differing Tones, Shared Goals

From “gold standard science” to biopharma “GNC store”, this year’s Food and Drug Law Institute (FDLI) 2025 Annual Conference in Washington, DC, on May 15–16, a vital gathering for life sciences professionals, was full of...more

Jones Day

Blurring the Line Between the Dry and Wet Lab: Joint Inventorship in AI-Assisted Life Science Inventions

Jones Day on

In 2024, not one but two Nobel Prizes (in Chemistry and Physics) were awarded to researchers for their work in artificial intelligence ("AI"). Particularly noteworthy for the life science community is the Nobel Prize in...more

Gardner Law

Why Compliance Audits Are Non-Negotiable

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In today’s heightened enforcement environment, compliance auditing isn’t just a best practice—it’s a necessity. Federal and state laws and industry guidance, including the Office of Inspector General (OIG) Compliance Program...more

Morgan Lewis - As Prescribed

Venture Philanthropy More Important Than Ever for Rare Disease Care

Private foundations providing support, resources, and advocacy for individuals and families affected by rare diseases have played an important role for more than 30 years in the advancement of treatments for rare diseases....more

Skadden, Arps, Slate, Meagher & Flom LLP

Under RFK Jr., US Health Policy and FDA Operations May See Major Shifts

Robert F. Kennedy Jr. (RFK Jr.) has been confirmed by the Senate as secretary of the Department of Health and Human Services (HHS). In this capacity, RFK Jr. will oversee 13 agencies that are critical to U.S. health policy,...more

Hutchison PLLC

UNC’s Eshelman Innovation: Fueling North Carolina’s Next Big Breakthroughs

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North Carolina’s vibrant entrepreneurial ecosystem is a powerhouse for innovation, but there’s always room to improve, especially when it comes to turning cutting-edge research into real-world solutions. John Bamforth,...more

J.S. Held

Inside the Healthcare Industry: The Impact of Human Factors & User Experience in Healthcare

J.S. Held on

Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more

Skadden, Arps, Slate, Meagher & Flom LLP

EU and Germany Lay Groundwork for the Use of Medical Data for Research and AI Training

Both the EU and Germany are taking significant steps to accelerate digitalization in the health sector and facilitate the exchange and use of health data for research and innovation purposes. They aim to improve...more

Health Care Compliance Association (HCCA)

‘If Only She Could Have Been Stronger’: Miami Trial Fraud Leads to Prison, Personal Loss

In September 2015, while working in an office on the grounds of Mercy Hospital in Miami, Ivette Maria Portela Martinez learned about an upcoming clinical trial for treatment of symptoms of Clostridium difficile infections and...more

Robinson+Cole Data Privacy + Security Insider

HHS Addresses the Growing Influence of Artificial Intelligence in Health Care

Artificial Intelligence (AI) has emerged as a major player in the realm of health care, promising to completely transform­ its delivery. With AI’s remarkable ability to analyze data, learn, solve problems, and make decisions,...more

Seyfarth Shaw LLP

Pill Politics: Unveiling Biden’s Bold Blueprint for Affordable Drugs

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On December 7, 2023, the Biden administration announced a blueprint for a framework that may be a tough pill to swallow for the pharmaceutical industry. This framework suggests that drug prices should be a crucial factor in...more

Nelson Mullins Riley & Scarborough LLP

New FDA Draft Guidance Updates Recommendations for Good Clinical Practices

The U.S. Food and Drug Administration (FDA) recently published a draft of its updated Good Clinical Practice (GCP) guidance for modernizing clinical trials. The draft guidance will be open for public comment for 60 days from...more

Nelson Mullins Riley & Scarborough LLP

Heartburn for Valisure: Controversial Testing Lab Under Fire

In early December, a federal judge tossed plaintiffs’ expert evidence and dismissed some 2,450 lawsuits in the sprawling litigation involving the heartburn medication Zantac. U.S. District Judge Robin L. Rosenberg’s December...more

Knobbe Martens

Pfizer Australia Announces Deal to Acquire ResApp Health

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ResApp Health recently announced its planned sale to Pfizer Australia, a wholly owned subsidiary of Pfizer Inc. Pfizer agrees it would acquire 100% of the shares for AUD $0.115 / share, for a total equity value of...more

Knobbe Martens

Researchers Develop Blood Clot Test Based on Single Drop of Blood

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The University of Washington announced that a team of researchers has developed a prothrombin time/international normalized ratio (PT/INR) blood clotting test that requires only a single drop of blood and a smartphone....more

Hogan Lovells

Welcome to the real world: FDA issues long-awaited framework for evaluating the potential use of real-world evidence to support...

Hogan Lovells on

On December 6, the Food and Drug Administration (FDA) published a framework for its Real-World Evidence (RWE) Program to strategically leverage information gathered from real-world data (RWD): data that relates to patient...more

Hogan Lovells

China Takes Significant Steps to Consolidate Generic Drug Industry and Lower Prices

Hogan Lovells on

With the opportunity for global pharmaceutical companies to gain new access to the Chinese market presenting itself like never before, significant news broke on December 7, 2018, regarding a newly implemented pilot...more

Ballard Spahr LLP

Obama Signs 21st Century Cures Act, Adding $6.3 Billion For Medical Research

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The Cures Act aims to increase the speed by which new drugs are brought to market by streamlining clinical trials, allowing the use of patient data in the regulatory review process, and modernizing U.S. Food and Drug...more

Foley & Lardner LLP

Three Pressing Challenges for Personalized Medicine

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Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

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