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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
Rothwell, Figg, Ernst & Manbeck, P.C.

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

Rothwell, Figg, Ernst & Manbeck, P.C. on

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...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

Latham & Watkins LLP

FDA and NIH Announce Initiatives to Reduce Animal Testing and Encourage Alternative Methodologies

Latham & Watkins LLP on

The initiatives reflect the latest measures from federal agencies to reduce and ultimately replace animal testing in drug development and biomedical research....more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Latham & Watkins LLP

Healthcare and Life Sciences Trends and Developments Across MENA

Latham & Watkins LLP on

The healthcare and life sciences ecosystem is witnessing significant growth in the Middle East as the GCC continues to seek economic diversification. The United Arab Emirates (UAE) and Kingdom of Saudi Arabia (KSA) are...more

Skadden, Arps, Slate, Meagher & Flom LLP

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

Skadden, Arps, Slate, Meagher & Flom LLP on

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

Health Care Compliance Association (HCCA) on

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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

Davis Wright Tremaine LLP

Project W: Uncovering a Promising Sector in Climate Tech

Davis Wright Tremaine LLP on

The food and ag sectors are tied to nearly a quarter of all global greenhouse gas emissions. However, those sectors receive disproportionately less climate tech venture funding. Beatriz Franco and Maya Benami of Vita Vera...more

BakerHostetler

Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products

BakerHostetler on

On May 10, the U.S. Food and Drug Administration (FDA) published a discussion paper, “Using Artificial Intelligence & Machine Learning in the Development of Drug & Biological Products.” The paper is a collaboration between...more

Vicente LLP

Understanding the Current Legal Status of Psychedelics in the United States

Vicente LLP on

In a previous article, we explored one potential current opportunity for entrepreneurs interested in psychedelics and mycelium—producing non-psychoactive mushroom supplements. But are there any current commercial...more

Maynard Nexsen

The Impact of COVID-19 on Clinical Research in the Life Sciences Industry: Is there a Silver Lining?

Maynard Nexsen on

Clinical research is one of the foundations of the Life Sciences industry as it involves the scientific investigation and treatment of diseases and other medical conditions in order to improve medical knowledge related to the...more

Haug Partners LLP

Vaccine Design Will Likely Determine the Success of Each COVID-19 Vaccine

Haug Partners LLP on

This article provides a basic overview of the immune system and how its successful engagement is necessary to produce a commercial vaccine, with a specific focus on the SARS-CoV-2 virus that causes the COVID-19 disease and...more

Goodwin

Global Trends and Opportunities in Life Sciences Real Estate – Spotlighting the U.S. and the UK

Goodwin on

An aging global population, a once-in-a-century pandemic and the continued convergence of scientific breakthroughs like cell and gene therapies and artificial intelligence are among just a few of the key factors that continue...more

Robinson+Cole Data Privacy + Security Insider

Chinese and Russian Hackers Targeting COVID-19 Vaccine Makers in U.S. Crosshairs

Robinson+Cole Data Privacy + Security Insider on

Last week, authorities from the United States, United Kingdom and Canada accused a well-known hacker group tied to the Russian government, APT29 a/k/a Cozy Bear of using malware to exploit security vulnerabilities to enable...more

Herbert Smith Freehills Kramer

Biopharmaceutical Industry Fights COVID-19 Pandemic with Innovation and Speed

Herbert Smith Freehills Kramer on

The COVID-19 pandemic has created unprecedented challenges for almost every industry. Most acute is the clinical challenge facing overwhelmed and underequipped hospitals and health care workers....more

Jones Day

Artificial Intelligence and the Biopharmaceutical Industry: What's Next?

Jones Day on

The Situation: Artificial intelligence ("AI") is emerging as a key driver of innovation in the biopharmaceutical industry, which uses AI in research and development ("R&D") to analyze big data. The Result: AI is already...more

Searcy Denney Scarola Barnhart & Shipley

Hacking Gains New Heights with Threat to Big Pharma

Searcy Denney Scarola Barnhart & Shipley on

Cyber attacks have broken free from their initial molds of carting off with consumer credit card numbers or stealing someone’s identity. The act of digitally digging into cyberspace has hit the U.S. Department of Health &...more

BakerHostetler

Pharmaceutical Life Cycle Management: Navigating the New IP, FDA and Antitrust Terrain

BakerHostetler on

Efforts to extend the life cycle of pharmaceutical products frequently involve innovations and improvements in product design, formulation, route of administration and treatment indications. In addition, negotiation of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Guest Post: $2.6 Billion Per Drug: Is Your Patent Portfolio Strong Enough to Protect Your Investment?

McDonnell Boehnen Hulbert & Berghoff LLP on

Late last year, the Tufts Center for the Study of Drug Development (CSDD) released a number that would cause jaws to drop all around the healthcare world.  The estimated cost for developing a new drug was an astounding $2.558...more

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