News & Analysis as of

Life Sciences Research and Development Prescription Drugs

DLA Piper

CRLs Made Public: What FDA’s New Policy Means For the Drug Industry

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The US Food and Drug Administration (FDA) recently announced the availability of the first-ever centralized database of Complete Response Letters (CRLs) on openFDA, one of several steps taken under the agency’s initiatives to...more

Morgan Lewis - As Prescribed

FDA's Recent Release of a Roadmap to Reduce Animal Testing

The US Food and Drug Administration (FDA) recently announced a strategic roadmap to phase out animal testing requirements for certain drug products, starting with monoclonal antibodies. This shift marks a significant change...more

Goodwin

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

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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

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

BakerHostetler

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

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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

MoFo Life Sciences

FDA Publishes Digital Health Technology Framework

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On Thursday, March 23, 2023, the Food and Drug Administration (FDA) announced the publication of the “Framework for the Use of Digital Health Technologies in Drug and Biological Product Development” (Framework) by the Center...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

Proskauer - The Patent Playbook

"Commercially Reasonable Efforts” Clauses in Drug Development Deals: What Level of Protection Do They Really Provide?

Pharmaceutical drug development is expensive. One recent study estimates that the median cost to develop a new drug is $985 million, while the average is $1.3 billion. And those figures appear to be on the low end of a broad...more

Hogan Lovells

Safeguarding drug development at academic institutions

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Academic institutions and faculty engaged in developing novel drug therapies are navigating an increasingly complex compliance landscape. ...more

Womble Bond Dickinson

Computer Science Meets Medicine in Drug Discovery

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AI has the potential to revolutionize healthcare worldwide. In drug discovery, AI has already shown success. Sumitomo Dainippon Pharma and the UK-based AI company Exscientia developed DSP-1181 to treat obsessive compulsive...more

Womble Bond Dickinson

Finding a New Way to Fight a Deceptive Disease

Womble Bond Dickinson on

Cancer is a horribly painful and debilitating illness, but would you ever call it “diabolical”? What about “conniving”? You might after you hear about the latest research out of Vanderbilt University showing that cancer cells...more

Seyfarth Shaw LLP

FDA Approves Veklury (remdesivir) As The First Treatment For COVID-19

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On October 22, 2020, the U.S. Food and Drug Administration (FDA) formally approved Veklury (remdesivir) as a treatment of COVID-19. Veklury, an antiviral drug, is the first treatment approved by FDA to treat COVID-19....more

Epstein Becker & Green

Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast

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This Diagnosing Health Care episode looks at the adjustments to business operations and compliance programs that pharmaceutical and medical device companies need to consider as they launch new products during the ongoing...more

Herbert Smith Freehills Kramer

Biopharma Develops Antibody and Stem Cell Therapies in the Fight Against COVID-19

SARS-CoV-2, the virus that causes COVID-19, is a novel coronavirus never before seen in humans. To date, it has caused 60,000 deaths in the United States – 56,000 of those in the last month alone. There does not yet exist an...more

Hogan Lovells

The Belgian AFMPS warns about risk of hemolysis associated with the use of hydroxychloroquine

Hogan Lovells on

On 14 April 2020, the Belgian Federal Agency for Medicines and Health Products (AFMPS), published a news flash warning physicians of the risk of hemolysis associated with the use of hydroxychloroquine in patients with...more

Herbert Smith Freehills Kramer

A Therapeutic Solution for COVID-19: Repurposing Existing Drugs

For decades, antiviral drugs have been used to combat viral infections, including HIV/AIDS and influenza. Now they are a source of hope in the fight against the COVID-19 pandemic....more

Morgan Lewis

Back to the Future but Still in Flux: Court Finds Law Requires ClinicalTrials.gov Posting of Ten Additional Years of Additional...

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The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

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We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Hogan Lovells

The Court of Justice of the European Union provides clarifications on the assessment under competition law of pay-for-delay deals...

Hogan Lovells on

On 30 January 2020, the Court of Justice of the European Union (CJEU) issued its decision on a request for preliminary ruling submitted by the UK Competition Appeal Tribunal (CAT) in a case concerning the long-standing...more

Knobbe Martens

The Druggable Microbiome

Knobbe Martens on

Discoveries regarding the role of the microbiome in human health and disease have been emerging with stunning frequency. While each new discovery builds upon the last, occasionally a point is reached at which, in the...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

Knobbe Martens

Practical Steps for Building a Strong Life Science Patent Portfolio Worth Billions of Dollars

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In the last four years, several companies with antiviral drug programs, including Alios BioPharma, Idenix, Inhibitex, InterMune and Pharmasset, have been acquired by large pharmaceutical companies (‘‘big pharma’’). One of the...more

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