News & Analysis as of

Life Sciences Research and Development Biologics

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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 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

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

Epstein Becker & Green

Is CMS Ignoring the Realities of Biopharmaceutical Costs?

On March 15, the Centers for Medicare and Medicaid Services (CMS) released guidance on the drug price negotiations provisions of the Inflation Reduction Act (IRA). The guidance contains CMS’s interpretations for a range of...more

Hogan Lovells

FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

Hogan Lovells on

U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser

Our “Innovation Conversations” series continues with our guest Dr. Claire Fraser, President of the American Association for the Advancement of Science (AAAS) and Director of the Institute for Genome Sciences at the University...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

[IP Hot Topics Podcast] Innovation Conversations: Dr. Claire Fraser (transcript)

Our “Innovation Conversations” series continues with our guest Dr. Claire Fraser, President of the American Association for the Advancement of Science (AAAS) and Director of the Institute for Genome Sciences at the University...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

Faegre Drinker Biddle & Reath LLP

What Is Involved in Clinical Trials and What Has Changed During COVID-19: A Brief Primer

Why Do Clinical Trials? Clinical trials are an important — and government-required — step on the way from an idea to a commercial medicinal product. All new pharmaceutical and biological products and most generic...more

Morgan Lewis

FDA COVID-19 Guidance Roundup for Drug and Biologics

Morgan Lewis on

From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more

Morgan Lewis

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

Morgan Lewis on

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

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

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