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Clinical Trials › Healthcare › Biologics

McDermott Will & Schulte

European Health & Life Sciences Symposium 2025: Key Takeaways

McDermott Will & Schulte on

In April 2025, we were proud to host the annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

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

Biosimilars at the Crossroads: A $234 Billion Opportunity or a Missed Chance for Healthcare Savings?

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

The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more

Napoli Shkolnik

The Risks of Unregulated Regenerative Medicine

Napoli Shkolnik on

A recent New York Times article reported that dozens of spine surgery patients at NewYork-Presbyterian/Weill Cornell Medical Center were treated with a product that was not approved for use in such procedures. Burst...more

McDermott Will & Schulte

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

McDermott Will & Schulte on

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

Hogan Lovells

The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

Hogan Lovells on

Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals. ...more

Nelson Mullins Riley & Scarborough LLP

FDA Finalizes Informed Consent Guidance for Drug and Medical Device Clinical Investigations

Nelson Mullins Riley & Scarborough LLP on

On August 15, the U.S. Food and Drug Administration (FDA or the Agency) published the final guidance document, “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors” (Final...more

Epstein Becker & Green

Is CMS Ignoring the Realities of Biopharmaceutical Costs?

Epstein Becker & Green on

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

Wilson Sonsini Goodrich & Rosati

FDA Issues Guidance on Drug and Biologic Submissions with Real-World Data and Real-World Evidence

Wilson Sonsini Goodrich & Rosati on

Last month, the U.S. Food and Drug Administration (FDA) issued a final guidance on drug and biologic submissions to the agency that include real-world data (RWD) and real-world evidence (RWE). The procedural guidance aims to...more

Faegre Drinker Biddle & Reath LLP

FDA Releases Draft Guidance for Sponsors on How to Comply with Study Data Standards When Submitting RWD-Sourced Study Data

Faegre Drinker Biddle & Reath LLP on

The U.S. Food and Drug Administration (FDA) issued a draft guidance titled Data Standards for Drug and Biological Product Submissions Containing Real-World Data on October 21, 2021. The guidance provides the Agency’s thoughts...more

Wilson Sonsini Goodrich & Rosati

What You Need to Know About the Right to Try Act and Patient Access to Experimental Drugs

Wilson Sonsini Goodrich & Rosati on

Recently, President Donald Trump signed into law the Right to Try Act of 2018 (RTTA).1 The RTTA represents the federal version of laws previously passed by a majority of the states, but with important differences. This WSGR...more

McAfee & Taft

New state law allows access to investigational drugs

McAfee & Taft on

In line with a nationwide movement, on April 21, 2015, Governor Fallin signed into law House Bill 1074, the Oklahoma Right to Try Act. The Act allows physicians to prescribe to terminally ill patients investigational drugs,...more

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