News & Analysis as of

Research and Development Clinical Trials Biosimilars

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

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

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

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

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

Goodwin

DEAL WATCH: Biosimilars, Biosimilars and More Biosimilars

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It has been a busy week so far for biosimilar developers, with multiple collaboration and commercialization deals announced. First, on November 4, Henlius and Ascentage Pharma announced that they entered into a...more

Goodwin

Biosimilars Development Updates

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We previously reported on collaborations between Amgen and Allergan on oncology-related biosimilars. On July 21, Amgen and Allergan announced results of a Phase III trial for their ABP 980 product, which is being developed...more

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