Popular, Biosimilars, Clinical Trials

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

Rothwell, Figg, Ernst & Manbeck, P.C. on 7/24/2025

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

Life in the Fast Lane: FDA Issues New Draft Guidance for Accelerated Approval of Drugs and Biologics

Arnall Golden Gregory LLP on 1/3/2025

In 1976, the Eagles released the song, “Life in the Fast Lane,” as part of their iconic album, Hotel California. Approximately 16 years later, the Food and Drug Administration began offering pharmaceutical companies their own...more

FTC Comment on FDA Draft Guidance on Interchangeability

Goodwin on 8/29/2024

We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

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

Goodwin on 1/4/2024

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

Health Care Week In Review: Surgeon General Advisory on Loneliness and EMTALA Requirements

Alston & Bird on 5/8/2023

Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more

Six strategies for clinical trial & marketing application success as FDA requires HCT/P BLAs

Hogan Lovells on 8/15/2022

Now that FDA’s grace period for regenerative medicines has ended, many manufacturers of human cell, tissue, or cellular- or tissue-based products (HCT/Ps) will be required to file a biologics license application (BLA) with...more

And So It Begins: House Energy and Commerce Leaders Unveil FDA User Fees Legislative Package

King & Spalding on 5/11/2022

On May 4, 2022, House Energy and Commerce (“E&C”) Committee leaders unveiled the legislative package to reauthorize the U.S. Food and Drug Administration (“FDA” or the “Agency”) user fee agreements (the “House Draft”)...more

Celltrion Biosimilars Update

Goodwin on 8/25/2020

Celltrion announced last Friday that it will begin Phase I clinical trials of its Prolia (denosumab) biosimilar (CT-P41) in September. Prolia, marketed and sold by Amgen, is a treatment for glucocorticoid-induced osteoporosis...more

EYLEA (Aflibercept) Biosimilar Development Updates (Part 2)

Goodwin on 7/28/2020

Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal...more

2019 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on 1/10/2020

In 2019, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. We review top developments below: 1) PMPRB: Amendments to Regulations will come into force July 1, 2020, court...more

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