News & Analysis as of October 18, 2024

FDA Approval

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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +

FDA Approves Moderna’s and Pfizer/BioNTech’s Updated COVID-19 Vaccines

Goodwin on 9/3/2024

On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...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FTC Comment on FDA Draft Guidance on Interchangeability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We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to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

FDA Approves New Indication for AstraZeneca and Daiichi Sankyo’s Cancer Drug ENHERTU

Goodwin on 4/10/2024

On April 5, the FDA granted accelerated approval to AstraZeneca and Daiichi Sankyo’s ENHERTU (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have...more

Biologics and Biosimilars Landscape: IP, Policy, and Market Developments

Fish & Richardson on 4/8/2024

In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on 7/5/2022

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Biosimilars 2021 Year in Review

Fish & Richardson on 1/12/2022

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Amgen v. Sandoz Update -- Supreme Court Seeks Views of United States

McDonnell Boehnen Hulbert & Berghoff LLP on 6/22/2016

In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United...more

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