Update: On March 16, 2022, the U.S. Court of Appeals for the Federal Circuit denied Biogen International’s petition for panel rehearing and rehearing en banc, following a November split decision discussed below.
Judges Lourie, Moore, and Newman dissented on the denial of en banc rehearing. …›
At the end of 2021, the Superior Court of New Jersey, Appellate Division upheld the decision by the New Jersey Board of Pharmacy (the “Board”) denying the application from a New Jersey oncology practice (the “Petitioner”) to register, open, and operate a pharmacy within …›
Jianyuan (Yuan) Hua, FDA Regulatory and Compliance Associate in New York, contributed to the drafting of this post.
On February 10, 2022, the U.S. Food and Drug Administration (FDA) held a public Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the sintilimab application based on …›
By: Brigid DeCoursey Bondoc, Zachary Fuchs, and Rachel Park
Earlier this month, the U.S. District Court for the Middle District of Alabama decided Method Pharmaceuticals, LLC v. H-2 Pharma, LLC, a dispute concerning labeling for fluoride products that raised a variety of issues with broader implications for industries regulated by the U.S. Food …›
Patent term extension (PTE) provides additional patent term for patents related to U.S. pharmaceutical products to compensate for the effective loss of patent term caused by delay during the drug approval process by the U.S. Food and Drug Administration (FDA).
To be eligible for …›
Our recent Life Sciences MoForum included in-depth discussions with industry insiders on the convergence of the life sciences with technology and healthcare and the trends that are driving the industry across the digital health, diagnostic, and drug markets.
Digital Transformation in the Life Sciences
The Digital …›
Last week, Morrison & Foerster’s Life Sciences & Healthcare Group hosted its first program of the year with the firm’s 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy. We welcomed 100+ participants over the three-day virtual program to hear from leaders from across …›
By: Rachel Park, Dan Kagan, and Brigid DeCoursey Bondoc
In December 2021, the U.S. Food and Drug Administration announced that it would make permanent its COVID-19-era enforcement policy, which allows for the delivery of the abortion pill (MIFEPREX (mifepristone)) by mail and through telemedicine in order to reduce the burden on patient access. …›
Morrison & Foerster kicked off its virtual 2022 Life Sciences MOFORUM – Growth, Innovation, and Strategy on January 25, 2022. With three days of programming planned, the series started with a discussion on the “Digital Transformation in Life Sciences,” featuring digital health advisor Melinda …›
Bethany Hills and Dan Rubin authored an article for Life Science Connect outlining the U.S. Food and Drug Administration’s (FDA) new draft guidance in its latest effort to clarify its expectations regarding the integration of real-world data and real-world evidence into clinical research, product …›
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