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Eleventh Circuit decision could significantly expand scope of orphan exclusivity

With the issuance of its mandate on January 28, 2022, in Catalyst Pharmaceuticals, Inc. v. Becerra, the U.S. Court of Appeals for the Eleventh Circuit has upheld the orphan exclusivity ...

News

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its...

News

Time’s up: New enforcement era for regenerative medicines begins June 1

On April 21, 2021, FDA’s Center for Biologics Evaluation and Research (CBER) Director Peter Marks M.D. confirmed that the grace period intended to provide developers of regenerative...

News

HHS now requires public posting of a decade of clinical trial results that were previously exempted

Earlier this year, we wrote about a ruling by the U.S. District Court for the Southern District of New York that, if upheld, would require companies to make public a decade of clinical...

News

Trump administration reversal would take away FDA’s authority to approve biosimilars

On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions ...

Insights

Court ruling would require public posting of a decade of clinical trial results that HHS regulation had exempted
Registered Content

A new ruling by the U.S. District Court for the Southern District of New York could require companies to make public a decade of clinical trial results for products that have been approved...

Hogan Lovells Publications

It’s Auer Over but the Shouting Appellate Alert

Recalibrating—And Restricting—The Deference Due Federal Agencies’ Interpretations Of Their Own Regulations

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