Drugs

WLF Urges 7th Circuit to Uphold Innovation Decision

Washington Legal Foundation (WLF) has submitted an amicus brief urging the 7^th Circuit Court of Appeals to affirm an Illinois federal court decision in a case involving drug patents under antitrust law. A WLF statement says UCFW Local 1500 Welfare Fund v. AbbVie challenges a settlement between AbbVie and several biosimilar manufacturers accused by AbbVie of infringing its Humira patents.

The parties settled the AbbVie suit by allowing the biosimilar manufacturers to enter the European market in 2018 and the U.S. market in 2023, before the expiration of the Humira patents.

The Welfare Fund suit against AbbVie claimed the settlement was an illegal reverse payment and said that AbbVie engaged in monopolization by asserting its patent portfolio against the other manufacturers.

WLF says the district court rejected the antitrust claims, holding that (1) global patent settlements do not violate antitrust law and (2) asserting valid patent claims also does not violate the law.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome