Drugs

U.S. Government Weighs in on Biosimilar Dispute

The U.S. government has stepped into an ongoing Biologics Price Competition and Innovation Act (BPCIA) dispute (Amgen v. Sandoz) involving biosimilar-related disclosure provisions. According to the U.S. amicus brief, the BPCIA “preempts any state-law remedies for an applicant’s decision not to make the disclosures identified in Section 262(l)(2)(A)... Allowing additional state law remedies also would impair important objectives the BPCIA’s patent-related provisions are designed to achieve.” The brief contends that “[t]ogether with the pre-existing body of federal laws and rules governing the adjudication of federal patent claims, the BPCIA leaves the states no room to prescribe or enforce procedural rules pertaining to biosimilar patent infringement claims.”

The brief was filed in response to a June U.S. Supreme court ruling (see story) that remanded the dispute to the Federal Circuit to determine whether an injunction might be available under state law. In the ruling, the high court also said sponsors of proposed biosimilar products do not have to wait until FDA approval to provide a required six-month marketing advance notice.

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