Drugs

SCOTUS to Hear Amgen/Sandoz Appeals

The Supreme Court has granted Sandoz’ petition and Amgen’s cross-petition that it hear their appeal of a federal appeals court decision in Amgen v. Sandoz. The acting solicitor general had urged the high court to hear the case, saying that the Federal Circuit Court of Appeals erred in concluding that a biosimilar applicant may provide the required 180-day advance notice of first commercial marketing only after FDA has licensed its biosimilar. The solicitor general also said the court erred in determining that a court may enforce a section of the law by enjoining an applicant from such marketing until 180 days after the applicant provides that notice. Those provisions were appealed by Amgen.

Sandoz challenged the court’s determination that where an applicant fails at the outset to provide the sponsor with its aBLA and manufacturing process information, the sponsor’s only recourse under the law is to bring an immediate patent suit. The acting solicitor general’s brief said the appeals court was correct in that decision.

“The proper interpretation of these provisions has a significant impact on the operation of the Biologics Price Competition and Innovation Act (BPCIA) and the ability of aBLA applicants promptly to bring their biosimilars to the public,” the brief said. “And because the provisions are integrally related, the court should consider all of the questions presented together.”

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