Drugs

Apotex Appeals Court Biosimilar Ruling

Apotex is asking the Federal Circuit Court of Appeals to review a lower court decision granting Amgen a preliminary injunction blocking Apotex from launching its biosimilar pegfilgrastim for 180 days after receiving FDA approval and giving notice of commercial marketing. A Big Molecule Watch blog post says that Apotex is arguing that because the two parties completed the Biologics Price Competition and Innovation Act (BPCIA) “patent dance” before the lawsuit was filed, a notice of commercial marketing is not required. Apotex says that the Amgen suit against it is different from Amgen v. Sandoz, in which Sandoz chose not to participate in the patent dance and was required to provide 180 days’ notice of commercial marketing.

Apotex also argues in its appeal that making the 180-day notice period mandatory in all cases, rather than only in cases when the biosimilar applicant chooses not to participate in the patent dance, would amount to a de facto extension of the 12-year exclusivity period provided under the BPCIA.

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