Drugs

Uphold District Court in Apotex Case: Amgen

Amgen is asking the Court of Appeals for the Federal Circuit to uphold a district court decision that Apotex is required to provide 180-day notice to Amgen of its intent to market a biosimilar version of Amgen’s Neulasta (pegfilgrastim). In its brief, Amgen says that “because the district court correctly concluded that Amgen is likely to succeed on the merits of its legal arguments that Apotex must provide such notice, and because Apotex stipulated and the district court found on the record before it that all of the other prerequisites for injunctive relief were satisfied, this court should affirm.”

The brief also challenges Apotex’ contention that the court is facing an issue of first impression, noting that the question of the pre-marketing notice was discussed in Amgen v. Sandoz and the court concluded that the provision is mandatory.

It points out that in the Sandoz case the court said that Sandoz could not market Zarxio until 180 days after the day of notice of first commercial marketing and the same requirement should be applied to Apotex and Neulasta.

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