Drugs

Janssen-Celltrion BPCIA Suit Updated

Three Fish & Richardson attorneys say that Janssen’s Massachusetts federal court suit against Celltrion is of interest because it is one of the few currently pending litigations related to biosimilars and the Biologics Price Competition and Innovation Act (BPCIA). Writing in an online blog post, the attorneys says that the litigation has focused on three issues: (1) infringement and validity of the patents-in-suit; (2) Celltrion’s notice of commercial marketing and the associated timing of its product launch; and (3) amendments to the protective order that would allow Janssen to use confidential information obtained from Celltrion to pursue other litigation.

At issue is Celltrion’s aBLA seeking to market Remsima, a biosimilar of Janssen’s Remicade. After FDA accepted the Celltrion application for review, the two parties engaged in the BPCIA “patent dance” provisions, although Janssen argues that Celltrion did not complete the process.

The post updates the legal maneuvering and actions of the two parties for each of the three BPCIA issues being contested.

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