Drugs

New ‘Patent Dance’ Suit Filed Over Avastin

Genentech filed suit in Delaware federal court 2/20 seeking a declaratory judgment that Amgen is violating the patent dance provisions of the Biologics Price Competition and Innovation Act in connection with its proposed biosimilar of Genentech’s Avastin (bevacizumab). The complaint says that Amgen opted to participate in the patent dance by providing a copy of its aBLA to Genentech, but has refused to disclose manufacturing information beyond the aBLA and has refused to authorize Genentech to provide the aBLA to Genentech’s external experts for review to determine potential infringement.

Genentech claims that it needs the additional manufacturing information to have a reasonable opportunity to take the next step in the patent dance of identifying and serving Amgen with a list of patents that Genentech believes could reasonably be asserted within 60 days of receiving Amgen’s information. The company says that Amgen has stressed the importance of the additional manufacturing information in other patent dance suits in which it is the innovator.

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