Drugs

Genentech Sues Pfizer Over Herceptin Patents

Genentech has filed suit in Delaware federal court claiming that Pfizer will infringe or induce infringement of 40 Genentech patents on its breast cancer drug Herceptin (trastuzumab) by proceeding with its aBLA for a biosimilar to Herceptin. Genentech says Pfizer notified it 11/17 under the Biologics Price Competition and Innovation Act that it intended to market its Herceptin biosimilar in the U.S.

“Plaintiffs thus seek a judgment that Pfizer’s submission of the aBLA to obtain approval to engage in the commercial manufacture, use, offer to sell, or sale of the Pfizer aBLA product prior to the expiration of the Genentech patents described below infringes those patents…,” the suit says. “Plaintiffs also seek a permanent injunction barring Pfizer’s manufacture, use, offer to sell, sale, or importation of its biosimilar product prior to the expiration of those patents. In the event that Pfizer launches its biosimilar product prior to the expiration of those patents, plaintiffs also seek monetary damages, including lost profits, and any further relief as this court may deem just and proper.”

Genentech was joined in the suit by City of Hope, Duarte, CA, described as a leading research hospital that incorporates cutting-edge research into patient care for cancer, diabetes, and other serious diseases.

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