Drugs

Another Amgen BPCIA Suit Against Sandoz

Three Fish & Richardson attorneys say that Amgen has filed another Biologics Price Competition and Innovation Act (BPCIA)suit against Sandoz, this time for infringement of two key Neulasta patents. Writing in an online blog post, the attorneys say that Amgen claims that Sandoz’ filing of its aBLA for a Neulasta biosimilar constitutes at act of infringement. “Defendants are piggybacking on the fruits of plaintiffs’ trailblazing efforts,” the suit says.

The complaint further alleges that if FDA approves the aBLA, Sandoz will inevitably infringe the patent that covers a method for purifying proteins used in manufacturing Neulasta by making, using, offering to sell, or selling an infringing product within the U.S. Amgen is asking for damages and an injunction against Sandoz. The court has granted the parties’ request to relate this suit with an earlier one that covered the BPCIA patent dance and commercial marketing notice provisions. The attorneys write that the effect of relating the cases is that the same judge will hear both cases that have been filed in a California federal court.

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