Drugs

Amgen Wants Sandoz Back in Neulasta ‘Patent Dance’

Amgen is asking a New Jersey federal court to rule that Sandoz cannot skip biosimilar “patent dance” negotiations over its Neulasta (pegfilgrastim). Big Molecule Watch reports online that Amgen told the court that (1) in 11/2015, Sandoz notified Amgen that FDA had accepted Sandoz’ pegfilgrastim aBLA and provided files identified as the aBLA and information about Sandoz’ manufacturing process; (2) on 1/12, Amgen provided Sandoz a list of patents that Amgen believed Sandoz’ biosimilar would infringe; and (3) on 2/2. Sandoz provided invalidity and non-infringement contentions, and said it no longer wanted to follow the Biologic Price Competition and Innovation Act patent dance provisions.

Amgen asked the court to declare that Sandoz’ attempt to skip the patent dance is impermissible and that Amgen is not barred from seeking injunctive relief or lost profits for failing to file a patent infringement before 3/4. Big Molecule Watch says it is notable that Amgen’s complaint includes no patent infringement claims.

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