Drugs

Appeals Court Sends Lantus Case Back to District Court

The First Circuit Court of Appeals has sent back to a Massachusetts federal court a case in which purchasers of direct insulin glargine alleged that Sanofi artificially restricted competition in the market for insulin glargine by impermissibly extending its monopoly over such products. The appeals court reported that the purchasers alleged that Sanofi improperly listed a patent in the FDA Orange Book for its Lantus SoloStar delivery device, delaying competition in the insulin glargine market and resulting in inflated prices. They also said that a Sanofi lawsuit alleging infringement of the patent was a “sham” suit that was filed merely to trigger the automatic stay of FDA’s approval of a competing KwikPen. They brought two antitrust claims under the Sherman Act.

The district court dismissed the Sherman Act claims, the appeals court says, reasoning that, as a matter of law, Sanofi’s decision to list the patent was reasonable and not objectively baseless, given what the court deemed to be ambiguities in the FDA listing requirements.

The First Circuit held that the facts and reasonable inferences found in the complaint describe an improper submission of the patent for listing in the Orange Book, that the defenses to antitrust liability as a result of such an improper submission include proving that the submission was the result of a reasonable, good-faith attempt to comply with the Waxman-Hatch scheme, and that the record does not allow for the adjudication of that defense as a matter of law.

The court sent the case back to the district court for further proceedings consistent with its findings.

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

Read more

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