Drugs

Novartis Sues Janssen Over Psoriasis Drug Promotion

Novartis has filed a Lanham Act suit in Washington, DC federal court against Janssen seeking to stop it from making false and misleading claims associated with Janssen’s Tremfya, indicated for treating moderate to severe plaque psoriasis. Novartis manufacturers and markets a competing product, Cosentyx.

The Novartis lawsuit claims that Janssen has recently presented Tremfya data from the Eclipse study in a “false and misleading manner” at two medical conferences. The presentations, Novartis alleges, made claims that Tremfya was both superior and noninferior to Novartis’ Cosentyx without including accurate and relevant safety information.

According to the lawsuit, Janssen omitted some of the most egregious adverse events, including malignancies and major adverse cardiac events. These adverse events were identified in the clinical trial, but are not Tremfya’s most-recent prescribing information, Novartis says.

In addition to stopping the Janssen promotions, Novartis is asking the court to order Janssen to initiate a corrective advertising campaign. It also seeks an accounting by Janssen of its gains and profits “realized by reason of its false advertising,” and an award for treble damages.

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