Drugs

Vanda Agrees to Pay Over $11 Million in Off-label Suit

Companies that market drugs for off-label uses need not only worry about running afoul of FDA but also shareholders who learn about such practices and decide to sue when such public information causes their stock to lose value. An Eastern New York federal judge has preliminarily approved an $11.5 million settlement in a case where investors sued Vanda Pharmaceuticals over alleged off-label promotion practices and alleged false statements made in violation of the Securities Exchange Act of 1934.

The case involved Vanda’s Fanapt, approved to treat schizophrenia in adults, and Hetlioz, approved to treat Non-24, a rare circadian rhythm disorder that occurs almost entirely in blind individuals. The complaint alleges the company was promoting Fanapt for use in children with schizophrenia, and Hetlioz for typical sleep disorders in patients who are not blind.

The lawsuit also alleged that Vanda made misleading and materially false statements about its investigational drug tradipitant. FDA reportedly asked Vanda to conduct a nine-month, non-rodent, study to ensure the drug’s safety before studying the use of Tradipitant in humans. When the company did not conduct the study, the agency slapped a clinical hold on the IND. The clinical trial infraction and the off-label allegations came to light in a short-seller report back in 2019, and shortly thereafter the lawsuit was filed after the company’s stock lost significant value.

Under the proposed settlement, the company and its executives admit to no wrongdoing.

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