Drugs

Novelion’s Aegerion Unit Resolves Juxtapid Case

A Massachusetts federal judge sentenced Aegerion Pharmaceuticals for improperly marketing its Juxtapid cholesterol drug and ordered that some of the $40.1 million it agreed to pay as part of a plea bargain be divided among some of the company’s victims. A Reuters report says that prosecutors had charged that after FDA approved Juxtapid in 2012 for treating high cholesterol in people with a rare genetic disease, the company promoted the expensive drug for patients who lacked the genetic disease. They said that numerous patients suffered side effects including liver toxicity and gastrointestinal distress.

Federal judge William Young rejected a 11/2017 plea deal saying it restricted his ability to impose a sentence. Under a new arrangement that gave him discretion to determine how much the company should pay, he ordered it to pay $7.2 million of the total $40.1 million to 91 patients who may have been harmed by Aegerion’s conduct. “I think you ought to pay more attention to the actual people who were harmed here,” Young reportedly told a prosecutor.

The judge also said he wanted to receive reports from an independent auditor during Aegerion’s three years on probation. Under the revised plea agreement, the company pleaded guilty to two misdemeanor counts of misbranding Juxtapid. In total the company agreed to pay $36 million to resolve criminal and civil claims by the Justice Department and $4.1 million to resolve a U.S. Securities and Exchange Commission case.

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