Drugs

Pharma CEO Pleads Guilty to FDA False Statements

Alain Bouaziz, a French national and Hexim Pharmaceuticals chief executive officer, has pleaded guilty to making false statements to FDA to gain control of the rights to sell a weight-loss drug in the U.S.

Beginning in 2018, The U.S. Justice Department says Bouaziz submitted forged documents and made false statements to FDA to try to fraudulently gain control of Novartis’ Sanorex (mazindol), which was approved in 1973 and discontinued in 1999. The drug is indicated for managing exogenous obesity as a short-term adjunct in a regimen of weight reduction based on caloric restriction in certain patients.

“Bouaziz sent letters and documents by email and in hard copy to the FDA falsely stating that Hexim had purchased the new drug application for Sanorex and requesting a meeting about marketing Sanorex in the United States,” the government contends. “These representations were false because neither Hexim nor Alkopharma owned the rights to distribute Sanorex.”

Bouaziz faces a maximum term of five years in prison and a fine of up to $250,000, or twice the gross gain or loss caused by the offense, whichever is greatest, according to the Justice Department. Sentencing is scheduled for 12/14.

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