Drugs

OCI Case Nets 2 on HIV, Covid Drug Convictions

A securities fraud case investigated by the FDA Office of Criminal Investigations has resulted in the conviction of two men for their roles in a scheme to lie to investors in CytoDyn, a firm purportedly developing leronlimab between 2018 and 2021 to treat HIV and Covid-19. A Justice Department statement says Nader Pourhassan of Lake Oswego, OR, and Kazem Kazempour of Potomac, MD, engaged in a scheme to deceive investors about the development of the drug to artificially inflate and maintain the price of CytoDyn stock and to attract new investors. Pourhassan was the CytoDyn CEO, the statement says, while Kazempour was the CEO of Amarex Clinical Research, the contract research organization that was hired to conduct the drug’s clinical trials and be the CytoDyn representative with FDA.

The department says the two made false and misleading statements about the timeline and status of CytoDyn’s regulatory submissions to FDA and then sold CytoDyn stock.

“These convictions demonstrate that those who make misleading statements about clinical trial results to the public, including to healthcare providers and patients, will be held accountable for their actions,” said Robert Iwanicki, FDA Office of Criminal InInvestigations special agent in charge of the Los Angeles field office.

Pourhassan was convicted on four counts of securities fraud, two counts of wire fraud, and three counts of insider trading. Kazempour was convicted on one count of securities fraud and one count of wire fraud related to the submission of an application to FDA and an attempt to trade CytoDyn shares the following day, the statement says. The two face a maximum penalty of 20 years in prison for each count of securities fraud, wire fraud, and insider trading.

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