Drugs

SEC Charges Ex-Puma Executive on Insider Trading

The Securities and Exchange Commission (SEC) has charged the former senior director of regulatory affairs for Puma Biotechnology with insider trading based on clinical trial data to which he was privy. The SEC alleges that Robert Gadimian gained more than $1.1 million in illicit profits by secretly purchasing Puma stock and short-term call options based on nonpublic and positive data from two clinical trials involving Puma’s drug neratinib. Gadimian allegedly bought Puma securities before the results from the first trial were announced in 12/2013 and again before the results of the second trial were announced in 7/2014.

Earlier this month, FDA accepted for review a Puma NDA for PB272 (neratinib), indicated for the extended adjuvant treatment of patients with early stage HER2-overexpressed/amplified breast cancer who have received prior adjuvant trastuzumab (Herceptin)-based therapy. The submission is based on data from the ExteNET Phase 3 study, in which treatment with neratinib resulted in a 33% risk reduction in invasive disease recurrence or death when compared with a placebo.

According to the SEC’s complaint, Puma confronted Gadimian after learning about his trades and he admitted to trading because of “greed.” He allegedly then altered his trading records before providing them to Puma for its internal investigation, deleting certain trades in Puma securities and renumbering the pages of the altered documents to hide his changes. Gadimian’s employment was terminated 10/2014.

In a parallel case, the U.S. Attorney’s Office for the District of Massachusetts also announced criminal charges against Gadimian.

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