Drugs

Aspects of Novartis Whistleblower Talks Released

Bloomberg News reports that a letter from a U.S. attorney describing settlement discussions with Novartis to resolve a six-year-old whistleblower suit alleging the company made illegal kickbacks to doctors to promote and use several of its drugs was accidentally made public for a short time before it was removed from a federal court docket. The news service says the letter indicated that “significant progress” had been made in the settlement talks and that there would be a “monetary aspect” to any settlement. It also indicated the company is negotiating a new corporate integrity agreement with the HHS Inspector General.

The letter said the settlement would be “substantially complete” by June 18 and the parties would have until August 13 to finalize and execute it, Bloomberg says.

The company is accused of paying thousands of doctors with speaking fees, fishing trips and outings at Hooters restaurants to boost sales of hypertension drugs Lotrel and Valturna and diabetes medication Starlix. There are reports the U.S. had once sought as much as $2 billion in damages, and indications Novartis may have been close to a $1 billion settlement last month.

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