Drugs

Daiichi Sankyo Settling Olmesartan Product Cases

Daiichi Sankyo says it will settle on behalf of its companies and Forest entities pending product liability litigation involving olmesartan products (Benicar, Benicar HCT, Azor, and Tribenzor). The suits, filed beginning in 1/2014, allege that the products cause sprue-like enteropathy and other severe gastro-intestinal symptoms, the company says.

A settlement fund is capped at $300 million, with a portion of that amount to be used for plaintiffs’ counsel fees and expenses and the cost of the claims administrator.

The company statement says that Daiichi Sankyo believes that the claims made in the suits are without merit and does not admit liability. The statement says the company “remains committed to our medications that contain olmesartan medoxomil, which remain widely used and available to patients with hypertension in the U.S.”

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