Drugs

Brothers to Fight Daiichi Arbitration Ruling

Brothers Malvinder Mohan Singh and Shivinder Mohan Singh, the former majority owners of Ranbaxy Laboratories, say they will fight a three-person Singapore arbitration panel’s 2-1 ruling that they must pay about $386 million in damages to Daiichi Sankyo in response to a Daiichi complaint that the two hid key information while selling their Ranbaxy stake to Daiichi. India’s Economic Times newspaper reports that the Singh brothers will appeal in the arbitration tribunal and also in one Indian court.

The newspaper says that the former chief justice of India, who was the brothers’ nominee to the panel, dissented and called for dismissing all claims made by Daiichi Sankyo. The dispute between Daiichi and the former Ranbaxy owners stems from the fact that Ranbaxy’s U.S. subsidiary pleaded guilty to seven felonies related to the manufacture and distribution of certain adulterated drugs made at units in India. In 5/2013, Ranbaxy agreed to pay $500 million to settle U.S. Justice Department suits.

In 2014, Daiichi sold Ranbaxy to India’s Sun Pharmaceutical Industries for about half of its $8.4 billion valuation.

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