Drugs

Genentech, OSI Paying $67 mil. for Tarceva False Claims

The Justice Department says that Genentech and OSI Pharmaceuticals, who are co-promoting the cancer drug Tarceva, have agreed to pay $67 million to resolve a whistleblower’s False Claims Act allegations that they made misleading statements about the drug’s effectiveness. A department statement says the allegations claimed that between 1/2006 and 12/2011 the two companies made misleading representations to doctors and other healthcare providers about Tarceva’s effectiveness to treat certain patients with non-small cell lung cancer when there was little evidence to show that the drug was effective to treat those patients unless they also had never smoked or had a mutation in their epidermal growth factor receptor.

Under terms of the agreement, the federal government will receive $62.6 million and state Medicaid programs will receive $4.4 million. The allegations were in a lawsuit filed in California federal court by a Genentech whistleblower, Brian Shields, who will receive about $10 million, the department says.

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