Drugs

Feds Looking Into Janssen False Claims Act Allegations

The Justice Department has opened an investigation into management and advisory services provided by Johnson & Johnson’s Janssen unit to rheumatology and gastroenterology practices that bought its Remicade (infliximab) and Simponi Aria (golimumab) arthritis drugs. Reuters reports that the company also indicated in a quarterly filing that the U.S. Attorney in Massachusetts is seeking documents broadly relating to drug co-payment support programs for Simponi, the hepatitis C drug Olysiotm (simeprevir) , and the Crohn’s disease drug Stelara (ustekinumab). The U.S. Attorney’s subpoena also seeks documents relating to average manufacturer price and best price reporting to the Center for Medicare and Medicaid services related to those products, as well as rebate payments to state Medicaid agencies, Johnson & Johnson said.

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