Drugs

J&J Settles Ohio Opioid Cases for $20.4 Million

Johnson & Johnson has agreed to pay $20.4 million to resolve claims by two Ohio counties relating to the company’s role in promoting opioid use. Reuters reports that J&J will pay $10 million to Cuyahoga and Summit counties, reimburse $5 million of their legal and other expenses, and provide $5.4 million to non-profit organizations that run opioid-related programs in the counties.

A company statement said the settlement “allows the company to avoid the resource demands and uncertainty of a trial as it continues to seek meaningful progress in addressing the nation’s opioid crisis. The company recognizes the opioid crisis is a complex public health challenge and is working collaboratively to help communities and people in need.”

J&J, which formerly marketed Duragesic and Nucynta said the settlement does not include an admission of liability.

Mallinckrodt finalized a settlement with the same two Ohio counties for $24 million earlier this week, Reuters reports, and Endo and Allergan settled with the counties in August to avoid a trial. The remaining defendants in a scheduled 10/21 federal court trial include McKesson, AmerisourceBergen, Cardinal Health, Teva, Walgreens Boots Alliance, and Henry Schein Inc.

Earlier this year, an Oklahoma judge ordered J&J to pay $572.1 million to the state for its role in fueling an opioid epidemic by deceptively marketing addictive painkillers.

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