Drugs

BMS, Celgene Resolve FTC Antitrust Charge

Bristol-Myers Squibb and Celgene say they will divest Celgene’s psoriasis drug Otezla to Amgen for $13.4 million to settle Federal Trade Commission (FTC) charges that Bristol-Myers Squibb’s proposed $74 billion acquisition of Celgene would violate federal antitrust law. The commission has said that, as proposed, the acquisition of Celgene would harm consumers in the U.S. market for treatments taken orally for moderate-to-severe psoriasis. It notes that BMS has a pipeline product under development that is considered the most advanced oral treatment for moderate-to-severe psoriasis. According to the FTC complaint, the BMS pipeline product will likely be the next entrant into the market and would compete directly with Otezla.

“The commission has ordered BMS to divest Otezla to preserve BMS’ incentive to continue developing its own oral product for treating moderate-to-severe psoriasis,” FTC chairman Joseph Simons says. “The antitrust laws protect not only competition today, but competition in the future, especially when it comes to the development of new treatments for chronic conditions.”

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