Drugs

Marathon Pauses on Duchenne Drug Launch; PhRMA Criticizes

Faced with a backlash over its $89,000 annual price for a decades-old steroidal drug that was recently approved for treating Duchenne muscular dystrophy, Marathon Pharmaceuticals says it has paused its “commercialization efforts” in order to meet with Duchenne community leaders to review their concerns and discuss all options. To make matters worse, Pharmaceutical Research and Manufacturers of America (PhRMA) criticizes the pricing stance and appears to have distanced itself from Marathon and its CEO Jeff Aronin, who sits on the lobbying group’s board of directors.

PhRMA issued a statement to Endpoints News 2/16 that said: “We are pleased Marathon decided to pause the launch of their medicine to solicit additional input from patients and other stakeholders. Their recent actions are not consistent with the mission of our organization. In addition, the leadership of the PhRMA board of directors has begun a comprehensive review of our membership criteria to ensure we are focused on representing research-based biopharmaceutical companies who take significant risks to bring new treatments and cures to patients.”

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