Drugs

Tremeau Gains FDA Agreement to Develop Withdrawn Drug

Tremeau Pharmaceuticals says it has recently reached agreement with FDA on the development requirements to support an NDA for TRM-201 (rofecoxib), indicated as a as a non-opioid pain alternative for treating hemophilic arthropathy (HA). Rofecoxib was once marketed by Merck as Vioxx, but it was pulled from the market in 2004 after it was revealed that the drug increased the risk of heart attacks and strokes. The COX-2 selective, non-steroidal anti-inflammatory drug was recently granted an orphan drug designation for the new indication sought by Tremeau.

“The significant unmet medical need, and the known efficacy profile of rofecoxib enabled alignment on a streamlined program, including a single Phase 3 study, that, if successful, will inform the safe and effective use in the HA patient population,” the company says. Hemophilic arthropathy is a degenerative joint disease occurring in patients with hemophilia and is caused by recurrent intra-articular bleeding, and no drugs are currently approved to treat it.

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