Drugs

Mallinckrodt Rolling NDA for Terlipressin

Mallinckrodt has completed a rolling NDA submission for terlipressin, an investigational agent being evaluated for treating hepatorenal syndrome Type 1 (HRS-1). HRS-1 is a life-threatening condition involving acute kidney failure in people with cirrhosis.

In 2016, Mallinckrodt and the agency reached agreement on the Phase 3 CONFIRM trial protocol design and data analysis under the agency's special protocol assessment process. The agreement covered the acceptability of the clinical design, endpoints and statistical data analyses. Mallinckrodt says top-line results showed that the trial met the primary endpoint of verified HRS-1 reversal, comprising an improvement in renal function, dialysis avoidance, and short-term survival.

Terlipressin is described by Mallinckrodt as a potent vasopressin analog selective for V1 receptors.

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