Drugs

AstraZeneca Gets 2nd Complete Response on ZS-9

FDA has issued AstraZeneca a second complete response letter (CRL) on its NDA for ZS-9 (sodium zirconium cyclosilicate), indicated for treating hyperkalemia (high potassium level in the blood serum). A CRL was issued 5/2016 that identified observations during a pre-approval manufacturing inspection. The agency did not request any new data, AstraZeneca said at the time. The latest CRL followed an inspection by FDA of the ZS-9 manufacturing facility, according to the company, and it does not require the generation of any new clinical data.

ZS-9 is an insoluble, non-absorbed zirconium silicate with a three-dimensional crystalline lattice structure that was designed to preferentially trap potassium ions, AstraZeneca says. “The unique potassium selectivity of ZS-9 enables high in-vitro binding capacity for potassium ions even in the presence of other competing ions,” it says. The therapy has been studied in three double-blind, placebo-controlled trials, and in two ongoing 12-month open label studies in over 1,600 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