Drugs

Liquidia Refiles NDA for Pulmonary Hypertension

Liquidia has resubmitted its NDA for LIQ861 for treating pulmonary arterial hypertension. In 11/2020, FDA issued a complete response letter indicating that the application was incomplete and not ready for approval in its present form. At the time, the company said FDA indicated a need for additional information and clarification on chemistry, manufacturing, and controls data on the drug product and device biocompatibility.

Liquidia and the agency held a Type A meeting in January to discuss the requirements for the NDA resubmission. FDA also reconfirmed the need to conduct on-site pre-approval inspections, which were delayed due to Covid-19 restrictions, at two of the company’s U.S. manufacturing facilities before the NDA can be approved.

The company says the resubmitted NDA includes additional information and clarification on chemistry, manufacturing, and controls pertaining to the drug product as well as data on device biocompatibility. No additional data from clinical trials or studies related to toxicology or clinical pharmacology were required, it says. It expects FDA will classify the resubmitted NDA, if accepted, as a Class 2 resubmission, which would result in a six-month review cycle from the date of resubmission.

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