Biologics

CBER Accepts Portola Anticoagulation Reversal BLA

CBER has accepted for priority review a Portola Pharmaceuticals BLA for andexanet alfa, indicated for reversing anticoagulant activity of both direct and indirect Factor Xa inhibitors. The user fee review target date is 8/17. Portola says the therapy should be used to reverse anticoagulation, such as in life-threatening or uncontrolled bleeding or for emergency surgery and urgent procedures.

The submission is based on data from the company’s ANNEXA (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors) studies. It also included limited efficacy and safety data from initial patients enrolled in anongoing Phase 4 ANNEXA-4 study, an open-label confirmatory study in patients receiving apixaban, rivaroxaban, edoxaban and who present to the hospital with an acute major bleed.

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