Drugs

Agile to Pursue Twirla FDA Appeal

Agile Therapeutics says it will appeal to the CDER Office of New Drugs the decision by the Office of Drug Evaluation 3 (ODE3) director to deny its appeal of a Division of Bone, Reproductive, and Urologic Products complete response letter for its NDA for Twirla (levonorgestrel/ethinyl/estradiol transdermal system) that cited concerns about the product’s in vivo adhesion properties.

Twirla is described as an investigational low-dose once-weekly contraceptive patch.

Agile initiated formal dispute resolution with ODE3 on 6/6 to appeal the 12/21/17 complete response letter. Company officials say they continue to believe that the Phase 3 SECURE trial yielded in vivo adhesion data that are adequate for Twirla’s approval and did not affect clinical outcomes.

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