Drugs

Repros’ Proellex Remains on Hold Over Liver Safety Data

FDA has told Repros Therapeutics that its clinical development program for Proellex, an oral delivery mechanism for telapristone acetate for treating uterine fibroids, will remain on partial clinical hold based upon its review of existing liver function safety data. The agency has also indicated that the company will be required to compile a large pre-approval safety data base to support future development. Earlier this year, FDA told Repros that it was consulting with its liver experts regarding previously disclosed effects on the liver.

In light of the FDA guidance, the company says it is “assessing increasing its focus on its uterine fibroid and endometriosis development program utilizing a vaginal drug delivery program for telapristone acetate, a selective progesterone modulator... We are encouraged by our clinical studies with our vaginal drug delivery program, which may provide the potential opportunity to differentiate our treatment from other orally-dosed compounds in development or on the market to treat uterine fibroids. Clinical work done to date suggests that vaginal delivery of telapristone acetate has the potential to yield good efficacy with significantly lower systemic blood levels. Furthermore, we intend to leverage drug delivery technology that could offer dosing less frequently than once per day.”

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