Drugs

More Data Sought on Regulus HCV Therapy on Hold

FDA has told Regulus Therapeutics that a 6/2016 clinical hold remains in effect and it requested more information on the development program for RG-101, an investigational therapy for treating chronic hepatitis C virus (HCV). The hold was originally placed after the company reported a second serious adverse event involving jaundice. The event occurred in a HCV patient with end-stage renal disease on dialysis who was enrolled in an on-going Phase 1 study 117 days after receiving a single RG-101 dose (see earlier story).

Regulus says that late last year it submitted a complete response to the agency’s initial request for information, which included identification of a potential mechanism of hyperbilirubinemia. It also submitted a proposal to mitigate the risk. “Subsequently, the FDA has requested the final safety and efficacy data from on-going RG-101 clinical and pre-clinical studies before reconsidering the clinical hold,” it says. “These data will be available once the current study protocols are complete through 48 weeks of follow up, which is anticipated in the fourth quarter. The FDA also requested additional expert review of liver safety data in light of the proposed mechanism of hyperbilirubinemia.”

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