Drugs

Sanofi Scraps Phase 2 Study of Lademirsen

Sanofi has told Regulus Therapeutics that it is terminating a Phase 2 clinical study (HERA Study) of lademirsen (RG-012) for treating Alport syndrome after data failed to meet Sanofi’s pre-defined futility criteria. Previously, Sanofi acquired from Regulus the rights for developing and marketing RG-012.

Regulus says that Sanofi also notified the company that it is currently evaluating different opportunities involving RG-012. Under their agreement, Regulus was eligible to receive a $25 million milestone payment upon the successful completion of the HERA study. Regulus says it still remains eligible for the milestone payment in the event of successfully completing a Phase 2 fibrosis proof of concept study

Lademirsen was designed to block the activity of a small RNA molecule called miR-21, which is believed to be associated in the development of kidney tissue scarring (fibrosis) and damage. The drug has been granted orphan drug status by FDA as a potential therapy for Alport syndrome.

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