Drugs

Fast Track Status for Lyric Pharma Drug

FDA has granted Lyric Pharmaceuticals a fast track designation for ulimorelin (LP101) for treating enteral feeding intolerance (EFI) in critically ill patients. Ulimorelin, a macrocyclic agonist of the hormone ghrelin, is under clinical development for treating EFI and for other disorders affecting critically ill patients in intensive care units (ICU). The company says EFI is a common ICU condition in which impaired gastric emptying prevents adequate enteral nutrition from being delivered.

Lyric says it has completed two Phase 1 trials of LP101 “demonstrating gastrointestinal prokinetic activity as shown by significantly accelerated gastric emptying. PROMOTE, a Phase 2 study of LP101 for the treatment of EFI, is currently enrolling, with data expected in mid-2018.”

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