Jazz Pharmaceuticals plc announced that the Company and its partners will present 17 new abstracts from across its neuroscience portfolio at SLEEP 2022, the 36th annual meeting of the Associated Professional Sleep Societies (APSS) being held June 4-8, 2022. “Our latest research being presented at SLEEP 2022 provides important insights that benefit […]
Pharmacological
Idorsia Receives FDA Approval of QUVIVIQ for Insomnia
Idorsia Pharmaceuticals, US Inc. has announced that the US Food and Drug Administration (FDA) has approved QUVIVIQ™ (daridorexant) 25 mg and 50 mg for the treatment of adult patients with insomnia, characterized by difficulties with sleep onset and/or sleep maintenance1. The FDA approval of QUVIVIQ is based on an extensive […]
Xywav Granted Orphan Drug Exclusivity for Idiopathic Hypersomnia in Adults
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity (ODE) for Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution, for the treatment of idiopathic hypersomnia in adults, making it the second ODE for the medication following the exclusivity granted in the treatment […]
Investigational Sleep Apnea Pill Continues to Show Meaningful Benefit
Apnimed, a clinical-stage pharmaceutical company focused on developing oral pharmacologic treatments to address obstructive sleep apnea (OSA) and related disorders, today announced positive data across multiple endpoints from a Phase 2 randomized, double-blind, placebo-controlled, four-period, single-dose crossover factorial clinical trial (APC-003), and a 28-day open-label extension study, evaluating AD109 as […]
Jazz Presents Phase 3 Results of Xywav in Adults with Idiopathic Hypersomnia
Jazz Pharmaceuticals plc has announced positive results from the Phase 3 study of XywavTM (calcium, magnesium, potassium, and sodium oxybates) oral solution in adult patients with idiopathic hypersomnia, which will be presented during the Clinical Trials Plenary Session of the 2021 American Academy of Neurology (AAN) Annual Meeting. The presentation will further […]
Apnimed Sleep Apnea Pill Secures $25 Million in Financing
Apnimed raised $25 million in a Series B financing led by existing investor, Morningside Ventures, and joined by new investors, Seligman Investments and Tao Capital Partners. The proceeds will support Apnimed’s ongoing development and commercialization plans. The company is advancing its lead program, AD109, an oral disease-modifying therapeutic for the […]
First Patient Dosed in Second Phase 2 Clinical Trial of Oral OSA Medication
Apnimed, a clinical-stage pharmaceutical company focused on developing oral medicines to treat Obstructive Sleep Apnea (OSA) and related disorders, today announced that the first patient has been dosed in a Phase 2 clinical trial evaluating AD109 as a treatment for mild to moderate OSA. If successful, AD109 could offer an […]
Teva, Cephalon Gets $72 Million EU Fine for Nuvigil Pay-for-Delay
Teva Pharmaceutical Industries Ltd. and its Cephalon unit were fined 60.5 million euros ($72 million) by the European Union for a pact that delayed sales of a cheaper version of a sleep-disorder drug. Teva received cash payments and struck beneficial commercial side deals with Cephalon that stopped it from rolling out a generic version […]
FDA Expands Use Of WAKIX For Cataplexy
Harmony Biosciences Holdings, Inc. announced the FDA has approved WAKIX® (pitolisant) for the treatment of cataplexy in adult patients with narcolepsy. WAKIX is the first and only treatment approved by the FDA for people with excessive daytime sleepiness or cataplexy associated with narcolepsy that is not scheduled as a controlled […]
FDA Grants SPIRO-2101 CF Treatment Orphan Drug and Rare Pediatric Disease Designations
Spirovant Sciences, a gene therapy company developing treatments and cures for genetic lung diseases including cystic fibrosis, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug and Rare Pediatric Disease Designations to its lead product candidate, SPIRO-2101, for the treatment of cystic fibrosis. SPIRO-2101, an inhaled […]












