The Magazine for Sleep Professionals
Friday, May 15, 2026
Harmony Biosciences Holdings, Inc., today announced a settlement agreement with Lupin Limited, resolving the patent infringement litigation related to Lupin’s Abbreviated New Drug Application (ANDA) for a generic version of WAKIX® (pitolisant hydrochloride). As part of the agreement, litigation in the United States District Court for the District of Delaware will […]
Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, announced today that LUMRYZTM has been granted Orphan Drug Designation (ODD) from the U.S. Food & Drug Administration (FDA) for the treatment of Idiopathic Hypersomnia (IH). Specifically, ODD was granted based on the plausible hypothesis that LUMRYZ may […]
Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, today announced that new data supporting the use of LUMRYZ as a narcolepsy treatment and additional data to better understand the real-life experience of people living with narcolepsy will be presented in four oral presentations and 14 […]
Axsome Therapeutics, Inc. a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced that it has entered into a settlement agreement with Hetero Labs Ltd. and certain of its affiliates (Hetero) resolving patent litigation related to Axsome’s product SUNOSI® (solriamfetol). The litigation, which […]
Apnimed, Inc., a pharmaceutical company building the industry-leading portfolio of first-in-class oral drug candidates that address the root causes of obstructive sleep apnea (OSA) and other sleep-related breathing diseases, today announced positive topline results from its pivotal Phase 3 SynAIRgy clinical trial evaluating the efficacy and safety of Apnimed’s lead […]
Takeda announced that the New England Journal of Medicine published data from the Phase 2b trial of oveporexton (TAK-861) in people with narcolepsy type 1 (NT1). Oveporexton is an investigational oral orexin receptor 2 (OX2R)-selective agonist designed to restore orexin signaling to address the underlying orexin deficiency that causes NT1. Results demonstrated […]
K Pharmaceuticals has announced the launch of Aquoral, a clinically proven oral spray for dry mouth. Also known as xerostomia, it is a common, sometimes debilitating condition caused by disease, medication side effects, or other factors that result in discomfort or pain and may affect the ability to chew, taste, […]
Jazz Pharmaceuticals plc announced that seven abstracts from across its neuroscience portfolio will be featured at the 77th Annual American Academy of Neurology Meeting (AAN) being held April 5-9, 2025, in San Diego. Data presented at the meeting includes an updated presentation of top-line results of the open-label, single-arm, Phase 4 DUET (Develop hypersomnia Understanding by Evaluating […]
The thought of histamines might conjure up images of itchy hives or the tickling sensation just before a sneeze, but scientists have come to realize there is much more to histamines than their connection to allergies. Recent research reveals that histamines play a vital role in wakefulness. Produced by brain […]
Harmony Biosciences Holdings, Inc. announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) for pitolisant for the treatment of excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH). Harmony’s 2025 net revenue guidance of $820-$860 million remains unchanged. “We […]
