Tag: PHARMACEUTICALS

Alkermes Avadel Aquisition
Industry News Sleep Pharmaceuticals

Alkermes Completes Acquisition of Avadel, Accelerating Entry Into Sleep Medicine Market

Alkermes plc and Avadel Pharmaceuticals plc, announced Alkermes’ completion of its acquisition of Avadel, a commercial-stage biopharmaceutical company. The acquisition adds Avadel’s FDA-approved product, LUMRYZ®, to Alkermes’ commercial portfolio, and provides Alkermes with a commercial organization experienced in this disease state. This strategic move accelerates Alkermes’ entry into the sleep […]

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1
Sleep Pharmaceuticals Industry News Narcolepsy

Takeda Presents Orexin Data from Landmark Oveporexton (TAK-861) Phase 3 Program in Narcolepsy Type 1 at World Sleep 2025

Takeda will present data from two global Phase 3 double-blind, placebo-controlled studies of oveporexton (TAK-861)1, a potential first-in-class investigational oral orexin receptor 2 (OX2R)-selective agonist in narcolepsy type 1 (NT1), during multiple oral presentations at the World Sleep 2025 Congress in Singapore.   Both the FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002) […]

Avadel Strengthens Portfolio with Exclusive License of Valiloxybate
Sleep Pharmaceuticals

Avadel Pharmaceuticals Strengthens Sleep Medicine Portfolio with Exclusive License of Valiloxybate from XWPharma Ltd

Avadel Pharmaceuticals plc, a biopharmaceutical company focused on transforming medicines to transform lives, and XWPharma Ltd. (“XWPharma”) together announced today that Avadel has entered into an exclusive global license agreement with XWPharma to develop and commercialize valiloxybate, a GABAB receptor agonist, for all indications, including the treatment of sleep disorders, such […]

Awareness Narcolepsy Product/Vendor Updates Sleep Pharmaceuticals

Harmony Strengthens Patent With ANDA Settlement

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 […]

Idiopathic Hypersomnia Product/Vendor Updates Sleep Pharmaceuticals

Avadel’s LUMRYZ Receives FDA Orphan Drug Designation for Idiopathic Hypersomnia

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 […]

apnimed SynAIRgy Phase 3 Results
Obstructive Sleep Apnea Research/Studies Sleep Pharmaceuticals

Apnimed Announces SynAIRgy Phase 3 Results

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 […]