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 […]
Sleep Pharmaceuticals
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 […]
Teva Launches Two Digital Powder Inhalers in the U.S.
Teva Respiratory, LLC., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the launch of AirDuo® Digihaler® (fluticasone propionate and salmeterol) inhalation powder and ArmonAir® Digihaler® (fluticasone propionate) inhalation powder, two digital maintenance inhalers for patients with asthma. AirDuo® Digihaler® is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as […]
Trelegy Ellipta First Once-Daily Single Inhaler Triple Therapy for Both Asthma and COPD
GlaxoSmithKline plc and Innoviva, Inc. announced the US Food and Drug Administration (FDA) has approved a new indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol ‘FF/UMEC/VI’) for the treatment of asthma in patients aged 18 years and older adding to its current license for use in patients with chronic obstructive pulmonary disease […]
Jazz Gets FDA Approval of Xywav for Narcolepsy Related Cataplexy or EDS
Jazz Pharmaceuticals plc announced that the U.S. Food and Drug Administration (FDA) approved Xywav™ (calcium, magnesium, potassium, and sodium oxybates) oral solution on July 21, 2020 for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.1,2 Xywav is an oxybate product with […]
Nation Must Prepare for COVID-19 Related Drug Shortages
A new paper published online in the Annals of the American Thoracic Society examines the nation’s current shortage of vitally needed medications, and how this dangerous situation is being made worse by the COVID-19 pandemic. The authors provide recommendations on how clinicians and institutions might address potential scarcities of essential medications during the current […]












