Incannex Meets with FDA in Pre-IND Meeting for Sleep Apnea Drug Candidate
Incannex characterized the pre-investigational new drug application (pre-IND) meeting about IHL-42X as “highly constructive.”
Category: Laws & Regulations
Laws & Regulations
Latest
Laws & Regulations
LatestHospital System that ‘Falsely Diagnosed’ Sleep Apnea to Pay $1M Settlement
Cincinnati.com: The US Attorney's Office alleges that Mercy Health made medically unnecessary claims for machines used to treat sleep apnea.
Laws & Regulations
Latest
Philips Starts Repair & Replacement Program of First-Gen DreamStation Devices in United States
The company intends to complete the repair and replacement programs within approximately 12 months.
FDA
LatestFDA Grants Breakthrough Therapy Designation to Takeda’s Investigational Oral Orexin Agonist for Narcolepsy Type 1
The designation was based, in part, on early phase and preliminary clinical data that indicates Takeda’s investigational oral orexin agonist may demonstrate substantially improved objective and subjective measurements of daytime wakefulness in NT1 patients.
Patient Rights, Privacy
Latest
Philips CPAP Users Start Canadian Class Action
The case, brought by Sotos Class Actions, alleges that Philips received reports of degrading foam years earlier and that ought to have alerted Philips that the products were potentially dangerous.
Medicare & Medicaid
LatestAccessible & Approachable Dental Sleep Medicine
Kenneth A. Mogell, DMD, DABDSM, helps many people on Medicare treat their sleep apnea with oral appliances.
Fraud & Malpractice
LatestVA Respiratory Therapist Sentenced to Prison for Stealing & Selling Home Sleep Test and Other Medical Equipment
An investigation began in January 2020 when VAMC reported two bronchoscopes went missing from the hospital.
Financial
LatestEuropean Commission Fines Teva & Cephalon for Delaying Entry of Generic Modafinil
The commission investigation has found that for several years, this “pay-for-delay” agreement eliminated Teva as a competitor and allowed Cephalon to continue charging high prices even if the main modafinil patent had long expired.
Commercial Transportation
Latest5 Lawsuits From Hoboken Train Crash Settled for $8 Million
An investigation found the train engineer had undiagnosed sleep apnea, and a National Transportation Safety Board investigation faulted NJ Transit for not following its sleep apnea testing guidelines, reports NBC 4 New York.