Category: Laws & Regulations

Laws & Regulations

FDA Gives Tentative Approval to LUMRYZ, Avadel’s Narcolepsy Drug

The US Food and Drug Administration has granted tentative approval to LUMRYZ, also known as FT218, by Avadel Pharmaceuticals plc.

Laws & Regulations

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.”

Laws & Regulations

FDA to Philips: Safety Risks May Exist with the Replacement Foam for Recalled Devices

During the manufacturing facility inspection, the FDA obtained additional information regarding the silicone-based foam used in a device outside the United States that failed one safety test for the release of VOCs.

FDA

FDA Approves First-Ever Treatment for Idiopathic Hypersomnia

Xywav can be administered as a twice- or once-nightly regimen for the treatment of idiopathic hypersomnia in adults.

Patient Rights, Privacy

State Settles With Former University of Iowa Secretary Fired for Sleeping at Work

The Gazette: Peggy Waters reported being diagnosed with sleep apnea in 2014 while working at the university.

Medicare & Medicaid

Updating Medicare Coverage for Sleep Apnea, Hypoventilation Syndromes, & More: Panel Takes Step Toward Fixing Outdated National Coverage Determinations

Lifesaving equipment is being denied payment because of rigid criteria in local coverage determinations and existing coverage provided by CMS is not reflective of rapidly evolving technology in the field.

Fraud & Malpractice

VA Employee Steals $1.9 Million Worth of CPAP Equipment

Kevin Rumph Jr. used his government-issued purchase card to make unauthorized purchases of CPAP supplies from a supplier in Alabama.

Financial

European 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

5 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.