ResMed Respiratory Masks With Magnets Stay On Sale Despite Recall
The mask recall had been classified as "most serious" by the FDA because of the risk of injury or death. But ResMed argued the issue centers on a labeling matter and is not a product removal. Separately, a CRISPR gene therapy for sickle cell can be used on a different disorder, the FDA said.
Reuters:
ResMed Says Its Masks To Remain On Market Despite FDA Classification
ResMed said its respiratory masks containing magnets will remain on the market even though the U.S. Food and Drug Administration classified a recall of the product as most serious as their use could cause major injuries or death. The California-based medical device maker, which started the recall process on Nov. 20, said the classification was due to a correction in the labeling and is not a product removal. (1/16)
In other pharmaceutical news —
Axios:
FDA Expands Use Of Newly Approved CRISPR Therapy
A therapy based on CRISPR gene-editing technology that the Food and Drug Administration approved in December for sickle cell disease can be used for a second inherited blood disorder, the agency said on Tuesday. (Bettelheim, 1/17)
The Washington Post:
New AI Tool Can Screen Kids For Rheumatic Heart Disease
When Kelsey Brown met Mohammed, the 15-year-old Ugandan boy looked terribly worried. He was in the late stages of rheumatic heart disease, which kills about 400,000 people a year worldwide. His scheduled heart surgery to address the illness had been postponed a day. By this point, fluid that backed up from Mohammed’s heart into his lungs made it so hard to breathe that he had to sleep sitting upright. Brown, a cardiology fellow at Children’s National Hospital in Washington, assumed that he was anxious about undergoing the surgery. But Mohammed told her that he was not scared to face the procedure. (Johnson, 1/16)
Stat:
Chemo Hair Loss Is Focus Of Antibody Treatment In Development
The chemotherapy Christine Ko was prescribed for her breast cancer is pretty much a guarantee for losing your hair. The intervention her doctors offered to prevent the hair loss was a cold cap that, cooled to 32 degrees Fahrenheit, would turn her scalp into an icy crown. But, to her, it wasn’t much of an option. (Chen, 1/17)
St. Louis Post-Dispatch:
Washington U. Creates Drug Research Company, Backed By $130 Million From New York Firm
Washington University has joined up with a New York investment firm to launch a new drug research and development business, the school announced Tuesday. Deerfield Management Co. has committed up to $130 million over the next decade. The new company will be called VeritaScience, a nod to the university’s motto, “Per Veritatem Vis,” or “Strength Through Truth.” (Merrilees, 1/16)
Stat:
Survey: Confusion Over Key Requirements Means Clinical Trials Results Go Unreported
More than half of those responsible for registering clinical trials and reporting results fail to do so over confusion about key requirements, according to a new survey that highlighted ongoing difficulties in achieving transparency surrounding study data. (Silverman, 1/16)
KFF Health News:
Listen To The Latest 'KFF Health News Minute'
This week on the KFF Health News Minute: A national shortage of Adderall leaves people with narcolepsy struggling to live normal lives. and researchers find little evidence that mental health courts are keeping those who need them most out of lockup. (1/16)
