HHS Extends COVID-19 Public Health Emergency
At the end of July, the U.S. Department of Health and Human Services extended the national public health emergency declared for the COVID-19 pandemic, which grants COVID-19 payment and regulatory fl exibilities, for another 90 days.
Judge Rules Against Hospitals’ Suit Challenging New Price Transparency Rules
A federal judge ruled against the American Hospital Association and other hospital groups that filed suit in December contesting a finalized rule by the U.S. Department of Health and Human Services (HHS) that requires hospitals to disclose price information, including negotiated prices with insurers.
$1.95M Grant Awarded to Study Autoimmune Diseases
The National Institutes of Health (NIH) has awarded a $1.95 million federal grant to researchers investigating the underlying cause (molecular mechanisms) of autoimmune diseases.
FDA Implements New Warnings for Cigarette Packages and Advertisements
The U.S. Food and Drug Administration (FDA) issued a final rule to require new health warnings on cigarette packages and in cigarette advertisements, which feature textual statements with photo-realistic color images depicting some of the lesser-known, but serious health risks of cigarette smoking, including impact to fetal growth, cardiac disease, diabetes and more.
Stable and Durable Factor VIII Expression in Subjects Dosed with Investigational Hemophilia A Gene Therapy
More than two years after receiving Spark Therapeutics’ investigational adeno-associated virus (AAV)-mediated gene therapy (SPK-8011), five adult subjects with hemophilia A exhibited stable factor VIII (FVIII) expression, with no evidence of FVIII inhibitors or a cellular immune response.
New Site Tracks Vaccines and Drugs/Treatments in Development for COVID-19
BioRender, an online tool for creating scientific figures, has created a robust, interactive COVID VacTracker that is maintained regularly and updated daily.
CoVIg-19 Plasma Alliance Expands Membership and Clinical Trial Collaboration
The CoVIg-19 Plasma Alliance now includes 11 plasma companies, and now also includes global organizations from outside the plasma industry.
BCG Vaccine Being Studied as Potential Protection Against COVID-19
Because research has shown the Bacillus Calmette-Guérin (BCG) tuberculosis vaccine boosts production of immune cells, it is currently being trialed in people as potential protection against COVID-19.
Studies Show Influenza and Pneumonia Vaccines May Reduce Risk of Developing Alzheimer’s
Two studies show the influenza (flu) and pneumonia vaccines lessen the risk of developing Alzheimer’s disease (AD) in the future.
FDA Approves Uplizna to Treat Rare Autoimmune Disease of the CNS
The U.S. Food and Drug Administration (FDA) has approved inebilizumab-cdon (Uplizna) to treat neuromyelitis optica spectrum disorder (NMOSD) in adult patients with the anti-AQP4 antibody.