FDA Approves Octaplas to Treat Pediatric Patients Who Require Multiple Coagulation Factor Replacement
A revised product label for Octapharma USA’s Octaplas (pooled plasma [human] solvent/detergent treated solution for intravenous infusion) to treat critically ill pediatric patients who require replacement of multiple coagulation factors has been approved by the U.S. Food and Drug Administration (FDA).
HPV Vaccine Exceeds Expectations by Providing Herd Immunity
A new study shows the HPV vaccine is far more effective than expected, with benefits extending beyond those who receive the vaccine.
Researchers Discover New, Rare Autoimmune Disease
A previously unknown autoimmune muscle disease involving sudden onset of debilitating muscle pain and weakness has been identified by researchers at Washington University School of Medicine in St. Louis, Mo.
CMS Enacts Medicare, Medicaid and CHIP Fraud-Fighting Rules
A final rule that went into effect Nov. 4 strengthens the Centers for Medicare and Medicaid Services’ ability to stop fraud before it happens.
CMS Finalizes Rule for Programs of All-Inclusive Care for the Elderly
The Centers for Medicare and Medicaid Services (CMS) has finalized a rule to update and modernize the Programs of All-Inclusive Care for the Elderly (PACE) that reflects updates based upon best practices in caring for frail and elderly individuals.
FDA Issues Final Guidance on Biosimilar Interchangeability
The U.S. Food and Drug Administration (FDA) released guidelines on the studies companies need to conduct to show their biosimilar is interchangeable with a biologic.
CMS Finalizes Rule for Cuts to Medicaid DSH Payments
The Centers for Medicare and Medicaid Services (CMS) published a final rule for calculating state Medicaid disproportionate share hospital (DSH) cuts in the amount of $4 billion in 2020 and $8 billion for each subsequent year through 2025.
$1 Billion Grant Awarded to Fight Addiction and Chronic Pain
The National Institutes of Health (NIH) has awarded $945 million to battle addiction and chronic pain.
Anti-Influenza Hyperimmune Immune Globulin Not Effective in Hospitalized Adults with Influenza Infection
A trial was conducted to assess the safety and efficacy of hIVIG (in conjunction with standard care) in adults hospitalized with laboratory-confirmed influenza A or B infection.
Emicizumab Prophylaxis Combined with ITI Effective in Pediatric Patients with Severe Hemophilia A and Inhibitors
Researchers at Emory University have described successful use of a novel treatment regimen, dubbed the “Atlanta Protocol,” that involved concomitant use of Hemlibra (emicizumab) prophylaxis and immune tolerance induction (ITI) to treat pediatric patients with severe hemophilia A and inhibitors.
