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.
ADMA Biologics Receives U.S. Patent for Treatment and Prevention of Pneumococcal Infections
The U.S. Patent and Trademark Office has issued a patent to ADMA Biologics for methods of treatment and prevention of S. pneumonia infection.
Researchers Develop Vaccine Candidates to Prevent Epstein-Barr Virus
An NIH research team has determined how several antibodies induced by Epstein-Barr virus (EBV) block infection of cells grown in the laboratory.
Sanofi Receives Narrow FDA Approval for Dengue Vaccine
FDA has given Sanofi SA’s dengue vaccine Dengvaxia a narrow approval since the vaccine can cause severe infections in some people.
Campaign Launched to Remind Families Teens Need Second Meningitis Booster Shot
The National Meningitis Association has launched a campaign to encourage more teens to get the meningitis booster.
FDA Approves Expanded Use of Doptelet to Treat Thrombocytopenia
FDA has approved an expanded indication for Dova Pharmaceuticals’ Doptelet (avatrombopag) to treat adults with chronic immune thrombocytopenia.