Zepatier Approval Expanded to Include HCV Treatment of Pediatric Patients
The approval was based on data from a phase 2b study which evaluated Zepatier in 22 patients aged 12 to less than 18 years.
Hepatitis
PreHevbrio, a 3-Antigen Hepatitis B Vaccine, Gets FDA Approval
PreHevbrio contains the small (S), middle (pre-S2) and large (pre-S1) hepatitis B surface antigens.
Bulevirtide BLA Submitted for Chronic Hepatitis Delta Virus Infection
The application submission is supported by data from the ongoing phase 3 MYR301 study, along with completed and ongoing phase 2 studies.
Drug-Induced Hepatotoxicity Ends Development of Novel HBV Therapy
The phase 2 trial was evaluating the effects of ABI-H2158 in 88 treatment-naïve patients with HBeAg positive or HBeAg negative chronic hepatitis B infection without cirrhosis.
New Vial Sizes for Bivigam, Nabi-HB Now Available
The new vial sizes are currently in stock and commercially available in the US.
Epclusa Approved for Younger Patients With Chronic Hepatitis C
The expanded approval was based on data from an open-label phase 2 trial that evaluated Epclusa in 41 patients 3 years to less than 6 years of age with chronic HCV infection.
New Formulation of Hepatitis B Immune Globulin Launches
HyperHEP B is the Grifol’s new formulation of its hepatitis B immune globulin.
FDA Says Do Not Drink ‘Real Water’ Brand Alkaline Water
As of April 26, there had been 11 probable cases and one suspected case of acute nonviral hepatitis in Nevada
FDA: ‘Real Water’ Alkaline Water May Be Linked to Hepatitis Outbreak
FDA is in beginning stages of investigation; there may be more products connected to hepatitis outbreak
Updates to the 2021 Adult Immunization Schedule
The ACIP emphasizes the importance of routine vaccinations during the pandemic to prevent diseases.
