CMV Saliva Test Approved by FDA
Meridian Bioscience has received FDA clearance for its new Alethia CMVMolecular Amplification Test (formerly, the Illumigene brand).
IVIG Manufacturing Process for Bivigam Approved by FDA
ADMA Biologics has received approval from FDA for its prior approval supplement for Bivigam, allowing the company to use its optimized IVIG manufacturing process and market Bivigam to PI patients in the U.S.
WHO Issues New Flu Vaccine Composition Recommendations for 2019-2020 Season
The WHO advisory board issued its new recommendations on the composition of the influenza vaccines for use in the 2019-20 flu season in the Northern Hemisphere.
Novo Nordisk’s Esperoct Approved to Treat Individuals with Hemophilia A
FDA approved Esperoct (antihemophilic factor[recombinant], glycopegylatedexei), an extended half-life factor VIII molecule for replacement therapy in people with hemophilia A.
FDA Takes Steps for the Development of Non-Opioid Pain Medications
FDA issuing documents that should lead to smaller clinical trials, faster approvals and quicker launches of nonopioid pain medications.
First Therapy Approved to Treat Rare Blood Clotting Disorder
FDA has approved Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive
therapy, for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura.
FDA Approves Hepatitis A and Measles Exposure Drug
FDA has approved Grifols’ GamaSTAN to treat people exposed to measles and the hepatitis A viruses.
Majority of Vaccination Bills Propose Increasing Exemptions, But Most Enacted Limit Exemptions
Although more antivaccination legislation was introduced between 2011 and 2017, bills that limited vaccine exemptions were significantly more likely to be enacted.
Subcutaneous Lanadelumab Treatment Reduces Attack Rate in Patients with Hereditary Angioedema
Subcutaneous administration of lanadelumab, an investigational monoclonal antibody intended for the prevention of attacks in patients with type I or II hereditary angioedema (HAE), significantly reduced the mean number of attacks compared to placebo treatment.
Study Finds Nasal Flu Vaccine Less Effective Than the Flu Shot
A recent meta-analysis of pooled individual patient-level data, researchers found reduced effectiveness of the quadrivalent live-attenuated influenza vaccine (LAIV4) against influenza A/H1N1pdm09 compared with inactivated influenza vaccine (IIV) in children and adolescents.
