FDA Approves Humira Biosimilar to Treat Autoimmune Disorders

The U.S. Food and Drug Administration has approved Samsung Bioepis; Halima (adalimumab-bwwd) for the treatment of several autoimmune disorders, including rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease.
Researchers Develop a New mRNA Vaccine to Treat Cancer

U.S. researchers have developed a new mRNA vaccine against cancer that delivers the drug directly to the lymphatic system and simulates a strong immune response.
New Test Identifies Patients at Risk of Severe COVID-19

U.S. scientists have developed a new genomic test that can predict a patient’s risk of developing severe COVID-19, an advance that could help doctors quickly begin tailored treatment.
Study Finds Pfizer’s RSV Vaccine Effective in Preventing Illness in Older Adults

Results of a recent study shows Pfizer’s experimental vaccine for respiratory syncytial virus is nearly 86 percent effective in preventing severe illness in older adults.
Experimental RSV Vaccine Shows Promise in Mice

An experimental vaccine shows promise for protecting mice from the respiratory syncytial virus, the pathogen that most commonly causes the chest infection bronchiolitis in young children.
$2 Million Awarded to Study Risks and Benefits of Social Media on Youth

Two million dollars in funding has been awarded to the American Academy of Pediatrics to establish a National Center of Excellence on Social Media and Mental Wellness.
WHO Publishes First Guidelines for Treating Ebola

The World Health Organization has published its first guideline for Ebola virus disease therapeutics, with new strong recommendations for the use of two monoclonal antibodies.
$11 Million Approved for Vaccine to Prevent Smallpox and Monkeypox

The U.S. Department of Health and Human Services will provide approximately $11 million to support the first U.S.-based fill and finish manufacturing of JYNNEOS, a vaccine approved to prevent smallpox and monkeypox.
RNA Interference Therapeutic Reduces Hepatotoxic Mutant Z-AAT Levels in Patients with Alpha1-Antitrypsin Deficiency

In a Phase II trial of participants with hepatic disease associated with congenital alpha1-antitrypsin deficiency, subcutaneous administration of fazirsitran, an investigational RNA interference therapeutic, reduced both serum and hepatic levels of the mutant hepatotoxic AAT protein Z-AAT, with concurrent improvements in enzymatic and histological markers of liver function.
Antibody Targeting Tissue Factor Pathway Inhibitor (TFPI) Sharply Reduces Bleeding Rate in Hemophilia A and B Patients

Subcutaneous administration of marstacimab, an investigational human monoclonal antibody targeting tissue factor pathway inhibitor, resulted in a roughly 10-fold lower annualized bleeding rate in 26 hemophilia patients than comparable control individuals in previous clinical trials who were treated on-demand with recombinant factor replacement therapy.