FDA Observes Serious Liver Injury After Treatment with Ocaliva

FDA identified cases of serious liver injury among patients being treated for primary biliary cholangitis with Ocaliva who did not have cirrhosis of the liver.
Trial Shows Experimental Cancer Drug Helped Reduce Risk of Death in Common Blood Cancer

Results of a trial of GSK’s experimental cancer drug Blenrep showed that the drug used in combination with other treatments reduced the risk of death by 42 percent in multiple myeloma, at or after first relapse, compared to an existing treatment.
COVID-19 Vaccine May Reduce Risk of Developing Long COVID

A new study published in the journal Vaccine, shows that receiving a COVID-19 vaccine could reduce the risk of developing long COVID if it’s administered five months before an infection.
FDA Approves YESINTEK to Treat Autoimmune Diseases

Biocon Biologics has received U.S. Food and Drug Administration (FDA) approval for YESINTEK, a monoclonal antibody for the treatment of autoimmune conditions, including Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Y
Study Reveals Best Time to Get RSV Vaccine During Pregnancy

New research led by investigators at Mass General Brigham suggests vaccination closer to 32 weeks of pregnancy, rather than the current guidelines of between 32 and 36 weeks, will better protect pregnant women’s newborns against respiratory syncitial virus (RSV).
Study Finds Link Between COVID-19 and Autoimmunity

A population-based study conducted by researchers from the Republic of Korea found a significantly higher risk of developing autoimmune and autoinflammatory conditions, such as rheumatoid arthritis (RA), lupus, Crohn’s disease, and alopecia, among individuals who had COVID-19, with risks particularly elevated for those with severe cases, Delta variant infections and those who were unvaccinated.
Nasal Swab May Predict Severity of COVID-19

New research suggests autoantibodies in the nasal cavity may predict the severity of COVID-19 disease.
IVIG Reduces Symptom Severity for AGID

A new study indicates intravenous immun globulin (IVIG) therapy can reduce symptom severity for patients with autoimmune gastrointestinal dysmotility (AGID), also known as gastroparesis.
CSL Begins Enrollment for Hizentra Study for POTS

CSL Ltd. has begun enrolling U.S. patients in a Phase III late-stage randomized control trial to assess whether Hizentra subcutaneous immune globulin (SCIG) can alleviate symptoms of postural orthostatic tachycardia syndrome (POTS) — a blood circulation disorder that is one of the most common and disabling symptoms of long COVID with no approved therapies.
mRNA Cancer Vaccine Begins Trials for Non-Small Cell Lung Cancer

An mRNA vaccine has entered human trials as a treatment for lung cancer. Unlike traditional cancer vaccines such as the HPV vaccine, BNT116 is a therapeutic cancer vaccine designed to reduce tumor growth in patients with cancer or prevent its recurrence.