FDA Introduces Biosimilar Action Plan
The U.S. Food and Drug Administration introduced its Biosimilar Action Plan to help speed up approvals to enhance access to lower-cost biologics.
HHS Loosens Restrictions on Short-Term Health Plans
A final rule issued by the U.S. Department of Health and Human Services allows insurers to once again sell short-term health insurance for up to 12 months, as well as makes the plans renewable for up to three years.
CMS Restores Risk Adjustment Program
The Centers for Medicare and Medicaid Services adopted an interim final rule to restore $10.4 billion in funding to insurers to help them provide coverage to sick and
costly enrollees.
Tuberculosis Vaccine May Reverse Type 1 Diabetes
A recent study shows two injections of the bacillus Calmette-Guérin (BCG) vaccine a few weeks apart may reverse the causes of type 1 diabetes over several years.
WHO Recommends Typhoid Vaccine in Children in Endemic Countries
The World Health Organization is recommending a single dose of the typhoid conjugate vaccine (Typbar-TCV) for use in infants and children older than 6 months and a catch-up vaccine in children up to 15 years in countries where the infection is endemic.
Immune System Response Discovery in Newborns Could Lead to Earlier Vaccine Administration
Researchers at the TCD School ofMedicine and the National Children’sResearch Centre in Ireland have discovered a distinct immune response in newborns that could lead to both earlier vaccine administration and reduced need for multiple booster shots.
Current Pertussis Vaccine Mounts a Weaker Recall Response with Booster Shots
Researchers at the La Jolla Institute for Allergy and Immunology have found individuals who had been inoculated with the newer pertussis (whooping cough) vaccine as part of their initial series of shots mount a weaker recall response when receiving booster shots later on.
FDA Approves First Treatment for High-Risk Prostate Cancer
The U.S. Food and Drug Administration has approved Erleada (apalutamide) to treat men with prostate cancer that has not yet spread but has a quickly rising PSA level while on treatment with hormone therapy, which causes concern for cancer growth and spread.
CDC Expects Shortage of New Shingles Vaccines
The Centers for Disease Control andPrevention is warning about a shortage of Shringrix, the newest shingles vaccine recommended for individuals 50 years and older, due to greater-than-expected demand.
Zika Virus Blood Screening Guidelines Revised by FDA
The Food and Drug Administration has revised its recommendations for testing blood donations for the Zika virus.
