By PBN staff PROVIDENCE – EpiVax Inc. said Tuesday it has received a $458,000, two-year grant to develop a universal influenza vaccine. “There is an urgent, unmet need for an influenza vaccine with greater potency and wider application to diverse flu viruses that can also be developed more rapidly than conventional influenza vaccines,” said Dr. […]
NIH should not be a pharmaceutical company
By Tevi Troy The National Institutes of Health recently announced that it would be engaging in a billion-dollar effort to encourage the development of new pharmaceutical therapies. The New York Times headline for this story sounded innocuous: “Federal Research Center Will Help Develop Medicines.” But not everyone is so sanguine about this effort. Fox News, […]
Feds Check Post-Vaccine Seizures In Young Kids
USDA: Seizures Occurred 1 Day After Getting Shot By MIKE STOBBE, AP Medical Writer ATLANTA — Government officials are investigating an apparent increase in fever-related seizures in young children after they got a flu shot. The U.S. Food and Drug Administration on Thursday said there have been 36 confirmed reports of seizures this flu season […]
Flu Vaccine: Infant Febrile Seizures
But FDA Says Early Reports of Seizures Does Not Mean Vaccine is Unsafe By Daniel J. DeNoon, WebMD Health News Jan. 20, 2011 — The FDA and CDC are investigating reports linking febrile seizure in infants to the Sanofi Fluzone flu vaccine. The reports come from the FDA/CDC Vaccine Adverse Event Reporting System (VAERS). It’s […]
January 13, 2011 FDA Approval Letter – Cervarix
Our STN: BL 125259/112 GlaxoSmithKline Biologicals Attention: Matthew Whitman 2301 Renaissance Boulevard P.O. Box 61540 King of Prussia, PA 19406-2772 Dear Mr. Whitman: We have approved your request to supplement your biologics license application for Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant, to include a Patient Package Insert to the full prescribing information. […]
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