Biological Safety

Alliance for Safe Biologic Medicines Welcomes Biosimilars Pathway

9 Feb 2012

Urges FDA to put patient safety first as draft guidance finalized

FDA Issues Draft Guidance on Biosimilar Product Development

9 Feb 2012

SILVER SPRING, Md., Feb. 9, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued three draft guidance documents on biosimilar product development to assist industry in developing such products in the United States.

Results From Phase I Clinical Trials Demonstrate Positive Safety Data of AVI BioPharma's RNA-Based Therapeutics for ...

9 Feb 2012

BOTHELL, WA-- - AVI BioPharma, Inc. , a developer of RNA-based therapeutics, today announced positive safety results from all six dose cohorts in the single ascending dose studies of AVI-6002 and AVI-6003, ...