by Waylon Wright | Feb 21, 2017
The biosimilars industry is still in its infancy in the U.S. marketplace, resulting in some growing pains for developers of these products. Biosimilars were created under the Biologicals Price Competition and Innovation Act (BCPIA) of 2009 and signed into law through...
by Waylon Wright | Feb 17, 2017
On March 9th, the RAPS Indiana Chapter, chaired by Pearl Pathways COO Gretchen Bowker, will host an interactive presentation from a senior FDA representative. The FDA representative, Jill R. Bourdage, RPh, PMP, will speak about processes and procedures of the Office...
by Waylon Wright | Feb 10, 2017
The United States Food and Drug Administration (FDA) approved its first Investigational New Drug (IND) submission for a gene-edited chimeric antigen receptor (CAR) T-cell product for clinical trials. CAR T-cell therapy involves using a virus to edit an immune cell...
by Waylon Wright | Feb 9, 2017
On February 23rd, Indy Science Connect will host a Night of Networking event from 6-8pm EST. The event will be held at The Tap in Indianapolis, Indiana. Indy Science Connect is a professional networking group that was “started by a small group of friends that wanted...
by Waylon Wright | Feb 9, 2017
Brandwood Biomedical, our Asia Pacific strategic partner, reported this week in a blog post that the China Food and Drug Administration (CFDA) aims to speed up regulatory reviews. The draft policy change, released on December 29, 2016, will impact submissions for...
