Cerus (CERS) Says CBC Submitted BLA to FDA for Interstate Export of INTERCEPT Platelet Components
Find out which companies are about to raise their dividend well before the news hits the Street with StreetInsider.com's Dividend Insider Elite. Sign-up for a FREE trial here.
Cerus Corporation (Nasdaq: CERS) announced that The Community Blood Center (CBC) of Appleton, Wisconsin has submitted the first Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) requesting allowance for interstate distribution of platelets that have been pathogen-reduced via the INTERCEPT Blood System.
“We look forward to the FDA’s review of our application, and our ability to supply INTERCEPT-treated platelets to hospital customers outside of the state of Wisconsin,” commented John Hagins, CBC’s president and chief executive officer.
“This first BLA submission is an important milestone for Cerus and for CBC as it improves patient access to INTERCEPT components,” said William “Obi” Greenman, Cerus’ president and chief executive officer. “A number of our other customers are also nearing their BLA submissions, moving us one step closer to supplying pathogen-reduced platelets to hospitals in any state in the U.S.”
The Biologics License Application is a common procedure for blood centers to request permission by FDA to introduce a biologic product into interstate commerce (21 CFR 601.2). The FDA has up to 12 months to review each BLA submission. Until a blood center obtains a BLA, they are restricted to distributing INTERCEPT-treated products to hospitals within the state in which they are produced. While some blood centers may distribute primarily in state, many U.S. blood centers have extensive interstate distribution.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Veracyte (VCYT) Announces Significant Data from Percepta Bronchial Genomic Classifier in Lung Cancer Screening
- Zimmer Biomet Holdings (ZBH) Announces Statistical Superiority in Seven-Year Follow-up of Mobi-C vs. Two-Level ACDF
- Verizon Communications (VZ) To Acquire Vessel's Technology
Create E-mail Alert Related CategoriesCorporate News, FDA, Management Comments
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!