XBiotech (XBIT) Announces Completion of EMA GMP Inspection; Facility Recommended for Xilonix Production
- Wall Street rises, buoyed by economic data; Dow sets high
- Twitter (TWTR) 'Takeover Money' Moves On as 'Trump Money' Moves In
- Amazon (AMZN) Could Open Over 2,000 Brick-and Mortar Groceries if Tests Succeed - DJ; Kroger (KR) on Watch
- Buy Any Seasonal Market Weakness Ahead of Year End Rally - Oppenheimer (SPY)
- After-Hours Stock Movers 12/05: (TXMD) (COUP) (BOBE) Higher; (SB) (LXRX) (STWD) Lower (more...)
Get daily under-the-radar research with StreetInsider.com's Stealth Growth Insider Get your 2-Wk Free Trial here.
XBiotech Inc. (Nasdaq: XBIT) announced a successful GMP (Good Manufacturing Practices) inspection by the European Medicines Agency (EMA). The EMA’s Competent Authorities of France [The French Agency for the Safety of Health Products], conducted the inspection in connection with the Xilonix Marketing Authorization Application. XBiotech’s production operations were deemed to be in general compliance with the principles and guidelines of good manufacturing practice as laid down in Commission Directive 2003/94/EC. The findings allow the French Agency to recommend to the EMA XBiotech’s current facility for the commercial manufacture of Xilonix.
XBiotech is pioneering a new manufacturing process using disposable bioreactor technologies. These manufacturing technologies reduce capital costs and operating complexity while improving flexibility of biological manufacturing compared to existing clean-in-place technologies. XBiotech CEO, John Simard, commented, “The confirmation of GMP compliance is an important step for our manufacturing platform and commercialization capabilities.”
The GMP inspection was performed as part of the evaluation of the Company’s Marketing Authorization Application for Xilonix for the treatment of advanced colorectal cancer. The Company expects EMA decision on the Marketing Application as early as the end of 2016.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- UDR, Inc. (UDR) Appoints New CFO
- Immunogen (IMGN) Announces Preclinical Data on IMGN63 at ASH Meeting
- Brixmor Property Group (BRX) Names New Board Member
Create E-mail Alert Related CategoriesCorporate News, 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!