Valneva SE: Business description, financial summary, 3yr and interim financials, key statistics/ratios and historical ratio analysis.
Provider: Reuters Investment Profile
NYSE and AMEX quotes delayed by at least 20 minutes. NASDAQ delayed by at least 15 minutes. For a complete list of exchanges and delays, please click here.
Valneva SE Wins FDA Market Exclusivity for the Pediatric Indication of IXIARO in the United States
Valneva SE announced that the United States Food and Drug Administration's (FDA) office of Orphan Drug Development (OOPD) granted a seven years orphan drug market exclusivity period for IXIARO for prevention of disease caused by Japanese Encephalitis (JE) virus in children two months to less than 17 years of age. During this seven-year exclusivity period, the FDA will not approve another vaccine for the prevention of JE in children less than 17 years of age, unless such competitive JE vaccine can be shown to be clinically superior to IXIARO in this pediatric population. The seven-year exclusivity period began on May 17, 2013, which coincides with the date of FDA's approval of the pediatric indication for IXIARO.
Latest Developments for Valneva SE
- Valneva SE announces first ever marketing approval in Europe for vaccine produced in EB66 cell line
- Valneva SE announces first marketing authorization for human vaccine produced in EB66 cell line
- Valneva SE announces approval and launch in South America of second veterinary vaccine produced in EB66 cell line
- Valneva SE issues FY 2014 revenue guidance
Latest Key Developments in Biotechnology
- Gene Techno Science Co Ltd to receive research subsidy from Northern Advancement Center for Science & Technology
- Incyte Corp announces top-line results from RELIEF trial of Ruxolitinib in patients with Polycythemia Vera
- Sangamo Biosciences Inc reaffirms FY 2014 revenue guidance
- La Jolla Pharmaceutical announces pricing of underwritten offering of common stock
- Share this
- Digg this