#59145
#59146
Re: Farmas USA
MLV Maintains Buy On Threshold Pharmaceuticals
MLV analyst Thomas Yip maintained a Buy rating onThreshold Pharmaceuticals, Inc. (NASDAQ:THLD) with a $14.50 price target
THLD
#59147
Re: Farmas USA
Puede ser, probable
NVAX
#59148
Re: Farmas USA
"Anticipate 1st of many partnerships outside of U.S"
AMRN
#59149
Re: Farmas USA
Arena says Belviq refiling in Europe should occur by Q1 2016 • 4:55 PM
Douglas W. House, SA News Ed...
- In a regulatory filing, Arena Pharmaceuticals (NASDAQ:ARNA) discloses that it expects commercial partner Eisai to refile the Marketing Authorization Application (MAA) in Europe for its obesity drug Belviq (lorcaserin HCl) by the end of the latter's fiscal year ending March 31, 2016.
- Arena originally submitted the Belviq MAA in March 2012. In January 2013 it received a Day 180 List of Outstanding Issues from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The major objections preventing approval pertained to non-clinical and clinical issues including tumors in rats, valvuopathy and psychiatric events. CHMP requested that the benefit-risk balance of Belviq be further justified taking these issues into consideration. After a written response to the Day 180 List and an oral presentation to CHMP failed to assuage its concerns, the company withdrew the MAA in May 2013.
ARNA
#59150
Re: Farmas USA
#59151
Re: Farmas USA
#59152
Re: Farmas USA
+11 en el after
mañana gap? Podria sre
AMRN