New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
May 21, 2014
09:01 EDTBAX, HALOBaxter provides U.S. regulatory update on HyQvia
Baxter International (BAX) and Halozyme Therapeutics (HALO) announced that the U.S. Food and Drug Administration has extended the PDUFA date for its review of the Biologics License Application for HYQVIA, the company’s investigational subcutaneous treatment for patients with primary immunodeficiency. The FDA is requiring additional time to review supplemental data that Baxter provided as part of the ongoing BLA process for HyQvia approval. The PDUFA date has been extended by three months, which is the standard extension period. As part of the FDA’s extended review of the HyQvia BLA amendment, Baxter now expects to participate in a Blood Products Advisory Committee meeting, which the agency has scheduled for July 31.HyQvia was approved by the European Commission for EU member states in 2013 and is available in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
News For BAX;HALO From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
January 26, 2015
07:17 EDTBAXSociety of Thoracic Surgeons to hold annual meeting
51st Annual Meeting of STS is being held in San Diego, California on January 24-28.
January 20, 2015
09:02 EDTBAXBaxter receives FDA approval for PHOXILLUM solution
Subscribe for More Information
08:16 EDTBAXMerrimack data of Phase 3 MM-398 NAPOLI-1 study supports development programs
Merrimack Pharmaceuticals (MACK) announced that additional analyses were presented on January 16, 2015 from the Phase 3 NAPOLI-1 study of MM-398, also known as nal-IRI, in patients with metastatic pancreatic cancer previously treated with gemcitabine-based therapy. Merrimack and Baxter International's (BAX) biopharmaceutical business are collaborating on the development and commercialization of MM-398 outside of the United States and Taiwan. PharmaEngine holds the rights to commercialize MM-398 in Taiwan. Additionally, Merrimack presented preclinical and clinical data from studies of its investigational agents MM-141 and MM-151 in pancreatic and colorectal cancer, respectively. An investigator-sponsored study of MM-398 in colorectal cancer was also presented. The extended analyses for the global NAPOLI-1 Phase 3 trial presented at ASCO GI support the robustness of the overall survival benefit of MM-398 in combination with 5-fluorouracil, or 5-FU, and leucovorin presented in June 2014, at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer, or ESMO GI. The primary analysis, presented at ESMO GI, demonstrated a statistically significant advantage in overall survival with an unstratified hazard ratio of 0.67, and a median of 6.1 months for the combination of MM-398 plus 5-FU and leucovorin compared to 4.2 months in the control arm.
January 13, 2015
10:17 EDTHALOOptions with decreasing implied volatility
Subscribe for More Information
January 12, 2015
09:15 EDTHALOHalozyme sees FY15 revenue $85M-$95M, consensus $97.23M
Subscribe for More Information
09:15 EDTHALOHalozyme anticipates expanding and accelerating PEGPH20 development efforts
Subscribe for More Information

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the theflyonthewall.com disclaimer & terms of use