New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
January 23, 2014
08:45 EDTBAXBaxter says recently received FDA warning letter on manufacturing
Baxter said it recently received an FDA warning letter primarily directed to its quality systems in Round Lake, Illinois for certain medical devices. Baxter says it is working with FDA on issues noted in the warning letter and that the company does not expect an impact on product availability based on the letter. The company also said, that while "it took longer than we expected" to complete the regulatory process, the company is "pleased" with the progress it is making on the integration of Gambro. Comments made during Q4 earnings conference call.
News For BAX From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
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.

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