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News Breaks
March 18, 2013
08:17 EDTSNY, MACKMerrimack completes enrollment in Phase 2 study of MM-121 in collaboration with Sanofi
Merrimack Pharmaceuticals (MACK) announced that the last patient has been enrolled in a Phase 2, open-label, randomized clinical trial of MM-121, a fully human monoclonal antibody that targets ErbB3, in combination with paclitaxel versus paclitaxel alone in patients with platinum-resistant or platinum refractory advanced ovarian cancers. MM-121 is being developed in collaboration with Sanofi (SNY).
News For MACK;SNY From The Last 14 Days
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January 26, 2015
05:14 EDTSNYRegeneron, Sanofi announce BLA for Praluent accepted for priority review by FDA
Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the Biologics License Application, or BLA, for Praluent, alirocumab. Under the Prescription Drug User Fee Act, or PDUFA, the goal for a priority review is six months, for a target action date of July 24. Alirocumab is an investigational monoclonal antibody targeting PCSK9 that is intended for the treatment of patients with hypercholesterolemia. The BLA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 ODYSSEY trials. Together with additional ongoing studies including ODYSSEY OUTCOMES, the ODYSSEY clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. Earlier this month, the companies announced that the European Medicines Agency accepted for review the Marketing Authorization Application for Praluent in the European Union. The EMA and FDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority.
January 22, 2015
18:28 EDTMACKOn The Fly: After Hours Movers
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17:54 EDTMACKMerrimack Chief Scientific Officer Ulrik Nielsen resigns
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05:22 EDTSNYGenzyme Cerdelga granted marketing authorization by EC
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January 21, 2015
10:16 EDTSNYLeerink biopharma analysts hold an analyst/industry conference call
Analyst Fernandez, along with Dr. Paul Gurbel and Dr. Richard Becker, discuss AstraZeneca's PEGASUS trial and the current use of Brilinta and dual antiplatelet therapy for prevention of CV disease and implications of the recently completed DAPT trial on an Analyst/Industry conference call to be held on January 21 at 1:30 pm.
January 20, 2015
08:16 EDTMACKMerrimack 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 15, 2015
07:59 EDTMACKAmerican Society of Clinical Oncology to hold a symposium
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January 14, 2015
07:37 EDTMACKJPMorgan to hold a conference
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