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News Breaks
July 1, 2014
09:05 EDTPFE, GLYCGlycoMimetics announces agreement with FDA for rivipansel
GlycoMimetics (GLYC) announced today that Pfizer (PFE) has reached agreement with the U.S. Food & Drug Administration under a special protocol assessment for a Phase 3 trial for rivipansel. A SPA is a written agreement between a trial’s sponsor and the FDA regarding the design, endpoints and statistical analysis approach of a Phase 3 clinical trial, results from which could potentially support approval of a New Drug Application. Rivipansel is being developed as a potential therapy for treatment of patients with sickle cell disease who are hospitalized for vaso-occlusive crisis. Rivipansel has previously received both Orphan Drug and Fast Track status for the treatment of VOC from the FDA. Pfizer plans to begin the Phase 3 program before the end of 2014.
News For GLYC;PFE From The Last 14 Days
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March 5, 2015
18:51 EDTPFETargacept, Catalyst Biosciences outline benefits of proposed merger
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March 3, 2015
12:06 EDTPFEPfizer receives orphan status for lung cancer drug
The FDA granted Pfizer orphan status for its treatment of non-small cell lung cancer with EGFR, HER2, HER4, or DDR2 mutations, dacomitinib.
09:02 EDTGLYCGlycoMimetics announces publication of Phase 2 rivipansel data in sickle cell
GlycoMimetics announced the publication of results from a randomized, placebo-controlled Phase 2 investigational study evaluating the efficacy, safety and pharmacokinetics of rivipansel in patients with sickle cell disease hospitalized for a vaso-occlusive crisis. Study results were pre-published online by Blood,1 the journal of the American Society of Hematology. The article, entitled “Randomized Phase 2 Study of GMI-1070 in SCD: Reduction In Time To Resolution Of Vaso-Occlusive Crisis and Decreased Opioid Use,” highlights rivipansel’s potential to improve clinical outcomes in sickle cell patients experiencing VOC. Results from the study were previously highlighted in two oral presentations and one poster presentation at the December 2013 ASH Annual Meeting and Exposition.
08:37 EDTPFEPfizer says EC approves expanded indication for Prevenar 13
Pfizer announced that the European Commission approved an expanded indication for the use of Prevenar 13 -- pneumococcal polysaccharide conjugate vaccine 13-valent, adsorbed -- for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults, which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia, including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease in adults aged 65 and older.
March 2, 2015
16:31 EDTPFEPfizer files automatic mixed securities shelf
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09:02 EDTPFEAstraZeneca mulls linking bonuses to Pfizer defense pledges, Sunday Times says
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February 26, 2015
12:31 EDTPFEPfizer says CDC recommends serogroup B meningococcal vaccine for those at risk
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February 24, 2015
08:07 EDTPFEPfizer announces Trumenba studies met primary objectives
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February 20, 2015
10:33 EDTPFEBattleground update: AbbVie named top global pick at Jefferies
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10:31 EDTPFEPfizer announces FDA acceptance of NDA for Rapamune
Pfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.
07:23 EDTPFEAbbVie replaces Pfizer as top global pharma pick at Jefferies
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February 19, 2015
18:25 EDTPFEPiper Jaffray biotech analyst to hold analyst/industry conference call
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14:49 EDTPFEWalgreens selected by Pfizer as one of pharmacies to dispense Ibrance
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07:12 EDTPFEWharton Health Care Club to hold a conference
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