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Stock Market & Financial Investment News

News Breaks
August 18, 2014
08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
News For PFE From The Last 14 Days
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January 29, 2015
08:15 EDTPFEOPKO Health, Pfizer receive regulatory clearance for global agreement
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January 28, 2015
07:39 EDTPFEPfizer CEO says company not in need of big M&A deal, FT reports
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January 27, 2015
07:16 EDTPFEPfizer drops 2.7% after FY15 outlook miss expectations
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07:07 EDTPFEPfizer sees FY15 adjusted EPS $2.00-$2.10, consensus $2.18
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07:01 EDTPFEPfizer reports Q4 adjusted EPS 54c, consensus 53c
Reports Q4 revenue $13.1B, consensus $12.9B.
January 26, 2015
16:15 EDTPFEPfizer commits to lower price for Prevenar 13 in developing countries
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15:40 EDTPFENotable companies reporting before tomorrow's open
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13:29 EDTPFEEarnings Preview: Pfizer set to report Q4 results as generics impact Celebrex
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January 23, 2015
16:08 EDTPFETeva volatility elevated, Pfizer approached late last year, Bloomberg says
Teva (TEVA) overall option implied volatility of 25 compares to its 26-week average of 23 according to Track Data, suggesting large price movement into Pfizer (PFE) approach late last year, Bloomberg says.
16:04 EDTPFETeva rebuffed Pfizer approach late last year, Bloomberg says
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January 22, 2015
11:23 EDTPFEPfizer says CHMP adopted positive opinion on Prevenar 13 expansion
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January 21, 2015
12:30 EDTPFEGlaxoSmithKline 'admired' by Pfizer CEO, FT reports
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January 15, 2015
11:20 EDTPFEGoldman cuts J&J to sell citing competitive pressures
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07:59 EDTPFEAmerican Society of Clinical Oncology to hold a symposium
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