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April 6, 2014
13:46 EDTPFEPfizer's palbociclib significantly prolonged PFS in metastatic breast cancer
Pfizer announced detailed results from the PALOMA-1 study, a randomized Phase 2 study of palbociclib, PD-0332991, in combination with letrozole. PALOMA-1 achieved its primary endpoint by significantly prolonging progression-free survival, PFS, compared with letrozole alone in post-menopausal women with estrogen receptor positive, ER+, human epidermal growth factor receptor 2 negative, HER2-, locally advanced or metastatic breast cancer. For women treated with the combination of palbociclib plus letrozole, the median PFS was 20.2 months, a statistically significant improvement compared to the 10.2 months of PFS in women who received letrozole alone. These data will be presented by Dr. Richard S. Finn, associate professor of medicine at University of California, Los Angeles at the American Association of Cancer Research (AACR) Annual Meeting 2014 in San Diego. "These data demonstrate the potential of palbociclib to be a major advance in the treatment of women with this type of advanced breast cancer," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. "We are proud to be at the forefront of research and development with respect to this promising new class of investigational anticancer agents and have initiated a broad clinical development program for palbociclib that includes breast and non-breast cancers." Final results for the secondary efficacy endpoints of duration of treatment and clinical benefit rate demonstrated superiority in the palbociclib plus letrozole arm compared to the letrozole-only arm. Per the PALOMA-1 trial protocol, an initial assessment of overall survival, OS, a secondary endpoint, was also performed. Based on the events at the time of the assessment, a median OS of 37.5 months was observed in the combination arm versus 33.3 months for those who received letrozole alone, a difference of 4.2 months. This OS observation at the time of final PFS analysis was not statistically significant. A follow-up OS analysis will be conducted following the accrual of additional events.
News For PFE From The Last 14 Days
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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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February 17, 2015
15:36 EDTPFETianyin JCM plans for FDA certification process
Tianyin Pharmaceutical (TPI) updated on the business and development at its Jiangchuan Macrolide Facility, or JCM, active pharmaceutical ingredients operation. In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's (PFE) and their subsidiaries in China, the company said. "This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets," Tianyin stated.
10:01 EDTPFECVS says PCSK9 inhibitors could cost system $150B annually
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February 13, 2015
10:28 EDTPFEPfizer announces FDA acceptance for review of NDA for ALO-02
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08:19 EDTPFEAckman noncommittal on McDonald's rumors, Bloomberg reports
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