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News Breaks
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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April 27, 2015
15:04 EDTPFENotable companies reporting before tomorrow's open
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14:41 EDTPFEEarnings Watch: Pfizer up over 6% since its last earnings report
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12:47 EDTPFEPfizer technical comments before earnings
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09:03 EDTPFEChina Jo-Jo Drugstore signs incentive agreement with Pfizer subsidiary
China Jo-Jo Drugstores (CJJD) announced its subsidiary, Hangzhou Jiuzhou Grand Pharmacy Chain, has signed a new sales incentive agreement with Wyeth Pharmaceutical, a wholly owned subsidiary in China of Pfizer (PFE). The Agreement illustrated specific approaches and conditions of Jiuzhou Pharmacy's collaboration with Wyeth, including sales targets, promotional incentive to consumers, products and pricing methods. In return, Wyeth will fully support Jiuzhou Pharmacy with priority delivery, favorable purchase prices and promotional activities.
08:41 EDTPFETelegraph discusses potential takeover of GSK by Pfizer
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06:19 EDTPFEPharmceutical companies buy drugs and raises prices, WSJ reports
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April 21, 2015
10:01 EDTPFEPfizer receives FDA breakthrough therapy designation for Xalkori
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08:18 EDTPFEPain Therapeutics resumes responsibility for Remoxy
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08:06 EDTPFEPfizer says Phase 3 inotuzumab ozogamicin study met first primary endpoint
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April 20, 2015
08:02 EDTPFEMerck KGaA, Pfizer initiate Phase III study with Avelumab
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06:05 EDTPFEProvectus receives notice of allowance for PV-10 combined with other drugs
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April 15, 2015
08:04 EDTPFEPfizer: PALOMA-3 trial for IBRANCE met primary endpoint, trial stopped early
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April 13, 2015
15:12 EDTPFEMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.

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