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Stock Market & Financial Investment News

News Breaks
January 4, 2013
18:23 EDTPFE, ENDPPfizer, Endo Pharmaceuticals to pay $18.17M each to Texas in Medicaid case
Texas Attorney General Greg Abbott announced that two civil Medicaid fraud settlements secured by the Attorney General’s Office will yield more than $36M for the state, and the settlement agreements announced resolve the state’s Medicaid fraud claims against Pfizer (PFE) and Endo Pharmaceuticals (ENDP). Under the agreements, the state will recover $18.17M each from Pfizer and Endo Pharmaceuticals. Reference Link
News For PFE;ENDP From The Last 14 Days
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August 20, 2014
08:03 EDTPFEBristol-Myers Pfizer to present new Eliquis data
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August 18, 2014
11:41 EDTPFECubist rises after report sparks takeover interest speculation
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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.
07:57 EDTPFECambridge Healthtech Institute to hold a summit
6th Annual Bioprocessing Summit to be held in Boston on August 18-22.
August 14, 2014
17:05 EDTPFEPfizer says FDA accepted for review BLA for bivalent recombinant LP2086
Pfizer announced that the FDA has accepted for review the Biologics License Application,BLA, for bivalent recombinant LP2086, the company’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. The FDA has also granted Priority Review designation for the BLA, providing an anticipated Prescription Drug User Fee Act, PDUFA, action date of February 14, 2015. “Pfizer has closely collaborated with the FDA since 2008 to develop our meningococcal B vaccine candidate with the intent to help prevent this devastating disease,” said Dr. Emilio Emini, senior vice president of Vaccine Research and Development for Pfizer. “Both the acceptance of Pfizer’s Biologics License Application today, and its Priority Review designation, are significant regulatory milestones that underscore the importance of our efforts to expedite the approval and subsequent availability of our meningococcal B vaccine for U.S. adolescents.”
07:46 EDTENDPEndo valuation attractive, says Goldman
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August 12, 2014
17:07 EDTPFEPfizer announces results from Lyrica studies conducted in China
Pfizer announced top-line results from two placebo-controlled studies conducted in China with Lyrica in patients with postherpetic neuralgia, pain after shingles or PHN, and painful diabetic peripheral neuropathy, pDPN, respectively.The PHN Phase 4 study, A0081276, met its primary endpoint by demonstrating a statistically significant reduction in pain when compared to placebo. Separately, the pDPN Phase 3 study, A0081265, did not meet its primary endpoint, a statistically significant change in endpoint mean pain score relative to placebo. The PHN study was an eight-week, randomized, double-blind, multi-center, placebo-controlled, post-marketing study evaluating the efficacy, safety and tolerability of pregabalin 300mg/day in the treatment of subjects with PHN. For the primary efficacy parameter, change from baseline in weekly mean pain scores, a significant treatment difference of -0.71 points for pregabalin relative to placebo was observed. The safety profile in this study was consistent with the known profile for Lyrica.
August 8, 2014
09:00 EDTENDPBioDelivery Sciences still a takeover target, says Janney Capital
Janney Capital continues to believe that BioDelivery Sciences (BDSI) could be a takeover target, noting that it thinks partner Endo International (ENDP) could be a potential buyer if BioDelivery has more positive top-line results and if the market weakens. The firm, which added that it likes BioDelivery Sciences as a stand-alone company as well, maintains its Buy rating and $15 fair value estimate on the stock.
06:39 EDTPFEPfizer faces torrent of Lipitor suits, Reuters says
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August 7, 2014
08:12 EDTPFEPfizer says EMA accpets application seeking new indication for Prevenar 13
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August 6, 2014
12:10 EDTPFEPfizer settles multi-state complaint on improper promotion of Rapamune
Attorney General Eric T. Schneiderman announced that he, along with 40 other state Attorneys General and the District of Columbia, reached a $35M settlement with Pfizer arising from alleged improper marketing and promotion of the immunosuppressive drug Rapamune. New York’s share of the settlement is over $1.7M. Pfizer, as parent of Wyeth Pharmaceuticals, agrees to be bound by the judgment and to resolve allegations that Wyeth unlawfully promoted Rapamune. Attorney General Schneiderman’s office served on the Executive Committee of this multi-state investigation. Reference Link
06:23 EDTPFEMitsubishi UFJ to hold a conference
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06:21 EDTPFEPiper Jaffray to hold a summit
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