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News Breaks
March 20, 2014
08:34 EDTPFEPfizer's Bivalent rLP2086 receives FDA Breakthrough Therapy designation
Pfizer announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to Pfizers vaccine candidate, bivalent rLP2086, currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in persons 10 25 years of age. Enacted as part of the 2012 FDA Safety and Innovation Act, Breakthrough Therapy designation is intended to expedite the development and review of potential new medicines for serious and life-threatening diseases. A Breakthrough Therapy designation conveys FDA's existing fast track development program features, as well as more intensive FDA guidance on an efficient drug development program. Pfizer is conducting a global clinical development program for rLP2086, which includes both Phase 2 and Phase 3 trials evaluating more than 20K participants, about 14K of whom will receive the investigational vaccine. Following interactions that the company has had with the FDA, Pfizer intends to submit a Biologics License Application to the FDA for bivalent rLP2086 by mid-2014.
News For PFE From The Last 14 Days
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July 22, 2014
16:18 EDTPFEPuma Biotech now responsible for R&D expenses associated with legacy trials
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July 17, 2014
08:08 EDTPFEBristol-Myers, Pfizer announce enrollment in Phase IV EMANATE trial for Eliquis
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July 16, 2014
10:36 EDTPFETreasury calls on Congress to halt inversion deals
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09:27 EDTPFEPfizer to acquire InnoPharma for upfront cash payment of $225M
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07:59 EDTPFETreasury Secretary urges Congress to take action on tax inversions
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07:04 EDTPFEPfizer says primary endpoint met in Phase 3 study of BeneFIX
Pfizer announced the positive results of a Phase 3 study comparing a prophylaxis regimen of BeneFIX Coagulation Factor IX 100 IU/kg once-weekly to on-demand treatment in people with moderately severe to severe hemophilia B. The top-line results of the study showed that the primary study endpoint was met and hemophilia B patients taking once-weekly BeneFIX showed a statistically significant reduction in the annualized bleeding rate relative to on-demand treatment with BeneFIX. In the study, the median ABR value, a commonly used measure of efficacy for prophylaxis regimens in hemophilia, was 2.0 for the prophylaxis regimen, compared to 33.6 for the on-demand regimen, representing a 94% decrease in bleeding rates. The mean ABR value was 3.6 for the prophylaxis period, compared to 32.9 for the on-demand treatment, which represents a reduction of 89%. Study results also showed that prophylaxis treatment significantly reduced both spontaneous and traumatic ABR compared to on-demand treatment with BeneFIX. In addition to meeting the primary endpoint, the secondary study endpoints showed that none of the 1,254 prophylaxis infusions administered during the study were associated with a less than expected therapeutic effect occurrence, which was defined as a spontaneous bleed occurring within 48 hours of a prophylaxis infusion. These results are preliminary, top-line data and are subject to additional analyses. Complete results from this study will be submitted for presentation at upcoming medical congresses and submitted for publication in a peer-reviewed journal.
July 9, 2014
06:49 EDTPFEPfizer given dismissal of U.S. investor class action before trial, Reuters says
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