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March 26, 2014
08:02 EDTPFEPfizer achieves primary endpoint in Phase 3 GENOTROPIN trial
Pfizer announced the top-line results from a Phase 3B study evaluating the 24-month efficacy of GENOTROPIN on the height in small-for-gestational-age children 24-30 months old. The primary endpoint of the study was achieved: there was a statistically significant difference at 24 months in change from baseline height between patients treated with GENOTROPIN and those in the untreated control group, as measured by height standard deviation score. The study was intended to generate additional data regarding the safety and efficacy of GENOTROPIN treatment in subjects born SGA who fail to achieve catch-up growth by two years of age. The study results showed, after 24 months of treatment, the GENOTROPIN group had a statistically significantly greater gain in height SDS compared to the untreated control group. The study was a controlled, multi-center study, randomizing SGA children to GENOTROPIN or an untreated control group. There were 43 participants from 16 centers in eight European countries, including Spain, Italy, Belgium, Switzerland, Czech Republic, Germany, Sweden and Netherlands. Participants in the study were between 24-30 months old and were randomized in a 1:1 ratio to receive GENOTROPIN 0.035 mg/kg/d or no treatment.A total of 39 participants completed the study, with two GENOTROPIN participants and two control-group participants withdrawing from the study. A total of 14 serious adverse events were reported in eight participants. Two serious adverse events, occurring to one participant, were deemed to be related to treatment with GENOTROPIN. The adverse events observed in the study were consistent with the known safety profile of GENOTROPIN.
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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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