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May 27, 2014
16:20 EDTACET, PFEACETO subsidiary launches generic version of Diflucan
ACETO (ACET) announced that Rising Pharmaceuticals, its finished dosage form generics subsidiary, has launched the 50 mg, 100 mg and 200 mg strengths of Fluconazole Tablets, USP, an FDA approved generic version of Pfizer's (PFE) Diflucan. According to IMS Health data, U.S. market sales for Fluconazole, which is used primarily for the treatment of vaginal candidiasis, oropharyngeal and esophageal candidiasis, and cryptococcal meningitis, were approximately $57M for the twelve months ended March 31. This is the fourth product launched by Rising during fiscal 2014 and the first launch from the combined pipeline resulting from the acquisition of PACK Pharmaceuticals, which was completed on April 30.
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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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