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March 22, 2014
18:33 EDTPFEPfizer reports detailed results from OPT Compare Phase 3 study of Tofacitinib
Pfizer announced detailed results from OPT Compare, a Phase 3 study of tofacitinib, the first in a new class of treatment, oral Janus kinase, JAK, inhibitors, the safety and efficacy of which are being investigated for the treatment of adults with moderate-to-severe chronic plaque psoriasis. Top-line results from OPT Compare were previously announced in October 2013. This is the first of five studies from the Phase 3 Oral treatment Psoriasis Trial, OPT, Program, one of the largest global clinical trial programs in moderate-to-severe chronic plaque psoriasis to date. The results of OPT Compare showed that in a step-down procedure design, tofacitinib 10 mg twice daily was non-inferior to high-dose ENBREL 50 mg twice weekly, and tofacitinib 5 mg twice daily did not meet the non-inferiority criteria compared to high-dose ENBREL. No new safety signals for tofacitinib were observed in the OPT Compare study. Detailed results of this study are being presented as an oral presentation during the Latest in Dermatology Research Symposium at the 72nd American Academy of Dermatology, AAD, Annual Meeting held in Denver.
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March 3, 2015
12:06 EDTPFEPfizer receives orphan status for lung cancer drug
The FDA granted Pfizer orphan status for its treatment of non-small cell lung cancer with EGFR, HER2, HER4, or DDR2 mutations, dacomitinib.
08:37 EDTPFEPfizer says EC approves expanded indication for Prevenar 13
Pfizer announced that the European Commission approved an expanded indication for the use of Prevenar 13 -- pneumococcal polysaccharide conjugate vaccine 13-valent, adsorbed -- for the prevention of pneumonia caused by the 13 pneumococcal serotypes in the vaccine in adults aged 18 years and older. The Summary of Product Characteristics has also been updated to include efficacy data from Pfizer’s Community-Acquired Pneumonia Immunization Trial in Adults, which demonstrated statistically significant reductions in first episodes of vaccine-type pneumococcal community-acquired pneumonia, including non-invasive/non-bacteremic CAP, and invasive pneumococcal disease in adults aged 65 and older.
March 2, 2015
16:31 EDTPFEPfizer files automatic mixed securities shelf
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09:02 EDTPFEAstraZeneca mulls linking bonuses to Pfizer defense pledges, Sunday Times says
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February 26, 2015
12:31 EDTPFEPfizer says CDC recommends serogroup B meningococcal vaccine for those at risk
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February 24, 2015
08:07 EDTPFEPfizer announces Trumenba studies met primary objectives
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February 20, 2015
10:33 EDTPFEBattleground update: AbbVie named top global pick at Jefferies
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10:31 EDTPFEPfizer announces FDA acceptance of NDA for Rapamune
Pfizer announced that the FDA has accepted for priority review a supplemental New Drug Application for RAPAMUNE for the treatment of lymphangioleiomyomatosis, a rare, progressive lung disease in women of childbearing age that is often fatal. With the Priority Review designation for the sNDA, Pfizer anticipates a decision in June of 2015 based on the anticipated Prescription Drug User Fee Act action date. The sNDA is based on results from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus Trial. The MILES Trial included 89 LAM patients with moderate lung impairment who were randomized to receive RAPAMUNE or placebo for 12 months, followed by a 12 month observation period. In the trial, those treated with RAPAMUNE for one year experienced stabilization of lung function as measured by forced expiratory volume in one second.
07:23 EDTPFEAbbVie replaces Pfizer as top global pharma pick at Jefferies
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February 19, 2015
18:25 EDTPFEPiper Jaffray biotech analyst to hold analyst/industry conference call
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14:49 EDTPFEWalgreens selected by Pfizer as one of pharmacies to dispense Ibrance
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07:12 EDTPFEWharton Health Care Club to hold a conference
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