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June 18, 2014
17:04 EDTPFEPfizer XELJANZ Phase 3 findings support safety, efficacy
Pfizer announced the publication of two-year results from the ORAL Start study in the June 19 issue of The New England Journal of Medicine. ORAL Start is a 24-month Phase 3 study in patients with moderately to severely active rheumatoid arthritis who had not previously received methotrexate. The study showed that XELJANZ 5 mg and 10 mg twice daily, as monotherapy, inhibited the progression of structural damage and reduced the signs and symptoms of rheumatoid arthritis, and was statistically significantly superior to methotrexate on these measures at Month 6 and at all measured time points up to 24 months. XELJANZ is not indicated in patients who had not previously received methotrexate. The safety profile of XELJANZ in the ORAL Start study was consistent with that seen previously in the clinical development program. In the United States, XELJANZ 5 mg tablets are indicated for the treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. XELJANZ may be used alone or in combination with methotrexate or other non-biologic, disease-modifying antirheumatic drugs. Use of XELJANZ in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended. The recommended dose is a 5 mg pill taken twice daily.
News For PFE From The Last 14 Days
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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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February 17, 2015
15:36 EDTPFETianyin JCM plans for FDA certification process
Tianyin Pharmaceutical (TPI) updated on the business and development at its Jiangchuan Macrolide Facility, or JCM, active pharmaceutical ingredients operation. In addition to JCM's certification at India, along with other international clients located at Bangladesh, Philippines and Iran on import status, TPI plans for FDA certification process at its JCM facility in order to service international clients such as Pfizer's (PFE) and their subsidiaries in China, the company said. "This is expected to translate to further demand for JCM's macrolide API business in both the domestic and international markets," Tianyin stated.
10:01 EDTPFECVS says PCSK9 inhibitors could cost system $150B annually
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