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News Breaks
August 18, 2014
08:01 EDTPFEPfizer announces submission of Palbociclib NDA to FDA
Pfizer announced it has completed the submission of a New Drug Application to the United States Food and Drug Administration for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor positive, human epidermal growth factor receptor 2 negative advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients. Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
News For PFE From The Last 14 Days
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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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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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