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News Breaks
January 25, 2013
16:24 EDTPFEPfizer receives FDA approval for use of Prevnar 13 in children and adolescents
Pfizer announced that the U.S. Food and Drug Administration has granted approval for the expansion of the company's pneumococcal conjugate vaccine, Prevnar 13, for use in older children and adolescents aged 6 years through 17 years for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. For this age group, Prevnar 13 is administered as a one-time dose to patients who have never received Prevnar 13. The FDA approval followed submission and review of a Phase 3, open-label trial of Prevnar 13 in 592 older children and adolescents, including those with asthma.
News For PFE From The Last 14 Days
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April 21, 2015
10:01 EDTPFEPfizer receives FDA breakthrough therapy designation for Xalkori
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08:18 EDTPFEPain Therapeutics resumes responsibility for Remoxy
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08:06 EDTPFEPfizer says Phase 3 inotuzumab ozogamicin study met first primary endpoint
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April 20, 2015
08:02 EDTPFEMerck KGaA, Pfizer initiate Phase III study with Avelumab
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06:05 EDTPFEProvectus receives notice of allowance for PV-10 combined with other drugs
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April 15, 2015
08:04 EDTPFEPfizer: PALOMA-3 trial for IBRANCE met primary endpoint, trial stopped early
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April 13, 2015
15:12 EDTPFEMylan enters settlement, license agreement with Pfizer regarding Viagra
Mylan (MYL) announced that its subsidiaries Mylan Inc. and Mylan Pharmaceuticals have entered into a settlement and license agreement with Pfizer (PFE), Pfizer Limited and Pfizer Ireland Pharmaceuticals to settle patent litigation relating to Mylan's Abbreviated New Drug Application filed with the U.S. FDA for Sildenafil Citrate Tablets 25 mg, 50 mg, and 100 mg. This product is the generic version of Viagra, which is indicated to treat erectile dysfunction. Under the terms of the agreement, Mylan will be able to launch its ANDA products pursuant to a royalty-bearing license as early as December 11, 2017, or sooner under certain conditions, subject to FDA approval. All other terms and conditions of the settlement and license agreement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. For the 12 months ending Dec. 31, 2014, Viagra had U.S. sales of approximately $1.3B, according to IMS Health.

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