Positive Study Results, Acquisitions, Drug Approval, Regulatory Updates, and Collaborations - Research Reports on Gilead, Pfizer, AbbVie, Pacira and Thermo Fisher
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NEW YORK, September 30, 2014 /PRNewswire/ --
Today, Analysts Review released its research reports regarding Gilead Sciences Inc. (NASDAQ: GILD), Pfizer Inc. (NYSE: PFE), AbbVie Inc. (NYSE: ABBV), Pacira Pharmaceuticals, Inc. (NASDAQ: PCRX) and Thermo Fisher Scientific, Inc. (NYSE: TMO). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/6854-100free.
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Gilead Sciences Inc. Research Reports
On September 24, 2014, Gilead Sciences Inc. (Gilead) announced that two Phase III clinical trials evaluating an investigational tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults met their primary objectives. According to the Company, the studies demonstrated that the single tablet regimen containing TAF was non-inferior to the Gilead's already approved HIV drug Stribild, based on the proportion of patients with HIV RNA levels (viral load) of less than 50 copies/ mL at 48 weeks of therapy. In addition, the drug containing TAF demonstrated more favorable renal and bone safety compared to Stribild. Gilead plans to submit regulatory applications for TAF in the U.S. and EU in Q4 2014. The full research reports on Gilead are available to download free of charge at:
http://www.analystsreview.com/Sep-30-2014/GILD/report.pdf
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Pfizer Inc. Research Reports
On September 25, 2014, Pfizer Inc. (Pfizer) announced that it has completed its acquisition of the pharmaceutical development company, InnoPharma, Inc., after receiving regulatory approvals from all the U.S. government authorities as required by the agreement. Commenting on the acquisition, John Young, Group President, Pfizer Global Established Pharma (GEP), said "We believe this acquisition will help Pfizer build a strong sterile injectables pipeline in areas such as oncology and central nervous disorders." The full research reports on Pfizer are available to download free of charge at:
http://www.analystsreview.com/Sep-30-2014/PFE/report.pdf
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AbbVie Inc. Research Reports
On September 25, 2014, AbbVie Inc. (AbbVie) announced that the U.S. Food and Drug Administration (FDA) has approved HUMIRA (adalimumab) for the treatment of pediatric patients 6 years of age or older with moderately to severely active Crohn's disease, when certain other treatments have not worked well enough. According to the Company, Humira also becomes the first biologic approved drug in the U.S. that can be administered at home. "Children living with moderate to severe Crohn's disease have limited treatment options and AbbVie is pleased that HUMIRA will now be an available option for many of these patients," said Michael Severino, M.D., Executive Vice President, Research and Development and Chief Scientific Officer, AbbVie. The full research reports on AbbVie are available to download free of charge at:
http://www.analystsreview.com/Sep-30-2014/ABBV/report.pdf
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Pacira Pharmaceuticals, Inc. Research Reports
On September 25, 2014, Pacira Pharmaceuticals, Inc. (Pacira) announced that it has received a warning letter from the U.S. Food and Drug Administration's (FDA) Office of Prescription Drug Promotion (OPDP) regarding the promotional materials on the Company's EXPAREL (bupivacaine liposome injectable suspension). In its letter to the Company, the OPDP has said that it has evidence that Exparel is intended for new uses for which it does not have approval, and for which its labeling does not provide adequate directions for use, which renders Exparel "misbranded". OPDP also said that the Company has promoted its Exparel as being able to control the pain beyond 24 hours when this has not been demonstrated. "These claims overstate Exparel's efficacy and are misleading," said OPDP in its letter. In response to the letter, Placira's Chairman, President and CEO Dave Stack stated, "We plan to explain our position to the FDA and will provide an update upon resolution of these issues." Shares of Pacira fell 10.97% to close at $94.62. The full research reports on Pacira are available to download free of charge at:
http://www.analystsreview.com/Sep-30-2014/PCRX/report.pdf
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Thermo Fisher Scientific, Inc. Research Reports
On September 25, 2014, Thermo Fisher Scientific, Inc. (Thermo Fisher) announced a collaboration with GlaxoSmithKline and Pfizer to develop a universal next-generation sequencing (NGS) oncology test for solid tumors that will serve as a companion diagnostic for multiple drug programs. The test will be developed using Thermo Fisher's Ion Personal Genome Machine (PGM) Dx Platform, Ion AmpliSeq technology, and content from the Oncomine Cancer Research Panel. Once developed and validated, the test will be submitted to the U.S. Food and Drug Administration (FDA) and other global regulatory authorities for premarket approval, said Thermo Fisher. "This collaboration with Pfizer and GSK enables us to build upon our market leading position in NGS oncology, with hundreds of customers around the world sequencing tens of thousands of tumor samples each month using Ion Torrent technology," said Mark Stevenson, President of Life Sciences Solutions at Thermo Fisher. The full research reports on Thermo Fisher are available to download free of charge at:
http://www.analystsreview.com/Sep-30-2014/TMO/report.pdf
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