Drug Approvals, Clinical Trial Result, and Philanthropic Activity - Research Reports on Johnson & Johnson, Biogen, Amgen, Medtronic and Merck
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NEW YORK, August 20, 2014 /PRNewswire/ --
Today, Analysts Review released its research reports regarding Johnson & Johnson (NYSE: JNJ), Biogen Idec Inc. (NASDAQ: BIIB), Amgen, Inc. (NASDAQ: AMGN), Medtronic, Inc. (NYSE: MDT) and Merck (NYSE: MRK). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/5855-100free.
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Johnson & Johnson Research Reports
On August 8, 2014, Janssen Pharmaceuticals, Inc. (Janssen), a subsidiary of Johnson & Johnson announced that it has received approval from the U.S. Food and Drug Administration (FDA) for INVOKAMET™, a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes. INVOKAMET™ provides the clinical attributes of INVOKANA® (canagliflozin), the first sodium glucose co-transporter 2 (SGLT2) inhibitor available in the U.S., together with metformin, which is commonly prescribed early in the treatment of type 2 diabetes. INVOKAMET™ is the first fixed-dose combination of an SGLT2 inhibitor with metformin approved in the U.S. Jimmy Ren, Ph.D., Therapeutic Area Lead, Metabolics, Medical Affairs, Janssen, said, "As with INVOKANA®, INVOKAMET™ provides adults with type 2 diabetes an oral therapy that lowers blood sugar and is also associated with reductions in body weight and systolic blood pressure." The full research reports on Johnson & Johnson are available to download free of charge at:
http://www.analystsreview.com/Aug-20-2014/JNJ/report.pdf
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Biogen Idec Inc. Research Reports
On August 15, 2014, Biogen Idec Inc. (Biogen) announced that the U.S. Food and Drug Administration (FDA) has approved PLEGRIDYTM (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). The Company stated that PLEGRIDY is the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the PLEGRIDY PEN, a new, ready-to-use autoinjector, or a prefilled syringe. Further, the approval of PLEGRIDYTM is based on results from one of the largest pivotal studies of beta interferon conducted, ADVANCE, which involved more than 1,500 MS patients. George A. Scangos, Ph.D., CEO, Biogen, said, "PLEGRIDY offers people with MS robust efficacy, a safety profile consistent with the established interferon class, and significantly fewer injections than other beta interferon treatments." The full research reports on Biogen are available to download free of charge at:
http://www.analystsreview.com/Aug-20-2014/BIIB/report.pdf
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Amgen, Inc. Research Reports
On August 13, 2014, Amgen, Inc. and its subsidiary Onyx Pharmaceuticals, Inc. (Onyx), jointly announced that the Phase 3 clinical trial FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study) did not meet its primary endpoint of improving overall survival (OS) (HR=0.975, 95% CI, 0.760, 1.249). The Companies informed that the 315-patient, open-label study evaluated single-agent Kyprolis® (carfilzomib) for Injection compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. Nearly all patients in the control arm received cyclophosphamide, and patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry. Pablo J. Cagnoni, M.D., President, Onyx, said, "While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world." The full research reports on Amgen are available to download free of charge at:
http://www.analystsreview.com/Aug-20-2014/AMGN/report.pdf
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Medtronic, Inc. Research Reports
On August 11, 2014, Medtronic, Inc. (Medtronic) reported that it will honor twenty-five long-distance runners who benefit from medical technology, with the title of "Medtronic Global Heroes" during the Medtronic Twin Cities Marathon or TC 10 Mile on October 5, 2014. The Company informed that this year's team includes runners from 10 different countries: Australia, Brazil, Canada, China, Colombia, Israel, Italy, Switzerland, U.K. and the U.S. Further, each runner has a medical device to treat conditions such as heart disease, diabetes, spinal disorders, chronic pain or neurological disorders. In addition, each winner is selected by Twin Cities In Motion, the non-profit organization that directs the Medtronic Twin Cities Marathon. The full research reports on Medtronic are available to download free of charge at:
http://www.analystsreview.com/Aug-20-2014/MDT/report.pdf
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Merck Research Reports
On August 13, 2014, Merck & Co., Inc. (Merck) announced that the U.S. Food and Drug Administration (FDA) has approved BELSOMRA® (suvorexant) for adults with insomnia who have difficulty falling asleep and/or staying asleep. The Company informed that BELSOMRA is a highly selective antagonist for orexin receptors. Orexin is a neurotransmitter found in a specific part of the brain that can help keep a person awake. According to Merck, the mechanism by which BELSOMRA exerts its therapeutic effect is presumed to be through antagonism of orexin receptors. In the clinical trials to support efficacy, BELSOMRA was superior to placebo for sleep latency and sleep maintenance as assessed both objectively by polysomnography and subjectively by patient-estimated sleep latency. The full research reports on Merck are available to download free of charge at:
http://www.analystsreview.com/Aug-20-2014/MRK/report.pdf
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