New Board Director, Clinical Trial Results, New Drug Designations and Marketing Authorizations - Analyst Notes on Johnson & Johnson, Merck, Novartis, GSK and Endo
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NEW YORK, July 10, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Johnson & Johnson (NYSE: JNJ), Merck & Co., Inc. (NYSE: MRK), Novartis AG (NYSE: NVS), GlaxoSmithKline plc (NYSE: GSK) and Endo International PLC (NASDAQ: ENDP). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.analystsreview.com/4619-100free.
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Johnson & Johnson Analyst Notes
On July 7, 2014, Johnson & Johnson reported the addition of D. Scott Davis, CEO and Chairman of United Parcel Service, Inc. (UPS), as a director to the Johnson & Johnson's Board. The Company informed that Davis will serve on the Audit Committee and the Regulatory, Compliance and Government Affairs Committee of the Board. "Along with his knowledge and passion for emerging markets and international operations, Scott Davis will also bring to our Board his unique expertise in supply chain logistics at a time of rapid global expansion in the health care industry," said Alex Gorsky, Chairman and CEO of Johnson & Johnson. The full analyst notes on Johnson & Johnson are available to download free of charge at:
http://www.analystsreview.com/Jul-10-2014/JNJ/report.pdf
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Merck & Co., Inc. Analyst Notes
On June 30, 2014, Merck & Co., Inc. (Merck) announced results from a global, investigational Phase 3 study evaluating the safety and efficacy of EMEND (aprepitant) in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients from 6 months to 17 years. The results found the use of the EMEND regimen for CINV prevention to be significantly more effective than a control regimen in order to achieve Complete Response in all phases of CINV. The Company defined Complete Response as no vomiting or retching and no use of rescue medication for nausea and vomiting. Based on the results, Merck announced its plan for worldwide regulatory submissions for EMEND beginning in the US. The Company intends to submit a NDA for a new pediatric formulation and a sNDA for use of the current formulation, both in H2 2014. The full analyst notes on Merck are available to download free of charge at:
http://www.analystsreview.com/Jul-10-2014/MRK/report.pdf
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Novartis AG Analyst Notes
On July 7, 2014, Novartis AG (Novartis) announced that the FDA has granted Breakthrough Therapy status to CTL019, an investigational chimeric antigen receptor (CAR) therapy for the treatment of pediatric and adult patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The Company noted that this is the fifth Breakthrough Therapy designation that it has received. "This Breakthrough Therapy designation underscores the potential of CTL019 as a life-saving therapy for patients with relapsed/refractory ALL, who are in desperate need of new treatment options," said David Epstein, Division Head of Novartis Pharmaceuticals. "Novartis welcomes increased dialogue with the FDA and a potentially expedited review to streamline the development of CTL019 and hopefully bring this promising therapy to patients as quickly as possible." The full analyst notes on Novartis are available to download free of charge at:
http://www.analystsreview.com/Jul-10-2014/NVS/report.pdf
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GlaxoSmithKline plc Analyst Notes
On July 4, 2014, GlaxoSmithKline plc (GSK) announced that the European Commission (EC) has granted marketing authorisation for Mekinist™ (trametinib) as a single agent in the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation. The Company informed that Mekinist is a MEK inhibitor that blocks the activity of a protein kinase called MEK. "MEK has been pursued as a therapeutic target in cancer for more than a decade, and Mekinist is the first medicine in this class to be licensed in Europe," said Dr. Paolo Paoletti, President of Oncology at GSK. The full analyst notes on GSK are available to download free of charge at:
http://www.analystsreview.com/Jul-10-2014/GSK/report.pdf
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Endo International PLC Analyst Notes
On July 7, 2014, Endo International PLC (Endo) announced that its subsidiary Endo Pharmaceuticals Inc. (Endo Pharmaceuticals) and BioDelivery Sciences International, Inc. (BioDelivery) announced positive top-line results from the pivotal Phase III efficacy study of BEMA buprenorphine in opioid-experienced patients with chronic pain. The results showed that the trial successfully met its primary efficacy endpoint in demonstrating that BEMA buprenorphine resulted in significantly improved chronic pain relief compared to placebo. "We are highly encouraged by today's announced study results, which we believe are meaningful for appropriate patients requiring an opioid," said Dr. Susan Hall, Executive Vice President, Chief Scientific Officer and Global Head of Research and Development and Quality. "And we look forward to now focusing on our upcoming pre-NDA meeting this month with FDA followed by the preparation and submission of our NDA for BEMA buprenorphine as soon as possible." The full analyst notes on Endo are available to download free of charge at:
http://www.analystsreview.com/Jul-10-2014/ENDP/report.pdf
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