NDA Filings, FDA Approvals, Executive Appointments, Ceased Clinical Trials, and Public Offerings - Analyst Notes on Johnson & Johnson, Pfizer, Merck, GSK, and Intercept
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NEW YORK, April 7, 2014 /PRNewswire/ --
Today, Analysts Review released its analysts' notes regarding Johnson & Johnson (NYSE: JNJ), Pfizer Inc. (NYSE: PFE), Merck & Co., Inc. (NYSE: MRK), GlaxoSmithKline plc (NYSE: GSK), and Intercept Pharmaceuticals, Inc. (NASDAQ: ICPT). Private wealth members receive these notes ahead of publication. To reserve complementary membership, limited openings are available at: http://www.AnalystsReview.com/register
Johnson & Johnson Analyst Notes
On April 1, 2014, Janssen Research & Development, LLC (Janssen), part of the Janssen Pharmaceutical Companies of Johnson & Johnson, announced that it has submitted a New Drug Application (NDA) to the FDA, seeking approval for a once-daily fixed-dose antiretroviral combination tablet containing darunavir (PREZISTA) with cobicistat. "Darunavir is the most prescribed HIV protease inhibitor in the United States1 and we are excited to be taking this important step in our efforts to offer it with an alternative boosting agent in a fixed-dose combination tablet," said Johan van Hoof, M.D., Therapeutic Area Head of Infectious Diseases and Vaccines at Janssen. "This filing demonstrates our ongoing commitment to develop new HIV treatment options and fixed-dose treatment regimens for those living with the disease." The full analyst notes on Johnson & Johnson are available to download free of charge at:
http://www.AnalystsReview.com/04072014/JNJ/report.pdf
Pfizer Inc. Analyst Notes
On March 28, 2014, Pfizer Inc. (Pfizer) announced that the FDA has approved over-the-counter Nexium 24HR (esomeprazole 20mg). According to the Company, the approval marks a key step towards providing those who suffer from frequent heartburn broader access to a brand doctors and patients have trusted for years. "Switching medicines, whenever appropriate, from prescription to non-prescription status improves access, empowers consumers to care for their own health and is an important strategy for Pfizer," said Paul Sturman, President of Pfizer Consumer Healthcare. "The FDA approval of Nexium 24HR is a significant milestone in executing against our plan." The Company said that it is working closely with AstraZeneca and retail partners to make Nexium® 24HR available to consumers in the U.S., and to follow in other markets in Europe in 2014. The full analyst notes on Pfizer Inc. are available to download free of charge at:
http://www.AnalystsReview.com/04072014/PFE/report.pdf
Merck & Co., Inc. Analyst Notes
On March 27, 2014, Merck & Co., Inc. (Merck) announced the appointment of Robert M. Davis as the Company's Executive Vice President and CFO, effective April 23, 2014. Succeeding Peter N. Kellogg, Davis will be responsible for overseeing corporate strategy and corporate business development. "Rob's broad, global business and healthcare experience, which encompasses commercial, R&D, quality, regulatory, manufacturing and supply chain, will be an asset to us in implementing a significantly streamlined, more flexible cost structure and operating model, while enabling us to focus on our highest-potential growth opportunities," said Kenneth C. Frazier, Chairman and CEO, Merck. The full analyst notes on Merck & Co., Inc. are available to download free of charge at:
http://www.AnalystsReview.com/04072014/MRK/report.pdf
GlaxoSmithKline plc Analyst Notes
On April 2, 2014, GlaxoSmithKline plc (GSK) announced its decision to stop the MAGRIT trial, a Phase III trial of the Company's MAGE-A3 cancer immunotherapeutic in non-small cell lung cancer (NSCLC) patients. The Company established that it will not be possible to identify a sub-population of gene-signature positive NSCLC patients that may benefit from the treatment, and thereby decided to cease the trial. "While we are extremely disappointed to learn that this trial did not have a positive outcome for the patients who participated in this trial, we are very grateful to its participants. We hope that the data generated in this trial will advance our understanding of the science of immunotherapeutics, and ultimately towards development of new therapies," said Vincent Brichard, Senior Vice President and Head of Immunotherapeutics at GSK Vaccines. The full analyst notes on GlaxoSmithKline plc are available to download free of charge at:
http://www.AnalystsReview.com/04072014/GSK/report.pdf
Intercept Pharmaceuticals, Inc. Analyst Notes
On April 1, 2014, Intercept Pharmaceuticals, Inc. (Intercept) announced that it has commenced an underwritten public offering of 1.0 million shares of its common stock. The Company informed that 0.6 million of the shares in the offering are to be sold by Intercept, and 0.4 million are to be sold by certain institutional selling stockholders. In addition, the Company informed that the selling stockholders intend to grant the underwriters a 30-day option to purchase up to an additional 150,000 shares of common stock on the same terms and conditions. The full analyst notes on Intercept Pharmaceuticals, Inc. are available to download free of charge at:
http://www.AnalystsReview.com/04072014/ICPT/report.pdf
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