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Merck & Co. (NYSE:MRK) has reported that the New Drug Application for suvorexant, its investigational insomnia medication, was accepted for standard review by the FDA and will be evaluated by the Controlled Substance Staff of the FDA during the NDA review. Should approval be granted, suvorexant will become available following a schedule assessment and determination has been completed by the United States Drug Enforcement Administration, which typically occurs after FDA approval. Meanwhile, Merck continues with plans to seek approval for suvorexant in other countries worldwide. The NDA for suvorexant was based upon data extracted from a broad clinical development program, which includes two pivotal, three-month efficacy trials that studied the ability of suvorexant to aid patients in falling asleep and staying asleep.
Microsoft Corporation’s (NASDAQ:MSFT) Chief Executive Steve Ballmer has no plans to exit the firm, said a Fortune report on Wednesday, which also named possible successors: Chief Research and Strategy Officer Craig Mundie, President of Windows and Windows Live Steven Sinofsky, and President Andrew Lees.
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Pfizer’s (NYSE:PFE) management believes that the firm is well-positioned to address the concerns contained in the FDA’s Complete Response Letter for Remoxy, based upon its review of recent written correspondence between Pfizer and the FDA. Remoxy received a Complete Response Letter in December 2008 and in June 2011, and Pfizer bears the sole responsibility for addressing the issues listed in the FDA’s Complete Response Letter, at its own expense. The company plans to meet with the FDA in March 2013 to discuss the drug, and it also reported the start of a new pharmacokinetic study on the same.
Verizon Communications (NYSE:VZ) announces that Hongkong and Shanghai Hotels, Ltd. has selecten a Verizon Terremark enterprise cloud computing solution through which to consolidate and centralize its tech infrastructure and to better support its customers.
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