Dallas, Texas 12/13/2013 (FINANCIALSTRENDS) – Danish pharmaceutical firm ALK declared that it had bagged unanimous backing from a USFDA advisory group for oral medicine Gratsek. The medicine, devised to take care of glass pollen allergic reactions, is one developed as part of ALK’s strategic affiliation with Merck & Co., Inc. (NYSE:MRK), a marriage which will offer the latter authorization to market and market the product in North American zones.
The FDA stated that the available facts revealed Gratsek’s effectiveness and protection among sufferers aged 5 to 65 years, but suggested further researches connected to its utilization among kids aged 11 years and below.
“ALK greets the FDA Advisory Committee’s conclusion that shows another vital step in this direction bringing this pioneering new cure to U.S. sufferers,” ALK chief executive officer Jens Bager stated in a declaration.
The FDA will appraise the company’s Biologic License Application for Gratsek, taking the advisory group’s opinion into thought, and the medicine’s authorization could be permitted as early as the first half of the coming year.
Merck & Co., Inc. (NYSE:MRK) Alzheimer’s medicine enters Phase III
Merck & Co., Inc. (NYSE:MRK) has reported promising development for its tentative Alzheimer’s drug MK-8931 after an optimistic safety appraisal.
A data monitoring group has considered interim security data from the stage II/III EPOCH research that comprised a safety cohort of 200 sufferers with mild to moderate Alzheimer’s handled with the medicine for at least 3 months. Based upon the DMC’s suggestions, Merck will carry on enrollment of the EPOCH research and will start dosing in a novel Phase III research (named APECS) assessing MK-8931 in sufferers with amnestic mild cognitive impairment because of Alzheimer’s.
The EPOCH experiment is now expected to enroll up to 1,960 sufferers, whilst Merck & Co., Inc. (NYSE:MRK) is making plans to take on 1,500 partakers for APECS.
This report is for information purposes only, and is neither a solicitation or recommendation to buy nor an offer to sell securities. Financials Trend is not-a-registered-investment-advisor. Financials Trend is not a broker-dealer. Information, opinions and analysis contained herein are based on sources believed to be reliable, but no representation, expressed or implied, is made as to its accuracy, completeness or correctness. The opinions contained herein reflect our current judgment and are subject to change without notice. Financials Trend accepts no liability for any losses arising from an investor's reliance on the use of this material. Financials Trend sometimes gets compensated up to one hundred and fifty thousand dollars per month for featuring particular stocks. See site disclaimer for complete compensation. Financials Trend and its affiliates or officers currently hold no shares of these stocks. Financials Trend and its affiliates or officers will purchase and sell shares of common stock of these stocks, in the open market at any time without notice. Financials Trend will not update its purchases and sales of these stocks in any future postings on Financials Trend's websites. Certain information included herein is forward-looking within the context of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning manufacturing, marketing, growth, and expansion. The words "may", "would," "will," "expect," "estimate," "anticipate," "believe," "intend," " project," and similar expressions and variations thereof are intended to identify for ward-looking statements. Such forward- looking information involves important risks and uncertainties that could affect actual results and cause them to differ materially from expectations expressed herein. *Financials Trend does not set price targets on securities. Never invest into a stock discussed on this web site or in this email alert unless you can afford to lose your entire investment.