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FDA Notifies Pharmaceutical Companies that Studies Conducted by Cetero Research May Require ReevaluationThe FDA is notifying pharmaceutical companies that bioanalytical studies conducted by Cetero Research, Houston, Texas (Cetero) between April 2005 and June 2010 in support of marketing applications may2011/8/3
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Bayer Sees Sales and Operating Results Rise AgainBayer Group's sales edged closer to the €10bn ($14.4bn) mark, rising 0.8% over last year's figure to €9.25bn ($13.36bn). The company's earnings before interest and tax increased 25.9% to €1.27bn (2011/8/2
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Mergers Wreck Pharma R&D, Says Ex Pfizer ChiefMergers and acquisitions in the pharmaceutical industry will significantly shrink drug research over the long-term, according to former Pfizer R&D chief John LaMattina. Writing in the online jo2011/8/2
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FDA approves Lannett's ANDA for Phentermine Resin Extended-Release CapsulesLannett Company, Inc. (NYSE AMEX: LCI) today announced the U.S. Food and Drug Administration (FDA) approved its Abbreviated New Drug Application (ANDA) for Phentermine Resin Extended-Release Capsules,2011/8/1
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FDA issues 90-day extension for Pfizer's Prevnar 13 sBLA to treat pneumonia in adultsPfizer Inc (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has issued a 90-day extension to the action date for the Company's supplemental Biologics License Application (sB2011/8/1
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SFDA issues notice on relevant issues on administrative licensing of health foodIn order to standardize and strengthen the management of health food administrative licensing, the State Food and Drug Administration (SFDA) recently issued a notice on relevant issues on the administ2011/7/29
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SFDA to intensify supervision over accepting pharmaceutical contract manufacturing assignments from overseas pharmaceutical companiesThe State Food and Drug Administration (SFDA) issued a notice on July 22, 2011, which specifies relevant requirements on intensifying supervision over accepting pharmaceutical contract manufacturing a2011/7/29
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Merck secures worldwide rights to vernakalant i.v.Merck (NYSE:MRK), known as MSD outside the United States and Canada, and Astellas US LLC ("Astellas"), the U.S. subsidiary of Astellas Pharma Inc. (Tokyo:4503) today announced that they have entered i2011/7/28
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High-dose vitamin D reduces musculoskeletal pain in breast cancer patientsHigh-dose vitamin D relieves joint and muscle pain for many breast cancer patients taking estrogen-lowering drugs, according to a new study from Washington University School of Medicine in St. Louis.2011/7/28
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Surge of generics will trigger drop in drug pricesWith a number of the world's best-selling drugs soon to go "off patent," patients and insurers will see a reduction in prescription drug costs.With a number of the world's best-selling drugs soon to go "off patent," patients and insurers will see a reduction in prescription drug costs. CBS/AP: Prescription Drug Prices Set To Fall As Paten2011/7/28