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FDA To Hold Meeting On Behind-the-Counter Drug Classification; Some Researchers Concerned About New FDA Center
October 30, 2007 on 12:57 pm | InWordPress database error: [Table 'tutspamanet.wp_terms' doesn't exist]
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Summaries of two recent developments related to FDA appear below.BTC classification: FDA next month plans to hold a meeting of stakeholders to consider the possibility of a behind-the-counter classification for medications, CongressDaily reports (Edney, CongressDaily, 10/15). [click link for full article]
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NACDS To Congress: Safeguard Legitimate DXM Use, Take Hard Line On Trafficking, Abuse
October 30, 2007 on 12:57 pm | InWordPress database error: [Table 'tutspamanet.wp_terms' doesn't exist]
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Last night’s House of Representatives passage of the “Dextromethorphan Distribution Act of 2007,” H.R. 970, is an important step toward preserving the availability of a safe and effective ingredient in over-the-counter cough and cold products, while preventing the sale and use of dextromethorphan (DXM) as a street drug, according to the National Association of Chain Drug Stores (NACDS). The bill, sponsored by Rep. Fred Upton (R-MI) and Rep. [click link for full article]
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Merck Announces Joint Agreement With ImClone And Bristol-Myers Squibb For Erbitux In Japan
October 29, 2007 on 8:53 am | InWordPress database error: [Table 'tutspamanet.wp_terms' doesn't exist]
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Merck KGaA announced that it has established an agreement with ImClone Systems Incorporated and Bristol-Myers Squibb Company for the co-development and co-commercialization of Erbitux® (cetuximab) in Japan if approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). [click link for full article]
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APP Receives Two FDA Approvals For Fludarabine Phosphate
October 29, 2007 on 8:53 am | InWordPress database error: [Table 'tutspamanet.wp_terms' doesn't exist]
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Abraxis Pharmaceutical Products (APP), the hospital-based business of Abraxis BioScience, Inc. (NASDAQ:ABBI), announced two approvals from U.S. Food and Drug Administration (FDA) to market the liquid and lyophilized versions of Fludarabine phosphate. The lyophilized version of fludarabine, which is the generic equivalent of Fludara® (fludarabine phosphate) for injection distributed by Bayer HealthCare Pharmaceuticals Inc., will be packaged in 50 mg/2mL single-dose vials. [click link for full article]
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Hydrogen’s Secrets Unlocked To Reveal Polymorphism In Pharmaceuticals
October 28, 2007 on 5:16 am | InWordPress database error: [Table 'tutspamanet.wp_terms' doesn't exist]
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Researchers at the University of Warwick and Astra Zeneca have found a new way to use solid-state NMR equipment to crack the secrets of hydrogen atoms and thus spot unwanted polymorphs in pharmaceuticals.Pharmaceuticals companies are constantly battling the problem of polymorphism in which an active drug can actually exist in more than one form or crystal structure which can cause the drug to act in very different ways. [click link for full article]
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FDA Approves Chemotherapy Drug Ixempra For Advanced Breast Cancer
October 28, 2007 on 5:16 am | InWordPress database error: [Table 'tutspamanet.wp_terms' doesn't exist]
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The US Food and Drug Administration (FDA) has approved a new chemotherapy drug called Ixempra (ixabepilone) for the treatment of advanced breast cancer.The announcement was made to the press by Bristol-Myers Squibb on 17th October, the maker of the new drug, who also said the drug will be available “within days”. [click link for full article]
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OMRIX Biopharmaceuticals Announces Positive Phase I Results With Fibrin Patch
October 26, 2007 on 11:09 am | InWordPress database error: [Table 'tutspamanet.wp_terms' doesn't exist]
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OMRIX Biopharmaceuticals, Inc. (”OMRIX” or “the Company”) (NASDAQ: OMRI), a biopharmaceutical Company that develops and markets biosurgical and passive immunotherapy products, announced the results of its prospective, open label, Phase I study of its novel Fibrin Patch. The results show that the Fibrin Patch appears to be safe as an adjunct to hemostasis. The fully absorbable Fibrin Patch, developed together with ETHICON, INC. [click link for full article]
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About 60% Of Medical School Department Heads Have Ties With Pharmaceutical Companies, According To Study
October 26, 2007 on 11:09 am | InWordPress database error: [Table 'tutspamanet.wp_terms' doesn't exist]
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About 60% of department heads at medical schools and teaching hospitals in the U.S. have personal financial relationships with pharmaceutical or medical device companies, according to a study published on Wednesday in the Journal of the American Medical Association, the AP/Philadelphia Inquirer reports. [click link for full article]
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MedImpact Study Highlights Treatment Challenges Among Those Suffering From Hypertension
October 25, 2007 on 9:58 am | InWordPress database error: [Table 'tutspamanet.wp_terms' doesn't exist]
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MedImpact, the nation’s largest pharmacy benefit management (PBM) company that does not sell drugs, announced research findings showing that many individuals who suffer from high blood pressure (hypertension) don’t always take important prescription medications that help control their condition. Understanding how these choices impact a patient’s health is important to payors focused on improving clinical care and managing overall health care costs. [click link for full article]
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Transformation Of Treatment Paradigm To Improve Patient Compliance With Multiple Sclerosis Therapy
October 25, 2007 on 9:58 am | InWordPress database error: [Table 'tutspamanet.wp_terms' doesn't exist]
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The multiple sclerosis (MS) market is undergoing a revolution with the imminent introduction of innovative therapies that will change the approach toward the treatment of the disease. This market evolution has not escaped the notice of pharmaceutical and biotechnology companies across various tiers, as they engage in a race to develop inventive and effective treatment options for MS. New analysis from Frost & Sullivan ( [click link for full article]
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