King Pharmaceuticals, Inc. (NYSE: KG) announced additional information regarding the resubmission plan for the REMOXY® New Drug Application (NDA). The Company is not required by the Food and Drug Administration (FDA) to conduct clinical trials in order to provide additional safety or efficacy data in patients with moderate to severe chronic pain.
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Allergan, Inc. (NYSE: AGN) announced that the United States Food and Drug Administration (FDA) has approved ACUVAIL(TM) (ketorolac tromethamine ophthalmic solution) 0.45%, an advanced, preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery.
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Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for ISENTRESS®. The broadened indication now includes use in the treatment of adult patients starting HIV-1 therapy for the first time (treatment-naïve), as well as in treatment-experienced adult patients. ISENTRESS is used in combination with other antiretroviral (ARV) medicines for the treatment of HIV-1 infection in adult patients.
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Merck is committed to putting patients first and providing accurate information regarding the efficacy, safety and tolerability of our medicines. Merck offers the following statement concerning the osteoporosis medication FOSAMAX® (alendronate sodium) and reports of jaw problems associated with delayed healing and infection of the jaw often following tooth extraction. The condition is known as osteonecrosis of the jaw (ONJ).
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Pfizer Inc (NYSE: PFE) and Medivation, Inc. (NASDAQ: MDVN) announced the initiation of a Phase 3 trial of the investigational drug dimebon (latrepirdine) in patients with Huntington disease. The international safety and efficacy trial, known as HORIZON, is designed to evaluate the potential benefits of dimebon on cognition (thinking and memory) in patients with Huntington disease. The companies also announced that the U.S.
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The drug giant, last week, started tweeting about corporate initiatives, job openings, and news. Is
Pfizer just jumping on the bandwagon, or is Twitter part of the company’s social media strategy? Pharm Exec talks
to Pfizer to find out more.
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Prescribers treating patients who have had total hip or knee replacement surgery can access an independent review of the oral anticoagulant rivaroxaban (Xarelto) in the August issue of NPS RADAR. NPS RADAR provides independent information about new medicines and changes to PBS listings to health professionals and is published to coincide with PBS updates, giving health professionals access to information when they need it.
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Laboratory studies at Kansas State University and the work of a K-State researcher are making headway in the effort to control the pandemic H1N1 virus. Juergen Richt is a Regents Distinguished Professor at K-State’s College of Veterinary Medicine and is a Kansas Bioscience Authority Eminent Scholar. His work at K-State and with outside collaborators is revealing the characteristics of the pandemic H1N1 virus.
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The body’s nanomachines that read our genes don’t run as smoothly as previously thought, according to a new study by University of California, Berkeley, scientists. When these nanoscale protein machines encounter obstacles as they move along the DNA, they stall, often for minutes, and even backtrack as they transcribe DNA that is tightly wound to fit inside the cell’s nucleus.
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VisEn Medical Inc., a leader in fluorescence in vivo imaging from research through medicine, announced that scientists reporting in the July 31 issue of SCIENCE have discovered a key disease-related biologic pathway using an integrated and innovative array of in vitro readouts and advanced in vivo imaging technologies. The newly reported biologic pathway relates to monocyte deployment from the spleen to inflammatory sites, including myocardial infarction.
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