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Weblog met nieuws over de pharmaceutische industrie

Archive for August, 2009

Certainly there is strength in numbers, but only if those numbers can effectively communicate with one another. Now, a new study finds that administration of a novel small molecule which effectively disrupts a key bacterial communication process protects an animal host from infection.
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  • Scientists from Scotland and Singapore have unraveled a mystery that has perplexed scientists since red wine was first discovered to have health benefits: how does resveratrol control inflammation? New research published in the August 2009 print issue of The FASEB Journal, not only explain
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  • As mathematics continues to become an increasingly important component in undergraduate biology programs, a more comprehensive understanding of the use of algebraic models is needed by the next generation of biologists to facilitate new advances in the life sciences, according to researchers at Sweet Briar College and the Virginia Bioinformatics Institute (VBI) at Virginia Tech.
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  • The effects of amphetamines on gene expression in zebrafish have been uncovered. This new study, published in BioMed Central’s open access journal Genome Biology, provides clues to the genetics that underlie susceptibility to addiction by describing the nad zebrafish mutant, which does not feel the rewarding effects of the drugs.
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  • GlaxoSmithKline (GSK) and Genmab A/S (OMX: GEN) announced preliminary top-line results from a Phase III study of ofatumumab administered intravenously for the treatment of rheumatoid arthritis (RA) in patients who had an inadequate response to methotrexate. The study met the primary endpoint, ACR20 at 24 weeks, which indicates a 20 percent or greater improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures.
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  • GSK announced that it has notified the European Medicines Agency of its decision to withdraw the Marketing Authorisation Application (MAA) in the EU for mepolizumab for the treatment of hypereosinophilic syndrome (HES).
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  • Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that it has received a Complete Response letter for INTUNIV TM (guanfacine) Extended Release from the Food and Drug Administration (FDA). This decision comes following labeling discussions with the FDA that did not result in agreement in time to meet the PDUFA date. The FDA did not identify safety concerns regarding INTUNIV in the Complete Response letter or request new clinical studies.
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  • Merck KGaA announced that it has requested re-examination of the negative opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), for the use of Erbitux® (cetuximab) in combination with platinum-based chemotherapy for the first-line treatment of patients with non-small cell lung cancer (NSCLC).
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  • The biotechnology medicine Ilaris® (canakinumab) has passed another major milestone with a recommendation for approval in the European Union to treat patients with a life-long and potentially fatal auto-inflammatory disease called cryopyrin-associated periodic syndrome (CAPS). When approved, Ilaris will be the only treatment in the EU indicated for CAPS patients aged four years and older[1].
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  • Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration (FDA) approved ONGLYZA™ (saxagliptin), a dipeptidyl peptidase-4 (DPP4) inhibitor. ONGLYZA is indicated as an adjunct to diet and exercise to improve blood sugar (glycemic) control in adults for the treatment of type 2 diabetes mellitus.
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