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FDA Approves 35 Novel Medicines in Fiscal Year 2011
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Erik Greb
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At a press conference held Nov. 10, 2011, FDA Commissioner Margaret Hamburg said the agency had approved 35 novel medicines in fiscal year 2011. Among the approved products were two drugs for late-stage metastatic melanoma and the first drug to treat Hodgkins lymphoma in 30 years.
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Merck & Co. Outlines Progress in Its Late-Stage Pipeline
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Patricia Van Arnum
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Merck & Co. highlighted the key developments in its late-stage pipeline and its near-term plans for regulatory filings. The company has 19 candidates in Phase III clinical trials and plans to submit eight new US regulatory filings in 2012–2013, including five new drug candidates.
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GSK Announces $50-Million Innovation Fund in Canada
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Stephanie Sutton
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GlaxoSmithKline is looking to advance the commercialization of scientific innovation in Canada with its launch of the GSK Canada Life Sciences Innovation Fund, which was announced at a GSK-hosted event in Toronto last week. The $50-million national fund will identify strategic investment opportunities in Canada's life-sciences industry, including academic and health institutions, translational research centers and start-up companies.
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Alliance Between Pharma and Nonprofits to Speed Development of Tuberculosis Therapies
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Amy Ritter
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AstraZeneca, Bayer, Sanofi, Tibotec, TB Alliance, and the World Health Organization agreed to share information on tuberculosis compounds within their respective drug pipelines, according to the Critical Path to TB Drug Regimens. The purpose of the agreement is to promote information sharing around scientific and clinical studies so that partners can identify opportunities to test compounds in combination.
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EMA Addresses Globalized Supply Chain Issues With Annex 16 Revisions
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Rich Whitworth
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The EMA released a concept paper for consultation on Nov. 8, 2011, that recommends a revision to Annex 16 of the Guide to Good Manufacturing of Medicinal Products to address more complicated global supply chains and new falsified medicines legislation.
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Week of Nov. 14, 2011: Ablynx, Merck Sorono Expand Osteoarthritis Partnership; Genzyme Makes Senior Appointments to Multiple Sclerosis, Rare Diseases Businesses; and More
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Ablynx, Merck Sorono Expand Osteoarthritis Partnership; Genzyme Makes Senior Appointments to Multiple Sclerosis, Rare Diseases Businesses; and More.
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Regulatory Roundup: ICH Steering Committee Approves Revised Guideline for Genotoxicity Testing and Data Interpretation for Medicines
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ICH Steering Committee Approves Revised Guideline for Genotoxicity Testing and Data Interpretation for Medicines.
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