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March 7, 2013
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News on diagnostic and therapeutic innovations and regulatory science

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  • API inspections may not avert drug shortages in Britain
    New EU import regulations of about 300 active pharmaceutical ingredients could result in shortages in Britain because of an estimated 300 sites that, lacking valid certifications, will require onsite inspections. Yet Britain's Medicines and Healthcare products Regulatory Agency says it lacks the resources to conduct inspections on such a scale. "Based on the latest analysis, inspection of those sites in third countries that are not planning to issue statements or apply for lisitng cannot be seen as a solution," the MHRA stated. (3/5) LinkedInFacebookTwitterEmail this Story
  • U.K. launches new effort against multiple sclerosis
    Britain's MS Society and the research organization Medical Research Council Technology have partnered to identify and develop new drugs for treating multiple sclerosis. The society will fund academic research programs over a two-year period, which will then be evaluated by MRC Technology for use in small-molecule and antibody projects that could lead to new MS therapies. PharmaTimes (U.K.) (3/6) LinkedInFacebookTwitterEmail this Story
7 keys: Put real-world evidence into action
Life sciences organizations need to know how their therapies work in the real world once clinical trials end. And these seven key components to standardizing real-world data and analytics platforms are how they get started. Read the paper, Institutionalizing Real World Evidence.
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  • Report: Generic drugs lowered 2012 spending on common conditions
    Spending on common chronic conditions such as high cholesterol and hypertension dropped last year for the first time since record keeping began due to higher utilization of generic drugs, an Express Scripts study found. Overall spending on prescription drugs rose 2.7%, driven by an 18.4% increase in spending on treatments for rheumatoid arthritis, cancer and hepatitis C and other specialty drugs, the study found. Reuters (3/5) , Bloomberg (3/5) , Fox Business/Dow Jones Newswires (3/5) LinkedInFacebookTwitterEmail this Story
  • CDC warns of deadly, antibiotic-resistant bacteria
    CDC data show that in the first half of 2012, 4% of U.S. hospitals and 18% of nursing homes had at least one case of carbapenem-resistant Enterobacteriaceae, a deadly bacteria resistant to even the strongest antibiotics. The CDC urged facilities to stop the spread of the bacteria by enforcing infection-control policies, grouping CRE patients together, alerting hospitals when these patients are transferred and using antibiotics judiciously. HealthDay News (3/5) LinkedInFacebookTwitterEmail this Story
  • Humira, Advair, Rituxan top list of 2012 best-selling drugs worldwide
    AbbVie's Humira, or adalimumab, topped this list of last year's 20 best-selling drugs worldwide, based on publicly available figures. GlaxoSmithKline's Advair came in second, followed by Roche Holding's Rituxan, or rituximab. Rounding out the top 10 were Sanofi's Lantus, Roche's Herceptin, AstraZeneca's Crestor, Johnson & Johnson's Remicade, Roche's Avastin, Eli Lilly and Co.'s Cymbalta, and Sanofi and Bristol-Myers Squibb's Plavix. Genetic Engineering & Biotechnology News (3/5) LinkedInFacebookTwitterEmail this Story
  DIA News 
  • Staying ahead of new pharmacovigilance legislation
    In an ever-changing regulatory environment, it is vital to remain abreast of any changes likely to impact on the Qualified Person for Pharmacovigilance’s (QPPV’s) essential role. The 7th European Forum for QPPV, to be held in London from April 17 to 18, aims to inform professionals in the field about challenges relating to the ongoing release of new pharmacovigilance legislation by the European Medicines Agency (EMA) and provide recommendations on incorporating those changes into their work. Read more. LinkedInFacebookTwitterEmail this Story

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