• Regulatory NewsRegulatory News

    AmpliPhi Biosciences Gets First cGMP Certification for Bacteriophage Facility

    AmpliPhi Biosciences announced Wednesday it has received the first ever good manufacturing practices certification for its bacteriophage facility in Slovenia. Background Bacteriophages are naturally occurring viruses that are capable of fighting bacteria. Phage therapy has been around for nearly a century, following the co-discovery of bacteriophages by Frederick Twort and Felix d'Hérelle in 1915 and 1917, respectively. Shortly thereafter, scientists began developing...
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    World Health Assembly Adopts Action Plan on Antimicrobial Resistance

    In Geneva Monday, members of the World Health Assembly (WHA) endorsed a plan to fight antimicrobial resistance (AMR) on a global scale. Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Organization (WHO) called AMR "so serious that it threatens the achievements of modern medicine." In recent years, health autho...
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    EU Parliament Calls for Measures to Combat Antimicrobial Resistance

    The European Parliament is calling for new measures to combat antimicrobial resistance (AMR) in Europe, where 25,000 die each year due to drug-resistant infections. Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World Health Organization (WHO) called AMR "so serious that it threatens the achievements of modern medicine." T...
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    To Fight Antimicrobial Resistance, FDA Asks Animal Drugmakers for More Information

    A new regulation proposed by the US Food and Drug Administration (FDA) would require manufacturers and sponsors of veterinary antibiotics used in food-producing animals to collect and submit data regarding the use of the drugs in specific animal species. The data is intended to help advance FDA's efforts to promote the "judicious use" of antibiotics as part of a broader initiative to stem the rise of antimicrobial resistance (AMR). Under the 2008 Animal Drug User Fee...
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    UK Review: New Models Needed to Fight Antimicrobial Resistance

    A review of antimicrobial resistance (AMR), commissioned by the UK and led by internationally renowned economist Jim O'Neill, is calling for billions of dollars in new funding intended to incentivize drug development and head off the threat of drug-resistant disease. Background Health authorities are increasingly citing AMR as one of the most pressing threats to global public health. In its 2014 Antimicrobial Resistance: global report on surveillance , the World He...
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    Public Health Groups Propose Global Drug Innovation Fund

    Two health advocacy groups, Médecins Sans Frontières (MSF) and the Drugs for Neglected Diseases initiative (DNDi) are urging public health authorities to create a global fund to tackle what they call "deadly gaps in innovation." Citing the rising threat of antimicrobial resistance (AMR), emerging infectious diseases and neglected tropical diseases (NTDs), the two organizations say the pharmaceutical industry is failing to address certain public health challenges. Back...
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    Global Efforts to Combat Antimicrobial Resistance 'Lacking,' WHO Report Finds

    The World Health Organization (WHO) has completed the first global assessment of national strategies to counter the rise of antimicrobial resistance (AMR). Only a quarter to countries had plans in place to limit the use of antimicrobials, leaving "major gaps" in the struggle against AMR in every region of the world. Background The rise of AMR is tied to the overuse and misuse of antimicrobial medicines such as antibiotics. When microbes targeted by antimicrobial medicin...
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    In Fight Against Antimicrobial Resistance, EMA Looks to Public for Help

    The European Medicines Agency (EMA) is looking for feedback on a new set of principles for setting the defined daily dose (DDDA) and defined course dose (DCDA) for antimicrobial products used in animals. The guideline was drafted by the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) committee, and is intended to establish standards for setting DDDA and DCDA amounts for veterinary antimicrobial products. The consultation is part of an ongoing...
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    EU Considers Major Revisions to Veterinary Medicines Regulations

    The European Parliament is considering major changes to how veterinary medical products are regulated in the EU. At the upcoming meeting of the Environment, Public Health and Food Safety (ENVI) committee on 18 March 2015, members will discuss a proposal for a new regulation which is intended to overhaul the regulation of veterinary medicines and streamline the European market for veterinary medicinal products. Background Veterinary and human medicines regulations in th...
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    EMA Releases new Policies Meant to Combat Antimicrobial Resistance

    As part of its efforts to combat antimicrobial resistance (AMR), the European Medicines Agency (EMA) has issued two draft guidelines related to the use of antimicrobial agents in veterinary medicinal products. Background Resistance to antimicrobials is not a new phenomenon. Scientists have observed AMR as far back as the late 1930s, following the discovery and mass use of sulfanilamide. Alexander Fleming, the scientist who discovered penicillin, warned of the risk...
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    Three EU Agencies Collaborate on Drug Resistance Study

    Three EU agencies have announced they will work together in the hopes of better understanding one of today's most pressing global healthcare issues: Antimicrobial resistance (AMR). Global and Historical Context Resistance to antimicrobials is not a new phenomenon. Scientists have observed AMR as far back as the late 1930s, following the discovery and mass use of sulfanilamide. Alexander Fleming, the scientist who discovered penicillin, warned of the risk of AMR in...
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    As US Falters in Fight Against Antibiotics Over-Prescribing, EU Makes Progress

    The European Union seems to be making substantial strides in something the US thus far has been unable to do: reducing the use of antibiotics in food-producing animals. In a new report issued on 15 October 2014, the European Medicines Agency (EMA)—the EU's version of the US Food and Drug Administration (FDA)—announced that between 2010 and 2012, the sales of antibiotics for use in animals fell 15% on average across 20 European countries. While some of those countries...