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    FDA Works to Reduce Dog Testing in Drug Development

    US Food and Drug Administration (FDA) researchers are working to develop a new informatics model to reduce the reliance on dogs to conduct studies in animal drug development.   The agency’s new study, which was proposed on Friday, is intended to aid animal drug developers in conducting certain research without the need for product testing on dogs.   Animal drug developers would be able to use the new model as a mechanism for comparing blood levels of certain oral...
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    Half of Clinical Trials Fail to Publish Results, UK Report Finds

    Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...
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    Best of 2017: What Readers Clicked on This Year

    From Trump to biosimilars to a new digital health pilot run by the US Food and Drug Administration (FDA), here are the top 10 most-read articles of 2017, with some updates on what has occurred since the stories were published. 10. EMA to Suspend More Than 300 Drugs due to Unreliable CRO Studies Back in March, the European Medicines Agency (EMA) recommended the suspension of more than 300 approvals and applications for generic drugs for which bioequivalence studies w...
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    FDA Closes Loophole Companies Used to Skirt Pediatric Study Requirements

    The US Food and Drug Administration (FDA) on Tuesday released draft guidance indicating that it no longer intends to grant orphan drug designation to drugs for pediatric subpopulations of common diseases except for under certain conditions. Those conditions are if the use of the drug in the pediatric subpopulation are for a valid orphan subset, meaning "that use of the drug in a subset of persons with a non-rare disease or condition may be appropriate but use of th...
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    Senate, House Agree to Cut Orphan Drug Research Credit in Half in Tax Bill

    Members of the House-Senate Conference Committee discussing the GOP's tax overhaul plan on Friday released the final text of the bill, which would reduce the rare disease research tax credits biopharma companies can claim by half. Currently, companies can claim a 50% tax credit for qualified clinical testing expenses incurred in testing certain drugs for rare diseases or conditions, generally referred to as "orphan drugs," affecting fewer than 200,000 persons in th...
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    Tracking Post-Approval Study Completion: Majority On-Schedule but Not Submitted

    The US Food and Drug Administration (FDA) on Thursday released its most recent report tracking the progress that new drug and biologic applicants are making on post-approval studies. The report found that the majority of post-marketing requirements (PMRs) and post-marketing commitments (PMCs) are progressing on schedule, though of those studies that are open (734 NDAs and 156 BLAs are open as of 30 September 2016) and on-schedule, few PMRs for new drug applications ...
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    Merck and PhRMA to FDA: Wait for ICH Before Finalizing Guidance on Toxicity Testing for Cancer Drugs

    Drugmakers and industry groups are calling on the US Food and Drug Administration (FDA) to hold off on finalizing a draft guidance until the International Council on Harmonisation (ICH) finalizes its own guidance on the topic of reproductive toxicity testing for oncology drugs. Comments were released last week on the FDA draft guidance from late September. Industry group PhRMA and Merck both called on FDA to ensure consistency between the draft guidance and relevant I...
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    Drug Labels: Experts Note Importance of Faster Updates

    The topic of cancer drug labels and how they can be updated more quickly, as well as how the labeling system needs to be reformed was front and center at several panels at the Friends of Cancer Research's annual meeting in Washington, D.C. on Wednesday. Janet Woodcock, director of the US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER), noted her agency has been working on the issue of label updates for a number of years, particul...
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    GOP Tax Reform Bill Would Repeal Orphan Drug Research Credits

    Republicans on Thursday rolled out their new tax reform bill, which among other provisions to lower taxes for Americans and businesses, proposes to repeal a provision that might cause the biopharma industry some concern. Under the House bill’s Subtitle E, section 3401 would repeal what amounts to half of the qualified clinical research costs for designated orphan drug products. Background Under the  Orphan Drug Act  of 1983, Congress sought to incentivize the d...
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    European Commission Consults on Recalibrating Aspects of Drug Patents, SPCs

    The European Commission last week released for consultation a proposal to re-work certain elements of the EU pharmaceutical patent system and industry group Medicines for Europe is calling for the introduction of a Supplementary Protection Certificate (SPC) manufacturing waiver and for a wider definition of the research exemption. Background In the EU, SPCs, which apply to innovative pharmaceutical and plant protection products and have been increasingly used sinc...
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    EMA Responds to BMJ Article Questioning Benefits of Recent Cancer Drug Approvals

    As more cancer drugs are approved and prices continue to rise, questions have circulated on whether these drugs are extending patient survival or improving quality of life (QoL). A research article published in the BMJ last week reviewed the approval of drugs by the European Medicines Agency (EMA) from 2009 to 2013 and noted that most drugs entered the market without evidence of survival benefits or QoL. "When there were survival gains over existing treatment o...
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    FDA Halts Monkey Study on Nicotine Dosing

    FDA last month halted monkey research on nicotine dosing following concerns, including those raised in a letter from primatologist Jane Goodall. Although an FDA spokesperson told Focus that the decision to halt the study last month was made independently from Goodall’s letter to FDA Commissioner Scott Gottlieb, according to the letter , FDA was performing research at its National Center for Toxicological Research (NCTR) in Jefferson, Arkansas involving more than...