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    Australia and Canada Jointly Approve Breast Cancer Drug

    As part of a push toward regulatory convergence, Health Canada and Australia’s Therapeutic Goods Administration (TGA) last week jointly approved Eli Lilly’s Verzenio (abemaciclib) for the treatment of metastatic breast cancer. Each regulator evaluated different parts of the regulatory submission dossier, although both made independent decisions regarding approval. Health Canada also worked with the Canadian Agency for Drugs and Technologies in Health (CADTH) on the appr...
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    Bispecific Antibodies: FDA Drafts Guidance for Developers

    With more than two dozen companies developing bispecific antibodies, the next frontier of cancer therapy may well involve these genetically engineered, recombinant antibodies, which is why the US Food and Drug Administration (FDA) on Thursday released new draft guidance to help developers of these products. In explaining why bispecific antibodies could be advantageous, FDA notes that they “can target multiple disease-modifying molecules with one drug, with possible adva...
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    Health Canada Encourages RWE Submissions

    In lock step with its US counterparts, Health Canada this week announced that it’s seeking to better use real-world evidence (RWE), while addressing certain specifics in protocol development and data quality concerns.  As real-world data (RWD) sources increase in quantity and quality, Health Canada explains how “prospectively planned clinical trials have been and continue to be considered the most robust tool for providing evidence of drug safety and efficacy,” although...
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    Two Gene Therapy Approvals Headline CBER’s FY 2018 Report

    The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Wednesday published its Fiscal Year 2018 report, highlighting two gene therapy approvals, as well as the approvals of a hepatitis B vaccine, a vaccine to prevent shingles and a flu vaccine for children as young as six months. Both of the gene therapy approvals occurred at the very beginning of the previous fiscal year, with CBER signing off on Spark Therapeutics’ Luxturna...
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    FDA to Launch New Website Next Week

    In his first “all hands” speech at the US Food and Drug Administration’s (FDA) White Oak campus on Tuesday, Acting Commissioner Ned Sharpless explained how he will pick up where Scott Gottlieb left off, and how next week, FDA will launch a new and improved FDA.gov website. “The work done over the past year to get us here will provide a more accessible, user-friendly site for the public to learn about recalls, get product safety alerts, and other important information ab...
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    FDA Halts All US Sales of Surgical Mesh

    Following thousands of patient lawsuits and a spike in adverse event reports, the US Food and Drug Administration (FDA) on Tuesday ordered the manufacturers of all remaining surgical mesh products indicated for the transvaginal repair of pelvic organ prolapse (POP) to stop selling and distributing their products in the US immediately. Since FDA reclassified surgical mesh products to class III (high risk) in 2016, the agency said the two manufacturers, Boston Scientific ...
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    Regulatory Explainer: Everything You Need to Know About FDA’s Priority Review Vouchers

    Since 2007, the US Food and Drug Administration (FDA) has issued a handful of special "priority review" vouchers (PRVs) which allow its recipient to expedite the review of any one of its new drug products. What are these vouchers, why is FDA issuing them and what benefit might they have for society? Find out in our latest Regulatory Explainer on the Priority Review Voucher system. Last updated on 16 April 2019 to include: FDA has accepted Novartis' BLA for brolucizuma...
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    Sterilization Facility Closure Leads to First Device Shortage

    With the closure of a medical device sterilization facility in Illinois, the US Food and Drug Administration (FDA) warned of device shortages, and last Friday announced a type of a tracheostomy tube manufactured by Smiths Medical is the first to be in shortage. Jeff Shuren, director of FDA’s Center for Devices and Radiological Health, said in a statement : “I want to assure you that the FDA is working closely with the company to quickly resolve their sterilization chal...
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    Health Canada Implements ICH Guideline on Multi-Regional Clinical Trials

    Health Canada last Friday said it has implemented International Council for Harmonisation’s (ICH) E17 guideline from November 2017 on multi-regional clinical trials (MCRTs). Health Canada’s adoption of E17 follows the European Medicines Agency’s implementation in June 2018, Japan’s MHLW/PMDA implementation also in June 2018 and the US Food and Drug Administration’s implementation in July 2018. As drug development becomes increasingly global, ICH said the guidelin...
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    EU Device Coordination Group Offers Eudamed Guidance

    The EU’s Medical Device Coordination Group (MDCG) on Monday released two new documents explaining how legacy devices can be registered in Eudamed without a unique device identifier (UDI) and how device companies will have until November 2021 to register device data elements in Eudamed. The two-page document on the registration of data elements explains how the text of the Medical Device Regulation (MDR) presents an inconsistency with regard to what different articles wi...
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    OMB’s New Reviews of FDA Guidance May Be a Boon for Biopharma Industry

    As regular readers of Focus know, the US Food and Drug Administration (FDA) releases draft and final guidance documents each year to help the biopharma industry understand the agency’s thinking on particular topics. The guidance (almost 100 new draft guidance documents are slated for release this year by FDA’s Center for Drug Evaluation and Research) can be a helpful way to keep industry informed of the agency’s expectations. But the guidance can also raise signific...
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    Pfizer, AstraZeneca and J&J Take Issue With FDA’s List of Companies Withholding Drug Samples

    When seven biopharma executives were asked by senators in February whether they had intentionally blocked generic competition, all of them said no. But several of the companies’ products were included in a recently updated list from the US Food and Drug Administration (FDA) showing inquiries to the agency from prospective generic applicants indicating that they would like to develop a generic, but are unable to obtain the necessary samples of the reference listed drug...