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  • EMA plans guidance on adapting vaccines for COVID variants

    The European Medicines Agency (EMA) on Wednesday said it will soon issue guidance explaining its expectations for adapting existing COVID-19 vaccines to protect against new and future variants of the virus.   The announcement comes just a week after the US Food and Drug Administration (FDA) said it is working on its own guidance to address these and other new variants of the virus. (Woodcock: FDA plans guidance to address new COVID-19 variants , Regulatory Focus 5...
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    WHO updates COVID vaccine and clinical care guidelines

    The World Health Organization (WHO) has released recommendations that include the use of low-dose anticoagulants for hospitalized patients with COVID-19 to reduce the risk of venous thromboembolism. That recommendation accompanies four other updates to the agency’s “living guidance” document for clinical management of patients with COVID-19.   For inpatients, the specific anticoagulation regimen recommended is thromboprophylaxis-level dosing rather than intermediate or...
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    COVID-19 IVD test kits: Expedited response by Asian regulatory authorities

    After COVID-19 quickly spread from China to nearby Asian countries in early 2020, regulatory authorities in those neighboring countries adapted rapidly to introduce regulatory pathways for approval of in vitro diagnostic (IVD) test kits to facilitate widespread testing and halt spread of the disease. An additional challenge was that authorities had to work around strict quarantine restrictions, and applications and consultations had to be conducted online instead of in per...
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    Australia’s TGA authorizes Pfizer COVID vaccine

    The Therapeutic Goods Administration (TGA) on Monday granted provisional approval to Pfizer and BioNTech’s COVID-19 vaccine Comirnaty for individuals aged 16 and older, making it the first COVID-19 vaccine authorized for use in Australia.   The approval follows a provisional determination by the agency in October allowing for the submission of the application under the provisional pathway. TGA has also granted provisional determinations for vaccines developed by Astra...
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    EU authorizes Pfizer-BioNTech COVID vaccine

    The European Commission on Monday conditionally authorized Pfizer and BioNTech’s COVID-19 vaccine after receiving a recommendation by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use earlier in the day.   The fast-tracked decision shortened what is usually a two-month procedure to a matter of hours, spotlighting the dire need for a vaccine as much of Europe faces lockdowns and restrictions amid a winter resurgence of the virus. The c...
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    EMA bumps up Moderna vaccine review

    As it faces increasing pressure to authorize vaccines to prevent COVID-19, the European Medicines Agency (EMA) on Thursday said it would speed up its assessment of Moderna’s mRNA COVID-19 vaccine by nearly a week after receiving the last outstanding data it needed to decide on the application.   The agency had initially scheduled an extraordinary meeting of its Committee for Medicinal Products for Human Use (CHMP) to conclude its assessment of Moderna’s conditional mar...
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    FDA authorizes Pfizer-BioNTech vaccine for emergency use

    The US Food and Drug and Drug Administration (FDA) on Friday authorized Pfizer and BioNTech’s COVID-19 vaccine for emergency use in individuals ages 16 and older just one day after the agency’s advisory panel voted 17-4 in favor of the vaccine.   Now that the vaccine has been authorized just three weeks after Pfizer and BioNTech submitted their emergency use authorization (EUA) request, a nationwide rollout of the vaccine is set to begin. FDA Commissioner Stephen ...
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    EMA chief says Pfizer, Moderna data ‘very robust,’ defends vaccine review approach

    Emer Cooke, the European Medicines Agency’s (EMA) newly installed executive director, on Thursday told a European Parliament committee that data submitted in support of COVID-19 vaccines developed by Pfizer/BioNTech and Moderna are “very robust”.   The meeting occurred hours before the US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee would meet to discuss authorizing the Pfizer/BioNTech vaccine for emergency use and ju...
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    November's Regulatory Focus: US, China, and EU: Regulatory and strategic considerations

    Feature articles during November focused on a range of topics, including a comparison of US drug regulatory pathways with those in China, as well as the application of EU and US guidelines during product development for advanced therapies. The line-up also included articles on the challenges in getting contemporaneous approval for medicines and companion diagnostics, and the importance of early planning in preparation for the transition to the EU In Vitro Diagnostic Devi...
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    Comparison of pharmaceutical development drug regulatory pathways in the US and China

    The US has the largest pharmaceutical market in the world, as well as the highest expenditure in research and development (R&D). Right behind the US is China, in second place, as it steadily closes the gap, with increasing government investment in R&D and programs promoting the development of innovative medicines targeting the global market. To close that gap, there should be a strong R&D infrastructure, effective intellectual property protection, integration in global sta...
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    Expected mistakes, the need for speed, and change to come: Marks looks ahead

    The US Food and Drug Administration’s (FDA’s) Peter Marks, MD, directs the agency’s Center for Biologics Evaluation and Research (CBER). In a wide-ranging 6 November discussion with the president and chief executive officer of the Friends of Cancer Research, Jeff Allen, PhD, Marks spoke to tempering public expectation, sustaining CBER staff despite a crushing workload during the coronavirus pandemic, and the possibility of more changes in 2021.   Under a new adminis...
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    FDA’s COVID-19 vaccine adcomm raises questions as first readouts loom

    With several COVID-19 vaccine candidates nearing Phase 3 readouts and the prospect that one or more could receive emergency use authorization (EUA) before the end of the year, advisors to the US Food and Drug Administration (FDA) met on Thursday to deliberate the standards the agency has set for authorization or licensure of a vaccine.   In a nine-hour public meeting meant to provide transparency and build public confidence in the process surrounding COVID-19 vaccine d...