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    EMA gives procedural guidance on variant COVID vaccines

    A new document from the European Medicines Agency (EMA) will give vaccine developers procedural guidance when the time comes for them to update COVID-19 vaccines to include protection against variant strains of SARS-CoV-2.   The procedural guidance was adopted by EMA’s human medicines committee on 24 June, and is meant to apply to vaccines against other human coronaviruses as well. Marketing authorization holders may submit a variation to change the composition of a CO...
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    EMA consults on ICH S12 guideline, shares comments on PFDD reflection paper

    The European Medicines Agency (EMA) on Thursday opened a public consultation on the International Council for Harmonisation’s (ICH) S12 guideline on nonclinical biodistribution (BD) considerations for gene therapies.   The S12 guideline recently reached Step 2b of the ICH process after being endorsed at the ICH Assembly virtual meeting earlier this month. (RELATED: ICH reports ‘significant milestones’ reached on guidelines ranging from impurity testing to eCTD standa...
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    Global regulators issue call for clinical trial data transparency

    World regulatory authorities are calling for increased transparency from the pharmaceutical industry in how they report and give access to clinical trial data. In a joint statement, the World Health Organization (WHO) and the International Coalition of Medicines Regulatory Authorities (ICMRA) cited need for “wide access to clinical data for all new medicines and vaccines.”   Data related to a therapy or vaccine “must be published at the time of finalization of the regu...
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    EMA finalizes guidance on parallel MAA, EU-M4all procedure

    The European Medicines Agency (EMA) on Thursday released the final version of its guidance detailing the agency’s procedure for parallel EU-M4all (Article 58) and centralized marketing authorization applications (MAAs).   The guidance was adopted earlier this month following a public consultation launched in January and includes some minor changes from the draft version. (RELATED: EMA offers parallel Article 58, centralized authorization reviews , Regulatory Focus ...
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    EMA, WHO investigate reported clots with AstraZeneca vaccine

    As countries in Europe and elsewhere continue to pause administration of the AstraZeneca COVID-19 vaccines over reports of clotting events in recipients, the European Medicines Agency (EMA) announced Monday that it worked through the weekend to analyze and make sense of these reports.   Continuing a “rigorous analysis of all the data related to thromboembolic events,” EMA announced that its safety committee (PRAC) will hold an extraordinary meeting on Thursday, 18 Ma...
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    WHO/IAEA tackle investigational radiopharmaceutical GMP in draft guidance

    The World Health Organization (WHO) and the International Atomic Energy Agency (IAEA) have released a draft guideline on good manufacturing practices for investigational radiopharmaceuticals.   The March 2021 document is the first working draft of a revision to the existing guidelines on good manufacturing practices (GMP) for investigational products. Consultation is open through the end of April 2021, with a revised document expected to be worked up for public consu...
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    AstraZeneca COVID vaccines receive WHO emergency use listing

    The World Health Organization (WHO) has granted two additional vaccines against COVID-19 emergency use listing (EUL). Two versions of the vaccine co-developed by AstraZeneca and the University of Oxford received EUL status from WHO on Monday, following an all-day meeting and one the previous Friday to weigh safety and efficacy recommendations and manufacturing and quality considerations.   The two vaccines had to be considered separately, said WHO director-general Tedr...
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    WHO's Essential Diagnostics List updated for COVID-19

    The World Health Organization (WHO) updated its list of essential diagnostics for 2021 on Friday to include recommendations for polymerase chain reaction and antigen-based diagnostic tests for COVID-19.   In making this and other recommendations to the “basket of recommended in vitro diagnostics” that makes up the organization’s Essential Diagnostic List (EDL), WHO also recommended additional tests that detect disease preventable by vaccines and other infectious dise...
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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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    FDA pilots program to encourage new drug development tools

    The US Food and Drug Administration (FDA) on Monday announced it will pilot a new program it hopes will spur the development of novel drug development tools (DDTs) that do not fit within the agency’s existing DDT qualification programs.   The qualification process for DDTs was revamped under the 21 st Century Cures Act and FDA currently offers specific qualification programs for biomarkers, clinical outcome assessments (COAs) and animal models for use under the Anim...
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    WHO backs off on remdesivir as FDA issues another EUA

    The World Health Organization is recommending against the use of the antiviral remdesivir (Veklury, Gilead) for the treatment of COVID-19.   “The antiviral drug remdesivir is not suggested for patients admitted to hospital with COVID-19, regardless of how severely ill they are, because there is currently no evidence that it improves survival or the need for ventilation,” according to the World Health Organization’s (WHO’s) Guideline Development Group, in a statement re...
  • WHO: Two-thirds of global population now participating in COVAX initiative

    Countries representing nearly two thirds of the world’s population have now signed on to The World Health Organization’s COVID-19 vaccine development and manufacturing accelerator. In all, 64 higher income countries have joined the COVAX facility, with an additional 38 expected to join soon. The United States, Russia and China are not among the countries joining the multinational effort.   World Health Organization (WHO) director-general Tedros Ghebreyesus led a 21 Sep...