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    EMA offers parallel Article 58, centralized authorization reviews

    The European Medicines Agency (EMA) on Thursday issued a draft guidance for consultation explaining how sponsors can pursue a parallel Article 58 (EU-M4all) opinion and centralized marketing authorization for medicines they intend to market in the EU and abroad.   The Article 58 procedure allows EMA’s Committee for Medicinal Products for Human Use (CHMP) to give opinions in cooperation with the World Health Organization (WHO) on medicines intended to be used in low- an...
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    EMA considers AstraZeneca vax; Swissmedic okays Moderna's

    The European Medicines Agency (EMA) could issue an opinion on the COVID-19 vaccine co-developed by AstraZeneca and the University of Oxford as early as 29 January, according to a press release the agency issued on Tuesday.   The agency announced that it has received the full application packet for conditional marketing authorization of the chimpanzee adenovirus vector vaccine following a rolling review that began 1 October.   The AstraZeneca vaccine, already author...
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    Updated: Documents leaked to the internet in wake of EMA cyberattack

    Editor's note: This article was updated 12 January 2021 to include information provided in EMA's fourth update on this cyberattack.  Some of the COVID vaccine-related documents obtained during an early December 2020 cyberattack on the European Medicines Agency (EMA) made their way to the internet, according to the agency's fourth update on the matter. EMA's ongoing investigation has shown that "some of the unlawfully accessed documents related to COVID-19 medicines an...
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    Euro Roundup: Onslaught of Brexit guidances from MHRA; Swissmedic's adverse event reporting challenges

    MHRA publishes 48 guidance documents on new regulatory regime   The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published 48 guidance documents on the processes that will apply now that the Brexit transition period has ended. Throughout 2020, MHRA published guidance on how drugs and medical devices would be regulated in the UK after Brexit. In the days before and after the transition period ended on 31 December, the agency released a flurry o...
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    EMA okays Europe's second COVID vaccine

    The European Commission has authorized a second vaccine against COVID-19 following a favorable review by the European Medicines Agency’s human medicines committee (EMA’s CHMP). On Wednesday, the messenger RNA (mRNA) vaccine co-developed by Moderna and the US National Institutes of Health was given a conditional marketing authorization.   “With the Moderna vaccine, the second one now authorized in the EU, we will have a further 160 million doses. And more vaccines will ...
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    COVID antigen testing framework laid out by EC

    The European Commission is purchasing more than 20 million rapid antigen tests for SARS-CoV-2, the virus that causes COVID-19, and making them available to member states. At the same time, EC is also proposing a framework for a common approach for use, validation and mutual recognition of the tests across the European Union’s member states.   Rapid antigen tests are a tool “to further strengthen countries’ overall testing capacity, particularly as testing remains a key...
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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 updates advanced therapy guidelines for developers

    The European Medicines Agency (EMA) has updated its guidance to industry on the development of new medicines with genetically modified cells, including a special section on considerations for developing chimeric antigen receptor (CAR) T-cell therapies.   “It is recognised that this is an area under constant development and the guideline should be applied to any novel product as appropriate,” the EMA wrote in the new guideline.   The 36-page guideline provides rec...
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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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    Despite data breach, CHMP set to consider Pfizer-BioNTech COVID vaccine

    A committee of the European Medicines Agency (EMA) has moved up a meeting to evaluate the COVID-19 vaccine developed by Pfizer and the German firm BioNTech. EMA’s human medicines committee (CHMP) announced on 15 December that an exceptional meeting is now scheduled for 21 December, with a placeholder kept for the original 29 December date if more time for evaluation is needed.   “The rate of progress is reliant on a robust and complete assessment of the quality, safety...
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    CHMP closes out 2020 by recommending 15 medicines

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday recommended 15 medicines for authorization following its December meeting.   Among the medicines are eight new drugs and biologics, four generics, two biosimilars and one hybrid medicine. The new drugs included three products with orphan designation: AstraZeneca’s Lumoxiti (moxetumomab pasudotox), which was recommended under exceptional circumstances to treat relapsed ...
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    EMA hit by cyberattack, Pfizer-BioNTech documents accessed

    In a scant notice posted to its website on Wednesday, the European Medicines Agency (EMA) divulged that it has been hit by a cyberattack. While the agency did not reveal any details about the extent of the attack, German vaccine developer BioNTech issued a statement saying that documents related its COVID-19 vaccine developed in partnership with Pfizer were “unlawfully accessed.” “It is important to note that no BioNTech or Pfizer systems have been breached in connectio...