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    European Commission kicks off review of pharmaceutical legislation

    As part of its broader pharmaceutical strategy, the European Commission on Tuesday released a roadmap for its planned revision of the EU’s aging pharmaceutical legislation next year.   The Commission adopted its pharmaceutical strategy last November following a public consultation earlier in the year. “[The strategy] is intended to make the European pharmaceutical system patient-centered, future-proof and crisis-resistant,” the Commission writes. (RELATED: European C...
  • FDA, EMA team up on pediatric oncology drug development template

    In a move that dovetails with other cooperative efforts in regulation of pediatric oncology drugs, regulators in the US and Europe have come together to provide a common template for drugmakers to use when planning clinical trials for pediatric cancer drugs.   A new Common Commentary template gives a framework for seeking scientific advice from both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) on new Pediatric Investigation Plans ...
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    AstraZeneca vaccine deemed safe by EMA, again

    In a Wednesday status update on the European Medicines Agency's (EMA's) ongoing investigation into rare reports of blood clotting problems in people who have received the AstraZeneca COVID-19 vaccine, EMA head Emer Cooke offered reassuring words about the vaccine’s benefit-risk profile.   “Two weeks ago, on the 18th of March, we gave an interim update of the assessment and we concluded at the time that the benefits of the AstraZeneca vaccine in preventing COVID-19 -- w...
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    CHMP recommends five new drugs, gives advice on Celltrion COVID antibody

    The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Friday issued positive opinions for five new medicines and six extensions of therapeutic indications following its meeting earlier this week.   The newly recommended medicines include Verastem’s Copiktra (duvelisib) to treat relapsed or refractory chronic lymphocytic leukemia and refractory follicular lymphoma and Janssen-Cilag’s multiple sclerosis treatment Ponvory (ponesimo...
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    EC advances amendment to speed adapted COVID vaccines

    The European Commission on Wednesday advanced a delegated regulation that would give the European Medicines Agency (EMA) the authority to more quickly authorize COVID-19 vaccines that have been adapted to address variants of the virus.   “We are enabling EMA to fast-track regulatory approval of updated vaccines to tackle new variants. Faster approval means more vaccines in circulation and more Europeans protected from the virus,” said European Commission President Ursu...
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    COVID innovation lessons could be applied elsewhere

    The global urgency of the COVID-19 pandemic spurred the development of new models of vaccine and drug development. Could these innovations help with researching non-pandemic vaccines or drugs, and potentially serve as a template in other areas of medicine?   Two papers recently published in Health Affairs suggest that, yes, these innovations could be applied elsewhere if deemed successful—but it’s also important to note the shortcomings of these new models as well. ...
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    No ivermectin for COVID, says EMA

    The antihelmintic drug ivermectin should not be used for COVID-19 treatment outside of the clinical trial environment, according to a statement issued Monday by the European Medicines Agency (EMA).   The European regulator’s statement parallels the position of the US Food and Drug Administration (FDA), which issued a 5 March update for consumers in response to “multiple reports of patients who have required medical support and been hospitalized after self-medicatin...
  • ReconRecon

    Recon: uBiome founders garner $60m SEC fraud charge; Idera's melanoma drug flops Ph 3

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies ( Pink Sheet ) Experts Warn U.S. Could See New Coronavirus Hot Spots ( NPR ) Biden says 65% of people 65 or older have received at least one COVID vaccine shot ( Reuters ) Drugmakers brace for a pricing fight as Xavier Becerra is confirmed as the next HHS secretary ( Endpoints ) New HH...
  • MDCG releases rapid COVID antibody test guidance

    Europe’s Medical Device Coordination Group (MDCG) has set out guidance for developers of rapid COVID-19 antibody tests, identifying minimum performance criteria and considerations for devices intended to detect antibodies against SARS-CoV-2.   In formulating the guidance , MDCG looked to other regulators’ considerations for antibody tests, including the World Health Organization (WHO). Additionally, the working group reviewed the instructions for use from 102 separate...
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    EMA offers labeling flexibilities for COVID therapeutics

    After providing flexibility on labeling requirements for COVID-19 vaccines last year, the European Medicines Agency (EMA) on Monday offered guidance on when those flexibilities could be applied to COVID-19 therapeutics.   The temporary labeling and packaging flexibilities for COVID-19 vaccines are outlined in a memorandum of understanding between the European Commission and EU member states and a questions and answers guidance from EMA . The flexibilities include al...
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    MDCG addresses custom devices under MDR

    The European Commission’s Medical Device Coordination Group (MDCG) on Monday issued a new questions and answers document addressing custom-made medical devices under the Medical Device Regulation (MDR) and providing considerations for adaptable and patient-matched devices.   Custom-made devices (CMDs) are defined under MDR as devices made specifically in accordance with a written prescription by an authorized person that have specific design characteristics and are i...
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    EMA updates: Zynteglo safety review, clinical trial information system and more

    The European Medicines Agency’s Management Board and Pharmacovigilance Risk Assessment Committee (PRAC) on Friday released lengthy updates on a range of issues from the rollout of the EU IT systems required by the Clinical Trial Regulation and safety reviews of several medicines.   Management Board updates   After its meeting on Thursday, EMA’s Management Board stressed the need for specialized experts and resources at the national level to support EMA’s work to ...