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    EMA's PRAC weighs in on more vaccine side effects

    The European Medicines Agency (EMA) has weighed in on several rare adverse events for COVID-19 vaccines and one gene therapy for treating thalassemia in their latest Pharmacovigilance Risk Assessment Committee (PRAC) meeting.   At its July meeting, EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) found mRNA-based COVID-19 vaccines, like Pfizer’s Comirnaty and the Moderna vaccine marketed in the EU as Spikevax, carry a small risk of myocarditis and pericarditis....
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    EMA updates Q&A on nitrosamine assessment and testing

    The European Medicines Agency (EMA) has published an updated “question and answer” guidance describing how manufacturers should assess the risk of nitrosamine impurities in drug products and how to test products for these impurities.   It contains minor revisions from a previous version published last year. (RELATED: EMA addresses risk evaluation, mitigation for nitrosamines , Regulatory Focus, 6 August 2020) . EMA wants marketing authorization holders (MAHs) ...
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    Recon: Biotech's 'coolers of cash;' Slipping pharma halo?

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cavazzoni Begins Putting Her Mark On FDA Drug Center With New Principal Deputy Position ( Pink Sheet ) ( Biocentury ) The Delta Variant Is The Dominant Coronavirus Strain In The U.S. ( NPR ) ( Reuters ) COVID-19 cases up in nearly half of US states: analysis ( The Hill ) Maryland says 100 percent of COVID-19 deaths last month were among unvaccinated ( The Hill...
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    Recon: AZ's $39B bid for Alexion cleared by EC; Leo taps X-Chem for derm drugs

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci: More than 99% of people who died from COVID-19 in June were not vaccinated ( The Hill ) The White House is taking right approach in fighting the Covid-19 delta variant, Gottlieb says ( CNBC ) Biden’s grand plan: ‘Blue Sky’ research to solve the biggest health problems ( MedCity News ) As COVID Vaccinations Slow, Parts Of The U.S. Remain Far Behind 7...
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    EC issues first COVID therapeutics portfolio

    As part of its strategy for COVID-19 therapeutics, the European Commission (EC) on Tuesday released a portfolio of the initial five therapeutics being considered for authorization for the treatment of COVID-19 patients.   Four of the candidate therapeutics are monoclonal antibodies in consideration under the European Medicines Agency’s rolling review process. The fifth therapeutic being considered, Eli Lilly’s Olumiant (baricitinib), is an orally administered immunosup...
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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 management board report: COVID coping, CTIS updates and more

    The management board of the European Medicines Agency (EMA) gave a generally positive assessment of the agency’s work through the COVID-19 pandemic, according to recently released highlights of the board’s June meeting.   The board has begun the process of conducting a formal reflection on lessons learned from the pandemic, with a more detailed discussion expected when the board reconvenes in October.   EMA’s board also reviewed the agency’s 2020 annual report publ...
  • EC proposes crisis-related devices role for EMA

    The European Council (EC) has proposed that the European Medicines Agency (EMA) take a stronger role in crisis management and preparedness, increasing its administrative oversight of medicinal products and also medical devices during emergencies such as the recent COVID-19 pandemic.   The proposal, first drafted in November 2020, is part of a triad of documents “aiming to strengthen the EU's health security framework and to reinforce the crisis preparedness and respons...
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    EMA updates COVID-19 vaccine risk management plans to reflect variant safety

    The European Medicines Agency (EMA) wants companies to provide safety information on additional strains or variants in an update to its guidance on risk management plans (RMPs) for COVID-19 vaccines. In the update, EMA also discourages sponsors from using passive surveillance to evaluate vaccine safety due to a lack of robustness in these methods.   The plan should be read in conjunction with EMA guidance on good pharmacovigilance practices, including GVP Module V, Mod...
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    Brexit, COVID-19 headline EMA’s 2020 annual report

    The European Medicines Agency (EMA) started 2020 by wrapping up challenges associated with the UK’s decision to leave the EU, only to run headlong into additional challenges brought on by the COVID-19 pandemic. In the annual report that also marked the agency’s 25 th anniversary, EMA outlined a year that looked different than most.   “As the scientific body in charge of the regulation of medicines, EMA had an essential part to play in ensuring treatments and vaccines ...
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    Recon: Novavax COVID-19 vax 90%-plus effective; GSK pays big for Iteos' TIGIT-targeted immunotherapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novavax Offers U.S. a Fourth Strong Covid-19 Vaccine ( NYT ) ( NPR ) ( Reuters ) Another Sad Coronavirus Pandemic Milestone Is Approaching ( NPR ) U.S. Not On Pace To Meet Biden's Vaccination Goal ( NPR ) Eight states see rise in new COVID-19 infections ( The Hill ) U.S. has administered over 309 million doses of Covid-19 vaccines, CDC says ( CNBC ) How did ...
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    EMA preps for EU common standard on electronic product information

    The European Medicines Agency (EMA) this week launched a stakeholder consultation on a draft EU common standard for electronic product information (ePI) for human medicines.   The common standard would provide a semi-structured template for ePI incorporating the authorized, statutory product information for medicines, including the summary of product characteristics (SmPC), labeling and package leaflet. EMA says that ePI will be better suited “for electronic handling a...