• Regulatory NewsRegulatory News

    PRAC investigates heart inflammation reports with Pfizer vaccine

    During an early May meeting, the European Medicines Agency’s safety committee concluded two reviews of safety signals related to COVID-19 vaccines, while it continued following other vaccine-related “topics of interest.” These included reports of heart muscle inflammation after receipt of the Pfizer-BioNTech vaccine.   EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) wrapped up a review of reports of facial swelling in recipients of Pfizer’s COVID-19 vaccine, k...
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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...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    A year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for a handful of treatments including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with etesevimab as well as Regeneron’s casirivi...
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    FDA awards two COA grants to study neurodevelopment disorders and nephrotic syndrome

    The US Food and Drug Administration (FDA) announced the awarding of two grants under its Clinical Outcome Assessments (COAs) program to inform the selection of clinical trial endpoints for drugs to treat neurodevelopmental disorders (NDDs) and nephrotic syndrome.   The grants “provide avenues to advance the use of patient input as an important part of drug development that can foster innovation and the availability of safe and effective drugs,” said the agency’s 4 May ...
  • ReconRecon

    Recon: Pfizer, BioNTech submit BLA for COVID vaccine; MHRA approves first drug under Project Orbis

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer-BioNTech files for US approval of COVID-19 vaccine ( Reuters ) ( NYTimes ) ( Politico ) ( Press ) Covid-19 Vaccines Are Wasted as Special Syringes Run Short ( WSJ ) How Big Pharma finds sick users on Facebook ( TNW ) ( Ars ) Adcomm splits slightly in favor of FDA approving ChemoCentryx’s rare disease drug ( Endpoints ) The US opened pandora’s box on IP...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. More than a dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in ...
  • Regulatory NewsRegulatory News

    Euro Convergence: Look for ‘positive sparks,’ says Klasen

    A key organizer of RAPS’ Euro Convergence 2021 speaks to what’s new this year, how the conference is approaching hot-button topics in the EU regulatory space and how first-time attendees can maximize their experience during the live, virtual event.   Eric Klasen, of Waypoint LC Consulting, is a co-chair of the RAPS Euro Convergence 2021 Conference Committee. Klasen, with co-chairs Gert Bos, executive director of Qserve Group, and Sabina Hoekstra-van den Bosch, a regula...
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    Pharma groups slam US decision to support COVID-19 vaccine patent waivers

    Pharmaceutical industry groups in the US and the EU lambasted a recent decision by the Biden Administration to support a proposal pending in the World Trade Organization (WTO) that would waive intellectual property patents for coronavirus vaccines, charging that the waiver is a bad idea that would compromise vaccine efficacy and safety. Their views clash with World Health Organization’s (WHO) arguments and other groups that the waiver is necessary to increase access to th...
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    EC strategy aims for 3-5 new COVID therapeutics by year end

    To support the development of therapeutics for COVID-19, the European Commission on Thursday announced a new strategy intended to bring at least three to five new COVID-19 therapeutics to market this year.   The strategy, which includes more than €140 million in funding, aims to streamline the development of promising new medicines and ensure their speedy rollout across the EU, complementing the strategy the Commission deployed for COVID-19 vaccines last year. (RELATED...
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    RAPS' LatestRAPS' Latest

    RAPS Euro Convergence: A preview

    RAPS Euro Convergence is just around the corner. The three-day conference devoted to European healthcare product regulations and regulatory issues kicks off Monday 10 May, running through 12 May. Pre-conference workshops begin Friday, 7 May.   This year’s all-virtual program will feature more than 130 expert speakers and more than 40 educational sessions. Attendees will hear from speakers representing the European Commission (EC), the European Medicines Agency (EMA),...
  • ReconRecon

    Recon: Moderna lifts guidance on COVID vaccine sales; US backing of patent waiver causes stir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US backs giving poorer countries access to COVID-19 vaccine patents, reversing stance ( Reuters ) ( STAT ) ( NYTimes ) ( Endpoints ) ( Harvard Bill of Health ) ( KEI ) ( Patent Docs ) Drugmakers say Biden misguided over vaccine patent waiver ( Reuters ) ( FT ) Global pharma shares slide as Biden backs COVID-19 vaccine IP waiver ( Reuters ) Explainer: COVID-19 ...
  • RoundupsRoundups

    Euro Roundup: EU committee publishes pharmaceutical strategy draft

    A draft report from the European Parliament health committee aims to ensure access to medicines, promote competitiveness and improve crisis-response mechanisms.   Proposals from the Committee on the Environment, Public Health and Food Safety (ENVI) address how medicines are regulated in the European Union and, to a lesser extent, overseas. The report stresses the need to cut national approval times and align them with European Medicines Agency (EMA) workflows. ENVI als...