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    EMA: J&J vaccine possibly linked to rare clots; benefit outweighs risk

    After a review by its safety committee, the European Medicines Agency (EMA) has concluded that a “possible link” exists between receipt of the COVID-19 vaccine from Janssen, the pharmaceutical division of Johnson & Johnson, and a rare combination of blood clots in large veins and low platelet counts.   In a press release and briefing, PRAC, EMA’s safety committee, announced that it judged that the overall benefit-risk profile for the vaccine remains positive but conclu...
  • ReconRecon

    Recon: Abbott profits triple with OTC test launch; Good news for bluebird

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Large clinical trial to study repurposed drugs to treat COVID-19 symptoms ( NIH ) Q&A with Acting FDA Commissioner Janet Woodcock on the Future of the FDA ( BioSpace ) Covid cases, vaccinations remain elevated as U.S. nears Biden’s 200 million goal ( CNBC ) U.S. CDC expands COVID-19 vaccine eligibility to 16 and older ( Reuters ) Johnson & Johnson reports...
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    ICH shares "work-in-progress" update to GCP guidance

    The International Conference on Harmonization (ICH) has made available a draft version of its updated principles for good clinical practice. The principles are to be considered a “work-in-progress,” wrote ICH in announcing the availability of the updates, which are still in development by the ICH’s E6(R3) expert working group.   “The principles are interdependent and should be considered in their totality to assure ethical trial conduct, participant safety, and reliabl...
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    MDR/IVDR: Commission adopts new standardization request

    The European Commission this week adopted a new standardization request for harmonized European standards in support of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) after its initial standardization request was rejected last year.   In a commission implementing decision dated 14 April 2021, the Commission calls on the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENE...
  • ReconRecon

    Recon: ThermoFisher acquires PPD for $17.4B; First chimeric human-monkey embryos

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Daily U.S. Covid cases remain above 70,000 amid Johnson & Johnson vaccine pause ( CNBC ) Fauci, Jim Jordan spar over pandemic restrictions ( The Hill ) What’s behind the wait on a J&J vaccine verdict ( Politico ) ( NYT ) ( WSJ ) The J&J Vaccine Pause Is Science Working Like It’s Supposed To ( Slate ) Why the Johnson & Johnson pause may not matter for Amer...
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    MDR/IVDR: Commission updates on implementation, notified body designation

    The European Commission last week updated its rolling plan detailing the actions and initiatives necessary to ensure the smooth rollout of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).   With MDR’s date of application just weeks away, Finland’s Eurofins Expert Services Oy on Wednesday became the 20 th notified body designated under the regulation. Just four notified bodies have been designated under IVDR.   Based on the pipeli...
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    MDCG offers guidance on Class D tests during IVDR transition

    The European Commission’s Medical Device Coordination Group (MDCG) on Friday issued guidance on how certifications of the highest risk in vitro diagnostics (IVDs) under the In Vitro Diagnostic Regulation (IVDR) will be handled during the transition period that runs until 26 May 2022.   Under IVDR, diagnostics are divided into four classes, A, B, C and D, from lowest- to highest-risk, based on their intended purpose and their inherent risks, with certain requirement...
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    ATMPs: Global regulators eye harmonization for ultra-orphan products

    Top regulators from the US, EU, UK and Japan view harmonization as a critical factor in enabling the development of advanced therapy medicinal products (ATMPs) for ultra-rare diseases.   Particularly for cell and gene therapies targeting patient populations numbering in the hundreds worldwide, commercial viability and the feasibility of clinical trials can be complicated by jurisdictional differences in regulatory requirements. Such challenges were the topic of convers...
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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...