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    Euro Convergence: Experts advise on ways to manage the MDR grace period

    Medical device companies in Europe have much work to do to get their products compliant with the EU’s new Medical Device Regulation (MDR) and should not be wasting any time, asserted a panel of experts who spoke at RAPS Euro Convergence 2021 on 10 May.   At the virtual meeting, the experts gave some concrete advice for device manufacturers to ready themselves for a seamless transition.   The EU Medical Device Regulations (MDR) is a new set of new regulatory require...
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    Euro Convergence: Regulators and industry seek ‘sparks’ of European change

    The opening plenary of RAPS Euro Convergence 2021 saw regulators, competent authorities, and industry representatives highlighting pressing regulatory issues for in vitro diagnostics and combination products, among other topics.   The plenary kicked off with regulators presenting “sparks,” or hot button topics intended to trigger discussion; an industry panel was then given the chance to respond to proposals from the panel of regulators and notified body representati...
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    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...
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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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    Merck KGaA raises full-year forecast; Perlmutter's new gig tackles 'undruggable targets'

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly hit by staff accusations, FDA scrutiny at COVID drug factories ( Reuters ) Pharma showers Menendez with rare, off-cycle burst of campaign cash as Democrats eye drug pricing reforms ( STAT ) Rising wholesale drug prices really do matter to half of all commercially insured Americans ( STAT ) Facing fresh pricing threats in D.C., pharma spent a record $92...
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    EMA begins rolling review of Sinovac's COVID vaccine

    The European Medicines Agency (EMA) has added Sinovac’s COVID-19 vaccine to its portfolio of vaccines under rolling review.   The inactivated, adjuvanted Vero cell vaccine, known as Coronavac, joins three others that are in EMA’s rolling review process, which allows sponsors to add to the candidate vaccine’s portfolio as data accrues.   EMA’s human medicines committee (CHMP) then meets periodically to assess reports in support of the submission, notifying the spons...
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    Pfizer COVID vaccine under EMA review for younger teens

    The European Medicines Agency (EMA) is evaluating an application submitted by Pfizer and BioNTech for use of their COVID-19 vaccine in children aged 12 to 15 years.   Pfizer reported that it submitted its application for extension of authorization last week, and EMA announced today that it has undertaken the evaluation of the messenger RNA (mRNA) vaccine. The vaccine has been authorized by the EU for use in people 16 years and up since December 2020.   Trials of ...
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    MDCG offers guidance on clinical investigations under MDR

    In new questions and answers guidance released last week, the European Commission’s Medical Device Coordination Group (MDCG) offers advice to device makers on the appropriate regulatory pathways and other considerations for conducting clinical investigations under the Medical Device Regulation (MDR).   The 19-page document features 28 questions and answers as well as two annexes charting the regulatory pathways for clinical investigations and a non-exhaustive list of...
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    CHMP recommends eight new medicines in April, including two orphans

    In its April meeting, the European Medicines Agency’s (EMA’s) human medicines committee recommended eight new medicines for approval, including three new non-orphan medicinal products and two orphan medicines.   EMA’s Committee for Medical Products for Human Use (CHMP) also issued positive opinions for extensions of therapeutic indications for nine medicines, bringing the total new indications for 2021 to 23.   Leo Pharma’s Adtralza (tralkinumab) was recommended ...
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    EMA clarifies application of GMP principles to ATMP starting materials

    The European Medicines Agency (EMA) issued a question-and-answer guidance on 23 April addressing how good manufacturing practices (GMP) principles should be applied to starting materials for advanced therapy medicinal products (ATMPs) of biological origin.   EMA said that the Q&A is not meant to set new GMP requirements but rather to give guidance on “what principles of GMP mean and how to implement them.” The guideline describes “minimal” requirements in the fields of...
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    EMA boosts mRNA vaccine capacity, refines AstraZeneca risk-benefit

      The European Medicines Agency (EMA) is working to secure additional doses of the COVID-19 vaccine developed by Pfizer and BioNTech with an aim to deliver 1.8 billion doses to Europe by the end of 2023.   After touring the Pfizer plant in Puurs, Belgium, European Commissioner Ursula von der Leyen issued a joint statement with Belgium’s prime minister and BioNTech’s chief medical officer. “I am now confident that we will have sufficient doses to vaccinate 70% of th...