• ReconRecon

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    EMA finalizes guidance on parallel MAA, EU-M4all procedure

    The European Medicines Agency (EMA) on Thursday released the final version of its guidance detailing the agency’s procedure for parallel EU-M4all (Article 58) and centralized marketing authorization applications (MAAs).   The guidance was adopted earlier this month following a public consultation launched in January and includes some minor changes from the draft version. (RELATED: EMA offers parallel Article 58, centralized authorization reviews , Regulatory Focus ...
  • RoundupsRoundups

    Euro Roundup: UK’s NICE launches five-year strategy

    The UK’s National Institute for Health and Care Excellence (NICE) on Monday announced a five-year strategy to revamp its approach to health technology assessments (HTA) to speed access to new and innovative treatments.   “The new strategy sets out a vision for the future where NICE will be more dynamic, work more collaboratively, and continue to build on the excellent foundations of the last 22 years,” said NICE Chief Executive Gillian Leng.   The strategy is built...
  • ReconRecon

    Recon: Vertex inks $900M deal with CRISPR Therapeutics; Congress investigates Emergent's contracts

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Is the US FDA at A Tipping Point? ( Pink Sheet ) New report finds COVID-19 pandemic causes dramatic shifts in prescription drug spending ( EurekAlert ) Trump administration awarded a firm $1.3 billion to make Covid vaccine syringes. Where are they? ( NBC ) U.S. Reaches Another Crucial Juncture In The Fight Against COVID-19 ( NPR ) Biden to push for more vacci...
  • Regulatory NewsRegulatory News

    EU clinical trial portal and database declared functional

    The European Medicines Agency (EMA) announced that its long-delayed EU clinical trial portal and database are fully functional, paving the way for the launch of the EU Clinical Trial Information System (CTIS) and the application of the EU Clinical Trial Regulation early next year.   The CTIS was originally expected in September 2018; however, a series of delays have pushed back the launch date for the system, and the EU Clinical Trial Regulation it is intended to suppo...
  • Regulatory NewsRegulatory News

    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...