• ReconRecon

    Recon: $26B Opioids lawsuit deal imminent; Amylyx closes $135M ALS financing deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How an Unproven Alzheimer’s Drug Got Approved ( NYT ) States and Cities Near Tentative $26 Billion Deal in Opioids Cases ( NYT ) Drug distributors settle New York opioid claims for up to $1.18B  ( Reuters ) Pharma CEOs, lobbyists showered Democrat with cash after his attempt to torpedo Pelosi’s drug pricing bill ( STAT ) Advocates urge Biden to name patent of...
  • Regulatory NewsRegulatory News

    AAM: Medicare Part D plans slow to adopt generics

    Medicare Part D plans are slow to adopt generic medications for their beneficiaries, according to a recent report released by the Association for Accessible Medicines (AAM).   For the 2021 plan year, Medicare Part D formularies covered 21% of approved first generic medications from the previous year compared with the 66% covered by commercial formulary plans, the report stated. But this is part of a years-long trend, according to AAM. Not only do Medicare Part D plans ...
  • Regulatory NewsRegulatory News

    MHRA announces streamlined clinical trial review process

    In the wake of the systemic changes flowing from the UK’s exit from the EU, the country’s Medicines and Healthcare products Regulatory Agency (MHRA) plans to streamline review of clinical trials for medicinal products.   Beginning in January 2022, new Clinical Trials of Investigational Medicinal Products (CTIMPs) will receive a combined review from MHRA and the UK Research Ethics Services, with collaboration from the UK’s Health Research Authority (HRA). The process is...
  • Regulatory NewsRegulatory News

    FDA’s regulatory affairs head previews Inspectional Affairs Council

    The top regulatory affairs official at the US Food and Drug Administration (FDA) gave a preview of a soon-to-be-launched council within the agency that will focus solely on inspection-related matters.   “We will soon stand up an agency-wide decision-making body; it’s called the FDA Inspectional Affairs Council,” said Judith McMeekin, FDA’s associate commissioner for regulatory affairs within the Office of Regulatory Affairs (ORA), speaking at a virtual webinar hosted W...
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    CBER Q&A addresses stem cell enforcement questions

    The US Food and Drug Administration (FDA) issued a question-and-answer document on Monday to address issues that may arise now that the agency's enforcement discretion policy against unauthorized marketing of these products has come to an end.   The agency’s Center for Biologics Evaluation and Research (CBER) ended a period of enforcement discretion against purveyors of unauthorized human cells, tissues, or cellular or tissue- based products (HCT/Ps) on 31 May 2021. Ac...
  • ReconRecon

    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...
  • ReconRecon

    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...
  • Regulatory NewsRegulatory News

    PIC/S finalizes GMP data integrity guidance

    This week, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and integrity for pharmaceutical manufacturers and distributors has come into effect.   When authorities inspect facilities of manufacturers and distributors of active pharmaceutical ingredients to ensure good manufacturing practice and good distribution practice (GMP/GDP) compliance, “The effectiveness of these inspection processes...
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    FDA issues draft guidance for transdermal adhesion systems

    The US Food and Drug Administration has issued new draft guidance for clinical trials examining the adhesion performance of transdermal and topical delivery systems (collectively, TDS) for new drug applications.   Surface area is an important variable in determining the amount of drug delivered through a TDS; adhesion performance can affect both safety and effectiveness of TDS products because adhesion failures can result in reduced effectiveness caused by suboptimal d...
  • Regulatory NewsRegulatory News

    FDA releases first Cures Act report on patient experience data in regulatory decision-making

    The US Food and Drug Administration (FDA) has published its first report on how it uses patient experience data in regulatory decision-making.   As part of the 21st Century Cures Act of 2016 , FDA is required to publish patient data assessment reports in 2021, 2026, and 2031. The agency contracted Eastern Research Group, Inc. to conduct the assessment and publish the report for 2021.   When assessing how FDA uses the experience of patients in their decision-making...
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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...