• Regulatory NewsRegulatory News

    EC announces €120 million in Horizon Europe funding

    The European Commission (EC) has pruned the list of COVID-19-related research projects it plans to fund, announcing Thursday a short list of 11 projects that will receive €120 million in total.   Funding for the projects will come from Horizon Europe, a research and innovation program that launched in 2021 and is planned to sunset by 2027. The program supports “urgent research” into COVID-19 with a focus on the emerging threats of variants of SARS-CoV-2, according to...
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    EMA begins rolling review of Sanofi Pasteur COVID vaccine

    The European Medicines Agency (EMA) has taken a fifth COVID-19 vaccine candidate into its rolling review scheme, evaluating data as they become available to speed a regulatory decision amid the ongoing public health emergency of the COVID-19 pandemic.   EMA’s decision to evaluate Sanofi Pasteur’s Vicprevtyn vaccine by rolling review is based on non-clinical data and early clinical studies “which suggest that the vaccine triggers the production of antibodies that target...
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    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...
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    Kineret under review by EMA for some COVID patients

    The European Medicines Agency has begun a new evaluation of an immunosuppressive drug to treat certain patients with COVID-19.   The agency announced Monday that it is reviewing an extension of indication for Kineret (anakinra, Swedish Orphan Biovitrum AB), to treat people with COVID-19 pneumonia at risk of developing severe respiratory failure. The human interleukin-1 (IL-1) antagonist was first authorized for use in the EU in 2002 and is currently authorized for th...
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    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...
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    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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    FDA reports rare complications with Pfizer COVID vaccine, updates J&J safety info

    A summary of results of near real-time monitoring of the safety of COVID-19 vaccines in  older individuals was reported Tuesday by the US Food and Drug Administration (FDA). The agency identified four potential health concerns associated with receiving one of the authorized vaccines.   Examining the database of Medicare health care claims for people aged 65 years and older who received the mRNA vaccine marketed by Pfizer/BioNTech, FDA identified four adverse events o...
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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...
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    Woodcock calls for investigation into Aduhelm approval

    The US Food and Drug Administration’s acting head has called on the Inspector General at the Department of Health and Human Services to conduct an investigation into matters related to the agency’s recent controversial approval of Biogen’s new Alzheimer’s disease drug Aduhelm (aducanumab).   Janet Woodcock, acting director of the US Food and Drug Administration (FDA), took to Twitter early Friday afternoon to make the announcement, sharing the letter she sent to Christ...
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    FDA trims Aduhelm's indicated population

    Biogen’s newly approved Alzheimer’s disease drug Aduhelm (aducanumab-avwa) received a labeling update Thursday to clarify that the drug is meant for individuals with mild cognitive impairment or dementia due to Alzheimer’s disease.   Just last month, Aduhelm received accelerated approval from the US Food and Drug Administration (FDA), a controversial decision that ran counter to the strong opinions of the agency’s Peripheral and Central Nervous System advisory committe...
  • 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...
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    FDA finalizes guidance on studying CNS metastases in cancer trials

    A final guidance document from the US Food and Drug Association (FDA) provides recommendations for drug developers on how best to evaluate the safety and efficacy of cancer drugs in patients with central nervous system (CNS) metastases. The document finalizes a draft guidance issued in August 2020.   "There are few effective treatments for patients with central nervous system (CNS) metastases – a type of cancer that has spread from the original tumor to the CNS and is ...