• Regulatory NewsRegulatory News

    FDA seeks global shift to include pregnant women in medical research

    The COVID-19 pandemic has put a spotlight on the paradox surrounding the inclusion of pregnant and breastfeeding women in medical research. Even when these women are at higher risk for severe illness and hospitalization, they are unlikely to be included in clinical trials for medical products and vaccines. In a recent article, officials at the US Food and Drug Administration (FDA) signaled their commitment to work with industry and other regulators to support the inclus...
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    House committee advances bills on advanced manufacturing, opioids and more

    Following a brief markup on Wednesday, the House Energy and Commerce Committee advanced 24 bipartisan health- and cybersecurity-related bills to the House for consideration, including bills aimed at advanced and continuous manufacturing for pharmaceuticals, supporting vaccination and addressing the ongoing opioid crisis. The first bill to be considered during the markup would amend the 21 st Century Cures Act to enable the US Food and Drug Administration (FDA) to des...
  • RoundupsRoundups

    FDA Approvals Roundup: Rezurock, Fexinidazole, Bylvay

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Rezurock cleared for treating chronic graft-versus-host disease Kadmon’s Rezurock (belumosudil) has been approved for treating chronic graft-versus-host disease (GVHD) in adults and children aged 12 years or older after failure of previous systemic therapy.   Approval of the kinase inhibitor was based on efficacy findings from the randomized...
  • ReconRecon

    Recon: J&J forecasts $2.5B in 2021 COVID vaccine sales; South Africa’s Biovac to make Pfizer-BioNTech vaccine in 2022

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Anthem still determining coverage policy for Biogen Alzheimer's drug ( Reuters ) Biogen Alzheimer's drug slow to take off as US Medicare wrestles with coverage ( Reuters ) Drugmakers, pharmacies next targets for US opioid settlements ( Reuters ) Former FDA adviser calls for wider probe into Biogen Alzheimer's drug approval ( Reuters ) J&J forecasts $2.5 bln i...
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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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    Senators press Woodcock on COVID vaccines, boosters

    Senators on both sides of the aisle pressed Janet Woodcock, acting commissioner of the US Food and Drug Administration (FDA), and other officials during a hearing on Tuesday. The senators asked for specifics on the timing of COVID-19 vaccine booster shots and when the vaccines currently authorized for emergency use might obtain full approval.   More than a year into the COVID-19 pandemic, the full Senate Health, Education, Labor and Pensions committee met to explore th...
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    Asia-Pacific Roundup: TGA seeks feedback on classification of devices applied to the skin

    Australia’s Therapeutic Goods Administration (TGA) has begun a consultation on refinements to the regulation of some medical devices. The proposals apply to devices that are substances introduced into the human body via an orifice or applied to the skin.   TGA published the proposals as part of its efforts to reclassify certain categories of medical devices so that they align with the new regulatory framework in the EU. Medical devices that consist of substances introd...
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    CBER targets four stem cell firms with untitled letters

    The US Food and Drug Administration’s Center for Biologics Evaluation and Research (FDA’s CBER) recently issued untitled letters to four companies for marketing unapproved stem cell products, indicating that despite the end of an enforcement grace period, companies are still resisting the agency’s efforts to get these products approved.   Effective June 1, companies are required to file biologics license applications for stem cell therapies that claim to treat a diseas...
  • 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...
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    Global regulators promote platform trials to assess new COVID vaccines

    Regulators from the United Kingdom and Japan are promoting the use of platform trials to evaluate second-generation COVID-19 vaccines as the pool of unvaccinated patients for testing new vaccines grows increasingly smaller. They also proposed the creation of a working group to build consensus on the design of master protocols, particularly in the context of health emergencies.   These pronouncements emerged from a 24 June virtual workshop on aligning approaches for dev...
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    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 ...
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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...