• TrackersTrackers

    COVID-19 therapeutics tracker

    A year into the pandemic, only a handful of repurposed therapeutics have been approved to treat COVID-19: dexamethasone in the UK and Japan; Avigan (favilavir) in China, Italy and Russia; and Veklury (remdesivir) in the US, UK and Japan.   The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for a handful of treatments including Eli Lilly and Company’s monoclonal antibodies bamlanivimab with etesevimab as well as Regeneron’s casirivi...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. More than a dozen vaccines now have been authorized around the globe; many more remain in development.   To clarify the landscape for our readers, our vaccine tracker has been split in two. The first chart details vaccines that have achieved regulatory authorization or approval; the second continues to follow candidates in Phase 1-3 clinical trials and some promising candidates in ...
  • Regulatory NewsRegulatory News

    What’s behind drug price spikes – and what can be done?

    Two newly published studies have highlighted the rising cost of brand-name and generic drugs, looking at why generic price spikes happen and how drug price hikes affect insured patients.   In an analysis published in Health Affairs , Aayan N. Patel, a researcher with the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital in Boston, and colleagues said that although there have been fewer spikes in drug prices be...
  • Regulatory NewsRegulatory News

    Older adults, Black patients underrepresented in post-marketing studies

    In postmarketing studies of cancer therapies approved by the US Food and Drug Administration (FDA), representation of older adults and Black patients does not appear to be improved compared with premarketing studies, a recent investigation in JAMA Network Open suggests.   In addition, the sex and race of participants were identified less frequently in postmarketing studies than premarketing studies, according to a cross-sectional analysis of 77 premarketing and 56 po...
  • Regulatory NewsRegulatory News

    GDUFA III: Use MDUFA model to create competition in generic drug markets

    As negotiations for the reauthorization of the Generic Drug User Fee Act (GDUFA) continue, stakeholders should consider a new financial model to improve equity and competition in generic drug markets, according to a recent Health Affairs blog post.   GDUFA was enacted in 2012 and reauthorized in 2017 as GDUFA II with the goal to “supplement FDA funds to expedite generic drug approval and inject competition in generic drug markets,” Margaret M. Dotzel, attorney and fo...
  • Regulatory NewsRegulatory News

    Insurance, physician barriers impede wider adoption of biosimilars

    Since 2015, the US Food and Drug Administration (FDA) has approved 29 biosimilar products, with some biologics having between four and five biosimilars now available.   When FDA approved the country’s first biosimilar, Zarxio (filgrastim-sndz) , the prospect that these products could help address the high cost of biologics and patient access issues seemed promising. However, the reality five years later is that uptake of biosimilars appears to be slow and inconsistent...
  • Regulatory NewsRegulatory News

    How to reduce bias, improve fairness in medical devices

    Lessons learned in the artificial intelligence community about addressing bias could also be applied to medical devices, according to a recent perspective in the journal Science .   “Initiatives to promote fairness are rapidly growing in a range of technical disciplines, but this growth is not rapid enough for medical engineering. Although computer science companies terminate lucrative but biased facial recognition systems, biased medical devices continue to be sold a...
  • Regulatory NewsRegulatory News

    HHS’ proposed 510(k) exemption proves the need for regulatory science

    Authors of a recent commentary in Nature Medicine have come out against a federal notice that would exempt more than 91 medical devices from premarket notification 510(k) requirements.   The notice , released by the Department of Health and Human Services (HHS) on 15 January, was published in the last days of the Trump administration without consulting the US Food and Drug Administration (FDA). It is currently on hold pending review per a “regulatory freeze” memora...
  • Regulatory NewsRegulatory News

    COVID innovation lessons could be applied elsewhere

    The global urgency of the COVID-19 pandemic spurred the development of new models of vaccine and drug development. Could these innovations help with researching non-pandemic vaccines or drugs, and potentially serve as a template in other areas of medicine?   Two papers recently published in Health Affairs suggest that, yes, these innovations could be applied elsewhere if deemed successful—but it’s also important to note the shortcomings of these new models as well. ...
  • Regulatory NewsRegulatory News

    FDA’s OCP 2020 report highlights achievements post-reorganization

    The US Food and Drug Administration’s (FDA’s) Office of Clinical Pharmacology has issued its 2020 report, highlighting the office’s contributions to drug development, research, policy and communication.   Describing the COVID-19 pandemic as the “personal and professional challenge of a lifetime,” Issam Zineh, PharmD, MPH, Director of the Office of Clinical Pharmacology (OCP), said OCP staff met the moment during a global public health crisis by creating “strike teams t...
  • Regulatory NewsRegulatory News

    GAO: COVID-19 vaccine production falls short of January 2021 goal

    The Operation Warp Speed (OWS) goal to produce 300 million COVID-19 vaccine doses by January 2021 was not met, according to a status report released by the US Government Accountability Office (GAO).   Companies with current emergency use authorizations (EUAs) for vaccines are contracted under the program to release a combined 200 million doses of their vaccines by the end of March 2021 but had released just 63.7 million doses (31.8%) as of 31 January 2021, the report n...
  • Regulatory NewsRegulatory News

    OCE year 4: Progress despite a pandemic

    Last year , the Oncology Center for Excellence laid out their vision for the future in the Project 2025 initiative, an ambitious effort to outline the future of cancer drug development and collaborate with stakeholders advance the field of oncology.   While the organization remains committed to Project 2025, they acknowledged efforts in 2020 soon shifted to address the needs of patients with cancer during the COVID-19 pandemic, according to Richard Pazdur, MD, directo...