• TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. 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 early deve...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Almost a year into the pandemic, 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 antibody bamlanivimab alone and in combination with etesevimab as wel...
  • 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...
  • Regulatory NewsRegulatory News

    Woodcock: FDA plans guidance to address new COVID-19 variants

    The US Food and Drug Administration is actively monitoring and assessing how current vaccines, therapeutics, and diagnostics are impacted by emerging COVID-19 variants and will issue guidance for ongoing medical product development against these variants.   In a recent statement, US Food and Drug Administration (FDA) acting commissioner Janet Woodcock, MD, said FDA has been monitoring potential new coronavirus variants since the start of the COVID-19 pandemic, and the ...