RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

  • TrackersTrackers

    COVID-19 therapeutics tracker

    As the COVID-19 pandemic continues, researchers and manufacturers are moving potential therapeutics into clinical trials at a dizzying pace. The search is on to find treatment candidates that lower mortality rates and lessen the severity of COVID-19.   To date, three therapeutics are approved to treat COVID-19: dexamethasone in the  United Kingdom ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan .   Potential therapies are being...
  • TrackersTrackers

    COVID-19 vaccine tracker

    Researchers worldwide are working around the clock to find a vaccine against SARS-CoV-2, the virus causing the COVID-19 pandemic. Experts estimate that a fast-tracked vaccine development process could speed a successful candidate to market in approximately 12-18 months – if the process goes smoothly from conception to market availability.   The pandemic has created unprecedented public/private partnerships.  Operation Warp Speed  (OWS) is a collaboration of several US ...
  • Regulatory NewsRegulatory News

    EU agencies clarify pharmacovigilance expectations amid COVID-19

    In an update to their joint questions and answers document on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, the European Medicines Agency (EMA), European Commission and Heads of Medicines Agencies (HMA) expand on their expectations for pharmacovigilance.   The updated document features three new questions related to pharmacovigilance, covering topics from corrective and preventive actions management to pharmacovigila...
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    FDA issues COVID-19 vaccine guidance, setting 50% effectiveness threshold

    In an immediately effective guidance issued Tuesday, the US Food and Drug Administration (FDA) sets its expectations for the development and licensure of vaccines to prevent coronavirus disease (COVID-19), including considerations for manufacturing, nonclinical and clinical studies and post-licensure requirements.   For a vaccine that would be widely deployed against COVID-19, FDA says it expects sponsors to demonstrate that the vaccine is at least 50% effective in a p...
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    WHO ACT-Accelerator prioritizes global vaccine approach

    The importance of a global approach to vaccine development and production, with a focus on collaboration, was a topic of a technical update and press briefing held 26 June by the World Health Organization (WHO).   The usual practices for drug development have been upended by the speed and scale of the COVID-19 pandemic, said officials. “I’m very hopeful and optimistic that this will be an unprecedented collaboration that also sets a model for the future,” said WHO Chie...
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    EMA revises methodological guidance for trials impacted by COVID-19

    Following a four-week public consultation, the European Medicines Agency (EMA) on Monday revised its guidance on methodological considerations for ongoing clinical trials amid the coronavirus disease (COVID-19) pandemic.   The agency also says it will extend its decision to hold all upcoming committee and working party meetings virtually through September 2020. The agency adds that it will continue its practice of holding stakeholder events virtually or postponing th...
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    Revise remdesivir EUA to add registry, say researchers

    The US Food and Drug Administration (FDA) should create a patient registry to track key information about COVID-19 patients treated with remdesivir, according to three Harvard Medical School researchers. The researchers also called for FDA to begin negotiations with Gilead, which markets remdesivir, about pricing for the antiviral drug.   In a Viewpoints article published yesterday in JAMA, Ameet Sarpatwari, PhD, JD, and coauthors noted that FDA’s 1 May emergency use...
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    EMA recommends remdesivir to treat COVID-19, authorization expected next week

    Following a rolling review that kicked off in late April, the European Medicines Agency (EMA) on Thursday recommended conditionally authorizing Gilead Sciences’ (Veklury) remdesivir to treat patients ages 12 and older with severe coronavirus disease (COVID-19) requiring supplemental oxygen.   EMA says it expects the European Commission to sign off on the conditional marketing authorization for remdesivir next week using a fast-track process, which will allow the drug t...
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    International regulators iron out COVID vaccine trial harmonization

    As more candidate vaccines for the novel coronavirus are progressing to advanced clinical trials, international regulators are planning for international convergence on the nuts and bolts of what is needed to move to phase 3 trials of COVID-19 vaccines. On Monday, a group of regulators were convened under the umbrella of the International Council of Medicines Regulatory Authories (ICMRA) for a multinational discussion. In all, 100 regulators from more than 20 countries ...
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    Hahn testifies on COVID-19 response, says FDA on target to hit user fee goals

    US Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, on Tuesday testified before the House Energy and Commerce Committee on his agency’s response to the coronavirus disease (COVID-19) pandemic.   User fee goals, policy review   Despite an “incredible surge in volume” of applications and constraints on the agency’s ability to conduct inspections, Hahn said that FDA, “Has maintained the same pace of meeting its goals on applications for medical produc...
  • FDA to sponsors: Early communication key during COVID-19

    Virtual meetings – a staple of business life during the COVID-19 pandemic – are an option for sponsors who seek meetings with the US Food and Drug Administration. Best routes of communication with the FDA both for coronavirus-related and other submissions and tips for having productive virtual meetings were shared with attendees of the virtual DIA 2020 global annual meeting by Khushboo Sharma, deputy director of operations at the Office of New Drugs at FDA’s Center for Dru...
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    Lawmakers ask FDA to outline COVID-19 vaccine approval process

    Key Democratic members in the US House of Representatives have called on Stephen Hahn, MD, commissioner of the US Food and Drug Administration (FDA), to brief their staff on how the agency plans to make decisions regarding the development, review and deployment of vaccines against the novel coronavirus SARS-CoV-2.   In a letter dated 18 June, Rep. Carolyn Maloney (D-NY), chairwoman of the House Committee on Oversight and Reform, Rep. Raja Krishnamoorthi (D-IL), chairma...