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 and Japan ; Avigan (favilavir) in  China , Italy and Russia; and Veklury (remdesivir) in  Japan  and Australia.   Con...
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    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.   To date, just one coronavirus vaccine has been  approved . Sputnik V – formerly known as Gam-COVID-Vac and developed by the Gamale...
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    Recon: Moderna releases COVID vaccine trial blueprint; BioNTech buys Novartis’ site to boost EU vaccine production

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna would seek limited emergency use of COVID-19 vaccine based on early data ( Reuters ) ( Boston Globe ) Moderna Shares the Blueprint for Its Coronavirus Vaccine Trial ( NYTimes ) Moderna to develop seasonal flu vaccine ( Reuters ) Biden-aligned group outlines potential Day 1 drug pricing actions ( STAT ) US plans for hundreds of millions of cheap, fast ...
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    Recon: US COVID vaccine distribution plans; EU plans new biomedical research agency

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US plans to distribute COVID-19 vaccine immediately after regulators authorize it ( Reuters ) ( Politico ) Trump says coronavirus vaccine could be weeks away ( Reuters ) HHS chief overrode FDA officials to ease testing rules ( Politico ) US FDA's Hahn plans 'significant' work with AstraZeneca in COVID-19 trial inquiry ( Reuters ) Pfizer says late-stage corona...
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    Recon: AstraZeneca resumes COVID vaccine trials in South Africa, Brazil, US study still on hold

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump says not pressing US government for coronavirus vaccine for political reasons ( Reuters ) AstraZeneca COVID-19 vaccine trial in US on hold until at least midweek – sources ( Reuters ) ( KHN ) Bill Gates Wonders Whether FDA Can Be Trusted on a Covid Vaccine ( Bloomberg ) Axios-Ipsos poll: Distrusting Big Pharma and the FDA ( Axios ) Compass Pathways set ...
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    Recon: Gilead to buy Immunomedics for $21B; Trump signs international reference pricing order

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump unveils plan to slash drug costs tied to what's paid abroad ( Politico ) ( NYTimes ) ( WSJ ) ( STAT ) Trump Pressed for Plasma Therapy. Officials Worry, Is an Unvetted Vaccine Next? ( NYTimes ) Gilead Reaches Deal to Buy Immunomedics for $21 Billion ( WSJ ) ( FT ) ( Reuters ) ( STAT ) Merck to buy $1 bln stake in Seattle Genetics, co-develop cancer thera...
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    Recon: US trials blood thinners in COVID patients; Pharma’s campaign against ICER

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Marks: Prepare for 'EUA-plus' for Covid vaccines ( Politico ) ( Pink Sheet ) FDA chief says he has ‘no intention’ of overruling career staff on coronavirus vaccine decision ( CNBC ) Covid vaccine becomes divisive issue in US election campaign ( FT ) FDA Regulators Publish Rare Self-Defense Amid Rising Vaccine Pressure ( NYTimes ) Big Pharma wages stealth war ...
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    Recon: FDA approves GSK's three-drug asthma inhaler; EMA extends review of BioMarin gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senior FDA career executives: We're following the science to protect public health in pandemic ( USA Today ) The coronavirus pandemic underscores the need to bring drug manufacturing back to US ( CNBC ) Several Covid-19 Vaccines Could Join Winner’s Circle ( WSJ ) GSK's three-drug inhaler wins US nod for use in asthma patients ( Reuters ) ( Endpoints ) Trump s...
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    Recon: AstraZeneca halts COVID vaccine trial; France fines Roche, Novartis €444 over Lucentis marketing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How drugmakers can keep their pledge and still deliver an October vaccine surprise ( Reuters ) FDA Sets Up Vaccine Safeguards to Counter Pressure From Trump ( Bloomberg ) FDA authorizes emergency use of COVID-19 test from Alphabet's Verily ( Reuters ) Liquid biopsy startup Grail, in filing for IPO, lays out investments and plans for growth ( STAT ) Drug, devi...
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    Recon: Russian COVID vaccine shows antibody response in early trials; AbbVie to develop, sell I-Mab cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Covid-19 Vaccine Race Turns Deep Freezers Into a Hot Commodity ( WSJ ) Leader of US vaccine push says he‘ll quit if politics trumps science ( Science ) ( NPR ) US will not 'cut corners' in developing coronavirus vaccine, Pence says ( Reuters ) White House: no one pressuring FDA to approve coronavirus vaccine ( Reuters ) Moderna slows vaccine trial enrollment ...
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    Recon: CDC tells states to prep for COVID vaccine by November; 76 wealthy countries join COVAX plan

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Admin Asks States to Be Ready for Vaccine by November ( WSJ ) ( Reuters ) ( NYTimes ) ( FT ) Pfizer targets end of next month for COVID-19 vaccine update ( Reuters ) Unlikely that a COVID-19 vaccine will be ready in October, but not impossible, Fauci says ( Reuters ) Merck CEO sees human trials for COVID-19 vaccine candidate 'fairly soon' ( Reuters ) Pr...
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    Recon: FDA communications shakeup continues; EU considers joining WHO vaccine purchasing scheme

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA to bring outside experts to review COVID-19 vaccines ( Reuters ) FDA shake-up continues as another comms official removed from top role ( Politico ) Convalescent plasma not recommended to treat COVID-19, government panel says ( NBC ) ( FT ) US says it won’t join WHO-linked effort to develop, distribute coronavirus vaccine ( Washington Post ) Trump says he...