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

  • ReconRecon

    Recon: WHO launches COVID-19 IP pool with 30 countries; Sanofi vaccine chief heads to Ipsen

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Administration initially dispensed scarce covid-19 drug to some hospitals that didn’t need it ( Washington Post ) Additional blood cancer responses seen with Allogene’s off-the-shelf CAR-T cells, updated study shows ( STAT ) ( Endpoints ) US hospitals slash use of drug championed by Trump as coronavirus treatment ( Reuters ) US FDA approves Eli Lilly's diagnos...
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    Recon: FDA finds NDMA in some metformin products; EU plans permanent medical stockpile

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US “I’ll Send You the Contact”: Documents Expose FDA Commissioner’s Personal Interventions on Behalf of Trump’s Favorite Chloroquine Doctor ( Vanity Fair ) US coronavirus deaths top 100,000 as country reopens ( Reuters ) FDA Finds Carcinogen in Some Versions of Metformin ( Bloomberg ) ( Reuters ) ( STAT ) Pfizer ties up with glass maker Corning for vial supply ( ...
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    Recon: France, Italy and Belgium halt hydroxychloroquine use for COVID-19; Novavax buys Praha vaccines for $167M to boost capacity

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci: Hydroxychloroquine not effective against coronavirus ( Politico ) Moderna execs have cashed out $89M in shares this year, as stock soared on vaccine hopes ( STAT ) Trump administration to take action to cap insulin costs for seniors ( Washington Post ) ( STAT ) ( NPR ) Quest Diagnostics launches coronavirus testing for employees returning to work ( Reut...
  • ReconRecon

    Recon: Sanofi to sell $13B stake in Regeneron; Merck to buy vaccine maker Themis Bioscience

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Regeneron to buy back $5 billion stake held by Sanofi ( Reuters ) ( Financial Times ) Merck to buy Austrian vaccine maker as it jumps into COVID-19 race ( Reuters ) ( STAT ) FDA shuffles longtime division head, Janet Woodcock, to focus exclusively on Covid-19 vaccine project ( STAT ) Evofem's gel first non-hormonal contraceptive to get approval in over 30 year...
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    Recon: FDA approves Sunovion Parkinson’s drug; Oxford-AZ vaccine moving to Phase 2/3 trials

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A quarter of Americans are hesitant about a coronavirus vaccine - Reuters/Ipsos poll ( Reuters ) Drug touted by Trump as COVID-19 treatment tied to increased risk of death: study ( Reuters ) ( Washington Post ) ( STAT ) ( The Lancet ) Prominent Scientists Denounce End to Coronavirus Grant ( NYTimes ) ( Science ) 'This is a bad practice': Doctors question FDA p...
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    Recon: US secures 300M doses of potential AZ-Oxford vaccine; Beximco launches generic remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US gives up to $1.2 billion to AstraZeneca for Covid-19 vaccine ( STAT ) ( Reuters ) ( FT ) Trump’s Vaccine Chief Has Vast Ties to Drug Industry, Posing Possible Conflicts ( NYTimes ) Biosimilars got the cold shoulder from health plans when it came to preferred coverage ( STAT ) GSK ties up with gene editing start-up Mammoth for COVID-19 test ( Reuters ) High...
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    Recon: Woodcock, Marks recuse themselves from COVID-19 vaccine approval decisions; FDA approves Lynparza for prostate cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amid conflict-of-interest criticisms, top FDA officials recuse themselves from Covid-19 vaccine approvals ( STAT ) Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine ( STAT ) Prototype Vaccines Protect Monkeys From Coronavirus ( NYTimes ) ( Reuters ) Inovio says COVID-19 vaccine produces antibodies in mice, guinea pigs ( Reu...
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    Recon: BARDA awards new firm $350M for domestic drug production; FDA approves Tecentric for first-line therapy for some lung cancers

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump says big announcements made and coming on therapeutics, vaccines ( Reuters ) Trump to Tap New Company to Make Covid-19 Drugs in the US ( NYTimes ) ( Reuters ) Politics could dictate who gets a coronavirus vaccine ( Politico ) Trump says he is taking hydroxychloroquine despite FDA warning ( Reuters ) CDC plans sweeping COVID-19 antibody study in 25 metro...
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    Recon: Moderna sees immune response in Phase 1 study; GSK says monthly injection tops Truvada in HIV prevention trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Early data show Moderna Covid-19 vaccine generates immune response ( STAT ) ( NYTimes ) ( Reuters ) Gilead to end coronavirus drug trials, adding to access worry: researchers ( Reuters ) Trump Vows Vaccine by End of Year, and Mobilizes Military to Help ( NYTimes ) ( STAT ) US to stockpile vaccine candidates as trials continue: health secretary ( Reuters ) Tru...
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    Recon: Pfizer plans Phase III study for DMD gene therapy; FDA rejects Blueprint cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer says efficacy of its Duchenne gene therapy outweighs side effects ( STAT ) ( Endpoints ) ( Reuters ) After a PhIII failure, the FDA delivers Blueprint an expected CRL ( Endpoints ) ( Reuters ) Trump Weighs Made-in-US Order for Vital Drugs, Devices ( Bloomberg ) Trump administration to expand strategic stockpile for pandemic needs ( Politico ) Convalesc...
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    Recon: Sanofi CEO promises access to COVID-19 vaccine after French backlash; Japan says remdesivir in use at hospitals

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Taps Ex-Glaxo Official and General to Lead Vaccine Race ( Bloomberg ) ( Reuters ) ( Politico ) Trump mobilizing US military to deliver coronavirus vaccine ( Reuters ) Trump administration fires back at ousted vaccine expert as he testifies on his role in US coronavirus response ( STAT ) ( WSJ ) Ousted vaccine chief: 'Our window of opportunity is closing'...
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    Recon: Gilead licenses remdesivir for distribution to 127 countries; FDA refuses BMS, Bluebird cell therapy application

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US French Drug Giant to Give U.S. Preference on Covid Vaccine ( Bloomberg ) Moderna CEO says no single drugmaker can produce enough coronavirus vaccine doses for the planet ( CNBC ) FDA refuses application for cell therapy from BMS, Bluebird, dealing both a major setback ( STAT ) ( Endpoints ) ( Press ) Top Science and Health Officials Offer Sobering View of Reop...