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

 
  • ReconRecon

    Recon: AstraZeneca gets partial liability protection in EU vaccine deal; Novavax COVID vaccine enters Phase 3

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How Trump is undermining his own vaccine race ( Politico ) Trump signs US healthcare executive orders that may have little impact ( Reuters ) ( WSJ ) Trump promises drug discount cards as a $200 pre-election gift ( NYTimes ) ( STAT ) ( Reuters ) ( Politico ) Cuomo says New York to review any COVID-19 vaccine authorized by federal government ( Reuters ) ( NPR )...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    Months into the COVID-19 pandemic, just three therapeutics have been 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.   Convalescent plasma may be used in the US to treat hospitalized patients under an emergency use authorization (EUA) or an investigational new drug application (IND). “Adequate and well-controlled randomized trials remain ne...
  • 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.   To date, just one coronavirus vaccine has been  approved . Sputnik V – formerly known as Gam-COVID-Vac and developed by the Gamale...
  • ReconRecon

    Recon: Trump says he may block FDA vaccine EUA guidance; Gilead to pay $97M to settle kickback claims

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Top adviser steps aside from FDA COVID-19 vaccine reviews over potential conflict ( Reuters ) Trump says he might reject stricter FDA vaccine guidelines ( Politico ) ( Reuters ) ( Endpoints ) Azar falls in line under Trump again. Experts say he's reinforcing a dark signal sent to the FDA ( Endpoints ) AstraZeneca still waiting for FDA go-ahead to resume US tri...
  • ReconRecon

    Recon: UK to host COVID vaccine challenge trials; Roche, AC Immune Alzheimer’s drug flops in Phase 2 study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA poised to announce tougher standards for a covid-19 vaccine that make it unlikely one will be cleared by Election Day ( Washington Post ) ( FT ) ( NYTimes ) ( Reuters ) CDC Advisory Panel to Delay Vote on Initial Covid-19 Vaccine Rollout ( WSJ ) US health agency sets October 16 deadline for states to submit vaccine plans ( Reuters ) J&J kicks off final stu...
  • ReconRecon

    Recon: COVID vaccine makers see EU liability shield; BMS lands FDA priority review for ide-cel CAR-T therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Decision Time Looms for Biotech’s Riskiest Bet ( WSJ ) After bruising rejection, bluebird and Bristol Myers Squibb land ide-cel priority review. But will it matter for the CVR? ( Endpoints ) ( Press ) Medicare Wouldn’t Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Authorization ( WSJ ) CDC Advisory Panel to Delay Vote on Initial...
  • ReconRecon

    Recon: HHS asserts rulemaking authority over FDA; AstraZeneca releases COVID vaccine trial blueprints

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US In ‘Power Grab,’ Health Secretary Azar Asserts Authority Over FDA ( NYTimes ) ( Endpoints ) ( HHS ) Democratic chairman says White House blocked FDA commissioner from testifying ( The Hill ) A Deal on Drug Prices Undone by White House Insistence on ‘Trump Cards’ ( NYTimes ) Top US Health Officials Tiptoe Around Trump’s Vaccine Timeline ( NYTimes ) Emails Deta...
  • ReconRecon

    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 ...
  • ReconRecon

    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...
  • ReconRecon

    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 ...
  • ReconRecon

    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...
  • ReconRecon

    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 ...