• TrackersTrackers

    COVID-19 therapeutics tracker

    A year into the pandemic, only 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 well ...
  • ReconRecon

    Recon: Pfizer, BioNTech seek to extend vaccine to ages 12-15; Deficiencies flagged in Provention diabetes drug application

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, BioNTech request expanded emergency use of Covid-19 vaccine for ages 12-15 ( CNBC ) Biden’s Orphaned AstraZeneca Stockpile Grows to 20 Million Doses ( Bloomberg ) Scientists work toward an elusive dream: a simple pill to treat Covid-19 ( STAT ) Biden pushes Congress to boost public health, pandemic preparedness funding ( STAT ) Inside the White House’...
  • TrackersTrackers

    COVID-19 vaccine tracker

    The worldwide endeavor to create a safe and effective COVID-19 vaccine is bearing fruit. More than 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 ...
  • ReconRecon

    Recon: Gilead gets full approval for breast cancer drug Trodelvy; OWS flagged issues at Emergent facility

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US allotting 85% less J&J vaccines to states next week, data shows ( Reuters ) The world is watching the FDA's AstraZeneca decision ( Axios ) Eli Lilly's arthritis drug fails to prevent mechanical ventilation in COVID-19 patients ( Reuters ) The big hole in America's plan to fight Covid-19 variants ( Politico ) Gilead wins full approval for drug acquired in I...
  • ReconRecon

    Recon: FDA approves Supernus ADHD drug Qelbree; Valneva to begin Phase 3 trial of its COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna Vaccine Production Pace to Increase at CMO Catalent ( WSJ ) ( Endpoints ) Walgreens Not Following US Guidance on Pfizer Vaccine Spacing ( NYTimes ) Biden Tax Plan Seen Hitting Tech, Pharmaceutical Companies ( Bloomberg ) Biden to speed up eligibility for vaccine as US hits milestone ( Reuters ) Former USAID chief tapped to lead vaccine diplomacy effor...
  • ReconRecon

    Recon: US puts J&J in charge of Emergent facility; FDA extends review of AbbVie’s Rinvoq for atopic dermatitis

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US puts J&J in charge of plant that botched COVID vaccine, removes AstraZeneca ( Reuters ) ( CNN ) ( NYTimes ) US searches for new AstraZeneca vaccine producer after Emergent mix-up ( Politico ) Emergent gets $23 million additional order for vaccine production ( Reuters ) Acadia preps for battle as the FDA rejects a potential blockbuster application ( Endpoint...
  • ReconRecon

    Recon: Moderna cleared to increase vaccine doses per vial; FDA investigating J&J vaccine mix-up at Emergent facility

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci says US may not need AstraZeneca COVID-19 vaccine ( Reuters ) FDA allows Moderna to put more coronavirus vaccine doses in each vial ( Politico ) ( Reuters ) ( FDA ) FDA Probes Cause of Failed Johnson & Johnson Covid-19 Vaccine Batch ( WSJ ) Why the Biden administration might not want to be content with just an acting FDA commissioner ( Endpoints ) Johns...
  • ReconRecon

    Recon: J&J discards 15M vaccine doses after mix-up at Emergent facility; GAO finds US doesn’t have patent rights to remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Factory Mix-Up Ruins Up to 15 Million Vaccine Doses From Johnson & Johnson ( NYTimes ) Company producing J&J vaccine had history of violations ( AP ) White House knew more than a week ago of J&J contractor vaccine-supply problems ( Politico ) An Accidental Disclosure Exposes a $1 Billion Tax Fight With Bristol Myers ( NYTimes ) ( Endpoints ) Pfizer shot 91% e...
  • ReconRecon

    Recon: Pfizer says COVID vaccine 100% effective in 12-15 year olds; FTC seeks to block Illumina’s Grail buyout

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden faces first Covid surge as allies brush off warnings ( Politico ) Pfizer COVID-19 vaccine safe, effective on adolescents in trial, companies say ( Reuters ) ( Press ) Pfizer to Test Covid-19 Vaccine That Doesn’t Need Ultracold Storage ( WSJ ) FTC seeks to block Illumina from buying Grail, citing threats to competition ( STAT ) ( FT ) ( WSJ ) How Biden’s...
  • ReconRecon

    Recon: Pfizer, BioNTech raise 2021 vaccine output to 2.5B doses; FDA rejects Keytruda in early breast cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The operation formerly known as Warp Speed: Biden leans heavily on the flagship Trump-era initiative ( STAT ) Pfizer raise 2021 vaccine output goal to 2.5B doses ( Reuters ) ( Endpoints ) ( FT ) Johnson & Johnson vaccine partner Emergent still lacks FDA's manufacturing green light ( Fierce ) Biden urged to keep patent protections for Covid vaccines ( FT ) FDA...
  • ReconRecon

    Recon: J&J, African Union reach deal for 400M COVID shots; Bluebird prices multiple myeloma CAR-T at $420K

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Pfizer, Moderna vaccines reduce COVID-19 infection risk by 90% after second dose ( Reuters ) US vaccination campaign gains steam as White House speeds shipments ( Reuters ) Biden admin remakes vaccine strategy after mass vaccination sites fizzle ( Politico ) Moderna says shipped 100 million COVID-19 vaccine doses to United States ( Reuters ) U.S. FDA approves Br...
  • ReconRecon

    Recon: GSK, Vir seek EUA for COVID antibody; FDA adcomm votes 19-to-1 against Pfizer’s tanezumab

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden sets goal of 200 million US COVID-19 shots in his first 100 days ( Reuters ) ( Politico ) J&J on track to meet vaccine delivery goal, White House says ( Politico ) For Biden, a New Virus Dilemma: How to Handle a Looming Glut of Vaccine ( NYTimes ) ‘Alex Azar Anonymous’: Trump health officials start a club to counter former HHS chief ( Politico ) Autopsy...