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  • ReconRecon

    Recon: Regeneron seeks EUA for antibody cocktail to prevent COVID; Sanofi to build €400M vaccine site in Singapore

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Regeneron to seek US OK for COVID-19 cocktail to be used for prevention ( Reuters ) ( STAT ) White House says J&J COVID-19 shot shipments to be low until U.S. vaccine plant cleared by regulators ( Reuters ) Eli Lilly to focus on selling COVID-19 antibody drug combination ( Reuters ) CEO at troubled vaccine plant received 51 percent compensation boost in 2020 (...
  • 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’...
  • 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: EMA says 'possible' AZ-blood clot link; Invitae's $1.2B gene testing investment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. begins study on allergic reaction risk in Moderna, Pfizer vaccines ( NIH ) ( Reuters ) CDC says variant from the UK is now the most common strain circulating in the U.S. ( CNBC ) U.S. delivering about 3 million COVID-19 vaccines per day, up 8%: CDC director ( Reuters ) U.S. surpasses 150 million vaccine shots under Biden, on track to hit President’s new 2...
  • 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...