• 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...
  • ReconRecon

    Recon: Pfizer begins pediatric trial of COVID vaccine; AstraZeneca revises vaccine efficacy rate to 76%

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer hopes for a happy ending for an osteoarthritis drug with a troubled history ( STAT ) Behind the scenes, companies helping big Covid-19 vaccine makers are getting rich ( STAT ) HHS is urged to use its patents for the Moderna Covid-19 vaccine to widen global access ( STAT ) HHS inspector general signs off on Novartis paying for pricey Kymriah ( Endpoints ...
  • ReconRecon

    Recon: Boston Scientific settles surgical mesh claims for $189M; EU tightens COVID vaccine export rules

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US J&J plant authorization clears way for big boost in US COVID-19 shots ( Reuters ) Boston Scientific in $189 million settlement with US states over surgical mesh devices ( Reuters ) Kaleido Biosciences says oral drug cuts COVID-19 recovery time, hospitalizations ( Reuters ) ‘A mess across the board’: Senate committee kicks off talks on drug pricing reforms ( En...
  • ReconRecon

    Recon: Abernethy to leave FDA next month; AstraZeneca’s ‘outdated’ vaccine data

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amy Abernethy, deputy commissioner who aimed to amp up FDA’s tech knowhow, to leave post ( STAT ) ( Endpoints ) AstraZeneca to issue trial update after US criticism over data ( Reuters 1 , 2 ) ( WSJ ) ( Endpoints ) ( STAT ) ( Politico 1 , 2 ) ( NYTimes ) ( FT ) Back and forth over Astrazeneca's COVID-19 statement an 'unforced error' – Fauci ( Reuters ) Biden...
  • ReconRecon

    Recon: AstraZeneca COVID vaccine 79% effective in US trial; FDA raises safety concerns ahead of tanezumab adcomm

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca US trial data a confidence booster for COVID-19 shot ( Reuters ) ( NYTimes ) ( STAT ) ( Press ) Covid-19 Vaccine Manufacturing in US Races Ahead ( WSJ ) Russia says unnamed US firm violated patent rights on Sputnik V vaccine ( Reuters ) Vaccine mystery: Why J&J’s shots aren’t reaching more arms ( Politico ) Push to make Covid vaccines causes US dr...
  • ReconRecon

    Recon: Senate confirms Becerra as HHS secretary; NICE rejects Keytruda for advanced bladder cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US How the bitter political fight over painkillers could derail Biden's FDA pick ( Politico ) Senate confirms Becerra in tight vote with just one GOP defection ( The Hill ) FDA official: US AstraZeneca stockpile not in danger of expiring ( The Hill ) Biden administration begins throwing out Medicaid work rules ( Politico ) Some Long Covid Patients Feel Much Bett...
  • Regulatory NewsRegulatory News

    Recon: EU threatens to curb COVID vaccine exports; Pfizer to halt biosimilar manufacturing in China

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA extends review period for expanded use of Abbvie's arthritis drug ( Reuters ) Democrats treading lightly on Biden’s next big health care promise ( Politico ) Pharma wins a round in a battle with HHS over a drug discount program for hospitals ( STAT ) ( Law360 ) ( Endpoints ) Washington may become the second state to distribute its own generic drugs ( STAT ...
  • ReconRecon

    Recon: Moderna begins pediatric COVID vaccine trial; Eli Lilly bowel disease drug succeeds in Phase 3

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US drug distributors urge govt to boost COVID-19 vaccine supply network ( Reuters ) Moderna begins study of COVID-19 vaccine in kids ( Reuters ) AstraZeneca, US agree 500,000 more supplies of COVID-19 antibody cocktail ( Reuters ) Purdue Pharma to use public trusts, Sackler cash to settle opioid litigation ( Reuters ) ( NYTimes ) Eli Lilly bowel disease treat...
  • ReconRecon

    Recon: Germany, Italy, France halt AstraZeneca shots; Roche buys GenMark for $1.8B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US data for AstraZeneca vaccine under review by independent advisers - U.S. official ( Reuters ) Roche buys GenMark for $1.8 million to challenge test rivals ( Reuters ) ( Press ) Gilead, Merck collaborate to develop long-acting HIV treatment ( Reuters ) ( BioPharmaDive ) AstraZeneca to seek U.S. authorization for COVID-19 vaccine this month or early next ( Re...
  • ReconRecon

    Recon: WHO okays J&J vaccine for emergency use listing; Sanofi, Translate Bio launch trial of mRNA COVID vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden: All US adults to be eligible for vaccines by May, some normalcy coming by summer ( Reuters ) Pharma Giants Get Their Pennies Pinched on Drug Pricing ( WSJ ) The top drugs that could be impacted by an obscure provision in the pandemic relief law ( BioPharmaDive ) To Extract More Doses per Vial, Vaccinators Put Squeeze on FDA to Relax Handling Advice ( KH...
  • ReconRecon

    Recon: EU extends vaccine export checks; Vir, GSK to seek EUA for COVID antibody treatment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Insider alleges Eli Lilly blocked her efforts to sound alarms about US drug factory ( Reuters ) Americans seek compensation for failed COVID-19 treatments from US fund ( Reuters ) House Gives Final Approval To $1.9 Trillion COVID-19 Relief Package ( NPR ) Pfizer/BioNTech say COVID-19 vaccine likely to prevent asymptomatic infection ( Reuters ) Vir, GSK plan t...
  • ReconRecon

    Recon: US to order 100M more J&J vaccine doses; Lilly antibody combo cut COVID hospitalizations, deaths in second Phase III study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US 6 former FDA commissioners push Biden to nominate a permanent chief ( STAT ) Biden to order 100 million more doses of Johnson & Johnson vaccine ( Politico ) ( Reuters ) Biden Got the Vaccine Rollout Humming, With Trump’s Help ( NYTimes ) Lilly's combo therapy for COVID-19 cuts serious illness and death in large study ( Reuters ) ( Endpoints ) ( Press ) Lawsui...