• ReconRecon

    Recon: Gruber and Krause to leave CBER; Sanofi refiles with FTC on $3.2B Translate Bio buyout

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Percentage of Americans who say they won't get vaccinated drops to record low in new poll ( The Hill ) US demand for COVID-19 antibody treatments rising fast ( PMLive ) CDC Staff Floats 'Risk-Based Approach' to Potential Booster Doses ( MPT ) CDC panel unanimously endorses full approval of Pfizer’s Covid vaccine for people 16 and older ( CNBC ) Nearly 1 m...
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    Recon: Baxter in late-stage talks for $10B Hillrom buy; Catalent drops $1B for gummy vitamin maker

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US COVID-19 Deaths And Hospitalizations Continue To Rise In The U.S. ( NPR ) HHS Lifts Pause on Lilly's Monoclonal Antibody Combo, Sort Of ( MPT ) U.S. CDC advisers vote in favor of Pfizer COVID-19 vaccine ( Reuters ) Baxter in late-stage talks to buy Hillrom for about $10B: WSJ ( MedTech Dive ) Reimbursement begins slowly for Biogen’s expensive Alzheimer’s ...
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    Recon: FDA investigates iPhone-pacemaker interference; Humacyte's $245M SPAC deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA warns of pacemaker-iPhone interference ( Healthcare IT News ) Opinion: Expanding the domestic public health supply chain is a matter of national security ( STAT ) BD gets emergency FDA nod for smartphone-enabled COVID-19 antigen test ( MedTech Dive ) Ivermectin Scripts, Poison Center Calls Boom During Delta Surge ( MPT ) U.S. COVID-19 tests again in short...
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    Recon: Biden admin eyes COVID booster shots at six months; AstraZeneca reports positive Phase 3 for Wilson disease drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden Administration Likely to Approve Covid-19 Boosters at Six Months ( WSJ ) Pfizer seeks U.S. approval for COVID vaccine booster ( Reuters ) Pfizer and BioNTech say a third shot boosts antibodies against the virus. ( NYTimes ) Biden Falls Short on Pledge for U.S. to Be the World’s Vaccine ‘Arsenal,’ Experts Say ( NYTimes ) Lilly puts more money into protei...
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    Recon: J&J says booster increased COVID antibodies in early studies; Samsung boosts investment in biotech business

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pentagon makes Pfizer vaccine mandatory after FDA approval- memo ( Reuters ) Moderna completes filing process for full approval of COVID-19 vaccine ( Reuters ) J&J says booster dose increased antibodies in early-stage studies ( Reuters ) ( NYTimes ) US data show rising 'breakthrough' infections among fully vaccinated ( Reuters ) ( NYTimes ) ( STAT ) ( Politico...
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    Recon: Pharma's rep down again; Roche ponies up $3B for Shape's RNA editing tech

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Six U.S. states do not join $26B opioid settlements with distributors, J&J ( Reuters ) ‘We Sent a Terrible Message’: Scientists Say Biden Jumped the Gun With Vaccine Booster Plan ( KHN ) Fauci says he hopes U.S. will have ‘some good control’ over Covid by spring 2022 ( CNBC ) American Medical Association calls for public, private sectors to mandate vaccines ( ...
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    Recon: FDA vax approval signals looming mandates; Pfizer's $2.3B Trillium takeover

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer's COVID Vaccine Gets Full Approval From The FDA ( NPR ) ( NYT ) ( NBC ) Biden calls on companies to mandate vaccines following FDA full approval ( The Hill ) Pentagon set to make Pfizer vaccine mandatory after FDA approval ( Reuters ) New York City, The Country's Largest School System, Mandates Teacher Vaccinations ( NPR ) The U.S. Is Getting a Cra...
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    Recon: NYT says Abbott destroyed COVID tests when sales dwindled; Woodcock out of running for FDA commissioner?

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Maker of Popular Covid Test Told Factory to Destroy Inventory ( NYT ) Acting FDA Chief Janet Woodcock Ruled Out as Biden Nominee ( Bloomberg ) Child Covid-19 hospitalizations soar, filling pediatric wings, data show ( NBC ) White House: More than one million vaccine doses administered in past 24 hours ( The Hill ) Three senators announce positive COVID-19...
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    Recon: Illumina closes Grail acquisition without go ahead from regulators; FDA approves Lilly, BI drug for heart failure

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden, first lady to get COVID-19 booster vaccine -ABC News interview ( Reuters ) Richard Sackler Says Family and Purdue Bear No Responsibility for Opioid Crisis ( NYTimes ) US states rush to meet deadline to join $26 billion opioid settlement ( Reuters ) FDA approves Lilly, Boehringer diabetes drug for heart failure ( BioPharmaDive ) ( Endpoints ) US officia...
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    Recon: Biden admin endorses COVID vaccine boosters beginning September; Sacklers threaten to exit opioid settlement without immunity

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US U.S. health officials recommend booster shots against Covid-19 ( AP ) ( Politico ) ( NYTimes ) ( HHS ) Over 100 lawmakers ask FDA about timeline for vaccines for children ( The Hill ) Purdue's Sackler: family has 'responsibility' to help curb opioid crisis but wants liability shields ( Reuters ) ( Endpoints ) ( STAT ) ( Law360 ) ( NYTimes ) Sesen Bio cancer dr...
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    Recon: Pfizer seeks clearance for COVID vaccine boosters; Court revives 6,000 suits over 3M surgical warming device

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, BioNTech Seek FDA Clearance for Covid-19 Booster ( WSJ ) ( Reuters ) US expected to recommend Covid-19 vaccine booster shots for all ( AP ) ( Reuters ) Antibody Cocktails to Treat Covid Take Off as Delta Surges ( Bloomberg ) U.S. court revives nearly 6,000 lawsuits over 3M surgical warming device ( Reuters ) ( Law360 ) Dueling 7-figure ad campaigns se...
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    Recon: MHRA staff fret over planned budget cuts; FDA rejects Sesen Bio's bladder cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck's Welireg scores FDA nod in cancers spurred by rare disease—and its label is broader than expected ( Fierce ) ( BioPharmaDive ) Zombie biotech Sesen Bio's resurrection plans limping again as FDA rejects bladder cancer drug ( Fierce ) FDA lifts clinical hold on Rocket gene therapy trial, creating launchpad for start of pediatric dosing ( Fierce ) ( BioPhar...