• ReconRecon

    Recon: FDA approves Takeda's lung cancer therapy; Moderna makes its case for boosters

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says COVID-19 vaccine protection wanes, makes case for booster ( Reuters ) U.S. Booster Policy Is in Flux as Studies Add to Dissent ( NYTimes ) U.S. FDA approves Takeda's lung cancer therapy ( Reuters ) ( FDA ) Drug Plan Fails, Signaling Thorny Path for Democrats’ $3.5 Trillion Bill ( NYTimes ) PhRMA launches 7-figure ad campaign against Democrats' dr...
  • ReconRecon

    Recon: US buys additional doses of Lilly, Regeneron antibodies; Centrists throw wrench in House Dems' drug pricing plans

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA staff say Pfizer COVID-19 boosters improve immunity but may not be needed ( Reuters ) Pfizer says third COVID-19 shot warranted in FDA document ( Reuters ) Biden to meet US CEOs in 'rallying cry' for vaccine mandates ( Reuters ) Centrists throw wrench in House Democrats’ drug pricing plans ( Politico ) ( STAT ) ( NYTimes ) Key senator opposes Democrats’ t...
  • ReconRecon

    Recon: CMS moves to end Trump-era MCIT rule; CureVac cuts vaccine productions plans

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden Covid team sees vaccine efficacy waning in unpublished data from Israel ( Politico ) Pioneering Gene Therapy Freed Her of Sickle Cell. Is a Cure at Hand? ( NYTimes ) Emergent to make Providence Therapeutics potential COVID-19 vaccine ( Reuters ) US judge grants Purdue Pharma's $7M exec bonus plan, faces blunt criticism ( Reuters ) Fourth boy dies in Ast...
  • ReconRecon

    Recon: UK launches trial of Grail blood test for 50 types of cancer; AbbVie hands Regenxbio $370M to develop gene therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA vaccine regulators argue against Covid-19 vaccine boosters in new international review ( STAT ) ( Endpoints ) ( NYTimes ) ( Politico ) GOP Seethes at Biden Mandate, Even in States Requiring Other Vaccines ( NYTimes ) Surgeon general: New vaccine policies neither illegal nor unusual ( Politico ) Novavax expects to make available at least 2 bln COVID-19 vacc...
  • ReconRecon

    Recon: BioNTech to seek approval for vaccine in children ages 5-11; Biden orders sweeping new vaccine mandates

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA says robust safety data needed before COVID-19 vaccine approval for kids ( Reuters ) ( FDA ) Attacking anti-vaccine movement, Biden mandates widespread COVID shots, tests ( Reuters ) ( NYTimes ) ( AP ) Senate considers pegging Medicare drug prices to deeply discounted Veterans Affairs rates ( STAT ) Martin Shkreli to go toe-to-toe with new FTC chair over D...
  • ReconRecon

    Recon: FDA declines EUA for Humanigen's COVID drug; CRISPR startup Mammoth raises $200M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biden to call for global summit on Covid response ( Politico ) FDA declines emergency use approval for Humanigen's COVID-19 drug ( Reuters ) ( STAT ) Biden Administration Unveils Plan to Cut Prescription-Drug Prices ( WSJ ) ( STAT ) ( Politico ) 'Failure is not a crime,' defense says in trial of Theranos founder Holmes ( Reuters ) ( NYTimes ) Theranos was run...
  • ReconRecon

    Recon: Sanofi acquires Kadmon for $1.9B; COVAX cuts 2021 delivery target by 1.425B doses

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna turns to biotech startup to ramp up Covid vaccine manufacturing ( STAT ) As experts debate boosters, vaccinated people are calling their own shots ( Washington Post ) Heather Bresch, Joe Manchin’s daughter, played direct part in Epipen price inflation scandal ( The Intercept ) Novavax begins early-stage trial for combined influenza/COVID-19 vaccine ( R...
  • ReconRecon

    Recon: EMA reviewing data on Pfizer booster shot; Roche, Adaptimmune sign $3B deal for off-the-shelf cell therapies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer on track for US vaccine boosters, Moderna lagging, Fauci says ( Reuters ) Israel to present COVID-19 booster shot data to FDA experts ( Reuters ) Biden’s Covid booster shot plan mired in confusion amid regulatory hold-ups ( FT ) Calls grow for FDA to speed authorization of kid Covid-19 vaccines ( Politico ) White House Seeks $65 Billion for ‘Apollo’ Pl...
  • ReconRecon

    Recon: US to invest $3B in COVID vaccine supply chain; EU ends dispute with AstraZeneca over vaccine deliveries

     Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US US to invest $3 bln in COVID-19 vaccine supply chain -White House official ( Reuters ) Health Officials Advise White House to Scale Back Booster Plan for Now ( NYTimes ) FDA retirements reignite debate over Biden booster plan ( The Hill ) Analysis: Are COVID boosters needed? FDA vaccine advisers wrestle with a thorny issue ( Reuters ) FDA nod for Janssen schizo...
  • ReconRecon

    Recon: FDA approves BeiGene's Brukinsa for rare blood cancer; House Committees request records from FDA's Aduhelm review

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna seeks US authorization for COVID-19 vaccine booster ( Reuters ) House Committees Demand FDA Records on Alzheimer’s Drug Approval ( NYTimes ) Purdue Pharma Is Dissolved and Sacklers Pay $4.5 Billion to Settle Opioid Claims ( NYTimes ) ( STAT ) ( Reuters ) FDA warns of heart-related events, cancer, blood clots, and death for JAK inhibitors ( Endpoints 1 ...
  • ReconRecon

    Recon: Novartis' Leqvio nabs NICE nod; HebeCell makes a foray into CAR-NK space

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US When Will the Delta Surge End? ( NYT ) Why can’t America fix its Covid-19 testing problems? ( VOX ) Vaccination Rates Rose In August As COVID Cases Surged Due To The Delta Variant ( NPR ) First vaccination doses up 17 percent since Pfizer approval: analysis ( The Hill ) Companies eye financial penalties for unvaccinated workers ( The Hill ) America has waste...
  • 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...