Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US “I’ll Send You the Contact”: Documents Expose FDA Commissioner’s Personal Interventions on Behalf of Trump’s Favorite Chloroquine Doctor ( Vanity Fair ) US coronavirus deaths top 100,000 as country reopens ( Reuters ) FDA Finds Carcinogen in Some Versions of Metformin ( Bloomberg ) ( Reuters ) ( STAT ) Pfizer ties up with glass maker Corning for vial supply ( ...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Fauci: Hydroxychloroquine not effective against coronavirus ( Politico ) Moderna execs have cashed out $89M in shares this year, as stock soared on vaccine hopes ( STAT ) Trump administration to take action to cap insulin costs for seniors ( Washington Post ) ( STAT ) ( NPR ) Quest Diagnostics launches coronavirus testing for employees returning to work ( Reut...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Regeneron to buy back $5 billion stake held by Sanofi ( Reuters ) ( Financial Times ) Merck to buy Austrian vaccine maker as it jumps into COVID-19 race ( Reuters ) ( STAT ) FDA shuffles longtime division head, Janet Woodcock, to focus exclusively on Covid-19 vaccine project ( STAT ) Evofem's gel first non-hormonal contraceptive to get approval in over 30 year...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A quarter of Americans are hesitant about a coronavirus vaccine - Reuters/Ipsos poll ( Reuters ) Drug touted by Trump as COVID-19 treatment tied to increased risk of death: study ( Reuters ) ( Washington Post ) ( STAT ) ( The Lancet ) Prominent Scientists Denounce End to Coronavirus Grant ( NYTimes ) ( Science ) 'This is a bad practice': Doctors question FDA p...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US gives up to $1.2 billion to AstraZeneca for Covid-19 vaccine ( STAT ) ( Reuters ) ( FT ) Trump’s Vaccine Chief Has Vast Ties to Drug Industry, Posing Possible Conflicts ( NYTimes ) Biosimilars got the cold shoulder from health plans when it came to preferred coverage ( STAT ) GSK ties up with gene editing start-up Mammoth for COVID-19 test ( Reuters ) High...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amid conflict-of-interest criticisms, top FDA officials recuse themselves from Covid-19 vaccine approvals ( STAT ) Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine ( STAT ) Prototype Vaccines Protect Monkeys From Coronavirus ( NYTimes ) ( Reuters ) Inovio says COVID-19 vaccine produces antibodies in mice, guinea pigs ( Reu...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump says big announcements made and coming on therapeutics, vaccines ( Reuters ) Trump to Tap New Company to Make Covid-19 Drugs in the US ( NYTimes ) ( Reuters ) Politics could dictate who gets a coronavirus vaccine ( Politico ) Trump says he is taking hydroxychloroquine despite FDA warning ( Reuters ) CDC plans sweeping COVID-19 antibody study in 25 metro...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Early data show Moderna Covid-19 vaccine generates immune response ( STAT ) ( NYTimes ) ( Reuters ) Gilead to end coronavirus drug trials, adding to access worry: researchers ( Reuters ) Trump Vows Vaccine by End of Year, and Mobilizes Military to Help ( NYTimes ) ( STAT ) US to stockpile vaccine candidates as trials continue: health secretary ( Reuters ) Tru...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer says efficacy of its Duchenne gene therapy outweighs side effects ( STAT ) ( Endpoints ) ( Reuters ) After a PhIII failure, the FDA delivers Blueprint an expected CRL ( Endpoints ) ( Reuters ) Trump Weighs Made-in-US Order for Vital Drugs, Devices ( Bloomberg ) Trump administration to expand strategic stockpile for pandemic needs ( Politico ) Convalesc...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Taps Ex-Glaxo Official and General to Lead Vaccine Race ( Bloomberg ) ( Reuters ) ( Politico ) Trump mobilizing US military to deliver coronavirus vaccine ( Reuters ) Trump administration fires back at ousted vaccine expert as he testifies on his role in US coronavirus response ( STAT ) ( WSJ ) Ousted vaccine chief: 'Our window of opportunity is closing'...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US French Drug Giant to Give U.S. Preference on Covid Vaccine ( Bloomberg ) Moderna CEO says no single drugmaker can produce enough coronavirus vaccine doses for the planet ( CNBC ) FDA refuses application for cell therapy from BMS, Bluebird, dealing both a major setback ( STAT ) ( Endpoints ) ( Press ) Top Science and Health Officials Offer Sobering View of Reop...

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna's potential coronavirus vaccine gains FDA's 'fast track' status ( Reuters ) ( STAT ) Novavax Jumps on $388 Million Funding From Vaccine Coalition ( Bloomberg ) Fauci Says ‘Consequences Could Be Really Serious’ for Reopening Too Soon ( NYTimes ) Hydroxychloroquine shows no benefit against coronavirus in NY study ( Politico ) White House Orders Staff To...