RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
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    Recon: New healthcare investing record; Sanofi slim-down, sell-off?

    Recon:   Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cuomo: Public should be 'very skeptical' about COVID-19 vaccine ( The Hill ) Dr. Scott Gottlieb: U.S. in 7th inning of the pandemic but the ‘hardest part’ is likely ahead ( CNBC ) For Trump, Covid-19 therapeutics are the new vaccines ( STAT ) Whatever happened to Deborah Birx? ( The Hill ) What about the German negotiation model? Biden steers ...
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    Recon: Pfizer won’t seek vaccine EUA before election; WHO trial finds remdesivir has little effect on COVID mortality

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer Says It Won’t Seek Vaccine Authorization Before Mid-November ( NYTimes ) ( Reuters ) ( Politico ) Trump’s election-eve drug discounts for seniors get snagged ( AP ) NIH to Study Three Drugs in Treatment of Covid-19 Patients ( WSJ ) ( Reuters ) It took AstraZeneca researchers 1 month to get vaccine trial data to FDA, source tells CNN ( CNN ) US Investig...
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    Recon: FDA approves first Ebola therapy; Advocacy groups push WTO on COVID IP rights

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Chief Defends Vaccine-Trial Halts as Vital to Safety System ( Bloomberg ) Examination shows how widely pharma showers campaign cash at the state level ( STAT ) Vertex, Amgen could be seeking new deals to fuel growth following pipeline stumbles ( STAT ) Vertex shelves experimental rare lung disease drug that once seemed promising ( STAT ) First Ebola thera...
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    Recon: Eli Lilly COVID antibody trial paused; Health Canada to review Moderna COVID vaccine in real time

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA faults quality control at Lilly plant making Trump-touted COVID drug ( Reuters ) Eli Lilly’s Antibody Trial Is Paused Over Potential Safety Concern ( NYTimes ) Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern ( Reuters ) FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’ ( Politi...
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    Recon: J&J halts COVID-19 vaccine trial; EU inks $1.2B deal for six-month supply of remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US J&J Covid-19 vaccine study paused due to unexplained illness in participant ( STAT ) ( FT ) ( Reuters ) J&J raises profit forecast as trial halt weighs ( Reuters ) ( CNBC ) ( MedtechDive ) Novavax to explore combined influenza/COVID-19 vaccine for use post pandemic ( Reuters ) Vaxart begins early-stage trial of oral COVID-19 vaccine candidate ( Reuters ) Peop...
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    Recon: New Zealand signs deal with Pfizer, BioNTech for 1.5M vaccine doses; Mallinckrodt files for bankruptcy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer trying to defuse critics amid push for vaccine before Election Day ( Politico ) Trump’s Testimonial Is a Double-Edged Sword for Regeneron ( NYTimes ) Can Trump Really Speed Approval of Covid Treatments? ( NYTimes ) First, a Vaccine Approval. Then ‘Chaos and Confusion.’ ( NYTimes ) Abbott wins US emergency use authorization for new COVID-19 antibody tes...
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    Recon: NIH launches late-stage study of remdesivir and convalescent plasma; China joins COVAX scheme

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead's remdesivir shaved five days off COVID-19 recovery time, reduced risk of death in some ( Reuters ) Late-stage study of COVID-19 convalescent-plasma treatment with remdesivir starts ( Reuters ) Fauci says 'reasonably good chance' Regeneron antibody therapy helped Trump ( Reuters ) Pfizer's breast cancer drug Ibrance fails late-stage study ( Reuters ) ( ...
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    Recon: Moderna to seek EU rolling review for COVID-19 vaccine; Regeneron requests EUA for COVID-19 antibodies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna Vows to Not Enforce Covid-19 Vaccine Patents During Pandemic ( WSJ ) Regeneron Asks FDA for Emergency Approval for Drug That Trump Claimed Cured Him ( NYTimes ) ( Bloomberg ) ( Endpoints ) ( Reuters ) Trump says ‘no president’s ever pushed’ the FDA like him, vaccine coming ‘very shortly’ ( CNBC ) Regeneron antibodies in demand after Trump treatment, do...
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    Recon: Eli Lilly seeks EUA for COVID antibody drug; BMS reports positive results for Opdivo plus chemo in NSCLC

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Says FDA Pulled ‘Political Hit Job’ With Vaccine Rules ( Bloomberg ) FDA Will Force Vaccine-Safety Disclosures If Makers Don’t ( Bloomberg ) Eli Lilly Asks FDA to Authorize Covid-19 Antibody Drug ( WSJ ) ( STAT ) ( Reuters ) FDA Redactions Upheld in FOIA Suit for Drug Approval Documents ( Bloomberg ) Bristol Myers' Opdivo succeeds in late-stage lung can...
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    Recon: Moderna vaccine trial struggling to enroll enough minorities; Russia fast-tracks second COVID-19 vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US White House Blocks New Coronavirus Vaccine Guidelines ( NYTimes ) ( Politico ) ( Reuters ) ‘Don’t Be Afraid of Covid,’ Trump Says, Undermining Public Health Messages ( NYTimes ) Moderna vaccine trial contractors fail to enroll enough minorities, prompting slowdown ( Reuters ) FDA hands Y-mAbs refusal to file letter in one of its pediatric neuroblastoma programs (...
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    Recon: BMS to buy MyoKardia for $13.1B; EMA’s PRAC reviews possible kidney injury from remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Warp Speed's focus on vaccines may have shortchanged antibody treatments ( Politico ) Bristol to Pay $13.1 Billion for Heart-Drug Maker MyoKardia ( WSJ ) ( STAT ) ( FT ) ( Press ) White House Takes Issue With FDA’s Plans for Authorizing a Covid-19 Vaccine ( WSJ ) Biotech Industry Pushes Trump Administration to Release New Vaccine Guidelines ( NYTimes ) Memo d...
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    Recon: Breakthrough status for Farxiga; 'Transformative' Zolgensma data

        Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US President Trump Tests Positive for Coronavirus ( WSJ ) ( NYT ) ( Washington Post ) ( CNBC ) ( Politico ) ( BBC ) ( Reuters ) First doses of US vaccine must be strictly rationed, says report ( Financial Times ) Dr. Scott Gottlieb sees antiviral remdesivir as best coronavirus treatment should Trump need one ( CNBC ) Where was Trump — and who was he with ...