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: Russia approves coronavirus vaccine before Phase 3 trials; Bayer to acquire women’s health focused KaNDy therapeutics

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump expected to give update on US COVID-19 vaccine development -White House ( Reuters ) Novavax expects it can meet US COVID-19 vaccine demand in 2021, executives say ( Reuters ) J&J eyes one billion doses of potential COVID-19 shot in 2021, weighs challenge trials ( Reuters ) Merck Bets On a One-Shot Vaccine in Race With Its Faster Rivals ( Bloomberg ) Mod...
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    Recon: Kodak $765M loan on hold; Gilead submits NDA for remdesivir

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Chief is Caught Between Scientists and the President ( NYTimes ) FDA’s reopening plan will keep biologics labs shuttered far longer than other government labs ( STAT ) Eastman Kodak's $765 million US loan agreement on hold after recent allegations ( Reuters ) ( Politico ) Gilead files US marketing application for remdesivir ( Reuters ) FDA approves first ...
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    Recon: Biogen gets FDA priority review for aducanumab; Japan signs deals for AstraZeneca, Novavax COVID-19 vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA grants expedited review to Biogen's Alzheimer's drug ( Reuters ) ( Bloomberg ) ( STAT ) Trump Signs Executive Order to Boost US Production of Essential Medicine ( WSJ ) ( STAT ) Teva CEO Has Doubts About Making Generic-Drug Ingredients in the U.S. ( Barron’s ) Moderna Backtracks to Open Covid Vaccine Trial to Those With HIV ( Bloomberg ) Pfizer to make Gi...
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    Recon: Trump expected to sign order to boost US drug manufacturing; FDA approves GSK’s blood cancer drug Blenrep

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump Plans Order Seeking to Return Drug Production to US ( Bloomberg ) ( Politico ) ( STAT ) ( Endpoints ) ( Reuters ) FDA commissioner: No matter what, only a safe, effective vaccine will get our approval ( Washington Post ) FDA Adviser: Not Realistic To Expect A COVID-19 Vaccine In 2020 ( NPR ) Trump says coronavirus vaccine possible before Nov. 3 ( Reuters...
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    Recon: US strikes $1B deal for J&J COVID-19 vaccine; Prosecutors seek up to $18B from Purdue

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to pay $1 billion for 100 million doses of Johnson & Johnson's COVID-19 vaccine candidate ( Reuters ) ( FT ) US government begins two trials testing Eli Lilly’s coronavirus antibody drug ( CNBC ) Justice Department Seeks as Much as $18.1 Billion From Purdue Pharma ( WSJ ) ( Reuters ) Novavax’s Covid-19 vaccine shows promising immune response, early data sho...
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    Recon: Abbvie cans pacts with Voyager; Bayer sees compounded troubles with COVID-19

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Generic drug approvals still winning the pandemic at US FDA ( Pink Sheet ) BARDA Begins Stockpiling APIs For Critical Drugs ( Pink Sheet ) Report: GoodRx files for IPO ( MedCity News ) CymaBay Reports Positive Results for Seladelpar in Patients with Primary Biliary Cholangitis ( Global Genes ) BARDA drafts Fujifilm Diosynth into its vaccine production effort, of...
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    Recon: Pfizer-US COVID vax deal details emerge; EC OKs Sanofi's aspart biosimilar

    ​Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US US Price for Pfizer COVID Vaccine Includes Company Distribution Efforts Directed By DOD, CDC ( Pink Sheet ) J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about? ( Endpoints ) Three More Experimental Therapies Receive Rare Pediatric Disease Designation by FDA ( Global Genes ) Kymera Therapeutics, fresh ...
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    Recon: US to pay $2.1B for Sanofi, GSK COVID-19 vaccines; AbbVie, Gilead report Q2 results

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to pay $2.1B to Sanofi, GSK, in COVID-19 vaccine deal ( Reuters ) ( Politico ) ( NYTimes ) ( Press ) Trump planning for US rollout of coronavirus vaccine falling short, officials warn ( Reuters ) Large US COVID-19 vaccine trials will exclude pregnant women for now ( Reuters ) Merck plans large trials of antiviral COVID-19 drug in September ( Reuters ) Chin...
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    Recon: J&J begins its first COVID-19 vaccine clinical trial; AstraZeneca reports rise in first-half profit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers Race to Build Covid-19 Vaccine Supply Chains ( WSJ ) FDA could issue emergency use authorization for coronavirus vaccine in a matter of weeks ( CNN ) FDA Nears Decision Authorizing Covid-19 Treatment With Convalescent Plasma ( WSJ ) J&J starts human study of COVID-19 vaccine after promising monkey data ( Reuters ) ( FT ) ( NYTimes ) Inovio vaccine ...
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    Recon: Moderna eyes $50-60 price for COVID-19 vaccine; UK signs deal for Sanofi, GSK coronavirus vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna pitches virus vaccine at about $50-$60 per course ( Financial Times ) ( STAT ) Moderna Vaccine Test in Monkeys Shows Promise ( NYTimes ) Most voters say they'd rather wait for an effective coronavirus vaccine ( Politico ) Public Health Experts Fear a Hasty FDA Signoff on Vaccine ( KHN ) ‘Nobody Likes Me,’ Trump Complains, Renewing Defense of Dubious S...
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    Recon: Pfizer, BioNTech begin pivotal COVID-19 vaccine trial; Drugmakers skip out on White House meeting

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers refuse to attend White House meeting after Trump issues executive orders on costs ( Politico ) ( Reuters ) Moderna, Pfizer start decisive COVID-19 vaccine trials, eye year-end launches ( Reuters ) ( NYTimes ) Pfizer-BioNTech begin late-stage study of lead COVID-19 vaccine candidate ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) Pfizer shares rise afte...
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    Recon: Moderna launches Phase 3 COVID-19 vaccine testing; AstraZeneca, Daiichi sign $6B deal for targeted cancer drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump signs orders aimed at lowering drug prices in largely symbolic move ( Washington Post ) ( STAT ) ( NYTimes ) ( Reuters ) Meadows says White House is 'hopeful' it can announce new coronavirus therapies 'in the coming days' ( The Hill ) Gilead's second act in cell therapy gets its first approval ( BioPharmaDive ) ( Endpoints ) ( FDA ) Moderna gets further ...