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  • ReconRecon

    Recon: Gilead claims remdesivir reduced mortality in Phase 3 study; FDA staff flag ocular toxicities ahead of GSK myeloma drug panel

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Special Report: How the Trump administration secured a secret supply of execution drugs ( Reuters ) Trump will sign three executive orders on lowering drug prices: chief of staff ( Reuters ) Gilead says remdesivir data show reduced risk of death ( Financial Times ) ( Endpoints ) ( Reuters ) ( Press ) FDA Says to Review Side Effect of GSK's Multiple Myeloma Dru...
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    Recon: Drugmakers launch $1B antibiotic development fund; Moderna taps Rovi to supply coronavirus vaccine outside US

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US In race to bring vaccine to market, big pharma struggles to protect its intellectual property rights ( CNBC ) Who Gets a Vaccine First? US Considers Race in Coronavirus Plans ( NYTimes ) Grave Shortages of Protective Gear Flare Again as Covid Cases Surge ( NYTimes ) Merck, Eisai's Keytruda-Lenvima combo stonewalled in liver cancer after Roche's first-in-class ...
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    Recon: EU reportedly strikes deals for Roche, Merck KGaA COVID drugs; Biogen submits aducanumab BLA

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump administration submits formal notice of withdrawal from WHO ( STAT ) ( WSJ ) Pence, Azar reassure governors Trump won't end virus emergency declaration ( Politico ) Drug prices steadily rise amid pandemic, data shows ( Politico ) In a test for Hahn's FDA, Biogen submits controversial Alzheimer's drug aducanumab ( Fierce ) ( Endpoints ) ( BioPharmaDive ) ...
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    Recon: Novavax, Regeneron get nearly $2B in Operation Warp Speed funding; FDA puts Cellectis CAR-T trial on hold after death

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna spars with US scientists over COVID-19 vaccine trials ( Reuters ) FDA warns of false positives with BD coronavirus diagnostic ( MedtechDive ) ( FDA ) US coronavirus response still crippled by lack of testing, Dr. Scott Gottlieb says ( CNBC ) Death in Cellectis off-the-shelf CAR-T trial triggers FDA hold ( Fierce ) ( STAT ) ( Endpoints ) US Will Pay $1...
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    Recon: GSK, Sanofi in talks for £500M UK coronavirus vaccine deal; Regeneron begins Phase 2/3 trial for COVID-19 antibody cocktail

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House teases executive orders on China, immigration and prescription drugs ( Politico ) Regeneron starts COVID-19 antibody cocktail late-stage trials, shares rise ( Reuters ) ( Press ) 2021 Health Plans Granted Leeway To Limit Consumers’ Benefit From Drug Coupons ( KHN ) FDA Commissioner Stephen Hahn won’t confirm Trump’s promises on vaccine timing ( ABC...
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    Recon: Takeda in for $900M on gene therapy R&D; Vertex gets quick win in England for CF triple therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gottlieb says worst of outbreak will pass by January; Pence sees no need for a mask mandate ( CNBC ) Coronavirus Update: Spooked By America’s COVID-19 Vaccine Skepticism, FDA Promises Not To Lower Standards ( Scrip ) AHA: Hospital losses could top $323B in 2020 ( HealthLeaders ) 2020 Fortune/IBM Watson Health 100 Top Hospitals List ( HITConsultant ) EUSA P...
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    Recon: Pfizer, BioNTech tout response in early COVID-19 vaccine study; Glenmark charged in price-fixing probe

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US risks 100,000 new Covid-19 cases a day, Fauci warns ( Politico ) Covid-19 vaccine from Pfizer and BioNTech shows positive results ( STAT ) ( WSJ ) Inside Moderna: The Covid Vaccine Front-Runner With No Track Record and an Unsparing CEO ( WSJ ) Trump officials seek to reassure public about safety of a potential coronavirus vaccine ( The Hill ) Ultragenyx wi...
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    Recon: Vertex, NHS reach deal for CF drugs; Canadian court dismisses drugmakers’ challenge to drug price rules

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US After pandemic, US senators want review of drug supply chain ( Reuters ) ( The Hill ) Inovio claims positive results on Covid-19 vaccine but critical data are missing ( STAT ) Companies have raised prices on 245 drugs during pandemic, advocacy group says ( The Hill ) Gilead’s pricing for remdesivir raises questions about the drug’s long-term prospects ( STAT )...
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    Recon: Gilead sets US remdesivir price; FDA rejects Intercept NASH drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead sets price for Covid-19 treatment as HHS secures doses ( Politico ) ( AP ) ( STAT ) ( Endpoints ) As the Coronavirus Spreads, Drug Pricing Legislation Remains Stalled ( NYTimes ) ( WSJ ) FDA rejects Intercept Pharma’s drug for NASH ( STAT ) US 'likely' to see shortage of pharmaceutical drugs if coronavirus outbreak continues, intelligence report finds (...
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    Recon: FDA rejects AbbVie eye drug BLA; Novartis, Alcon to pay $347M to settle bribery investigations

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis, Alcon Pay $347 Million to Settle Bribery Probes ( WSJ ) ( STAT ) ( DOJ ) FDA Approves Zogenix's Drug for Rare Childhood Epilepsy ( Reuters ) ( STAT ) ( FDA ) AbbVie's Allergan, Molecular Partners hit by FDA eye drug rejection ( Fierce ) ( Endpoints ) ( Press ) DBV lays off employees, scales down programs after receiving no word from FDA ( Endpoints )...
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    Recon: NIH may own IP for Moderna COVID-19 vaccine; UniQure sells gene therapy rights to CSL for $450M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump’s Drug Push Still Keeps Door Open for Banned Indian Firm ( Bloomberg ) Bolton casts light on Trump’s deference to China on coronavirus ( Politico ) Trump administration ending support for drive-thru testing sites ( Politico ) Breakthrough Drug for Covid-19 May Be Risky for Mild Cases ( NYTimes ) The NIH claims joint ownership of Moderna's coronavirus va...
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    Recon: Merck strikes deal with Yumanity for neurodegenerative disease drugs; Feds allege Regeneron used charity to pay kickbacks

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Federal prosecutors allege Regeneron used a charity to pay kickbacks to Medicare patients ( STAT ) Yumanity Therapeutics, Merck strike deal aimed at developing new medicines for neurodegenerative disease ( STAT ) ( Endpoints ) FDA urged to heighten safety warnings on common type 2 diabetes drugs ( STAT ) ( Public Citizen ) By $4M, La Jolla outbids Melinta for ...