• ReconRecon

    Recon: Chinese Scientist May Face Criminal Charges After Editing Babies' Genes

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The Warren bill could promote beneficial public-private partnerships in the life sciences ( STAT ) Tufts to review ties to Purdue Pharma after ‘deeply troubling’ disclosures ( STAT ) AbbVie's Imbruvica fails to meet main goal in pancreatic cancer study ( Reuters ) ( Evaluate ) ( Press ) Study Links Drug Maker Gifts for Doctors to More Overdose Deaths ( NYTimes...
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    Recon: FDA Panel Split on Sanofi-Lexicon Diabetes Drug; Lilly's Latruvo Fails Confirmatory Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA chief Scott Gottlieb warns 'we have many hard decisions ahead of us' if government shutdown persists ( CNBC ) Immunomedics' cancer treatment fails to win accelerated approval from the FDA ( Reuters ) ( STAT ) ( Endpoints ) Lilly’s approved cancer drug Lartruvo fails confirmatory study, setting the stage for withdrawal of regulatory endorsement ( Endpoints )...
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    Recon: NICE Recommends Lilly's Verzenios for Advanced Breast Cancer; J&J to Use Apple Watch for Heart Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Key House Dem: I don't want to 'punish' drug companies ( The Hill ) Rep. DeGette, newly atop an oversight subcommittee, promises to grill drug industry CEOs and investigate insulin makers ( STAT ) HHS secretary, Senate Finance Republicans talk drug pricing ( The Hill ) PhRMA CEO 'hopeful' Trump officials will back down on drug pricing move ( The Hill ) Johnso...
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    Recon: Massachusetts AG Says Sackler Family Pushed Opioid Sales

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sacklers Directed Efforts to Mislead Public About OxyContin, New Documents Indicate ( NYTimes ) ( Reuters ) ( WSJ ) ( NBC ) FDA nervous about PDUFA ( Politico ) ( CNN ) Senators Ask FDA to Update Rules on Certain Pot Products ( NYTimes ) ABC documentary on Theranos features ex-CEO deposition tapes ( Reuters ) Can Trump claim credit for $26 billion in savings ...
  • ReconRecon

    Recon: Edwards Pays Boston Scientific $180M to End Patent Dispute

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lawmakers want feds to look at how a Bristol-Celgene deal affects prices and competition ( STAT ) ( Letter ) Edward Lifesciences pays Boston Scientific $180 million to end patent row ( Reuters ) Biopharma Dealmaking in 2018 ( Nature ) 2018 FDA approvals hit all-time high — but average value slips again ( Nature ) Vermont Report Finds that the Costs of Prescri...
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    Recon: FDA Staff Unfazed by CV Signal in Amgen's Osteoporosis Trials; China Opens Probe Into Expired Polio Vaccines

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AstraZeneca Departures Continue as Medical Chief Bohen Exits ( Bloomberg ) ( Endpoints ) FDA staff largely unfazed by CV signal in Amgen osteoporosis drug trials ( Endpoints ) Trump falsely claims ‘drug prices declined in 2018’ ( STAT ) Booker tries to shake doubts about pharmaceutical ties ahead of 2020 ( The Hill ) Sanofi-Genzyme inappropriately sought conf...
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    Recon: NICE Rejects Novartis' Migraine Drug Aimovig

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump-Inspired Tweets Signal More Drug-Price Pressure ( Bloomberg ) Health-Care CEOs Outline Strategies at JP Morgan Conference ( WSJ ) JP Morgan's Dimon hosted a private dinner for pharma executives, and a major topic was Amazon ( CNBC ) For tiny biotechs, JP Morgan is a big opportunity — and a big cost ( STAT ) Big Pharma’s Cancer Race ( WSJ ) Former Insys...
  • ReconRecon

    Recon: Amgen's Osteoporosis Drug Evenity Approved First in Japan

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump summons advisers to White House over drug price hikes ( Politico ) Democrats seek early victories on drug prices ( The Hill ) Shutdown drags on ( Politico ) FDA employees think shutdown could be deadly ( CNN ) Where’s Big Tech at biopharma’s big bash? ( STAT ) Investors get dose of government shutdown as FDA chief loses audio while delivering keynote s...
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    Recon: Takeda Completes $62B Shire Acquisition

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biotech Proposes Paying for Pricey Drugs by Installment ( WSJ ) California to Flex Drug Purchasing Power ( WSJ ) ( Reuters ) Price hikes on existing medicines account for the lion’s share of higher drug costs ( STAT ) ( NPR ) ( Health Affairs ) All seven of the FDA’s recent commissioners agree it should be independent — but not on how to accomplish it ( STAT )...
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    Recon: Eli Lilly to Buy Loxo Oncology for $8B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly to buy Loxo Oncology in $8 billion cancer push ( Reuters ) ( STAT ) ( Endpoints ) ( Financial Times ) FDA plans to create a new office to leverage cutting-edge science ( STAT ) Sanofi to exit immuno-oncology collaboration with Regeneron ( STAT ) ( Endpoints ) US top court rejects Amgen over cholesterol medication patent fight ( Reuters ) ( Amgen ) Merck...
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    Recon: Verily Picks up $1B in Funding; NICE Backs Pfizer's Xeljanz for Ulcerative Colitis

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Alphabet's Verily gets $1 billion in funding round led by Silver Lake ( CNBC ) ( Endpoints ) Payers expect drug prices to rise 3 percent to 5 percent annually over the next three years ( STAT ) Scoop: MedImmune chief Bahija Jallal is leaving AstraZeneca and joining the trek into biotech ( Endpoints ) Biotech IPO Market: Closing The Books On 2018’s Crazy Year (...
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    Recon: BMS to Acquire Celgene in $74B Deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bristol-Myers Squibb will acquire Celgene in blockbuster $74B deal ( STAT ) ( NYTimes ) ( Endpoints ) ( The Hill ) ( CNBC ) ( Press ) Trump says he expects to see lower drug prices ( Reuters ) Supreme Court to examine a common legal strategy drug makers use to sidestep patient lawsuits ( STAT ) With Senate votes, Trump gets a permanent drug czar — and his firs...