• ReconRecon

    Recon: Canadian Fund Buys Keytruda Rights from UK's LifeArc for £1B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gates-backed Schrödinger raises $110m for new drug push ( Financial Times ) ( Fierce ) Exit Of No. 2 At Amazon’s Haven Keeps Walmart Employee Health Strategy In Lead ( Forbes ) ( STAT ) Dana-Farber prevails in immunotherapy dispute over patents behind blockbuster drug ( STAT ) ( Endpoints ) Commentary: We need to make sure new drug cures don’t widen income gap...
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    Recon: NICE Backs Revlimid for First Line Multiple Myeloma Treatment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US House Passes Legislation Aiming to Shore Up Health Law and Lower Drug Costs ( NYTimes ) ( The Hill ) ( Politico ) Trump administration backs off a proposal to let Medicare plans exclude certain drugs ( STAT ) ( CNBC ) Gilead CEO parries with congressional Democrats over an HIV prevention pill ( STAT ) ( Endpoints ) AbbVie halts enrollment after brain cancer tr...
  • ReconRecon

    Recon: FDA Approves First Blood Thinner for Pediatric Use

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves first anticoagulant (blood thinner) for pediatric patients to treat potentially life-threatening blood clots ( FDA ) Roche: FDA approves drug combo Venclexta plus Gazyva for previously untreated chronic lymphocytic leukemia ( Reuters ) ( Press ) Gilead CEO to testify before a House committee about pricing for its HIV prevention pill ( STAT ) Novar...
  • ReconRecon

    Recon: Japan Clears $306k Pricetag for Novartis’ Kymriah

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vertex to pay startup Kymera $70 million in R&D deal ( STAT ) ( Endpoints ) Gilead struck anti-competitive deals to bolster profits on an HIV drug, lawsuit says ( STAT ) ( CNBC ) To Combat Generic Drugs' High Prices, Civica RX To Make 2 Antibiotics ( NPR ) ( STAT ) ( WSJ ) Alphabet is funding a new way to reduce heart disease, the leading cause of death in the...
  • ReconRecon

    Recon: AbbVie, Boehringer Settle Humira Patent Dispute

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AbbVie, Boehringer Settle US Patent Dispute Over Drug Humira ( WSJ ) ( BioPharmaDive ) ( Center for Biosimilars ) ( BI ) ( AbbVie ) Gilead Sciences Statement On Inaccurate Reporting On Truvada ( Press ) How to jump-start a fledgling class of new, cheaper drugs ( Axios ) Trump touts Democratic playbook in crackdown on drug costs ( Politico ) Dems tee up new do...
  • ReconRecon

    Recon: Grail Gets FDA Breakthrough Device Designation for Multi-Cancer Early Detection Test

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Grail, the liquid biopsy startup, picks an approach for its cancer test ( STAT ) ( Press ) ElevateBio launches to help other cell, gene therapy companies lift off ( STAT ) ( Xconomy ) Following Opioid Suits, Family Behind Deadly OxyContin Squabbles ( Reuters ) The inside story of why Amazon bought PillPack in its effort to crack the $500 billion prescription m...
  • ReconRecon

    Recon: Gilead to Donate 2.4 Million Bottles of Truvada to US HIV Prevention Initiative

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead will donate Truvada for HIV prevention, but reaction is mixed ( STAT ) ( NYTimes ) ( CNBC ) ( Politico ) ( AP ) ( Washington Post ) How Insys undermined an FDA effort to protect the public from dangerous opioids ( STAT ) ICER chastises J&J for overpricing depression drug esketamine ‘where there is such need for treatment’( Endpoints ) Puma investors fre...
  • ReconRecon

    Recon: Takeda Offloads Xiidra to Novartis, TachoSil to Ethicon to Pay Down Debt

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bristol-Myers' Opdivo fails late-stage brain cancer trial ( Reuters ) ( Endpoints ) ( Press ) Generic Drug Stocks are ‘Worst Ever’ ( WSJ ) Nearly One in Two Americans Takes Prescription Drugs: Survey ( Bloomberg ) Trump gambles in push for drug import proposal ( The Hill ) Prescription Opioid Use Plummeted Most on Record Last Year ( Bloomberg ) Addiction Med...
  • ReconRecon

    Recon: Pfizer Buys Swiss Rare Disease Biotech Therachon for up to $810M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer to Acquire Therachon for Up to $810M ( GEN ) ( Endpoints ) ( PMLive ) ( BioPharmaDive ) ( Press ) Gilead goes for Goldfinch in $109M kidney deal ( BioCentury ) ( STAT ) ( Endpoints ) J&J Pays About $1 Billion to Resolve Pinnacle-Hip Suits ( Bloomberg ) ( Reuters ) Pharma pushes back against setting international standards for drug-pricing transparency (...
  • ReconRecon

    Recon: FDA Approves Jacobus’ Ruzurgi for Children With LEMS

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder ( FDA ) ( Endpoints ) In a crafty move, FDA may have found a way to dampen controversy over a $375,000 rare-disease drug ( STAT ) Allergan lifts outlook after Botox plumps quarterly earnings ( Financial Times ) Allergan chief Saunders takes a painful $2...
  • ReconRecon

    Recon: FDA Approves Two Formulations of Pfizer’s Tafamidis for Cardiomyopathy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer gets US approval for $225,000 a year heart drug ( Reuters ) ( Endpoints ) ( Press ) ( FDA ) Cytokinetics pushes ahead with ALS drug despite negative clinical trial outcome ( STAT ) ( Endpoints ) Most AbbVie shareholders are unfazed that the CEO’s bonus is tied to high prices for Humira ( STAT ) The health care votes that Democrats are planning this week...
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    Recon: FDA Declines to Ban Textured Breast Implants Linked to Rare Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Won’t Ban Sales of Textured Breast Implants Linked to Cancer ( NYTimes ) ( AP ) ( MassDevice ) ( FDA ) Biotech runs on venture capital. But not all VC models are created equal ( STAT ) Budget office: $177B in added costs from Trump drug plan ( AP ) ( Bloomberg ) Gilead tops earnings forecast as cancer drug drives sales ( Financial Times ) Gilead unveils p...