• ReconRecon

    Recon: Bluebird Prices Gene Therapy Zynteglo at €1.575M Over 5 Years

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US White House allies rally for looming rebate rule ( Politico ) Global Blood’s sickle cell disease drug heads to the FDA, but questions about benefit linger ( STAT ) ( Endpoints ) Facing progressive pressure, Pelosi could expand her drug pricing plan to negotiate prices for $118B worth of drugs ( STAT ) Allscripts is buying ZappRx, a prescription drug start-up (...
  • ReconRecon

    Recon: GSK Teams up With CRISPR Pioneers for New Drug Discovery Lab

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US GSK signs up gene-editing pioneers in drug discovery alliance ( Reuters ) ( Financial Times ) ( Endpoints ) Trump Offers to Negotiate Price of J&J Anti-Depressant for VA ( Bloomberg ) ( Endpoints ) Nebraska’s AG is lone holdout in pursuing opioid cases ( AP ) A CRISPR startup is testing pig organs in monkeys to see if they’re safe for us ( MIT Technology Revie...
  • ReconRecon

    Recon: France’s Dassault to Buy Medidata for $5.8B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Move Over, Martin Shkreli: This Pharma Exec Is Accused Of Fixing Prices On 107 Drugs ( Forbes ) Daily HIV Prevention Pill Urged for Healthy People at Risk ( AP ) ( CNBC ) J&J ‘Did Everything’ to Push Opioids, Oklahoma Witness Says ( Bloomberg ) Judge holds up Teva's $85M opioid settlement, sinking shares back to pre-2000 levels ( Fierce ) ( Law360 -$) Acciden...
  • ReconRecon

    Recon: Merck’s Keytruda Picks up Two New Indications for Head and Neck Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck's Keytruda wins FDA approval to treat head & neck cancer ( Reuters ) ( Endpoints ) ( Press ) ( FDA ) Startup offering free DNA sequencing signs first pharma sponsor ( STAT ) How pharma could benefit from one of Congress’ signature drug pricing ideas ( STAT ) Jacobus prices its rare disease drug at half of what Catalyst charges, but will doctors prescribe...
  • ReconRecon

    Recon: Merck to Acquire Tilos for $773; Roche Gets Accelerated Approval for Lymphoma Drug Polivy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck to buy Tilos Therapeutics for up to $773 million ( Reuters ) ( STAT ) ( Endpoints ) ( Press )  Merck’s Baby Biotech Splurge Won’t Fix Its Reliance on Keytruda ( Bloomberg ) In a boost to Rituxan franchise, Roche nabs quick approval for Polivy ( Endpoints ) ( Press ) ( FDA ) Co-owner, ex-employee of pharmacy in U.S. meningitis outbreak acquitted ( Reuters...
  • ReconRecon

    Recon: Sanofi Names Novartis’ Hudson as CEO; FDA Panel Backs TB Alliance’s TB Treatment

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Vertex Pharmaceuticals expands into Duchenne gene therapy with new deals ( Reuters ) ( PMLive ) ( Endpoints ) ( Fierce ) FDA advisory panel recommends approval of TB Alliance's tuberculosis treatment ( Reuters ) In a surprise, Hans Bishop takes over as CEO of Grail, the liquid biopsy startup ( STAT ) ( Endpoints ) AIDS groups criticize Express Scripts for excl...
  • ReconRecon

    Recon: Insys, Mallinckrodt Settle Opioid Cases; Takeda Drops Late-Stage Amyloidosis Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Third Rock raises $770 million in new funding round ( STAT ) ( Endpoints ) ( Fierce ) Liberals fight their own party over drug prices ( Politico ) ( The Hill ) Insys to pay $225 million, plead guilty in US over opioid kickbacks ( Reuters ) ( NYTimes ) ( STAT ) ( Endpoints ) ( Law360 -$) ( DoJ ) Mallinckrodt to settle U.S. drug marketing probe, fight kickback c...
  • ReconRecon

    Recon: FDA Approves Lilly’s Emgality as First Drug to Treat Cluster Headaches

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Lilly's migraine drug as first ever cluster headache treatment ( Reuters ) ( Endpoints ) ( FDA ) ( Press ) Pfizer had clues its blockbuster drug could prevent Alzheimer’s. Why didn’t it tell the world? ( Washington Post ) ( Endpoints ) Welcome to the Age of One-Shot Miracle Cures That Can Cost Millions ( Bloomberg ) Ned Sharpless weighs in on gene...
  • ReconRecon

    Recon: Bayer Signs Deal With US Biotech Arvinas to Develop Protein Degradation Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bayer teams up with biotech firm Arvinas in deal worth up to $750 million ( Reuters ) ( Endpoints ) ( Fierce ) ( Press ) What you missed at ASCO? A lot, as cancer research hastens on ( STAT ) Congress weighs dropping ban on altering the DNA of human embryos used for pregnancies ( STAT ) Updated Apple Watch will track your menstrual period and aim to protect yo...
  • ReconRecon

    Recon: Merck’s Keytruda Raises Survival Standard for Advanced Lung Cancer; Amgen KRAS Drug Shows High Response Rate

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugs make headway against lung, breast, prostate cancers ( AP ) Who Won and Lost at One of the Year's Biggest Medical Meetings ( Bloomberg ) ( CNBC ) Moderna makes ASCO debut with an early look at a personalized cancer vaccine ( STAT ) ( Press ) Amgen drug shows high response rate in small lung and colon cancer trial ( Reuters ) ( STAT ) ( Endpoints ) ( Finan...
  • ReconRecon

    Recon: China Approves Third Domestic PD-1 Drug; Fosun Rethinking US Deals Amid Trade Tensions

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Grail, a deep-pocketed startup, shows ‘impressive,’ if early, results for cancer blood test ( STAT ) ( Fierce ) ( Press ) Turning Point Therapeutics drug shows benefits for patients with rare lung cancer gene ( STAT ) ( Endpoints ) Epizyme seeks early approval for drug to treat ultra-rare tumors ( STAT ) US drugmaker charged in generics price-fixing investigat...
  • ReconRecon

    Recon: NICE Backs Merck’s Prevymis for CMV; China’s Hansoh Pharma Eyes $1B IPO

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Merck’s R&D boss sees more promise in his big drug and a $1 billion deal ( STAT ) Biologic medications for arthritis and psoriasis have flooded the market — and been linked to 34,000 deaths ( Journal Sentinel ) California may make anti-HIV drug available without prescription for 30 days ( SF Chronicle ) Groupon Cofounder’s Cancer Startup Is Now Worth $3.1 Bill...