• ReconRecon

    Recon: Drug Suppliers Say Brexit Freight Plans Urgently Needed; Philippines Prepares Vaccination Campaign After Polio Reemerges

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pelosi Unveils Plan to Lower Prescription Drug Prices ( Focus ) US House speaker: Drug pricing plan should be priority for White House ( Reuters ) Democrats' drug pricing proposal 'dead on arrival' in Senate: leading Republican ( Reuters ) ( Politico ) Trump says he likes a Republican drug bill after Democratic alternative unveiled ( Reuters ) How An 'Interna...
  • ReconRecon

    Recon: FDA Panel Backs GSK's OTC Nicotine Spray; Swiss Competition Watchdog Raids Makers of Stomach Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Industry groups push back against ‘troubling’ FDA crackdown on genetic tests used to predict response to drugs ( STAT ) GSK's over-the-counter nicotine oral spray gets FDA panel backing ( Reuters ) Ginkgo Bioworks scores an eye-popping valuation with latest fundraise ( STAT ) Insys Bankruptcy Plan Comes Up Short in Paying Justice Department ( WSJ ) Bristol jo...
  • ReconRecon

    Recon: Senators Urge More FTC Scrutiny for Pharma Mega-Mergers; WHO Panel Warns on Pandemic Risk

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Grassley's fight to win over GOP on drug prices ( Politico ) Hearing on "Profits Over Consumers: Exposing How Pharmaceutical Companies Game The System" ( House E&C ) Medicare Part D rebates ‘substantially’ reduced drug spending, but not enough to offset price hikes ( STAT ) US Senators urge FTC to scrutinize multi-billion dollar pharma mergers ( Reuters ) ( ST...
  • ReconRecon

    Recon: Insulin Makers Brace for Brexit; Fire at Facility Housing Smallpox Virus in Russia

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Would a Purdue Bankruptcy Protect the Sacklers? Good Question. ( NYTimes ) Purdue Pharma’s Bankruptcy Deal Has Holes the Size of 24 States ( Bloomberg ) Purdue Pharma's battle isn't over ( Politico ) Former FDA Commissioner Scott Gottlieb joins Aetion's Board of Directors ( Press ) Opioid plaintiffs fight bid to disqualify US judge before trial ( Reuters ) ...
  • ReconRecon

    Recon: Lundbeck Buys Alder for $2B; Purdue Pharma Files for Bankruptcy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US First peanut allergy treatment gains backing from FDA advisory panel ( Science ) ( Atlantic ) ( AP ) Purdue Pharma, maker of OxyContin and other drugs, files for bankruptcy ( Stat ) ( Bloomberg ) ( WSJ ) ( Guardian ) Opioid Defendants Seek to Disqualify Judge Overseeing 2,300 Cases ( NY Times ) The Startup That Manipulated Data to Get a Miracle Drug to Market ...
  • ReconRecon

    Recon: Biogen, Eisai Abandon Two Phase 3 Alzheimer’s Studies Over Safety Concerns

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biogen scraps two late-stage Alzheimer's trials ( Reuters ) ( Fierce ) ( Endpoints ) ( Press ) Inside the drug industry’s plan to disarm the DEA ( Washington Post ) While battling opioid crisis, US government weighed using fentanyl for executions ( Reuters ) Purdue Pharma Made, Then Ditched, Plans for Opioid-Treatment Nonprofit ( WSJ ) Chaotic talks show chal...
  • ReconRecon

    Recon: FDA Approves Aspen’s Drug to Prevent Preterm Birth; At Least 20 States Reject Purdue Settlement

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US At least 20 states reject settlement with OxyContin maker Purdue Pharma ( NBC ) ( AP ) Purdue OxyContin settlement would rank among largest in pharma history ( Reuters ) US judge approves novel framework for opioid settlement talks ( Reuters ) Carcinogens Have Infiltrated the Generic Drug Supply in the US ( Bloomberg ) Aspen's drug to prevent preterm birth ap...
  • ReconRecon

    Recon: Court let Merck Hide Propecia Data; Sanofi to Pay Lexicon $260M to end Partnership

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Court let Merck hide secrets about a popular drug’s risks ( Reuters ) Why Aren’t There Better Cancer Drugs? Scientists May Have Picked the Wrong Targets ( NYTimes ) ( STAT ) ( Science ) ( Study ) ICER dings Novo's new oral diabetes drug ( BioPharmaDive ) Purdue Close to Settlement with Cities and Half of States Over Opioid Crisis ( WSJ ) ( Reuters ) ( CNBC ) ...
  • ReconRecon

    Recon: Pelosi’s Drug Pricing Plan Includes Medicare Negotiation, International Price Index; Mallinckrodt to Sell BioVectra for $250M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pelosi’s drug pricing plan is more aggressive than expected ( STAT ) ( NYTimes ) ( Washington Post ) ( CNBC ) ( The Hill ) US judge allows public nuisance claim in opioid trial ( Reuters ) Sackler Family To Give Up Value Of Purdue Pharma To Settle Opioid Claims ( NPR ) Delaware DOJ files lawsuit against Sackler family, owners of Purdue Pharma companies ( Delaw...
  • ReconRecon

    Recon: Amgen, Lilly Report Tumor Shrinkage in KRAS, RET Lung Cancer Studies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lung cancer drug Lilly bought for $8 billion delivers strong results ( STAT ) ( Endpoints ) ( Reuters ) Amgen Slips as Gene-Targeting Drug Misses Some ‘Lofty Hopes’ ( Bloomberg ) ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) Sacklers Reject Demand That They Surrender Personal Wealth To Settle Opioid Claims ( NPR ) Novartis Makes New Data Integrity Commitment ( ...
  • ReconRecon

    Recon: Novo Nordisk to Cut US Insulin Price With Authorized Generic; Alexion Suffers EU Patent Setback

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Q&A: How the future of medicine looks to the FDA’s top drug regulator ( LA Times ) Novo Nordisk rolls out authorized insulin generics, following similar moves by Lilly and Sanofi ( Fierce ) ( Reuters ) ( STAT ) ( Press ) MD Anderson cancer doctor emerges as a top candidate for FDA job ( Washington Post ) ( WSJ ) ( STAT ) ( Politico ) Inside drugmakers' strateg...
  • ReconRecon

    Recon: Cigna Announces Plan to Cover Expensive Gene Therapies; BMS’ Opdivo Misses in Third Glioblastoma Trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US A Turn for the Worse for Biotech Stocks ( WSJ ) Cigna rolls out new plan to fully cover multi-million dollar gene therapies ( Reuters ) ( WSJ ) BMS’ Opdivo fails third straight test in tough-to-treat brain cancer ( Fierce ) ( Endpoints ) ( Press ) Mallinckrodt Mulls Restructuring as a Major Opioid Trial Nears ( Bloomberg ) ( Reuters ) Drug Maker Mallinckrodt ...