• ReconRecon

    Recon: Low Dose of Pfizer, Lilly Painkiller Misses Goals in Phase III Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Federal judge scolds Purdue, Endo and Mallinckrodt for stall tactics in opioids case ( Fierce ) ( Law360 -$) 'Old guard' generics players yield U.S. lead to Indian up-and-comers: analyst ( Fierce ) Judge rejects challenge of New York City's mandatory measles vaccination order ( Reuters ) Washington State Senate Passes Bill Removing Exemption For Measles Vaccin...
  • ReconRecon

    Recon: Mustang Bio Soars After Gene Therapy Appears to Cure ‘Bubble Boy’ Patients

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US ‘Bubble Boy’ Biotech Mustang Bio Soars 250 Percent After Cure Announcement ( Bloomberg ) ( Reuters ) ( NPR ) ( Endpoints ) ( NIH ) Pricing is taking a toll on the reputation of the pharmaceutical industry ( STAT ) A biotech startup’s lofty goal: Kill cancer with pills that target RNA instead of proteins ( STAT ) ( Xconomy ) Drugmakers Reveal List Prices Online...
  • ReconRecon

    Recon: Roche Raises Forecasts on Strong Sales of New Drugs; CVS Fined for Filling Fake Percocet Prescriptions

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CVS Fined $535K for Filling Forged Percocet Prescriptions ( NYTimes ) ( The Hill ) Stanford clears three faculty members of ‘CRISPR babies’ involvement ( STAT ) ( NYTimes ) As calls mount to ban embryo editing with CRISPR, families hit by inherited diseases say, not so fast ( STAT ) ‘Patients are not a company’s resource’: FDA cancer czar Richard Pazdur has a ...
  • ReconRecon

    Recon: Gilead Enlists Insitro to Develop Experimental NASH Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead teams up with Insitro for experimental NASH treatments ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) J&J’s first-quarter earnings drop 14% as legal costs soar ( CNBC ) FDA’s Woodcock on developing neuromuscular drugs: ‘We have to change our approach’ ( STAT ) The health policy experts shaping Nancy Pelosi’s approach to drug pricing ( STAT ) Amgen sets $...
  • ReconRecon

    Recon: Catalent to Buy Gene Therapy Manufacturer Paragon for $1.2B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US Supreme Court rejects Allergan bid to use tribe to shield drug patents ( Reuters ) ( STAT ) Contract Drug Manufacturer Catalent to Buy Paragon Bioservices in $1.2 Billion Deal ( WSJ ) ( Reuters ) ( Endpoints ) Johnson & Johnson wins US FDA approval for bladder cancer drug ( Reuters ) ( FDA ) ( Press ) Democrats feud over drug pricing policy, as progressives...
  • ReconRecon

    Recon: Gilead, Novo Nordisk Team up to Test NASH Combo

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novo Nordisk and Gilead team up to test fatty liver disease treatment ( Reuters ) ( Endpoints ) ( Fierce ) ( Press ) FDA expands Keytruda label to include stage 3 and 4 non-small cell lung cancer ( Pharmafile ) ( Press ) Bristol-Myers shareholders back the big Celgene buyout. What happens now? ( Endpoints ) ( Celgene ) ( BMS ) Many employers would like to elim...
  • ReconRecon

    Recon: AskBio Raises $235M for Gene Therapy Trials

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AskBio’s $235 million financing provides clues to the direction of gene therapy investment ( STAT ) ( Xconomy ) Grassley, Wyden Ask HHS Watchdog to Investigate Middlemen ‘Spread Pricing’ ( Senate Finance ) Gilead Sciences to lay off one-fifth of sales force as financial pressures build ( STAT ) ( Endpoints ) Blame Game Continues at House E&C Hearing on Insulin...
  • ReconRecon

    Recon: US Indicts Indivior Over Suboxone Marketing Tactics

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sanofi to cut US insulin costs for some patients to $99 per month ( Reuters ) ( STAT ) ( CNBC ) ( Endpoints ) ( Press ) US indicts Indivior over Suboxone opioid treatment marketing ( Reuters ) ( STAT ) ( Endpoints ) ( DoJ ) Amgen's postmenopausal osteoporosis drug gets FDA greenlight ( Reuters ) ( Endpoints ) ( NYTimes ) ( FDA ) 5 names to know at Verily: Play...
  • ReconRecon

    Recon: PBMs Blame Drugmakers for High Prices at Senate Hearing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pharmacy benefit managers in the spotlight ( Politico ) CVS, Cigna, Humana at Senate hearing blame Big Pharma for high drug prices ( CNBC , Video ) These Senators Received The Biggest Checks From CVS, Humana And Other Pharmacy Benefit Managers Testifying Tuesday ( Forbes ) Democrats to push DOJ on Obamacare stance ( Politico ) Zogenix's seizure drug filing f...
  • ReconRecon

    Recon: Regeneron to Invest $800M in Alnylam to Develop RNAi Treatments

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Regeneron to invest $800 million in Alnylam, betting on RNAi ( STAT ) ( Reuters ) ( Endpoints ) ( Press ) Why Big Pharma Is Winning the Drug Price Wars ( Bloomberg ) Audentes Therapeutics to develop gene therapies for two types of muscular dystrophy, including Duchenne ( STAT ) ( Endpoints ) Celgene, Acceleron submit FDA application for billed blockbuster lusp...
  • ReconRecon

    Recon: NY AG Sues Stem Cell Clinic Over Unproven Therapies

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The last day of Commissioner Gottlieb ( Politico ) ( FDA ) Powerful House committee to weigh legislation aimed at shedding more light on high drug prices ( STAT ) Oklahoma drops several claims in opioid case against J&J, Teva ( Reuters )  ( Law360 -$) Drug company founder, execs exploited patients to sell opioid: US prosecutor ( Reuters ) Dems struggle to uni...
  • ReconRecon

    Recon: Jazz, Lundbeck and Alexion Pay $123M to Settle Kickback Probe; Novartis Sues Amgen Over Aimovig

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers pay $123 million to resolve US charity kickback probe ( Reuters ) ( STAT ) ( DoJ ) Novartis sues Amgen over migraine treatment Aimovig ( Reuters ) FDA’s Gottlieb heads back to AEI to tackle drug prices ( Washington Post ) ( The Hill ) ( Endpoints ) Outgoing FDA chief Gottlieb raises 'concern' over Walgreens, CVS selling CBD products ( CNBC ) US to ...