• ReconRecon

    Recon: EMA Loses Bid to End London Lease; Merck’s Keytruda Fails Late-Stage Liver Cancer Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US CVS Needs More Expensive Drugs ( WSJ ) ( Forbes ) US top court rejects bid to block Indivior opioid drug copycat ( Reuters ) Indivior launches generic version of its Suboxone opioid drug ( Reuters ) Merck's Keytruda fails late-stage study in liver cancer patients ( Reuters ) ( Endpoints ) ( Press ) FDA chief says feds might intervene if states continue allowi...
  • ReconRecon

    Recon: Intercept to Seek Approval for NASH Drug After Mixed Phase III Results; Philippines Revokes License for Sanofi’s Dengvaxia

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Intercept's fatty liver drug meets late-stage main goal, shares soar ( Reuters ) ( STAT ) ( Endpoints ) Stealth player is poised to win a CRISPR patent that could speed the development of therapies ( STAT ) Here’s how prosecutors say generic drug makers schemed to fix prices ( STAT ) Throwing in the towel, troubled antibiotic maker Aradigm files for Chapter 11...
  • ReconRecon

    Recon: ICER Says Praluent Still Too Expensive After 60% Price Cut; NICE Backs Perjeta for HER2-Positive Breast Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US High stakes as Trump, Dems open drug price talks ( The Hill ) Praluent price cut still not enough, says ICER ( PharmaLetter -$) ( ICER ) Drug Giants Can Save America Billions. But Will They? ( Bloomberg ) The top 10 pipeline blowups, setbacks and snafus for H2 2018 ( Endpoints ) The golden age of dark web drug markets is over ( The Verge ) Trump's Drug Rebat...
  • ReconRecon

    Recon: Medicare Proposes Coverage for CAR-T Therapies; Bayer Options Full Rights to Loxo’s Vitrakvi

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The Instant, Custom, Connected Future of Medical Devices ( NYTimes ) Tropical Disease PRV Fix Didn’t Stop Novartis From Winning Another ( Focus ) Appropriations Bill Would Give FDA $269M Boost Over FY2018 Budget ( Focus ) Medicare would provide national coverage for CAR-T cancer therapies under new proposal ( STAT ) ( Reuters ) Former CEO said he was made the...
  • ReconRecon

    Recon: FDA Rejects Motif Bio Antibiotic; AstraZeneca Drops MedImmune Name in R&D Restructuring

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biotech Hedge Fund Bailed on Drugmaker Before Its Depression Treatment Scored ( Bloomberg ) Pfizer still holds the lead in the erectile dysfunction market even as Viagra sales falter ( CNBC ) In rap video, Insys opioid salesmen boasted of their prowess ( Boston Globe ) Motif Bio’s turnaround quest for once-rejected antibiotic hits the CRL wall ( Endpoints ) ( ...
  • ReconRecon

    Recon: J&J to Buy Surgical Robotics Firm Auris Health for $3.4B; FDA Panel Backs J&J’s Nasal Spray for Depression

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Johnson & Johnson to buy robotics group Auris Health for $3.4B ( Financial Times ) ( WSJ ) ( Endpoints ) ( MassDevice ) ( Press ) Johnson & Johnson's nasal spray for depression wins FDA panel backing ( Reuters ) ( STAT ) ( Endpoints ) ( NYTimes ) ( Bloomberg ) ( Press ) Former CEO says Insys founder pushed for higher doses of opioid ( Boston Globe ) ( Law360 -$...
  • ReconRecon

    Recon: Mylan Launches Generic Advair at One-Third Price of Original

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Mylan launches Advair generic at one-third price ( Reuters ) FDA Panel to Assess Risks of Women’s Surgical Mesh ( WSJ ) Vaccine storage too often fails to meet standards ( KHN ) Gilead's Liver-Drug Setback Clouds $35 Billion Dream ( Bloomberg ) ( STAT ) ( Endpoints ) ( Reuters ) ( Press ) A big PBM wants drug makers to agree to rebate demands that would preserve...
  • ReconRecon

    Recon: Sanofi and Regeneron Cut Price of Praluent by 60%

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sanofi and Regeneron cut list price of cholesterol drug by 60 percent ( Reuters ) ( STAT ) ( Endpoints ) ( Press ) J&J’s nasal antidepressant heads for FDA panel ( Fierce ) ( BioPharmaDive ) PhRMA asks the US trade rep to place added pressure on four countries over patent and pricing policies ( STAT ) ( PhRMA ) An early study ‘infuses hope’ back into attempts ...
  • ReconRecon

    Recon: Pfizer Japan Recalls Blood Pressure Drug; Seres Lays Off 30% of Staff

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Johnson & Johnson to be first drug maker to list prices in TV commercials ( STAT ) ( Reuters ) Gene therapy stocks plunge after poor trial data ( Reuters ) Seres Lays Off 30% of Staff, CSO Leaves After Pipeline Review ( Xconomy ) ( Fierce ) Does the NIH Deserve A Piece Of Biopharma's Profits? ( Forbes ) Philly city council defeats move to license sales reps a...
  • ReconRecon

    Recon: Sangamo Tanks on Weak Genome Editing Data; FDA Approves Sanofi Rare Blood-Clotting Disorder Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sanofi blood disorder drug wins FDA approval ( Reuters ) ( FDA ) ( Press ) Sangamo Therapeutics shares dive after poor early-stage trial data ( Reuters ) ( Bloomberg ) ( STAT ) ( Endpoints ) ( Press ) White House shakes up drug policy office ( Politico ) Trump Administration Salutes Parade Of Generic Drug Approvals, But Hundreds Aren’t For Sale ( KHN ) Congre...
  • ReconRecon

    Recon: Trump Takes Aim at Drug Prices in SOTU; Jury Orders Takeda to Pay Bayer $155M Over Patent Dispute

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pharma CEOs to Testify at Senate Drug Pricing Hearing ( Reuters 1 , 2 ) ( BioPharmaDive ) Pharma execs will testify before Congress 'one way or another,' US senator says ( CNBC ) Trump, claiming progress in lowering drug prices, tells Congress ‘we must do more’ ( STAT ) ( Endpoints ) ( NBC ) ( NPR ) ( KHN ) ( Politico ) ( The Hill ) ( BIO ) AP Fact Check: Tru...
  • ReconRecon

    Recon: GSK to Pay Merck KGaA up to $4.2B to Develop Immunotherapy Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Roche adapts newer breast cancer drug in face of Herceptin imitations ( Reuters ) ( Endpoints ) ( Press ) The bispecific boom: Genentech pays $120M to tie the knot with Xencor on an IL-15 alliance ( Endpoints ) Uncertainties remain in Trump rebate plan ( Politico ) The health care themes to watch in Trump's address ( Politico ) Flip the Script: Drugmakers Bla...