• ReconRecon

    Recon: FDA Rejects Vanda’s Jet Lag Drug; Roche and AbbVie Price New Cancer, RA Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AbbVie prices new rheumatoid arthritis drug at $59,000 a year ( Reuters ) Roche cancer treatment priced at $17,050 a month, lower than rival Vitrakv ( Reuters ) Minority racial groups continue to be dismally represented in cancer trials ( Endpoints ) ( STAT ) ( JAMA ) Vanda shares slide after FDA spurns their big endpoint and rejects a pitch on jet lag relief ...
  • ReconRecon

    Recon: Edwards, Medtronic Valves Win Expanded Low-Risk TAVR Indication; FDA Approves AbbVie’s Rinvoq

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Zimmer Biomet’s pediatric spinal tether for scoliosis ( MassDevice ) ( FDA ) ( Press ) Edwards, Medtronic win expanded indications for low-risk TAVR patients ( MedtechDive ) ( FDA ) ( Press ) ( Press ) FDA approves AbbVie's new rheumatoid arthritis drug ( Reuters ) ( Press ) Trump health official: Controversial drug pricing move is 'top priority' ...
  • ReconRecon

    Recon: Affordability Questions Follow New TB Approval; Sanofi Handed Win in Jevtana Patent Suit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves TB pill that cures more hard-to-treat patients ( AP ) ( Reuters ) ( NYTimes ) ( FDA ) Nonprofit under pressure to make new TB drug affordable ( BioPharmaDive ) ( MSF ) The Creation Of Biotech Startups: Evolution Not Revolution ( LifeSciVC ) Compass Therapeutics and these three other biotech startups got venture funding a year ago. Where are they n...
  • ReconRecon

    Recon: Cummings, Sanders Question Mylan, Teva & Heritage for Obstructing Price Fixing Probe

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Cummings, Sanders investigate drug companies for 'obstructing' probe ( The Hill ) ( STAT ) ( Politico ) ( Reuters ) ( House Oversight ) Novartis ousted top scientists over Zolgensma data manipulation ( STAT ) ( Endpoints ) ( Reuters ) Novartis violated FDA’s sacred principle: In God we trust, all others must bring data ( STAT ) Novartis chooses internal replac...
  • ReconRecon

    Recon: Trump’s Canada Drug Import Plan Needs Pharma’s Cooperation; Top HHS Drug Pricing Advisor to Depart

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Deciphera shares skyrocket as cancer drug improves progression-free survival ( Reuters ) ( Endpoints ) ( Press ) Trump’s Canada Drug Import Plan Can’t Happen Without Big Pharma ( Bloomberg ) Trump's key drug pricing advisor O'Brien makes HHS exit ( Endpoints ) Senator Grassley seeks info on Novartis's Zolgensma data issues ( Reuters ) ( Endpoints ) ( Letter ) ...
  • ReconRecon

    Recon: Two Promising Drugs Emerge in Congo Ebola Trial; NHS Scotland Denies CF Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Biotech faces a crisis in credibility fueled by boom-era hubris ( STAT ) US patients struggle to obtain Eli Lilly’s half-price insulin ( Financial Times ) These health-tech veterans want to avert the next Theranos disaster with ‘medical diligence’ ( CNBC ) Deals Give Drugmakers Rights to DNA Data ( WSJ ) Drug Shortage Leaves Patients Without Immune-Disorder T...
  • ReconRecon

    Recon: China NMPA Approves Gilead’s Biktarvy for HIV-1; FDA Rejects Kala Eye Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Sarepta says adverse event report for DMD gene therapy erroneously submitted ( Reuters ) ( STAT ) ( Endpoints ) Senators blast Novartis over data manipulation before approval of Zolgensma ( STAT ) ( The Hill ) ICER closely monitoring FDA’s Zolgensma investigation ( PMLive ) Potential new PrEP drug exposes gaps in data for women ( Politico ) House GOP unaware ...
  • ReconRecon

    Recon: CMS Finalizes CAR-T Coverage Decision; Bayer Buys Remaining Stake in Cell Therapy Co. BlueRock

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Bayer to buy rest of US biotech company in rare offensive move ( Financial Times ) ( Endpoints ) ( Press ) CMS finalizes long-sought rules for Medicare CAR-T coverage ( STAT ) ( WSJ ) ( Reuters ) ( CMS ) Better Birth Control Could Exist, But It Wouldn’t Pay for Big Pharma ( Bloomberg ) Bausch Health CEO: Big Pharma will survive US drug regulations ( CNBC ) FD...
  • ReconRecon

    Recon: AZ Claims Phase III Success for Lynparza in Prostate Cancer; NICE Backs Nerlynx in Adjuvant HER2+ Breast Cancer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amag's female libido injectable therapy to sell at $899 ( Reuters ) Patient groups push back against Gilead's pricey HIV prevention treatment ( Reuters ) Opioid Distributors Propose $10 Billion to End State Claims ( Bloomberg ) ( CNBC ) US Judge Expresses Support for Novel Opioid Settlement Talks Framework ( Reuters ) Boom in overdose-reversing drug is tied t...
  • ReconRecon

    Recon: GSK Ends Ebola Vaccine Development, Transfers Vaccine Candidates to Sabin Institute

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US 2020 election creates ‘perfect storm’ for drug price reform by year-end ( CNBC ) Deadly Germ Research Is Shut Down at Army Lab Over Safety Concerns ( NYTimes ) Diabetes drug maker Novo Nordisk buys pill factory in North Carolina ( Reuters ) Amid rising concern, pay-to-play clinical trials are drawing federal scrutiny ( STAT ) Help how? Patient charities favor...
  • ReconRecon

    Recon: Roche Reports Positive Phase III Results for Tecentriq Combo in Bladder Cancer; Colombia Fines Pfizer for Exceeding Price Caps

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA approves Daiichi Sankyo's treatment for rare joint tumor ( Reuters ) ( Endpoints ) ( FDA ) ( Press ) White House Weighs September Rollout of Health Plan ( WSJ ) ( Reuters ) Drug industry urges Canada to act early on U.S. import plan ( Reuters ) Eli Lilly confirms probe by New York’s Attorney General over insulin prices ( CNBC ) States Clash with Cities Ov...
  • ReconRecon

    Recon: Philippines Considers Reviving Use of Sanofi Dengue Vaccine

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US PhRMA’s top lobbyist will leave at the end of August ( STAT ) A Blood Test for Alzheimer’s? It’s Coming, Scientists Report ( NYTimes ) Federal judge allows pharma to proceed with lawsuit against California transparency law ( STAT ) BioMarin drops lower dose of its hemophilia gene therapy as it eyes submissions by year-end ( Fierce ) ( Endpoints ) Clovis dives...