• ReconRecon

    Recon: Sales of Essure birth control implant halted by Bayer

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Sales of Essure birth control implant halted by Bayer; U.S. was last to sell controversial device ( The Washington Post ) ( NYT ) Novartis Sues to Block Generic Sales of Top Drug Gilenya for MS ( Bloomberg ) ( Fierce ) Merck Is Lowering Drug Prices. There’s a Catch. ( NYT ) ( WSJ ) ( The Hill ) ( Reuters ) Risks Just Rose for Drug Middlemen ( WSJ...
  • ReconRecon

    Recon: Trump Plan to Lower Drug Prices Moves Forward on Several Fronts

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Trump Plan to Lower Drug Prices Moves Forward on Several Fronts ( Bloomberg ) ( STAT- $) ( WSJ -$) Trump thanks major pharma companies for not raising prices ( New York Post ) ( Reuters ) ( The Washington Post ) Roche takes Tecentriq hit on survival data ( Reuters ) ( Endpoints ) In two PhIII wins for Allergan/Molecular Partners, wet AMD drug shows ...
  • ReconRecon

    Recon: Following Pfizer, Novartis Hits Pause on Price Hikes

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Bill Gates jump-starts research for an affordable Alzheimer's test ( CNN ) ( Fortune ) ( Forbes ) Novartis shelves US price increase ( Financial Times ) ( CNN ) ( WSJ ) ( Bloomberg ) ( Reuters ) Pfizer-Lilly pain drug meets late-stage trial goals ( Reuters ) ( BioPharma Dive ) ( Endpoints ) ( Fierce ) Sanofi bags rights to Revolution’s SHP2 cancer drug ( Fierce )...
  • ReconRecon

    Recon: Mylan Signs Licensing Deal on Humira with AbbVie

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US South Dakota judge blocks drug price cap measure from ballot ( AP News ) ( STAT ) Pharma fuels Johnson & Johnson's earnings beat, consumer lags ( CNBC ) ( Reuters ) ( WSJ ) Mylan signs U.S. license deal on Humira with AbbVie ( Reuters ) ( The Center for Biosimilars ) Roche hands over another batch of positive PhIII data on its new flu drug, looking ...
  • ReconRecon

    Recon: China Pushes for Lower Cancer Drug Prices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Trump Fails at Lowering Drug Prices as Costs Keep Going Up ( Bloomberg ) This Form of Ambien Now Costs Over 800% More ( WSJ -$) Lawmaker asks Pfizer to make recent rollback on drug prices permanent ( Stat -$) Drug to Treat Smallpox Approved by FDA, a Move Against Bioterrorism ( NYT -$) ( Endpoints ) ( FDA ) Drug industry takes center stage in Senate race, as Hug...
  • ReconRecon

    Recon: FDA Panel Backs Malaria Drug; Senate Report on Trump Lawyer and Novartis

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Senate Democrats blast former Trump attorney for 'selling access' to White House ( ABC News ) ( Endpoints ) ( STAT ) ( Business Insider ) ( Bloomberg ) ( Report ) HHS OIG Report on Tom Price’s Flights ( Report ) ( NYT -$) Amgen, UCB are back pitching once-rejected osteoporosis drug to the FDA — but big hurdles lie ahead ( Endpoints ) ( Fierce ) FDA P...
  • ReconRecon

    Recon: Pfizer Agrees to Postpone Drug Price Hikes, Plans Split Into 3 Units

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Pfizer Agrees To Postpone Drug Price Hikes After Trump Tweet ( NPR ) ( Bloomberg ) ( NYT ) ( Forbes ) Pfizer to split into three units, separates consumer healthcare ( Reuters ) ( WSJ ) ( Endpoints ) ( CNBC ) Drugmakers Cancel Price Hikes After California Law Takes Effect ( Bloomberg ) BioCryst stockholders call off merger with Idera Pharmaceuti...
  • ReconRecon

    Recon: Trump Shames Pharma Over Price Hikes, FTC Clears $62B Takeda-Shire Deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Trump says Pfizer, others 'should be ashamed' for raising drug prices ( CNBC ) ( The Hill ) ( STAT ) Azar Calls for Changes in 340B Drug Pricing Program ( MedPage Today ) ( STAT- $) HHS secretary: Recent drug price increases 'creating a tipping point' ( The Hill ) After rosiptor's phase 3 rout, Aquinox to cut staff by 53% ( Fierce ) ( Endpoints ) A 7-year-old al...
  • ReconRecon

    Recon: CMS Quietly Quit Deal to Pay for Kymriah Performance

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US CMS quit test of pricey cancer treatment ( Politico ) Cytori shares surge on mixed results for its PhI erectile dysfunction study ( Endpoints ) ( Fierce ) Regulus stock plummets as company faces 60% staff cuts ( The Pharma Letter -$) ( Endpoints ) CTI Biopharma's cancer drug fails late-stage trial, shares tumble ( Reuters ) ( Endpoints ) Fed. Circ. O...
  • ReconRecon

    Recon: AbbVie Reverses $140M AndroGel Verdict, Biogen-Eisai Alzheimer’s Drug Makes a Comeback

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US AbbVie wins reversal of $140 million verdict in case over AndroGel risks ( Reuters ) ( Fierce ) Boston Scientific buys up cardiac cryoablation device firm Cryterion for $202M upfront ( Fierce ) ( Minneapolis Star Tribune ) ( Boston Business Journal -$) Teva moving North America headquarters from North Wales to North Jersey ( Philadelphia Business Journa...
  • ReconRecon

    Recon: Sanofi Plans $76M R&D Center in China

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Novartis Injects Itself Into Planned Rollout of EpiPen Competitor ( WSJ -$ ) ( DDBN ) US drugmaker Pfizer lifts price of Viagra and 100 other products ( Financial Times ) Liquidia files for IPO to challenge United Therapeutics in PAH ( Fierce ) ( Endpoints ) No Assurance About Insurance Under Experimental Drug Law ( Bloomberg ) Medicare spent $2 billi...
  • ReconRecon

    Recon: Novartis to Spin Off Alcon; Biogen to Pay $700m for Samsung Joint Venture Stake

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Biogen to pay $700M to boost stake in Samsung biologics joint venture ( Boston Business Journal -$) ( GEN ) ( Reuters ) ( Endpoints ) ( Fierce ) Novartis to Spin Off Alcon Eye-Care Business ( WSJ ) ( Financial Times ) ( Bloomberg ) ( Reuters ) CVS to Pay $1.5M to Settle Probe of Opioid Reporting Lapses ( Bloomberg ) ( Reuters ) Indivior gets...