• ReconRecon

    Recon: FDA Rejects Lipocine Testosterone Drug for the Third Time; Roche SMA Drug Hits Goal in Pivotal Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democratic presidential hopefuls want to take on pharma. Here’s how they’d do it ( STAT ) Voters Say Congress Needs to Curb Drug Prices, But Are Lawmakers Listening? ( KHN ) Celgene's drug for anemia in beta thalassemia priced at $3,441/ 25 mg vial ( Reuters ) ( Endpoints ) ( FDA ) FDA rejects Lipocine's testosterone drug for third time ( Reuters ) ( Endpoints...
  • ReconRecon

    Recon: FDA Panel Warns No Adequate Replacement for Ethylene Oxide; Cardinal Health Wins $2.25B DoD Medical Supplies Contract

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Ethylene oxide plant closures put US on 'cusp of a major medical logistical failure' ( MedtechDive ) AdvaMed Statement on EtO Air Testing by EPA ( AdvaMed ) ( EPA v) Sarepta Therapeutics CEO playing nice with FDA over rejection of Duchenne drug ( STAT ) ( Fierce ) House Speaker Nancy Pelosi pushes vote on sweeping drug-pricing bill to December ( CNBC ) Senate...
  • ReconRecon

    Recon: J&J Submits Ebola Vaccine for EU Review; First Rituxan Biosimilar to Launch in US at 10% Discount

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US Sues Gilead Over HIV Drug Patents ( Focus ) ( NYTimes ) ( STAT ) ( Endpoints ) ( Law360 -$) George Church startup eGenesis rakes $100M for CRISPR pig organ transplants ( Endpoints ) ( Press ) Purdue Opioid Suits Put On Hold Until April ( Law360 -$) ( Reuters ) Teva puts further $468m aside for opioid-related settlements ( Financial Times ) How the FDA & EP...
  • ReconRecon

    Recon: AZ Backs $1B China Biotech Fund; Confirmation Hearing for FDA Commissioner set for 20 November

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Senate HELP Committee to Hold Confirmation Hearing for Nominee Hahn on 20 November ( HELP ) CRISPR Takes Its First Steps in Editing Genes to Fight Cancer ( NYTimes ) ( AP ) ( NPR ) White House and Pelosi part ways on relief for drug prices ( AP ) ASH preview: Celgene, Bluebird, and J&J out with early but telling data in blood cancer ( STAT ) Mallinckrodt rece...
  • ReconRecon

    Recon: Takeda Licenses MD Anderson CAR NK Therapies; FDA Offered Divergent Forecasts on Fecal Transplants

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Concerns raised about Giroir at FDA ( Politico ) FDA Approves 24th Biosimilar, 3rd for Neulasta  ( Focus ) ( Reuters ) ( Endpoints ) 1 in 2 seriously ill Medicare enrollees struggles with bills ( AP ) ( Axios ) A New Approach to Gene Therapy—Now In Dogs, Maybe Later In Humans ( WSJ ) Obscure Model Puts a Price on Good Health—and Drives Down Drug Costs ( WSJ )...
  • ReconRecon

    Recon: Stryker to Buy Wright Medical for $4B; China Conditionally Approves First Domestically Developed Alzheimer’s Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Stryker boosts bone implants with $4 billion Wright Medical buyout ( Reuters ) ( Financial Times ) Halozyme’s lead drug fails; company will cut 55% of workforce in bid for profitability ( STAT ) ( Endpoints ) Trump Nominates Hahn to be FDA Commissioner ( Focus ) FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns ( The Daily Be...
  • ReconRecon

    Recon: Amgen Takes 20.5% Stake in BeiGene; Novartis Cosentyx Fails to Top Humira in Head-to-Head Trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA is modernizing its technology to prepare for a new wave of therapies ( Politico ) Google takes on wearables giants with $2.1 billion Fitbit deal ( Reuters ) ( WSJ ) Realizing the Dream of Molecularly Targeted Therapies for Cystic Fibrosis ( NEJM ) ( NIH ) ( NYTimes ) AbbVie Earnings, Revenue Beat in Q3 ( Yahoo ) ( Press ) AbbVie says multiple parties vyin...
  • ReconRecon

    Recon: Swiss Competition Authority Names Boehringer, 10 Others in Antitrust Probe; Roche Pays $200M to License Dicerna RNAi Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pelosi Calls Pharma’s Bluff on Drug Prices ( Bloomberg ) Insurance, pharma figures spar over drug price legislation’s innovation impact ( STAT ) Merck loses bid to revive $2.54 billion patent verdict against Gilead ( Reuters ) ( Law360 -$) How Contaminated Stool Left a Fecal Transplant Patient Dead ( NYTimes ) ( STAT ) ( NEJM ) CMS proposes lifting restrictio...
  • ReconRecon

    Recon: Novartis’ Zolgensma Study Halted on Safety Concerns; FDA Panel Backs Withdrawing Approval for Amag’s Makena

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Novartis' Zolgensma study halted by FDA amid safety questions ( Reuters ) ( Endpoints ) ( STAT ) FDA panel recommends removing the Makena drug for preventing premature births ( STAT ) ( BioPharmaDive ) ( Endpoints ) ( Evaluate ) Small relief for Biogen in MS drug approval ( Reuters ) ( Endpoints ) ( Press ) Amgen posts higher biosimilar sales, ends neuroscienc...
  • ReconRecon

    Recon: Pfizer Raises 2019 Guidance on Strong Cancer, Heart Drug Sales; Drugmakers Settle Medicaid Fraud Suit for $248M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer raises 2019 forecast as sales of cancer drug, heart medicine surge ( Reuters ) ( Financial Times ) ( WSJ ) ( Press ) Mirati gives a first look at its KRAS-blocking cancer drug ( STAT ) ( Endpoints ) ( Reuters ) ( Press ) Will an FDA panel recommend a drug for preventing premature births remain available? ( STAT ) Drugmakers Ink $242M Settlement In Ill. ...
  • ReconRecon

    Recon: EU, UK Agree to Brexit Extension; Allergan Settles Alzheimer’s Suit for $750M

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Allergan settles Alzheimer's therapy lawsuit for $750 million ( Reuters ) ( Endpoints ) AstraZeneca aims to carve into Merck’s immunotherapy dominance ( STAT ) ( Endpoints ) ( Press ) Seniors clamor for high-dose flu shot, but it’s not always easy to find ( STAT ) Patient Assistance Groups Settle Kickback Claims For $6M  ( Law360 -$) ( STAT ) What to make of ...
  • ReconRecon

    Recon: EMA Discusses Drug Regulation with Chinese Authorities; FDA Raises Concerns on Device Shortages

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Nonpartisan congressional report: Pelosi’s drug pricing bill could be found unconstitutional ( STAT ) 'Patent thicket' bill caught in price reform tug-of-war ( Politico ) FTC staff recommends approval of Roche deal for Spark: report ( Reuters ) ( Endpoints ) The downside of cheap generics ( Axios ) Biogen's secret campaign to bring its Alzheimer's drug back f...