• ReconRecon

    Recon: Horizon Prices Newly Approved Tepezza at $14,900 per Vial; GSK Pay-for-Delay Appeal Faces EU Rebuke

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Horizon prices newly approved thyroid eye disease therapy at $14,900 per vial ( Reuters ) ( Endpoints ) ( FDA ) ( Press ) Johnson & Johnson beats Wall Street expectations on profit, misses on revenue ( CNBC ) California considers declaring common pain killer carcinogen ( AP ) Ex-drug execs get over 2 years in prison for bribery scheme ( AP ) ( Law360 -$) Suns...
  • ReconRecon

    Recon: GSK Nabs Priority Review for Myeloma Drug; BeiGene Lung Cancer Treatment Hits Goals in Phase III Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US GSK advances blood cancer drug to FDA, but rivals threaten ( BioPharmaDive ) ( Endpoints ) ( Press ) Scientists find unexpected anti-cancer activity in range of non-oncology drugs ( Endpoints ) ( Scientific American ) ( Broad ) Pfizer’s big data exec on pharma’s ‘arms race’ to partner with companies like Fitbit, 23AndMe, and others ( STAT ) Will the FDA give t...
  • ReconRecon

    Recon: China Says New Coronavirus Can Spread From Human to Human; GSK, 23andMe Seek First Drug Target

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Despite US law, many clinical trial results go unreported ( Reuters ) ( The Lancet ) FDA delays decision on Intercept's NASH drug by three months ( PMLive ) ( BioPharmaDive ) Patients Still Struggle To Balance High Costs Of MS Treatment, Despite Generic ( NPR ) Judge slashes $8B Risperdal award against J&J to $6.8M ( Reuters ) ( NYTimes ) Medicare’s Part D Do...
  • ReconRecon

    Recon: FDA Panel Split on Durect Non-Opioid Painkiller; Novo’s Ozempic Gains CV Indication

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA panel split over approval of Durect's non-opioid painkiller ( Reuters ) ( Endpoints ) Republican FTC commissioner says she supports Medicare negotiating drug prices ( The Hill ) ( STAT ) Novo Nordisk's diabetes pill Rybelsus to be covered by Express Scripts ( Reuters ) Novo Nordisk's blockbuster Ozempic wins FDA label boost with CV indication ( Endpoints )...
  • ReconRecon

    Recon: BioMarin Eyes $2-3M Price for Hemophilia Gene Therapy as Other Gene Therapies Test Europe’s Willingness to Cover Them

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US BioMarin Explores Pricing Experimental Gene Therapy at $2 Million to $3 Million ( WSJ ) Neon Therapeutics makes one last retreat, selling itself cheap in a bargain basement M&A deal ( Endpoints ) ( BioPharmaDive ) Hedge fund veteran looks to cash in on biotech boom ( Financial Times ) Pharma execs pitch ideas at JPM to lower drug costs. None include dropping t...
  • ReconRecon

    Recon: Nektar Withdraws Opioid NDA After FDA Panel Votes Unanimously Against Approval

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Nektar withdraws NDA for opioid after FDA panel's unanimous vote against it ( Reuters ) ( Endpoints ) ( Press ) FDA staff highlights neurological safety concerns with Durect's pain drug ( Endpoints ) More Than 100 Billion Pain Pills Saturated The Nation Over Nine Years ( Washington Post ) New York drug distributor exits opioids after admitting role in crisis (...
  • ReconRecon

    Recon: Novartis, NHS Reach Deal on Yet-to-Be Approved Heart Drug Inclisiran; Roche Aims to Undercut Rivals With SMA Drug Pricing

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US All talk, no M&A makes for a down JPM Day ( STAT ) ( Pink Sheet -$) Roche aims to 'underwhelm' on SMA drug price to challenge rivals ( Reuters ) ( Endpoints ) GlaxoSmithKline CEO expects to get ‘at least’ six drug approvals from the FDA in 2020 ( CNBC ) Eyeing more data, Livongo will integrate continuous glucose monitor into diabetes coaching program ( STAT ) ...
  • ReconRecon

    Recon: Startup EQRx Raises $200M in Effort to Bring Cheaper Drugs to Market; Incyte Buys Rights to MorphoSys CAR-T Rival

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US JPM health conference kicks off ( Politico ) High Drug Prices? Pharma Startup Thinks It Has the Right Medicine ( WSJ ) ( Axios ) ( STAT ) ( Endpoints ) ( Financial Times ) ( Fierce ) FDA and NIH let clinical trial sponsors keep results secret and break the law ( ScienceMag ) Biogen to buy early-stage potential Alzheimer's, Parkinson's treatment from Pfizer ( R...
  • ReconRecon

    Recon: Lilly to Acquire Dermira for $1.1B; Idorsia, Neurocrine Pair for $400M Epilepsy Drug Deal

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Lilly to acquire Dermira for $1.1 billion, adding eczema drug to its pipeline ( STAT ) ( Endpoints ) Blackstone raises three-quarters of targeted $4.6 billion life sciences fund ( Reuters ) ( Endpoints ) BMS confident of approvals linked to higher Celgene investor payout: Bristol executive ( Reuters ) FDA approves Blueprint's stomach cancer therapy priced at $...
  • ReconRecon

    Recon: California Looks to Sell its Own Line of Generics; Boehringer Signs With Singapore’s Enleofen to Develop Anti-Fibrotic Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US California eyes selling its own brand of generic prescription drugs to battle high costs ( LA Times ) ( Sac Bee ) ( WSJ ) ( The Hill ) Merck's Keytruda wins FDA approval for bladder cancer ( Reuters ) ( Endpoints -$) ( FDA ) ( Press ) Amag Pharmaceuticals to divest two women's health drugs, CEO to step down ( Reuters ) ( Press ) Two Big Drug Flops Show How Hea...
  • ReconRecon

    Recon: AbbVie to Split Allergan Cosmetics Into Separate Unit; Pharmacy Chains Sue Prescribers in Opioid Spat

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US AbbVie to house Allergan Botox business in separate unit ( BioPharmaDive ) Less Is More for Big Pharma in 2020 ( WSJ ) Why Humira’s price keeps rising despite FDA approval of generic competition ( Washington Post ) At 2020 deadline, progress in Patrick Soon-Shiong’s ‘cancer moonshot’ is hard to find ( STAT ) Pharmacies say prescribers bear opioid crisis respo...
  • ReconRecon

    Recon: Apellis’ PNH Drug Tops Soliris in Phase 3 Study; Teva to Pay $54M to Settle Copaxone Bribery Suit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Apellis' blood disorder drug outdoes Alexion's Soliris in improving hemoglobin levels ( Reuters ) ( STAT ) ( Endpoints ) Teva To Pay $54M To End FCA Suit Alleging Bribes To Doctors ( Law360 -$) ( Fierce ) ( Globes ) Allergan To Pay $300M To End Birth Control Antitrust Case ( Law360 -$) Merck's Keytruda shows mixed results in phase 3 trial for small cell lung c...