• ReconRecon

    Recon: Novartis to Cut 2,550 Jobs in Switzerland, UK

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amarin Sees Off-Label Claims Boosted By Study Results ( Law360 -$) J&J pledges to end global TB pandemic ( Pharmafile ) Drug Industry Tries to Slip $4 Billion Windfall Into Opioid Bill ( NYTimes ) Roche's Tecentriq adds two months to lung cancer patients' lives: study ( Reuters ) ( Endpoints ) ( Press ) Gilead to launch generic versions of its hepatitis drugs...
  • ReconRecon

    Recon: Amarin’s Fish Oil Drug Cut Heart Risks by 25% in Ph. III Study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US In Blowout, Amarin's Fish-Oil-Derived Drug Dramatically Cuts Heart Risk In Study ( Forbes ) ( STAT ) ( Endpoints ) ( Xconomy ) ( CNBC ) ( Press ) Alexion’s Soliris wows in rare disease PhIII trial, opening up a new franchise worth $500M-$700M ( Endpoints ) ( Press ) FDA lifts clinical hold on Sarepta’s Duchenne MD gene therapy, clearing the way to a quick launc...
  • ReconRecon

    Recon: Medtronic to Acquire Mazor Robotics for $1.6B; Dozens Lose Sight After Being Injected with Compounded Eye Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Medtronic to Acquire Mazor Robotics ( Press ) ( MassDevice ) We Can’t Afford the Drugs That Could Cure Cancer ( WSJ ) At Least 68 People Are Nearly Blind After A Botched Drug Was Injected Into Their Eyeballs ( BuzzFeed ) Why Former Novartis CEO Joe Jimenez Joined A Microbiome Startup's Board ( Forbes ) ( Endpoints ) Sloan Kettering’s Cozy Deal With Start-Up I...
  • ReconRecon

    Recon: Amicus Buys Celenex Gene Therapy Portfolio for $100M; EU Approves 5th Humira Biosimilar

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Amicus Therapeutics acquires portfolio of gene therapies targeting neurologic disorders ( STAT ) ( Endpoints ) ( Forbes ) ( Xconomy ) In the battle for life sciences companies, one state shows up behind enemy lines ( STAT ) Life sciences industry rallies behind Calif. bill to prevent a nightmare scenario for clinical research ( STAT ) Shares in Molecular Templ...
  • ReconRecon

    Recon: Gilead, Galapagos Report Positive Phase III Results for RA Drug Filgotinib

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Americans are hoping Amazon can save them from sky-high drug prices ( Quartz ) Gilead, Galapagos report competitive numbers for first big PhIII readout for filgotinib in RA ( Endpoints ) ( Fierce ) ( Press ) Galapagos shares soar on $4-6 billion hopes for new drug ( Reuters ) Gilead partners with gene-editing upstart Precision Bio in hunt to cure hep B ( Endpoint...
  • ReconRecon

    Recon: Appeals Court Invalidates Acorda’s MS Drug Patents; Nostrum CEO Defends 400% Price Hike

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US US appeals court invalidates Acorda patents on MS drug ( Reuters ) ( Biocentury ) Orexo soars after winning opioid drug appeal against Teva ( Reuters ) ( Law360 -$) When Courts Allow Changes To Hatch-Waxman 30-Month Stay ( Law360 -$) Senate Poised to Pass Bill to Stop Flow of Opioids Through the Mail ( NYTimes ) Pharma chief defends 400% drug price rise as a ‘mo...
  • ReconRecon

    Recon: US Appeals Court Upholds Broad Institute’s CRISPR Patent

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Appeals court upholds CRISPR patents awarded the Broad Institute ( STAT ) ( Bloomberg ) ( Broad ) Pharma Billionaire Charged With Penny Stock Fraud ( Forbes ) ( Endpoints ) ( BioCentury ) GSK says U.S. FDA wants more information on pulmonary drug ( Reuters ) Cheap Custom-Made Versions of High-Cost Drugs Spur Backlash ( WSJ ) Biotech Venture Deal Terms Are More “...
  • ReconRecon

    Recon: Akcea to Cut 10% of Workforce; Hospitals Form Generic Drug Company

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US Trump health chief meets with GOP lawmakers on lowering drug prices ( The Hill ) Akcea reducing workforce 10% following Waylivra rejection ( BioPharma Dive ) ( Reuters ) ( Fierce ) A Superstar Team of Hospitals Is Sick of High Drug Prices—And Launching a Nonprofit Drug Company to Fight Them ( Fortune ) ( AP News ) ( Forbes ) ( NPR ) ( BioPharma Dive ) Boston Sci...
  • ReconRecon

    Recon: Aurobindo to Buy Sandoz Assets for $900M; FDA Extends Review of Roche's Tecentriq Combo by Three Months

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA extends review of Roche's Tecentriq by three months ( Reuters ) ( PharmaTimes ) GSK to axe 650 positions across US workforce ( Pharmafile ) The reinvention of Bob Hugin: Amid anger over drug prices, a former pharma CEO makes a run for the Senate ( STAT ) Sangamo team rushes to defend first human gene editing data as MPS II therapy offers a hit — and a miss ( ...
  • ReconRecon

    Recon: Embattled Theranos to Finally Shut Down; NICE Okays Novartis' Kymriah After Price Drop

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Blood-Testing Firm Theranos to Dissolve ( WSJ ) ( CNBC ) ( Financial Times ) Report: Hospitals mark up drugs by 500% ( Axios ) Insurance tactic drags down U.S. drug prices in second quarter: analyst ( Reuters ) Agios names former Celgene executive Jacqualyn Fouse as next CEO ( Reuters ) ( Forbes ) Scientists Are Retooling Bacteria to Cure Disease ( NYTimes ) Go...
  • ReconRecon

    Recon: Sanofi Wins EU Approval for Rare Blood Disorder; FDA Rejects Sunovion ADHD Drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA rejects Sunovion’s ADHD drug ( PharmaTimes ) ( Press ) First CRISPR clinical trial backed by U.S. companies launches ( STAT ) ( BioCentury ) Once charged with speeding up Eli Lilly’s slow-mo R&D group, Anne White is handed the reins at Lilly Oncology ( Endpoints ) ( Fierce ) Insurers Fret Over How To Pay For Gene Therapy As The Science Advances ( Forbes ) Ph...
  • ReconRecon

    Recon: AZ's Lupus Drug Fails in Phase III; FDA Approves Two Merck HIV Drugs

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US FDA approves two new HIV drugs from Merck ( Reuters ) ( Press ) FDA widening probe into heart drugs linked to cancer risk ( STAT ) ( CNN ) ( FDA ) Big Data Is Remaking Big Pharma ( Forbes ) Pew Urges FDA to Ensure Appropriate Use of Antibiotics Approved Through Limited Population Pathway ( Pew ) Trump administration resists WHO efforts to tackle antimicrobial re...