Regulatory Focus™ > News Articles > Regulatory Recon: EMA Conditionally Backs Intercept's Ocaliva to Treat Rare Liver Disease; NHS, NICE

Regulatory Recon: EMA Conditionally Backs Intercept's Ocaliva to Treat Rare Liver Disease NHS, NICE Plan to Fast Track Appraisals for Most Cost-Effective New Drugs (14 October 2016)

Posted 14 October 2016 | By Michael Mezher 

Regulatory Recon: EMA Conditionally Backs Intercept's Ocaliva to Treat Rare Liver Disease NHS, NICE Plan to Fast Track Appraisals for Most Cost-Effective New Drugs (14 October 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • FDA says it won't meet PDUFA goal date for Egalet's Arymo ER (PharmaLetter-$)
  • Clinton Transition Co-Chair Tanden Offers Themes For A Drug Pricing Bill In 2017 (Pink Sheet-$)
  • CDC Links Bacterial Infection in Patients to LivaNova Surgical Device (WSJ) (Reuters) (Medpage) (Forbes) (FDA 1, 2)
  • LivaNova's Sorin can't shake heater-cooler lawsuit (MassDevice)
  • Update on Prosecution for Truthful Off-Label Promotion (Drug and Device Law)
  • FDA Gets Pushback on Move to Regulate Lab Developed Tests (Medpage)
  • Productivity Over the Years (In The Pipeline)
  • How Bad Is The Drug Industry's Reputation After Pricing Kerfuffles? (Forbes)
  • Exploring Company Contributions To The Origination Of New Medicines (Forbes)
  • As Deadly Superbugs Rise, Big Pharma Presses Farm Antibiotics (Bloomberg)
  • Brain Implant Allows Man to Feel Touch on Robotic Hand (IEEE Spectrum) (Washington Post)
  • Patent watch: Microscale implantable drug delivery systems: emerging IP strategies (Nature)
  • FDA Releases Guidance on Software as a Medical Device for Consultation (Focus)
  • Breast Cancer Death Rates Are Down, But Racial Disparities Persist (NPR)
  • Experiment in monkeys raises hopes of "functional cure" for HIV (Reuters)

In Focus: International

  • Why losing the European Medicines Agency is bad news for patients, jobs – and the NHS (The Guardian)
  • Pfizer vows to persist in court battle over Lyrica (Financial Times)
  • Intercept's liver drug gets conditional backing of EMA panel (Reuters) (EMA)
  • CHMP Recommends Eight Drugs, Including Four Orphans and Three Generics; Supports Four Label Expansions (EMA)
  • The US, Germany and UK Top the List of First Launch Wave Countries (Cutting Edge Info)
  • UK plans 'fast track' for most cost-effective new medicines (Reuters) (PharmaTimes) (BioCentury)
  • NICE says case for Opdivo to treat lung cancer is not clear cut (PharmaLetter-$) (PharmaTimes) (BioCentury)
  • GSK's David Leather On Transitioning from GP And Radio Doctor To Real World-Evidence Czar (Pink Sheet-$)
  • Interview – Abivax aims high in HIV care (EP Vantage)
  • China, Korea Eye the Latest Multi-Billion Blockbuster Drug Market (Bloomberg)
  • EMA Report Emphasizes Need for Coordinating International Regulatory Initiatives (Focus)
  • Sales of veterinary antibiotics continue to decline in most European countries (EMA)
  • EMA recommends measures to ensure safe use of Keppra oral solution (EMA)
  • Use of metformin to treat diabetes now expanded to patients with moderately reduced kidney function (EMA)
  • Bayer's medical skin creams draw suitors Lupin, BC Partners: sources (Reuters)

US: Pharmaceuticals & Biotechnology

  • Allegro's DME Drug Could Over-Throw Off-Label Avastin, Says CMO (SCRIP-$)
  • 2016 CDISC International Interchange: Standards, Metadata and the FDA (BioClinica)
  • Pfizer on CMOs: $180bn is at stake so being first-to-market is critical (InPharmaTechnologist)
  • Lack of Catalysts Keeps Analysts Away From Pfizer (The Street)
  • Curis thinks small to hit big immuno-oncology target (EP Vantage)
  • Adaptimmune puts fludarabine back on the agenda (EP Vantage)
  • The mythology of CRISPR (Science)
  • Obesity and Diabetes Tied to Liver Cancer (NYTimes)
  • Money up but deals edge down for biotech in Q3 as Moderna leads the U.S. venture drive (Fierce) (PwC)
  • Opioids May Interfere With Parenting Instincts, Study Finds (NYTimes)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

  • Trevi Therapeutics Announces Positive Results from Phase 2 Trial in Prurigo Nodularis (Press)
  • C2N Diagnostics Completes Phase 1 Clinical Study of C2N-8E12 (ABBV-8E12) Among Individuals with Progressive Supranuclear Palsy (Press)
  • Esperion expanding Phase III program for bempedoic acid (BioCentury)
  • TG Therapeutics slides on ublituximab study changes (BioCentury)
  • FDA reviewing Sunovion's COPD therapy (BioCentury)

US: Medical Devices

  • Class 1 Device Recall HeartWare Ventricular Assist System (FDA)
  • Medtronic touts cryoballoon cost savings data from Fire & Ice trial (MassDevice)
  • U.S. Government Awards $20 Million for Electroceuticals Research (IEEE Spectrum)
  • Personalized Medicine Draws Closer With Cheap and Accurate DNA Sequencer (IEEE Spectrum)
  • Scientists Use 3D Printers to Recreate Kidney's Proximal Tubules (medGadget)
  • Medtronic Cardiac Devices Gain FDA Approval to Enable Patient Access to the Most Advanced Diagnostic Imaging (Press) (MassDevice)

US: Assorted & Government

  • Other Devices' Failures and Labeling Are Not Enough to Get a Plaintiff to Trial (Drug and Device Law)
  • U.S. rep's new drug pricing bill proposes Clinton-style panel to punish 'bad actors' (Fierce) (DeLauro)
  • DOJ Weighs in on Discount Safe Harbor (FDA Law Blog)
  • Health Care Quality: HHS Should Set Priorities and Comprehensively Plan Its Efforts to Better Align Health Quality Measures (GAO)
  • Pradaxa Warnings Were Adequate, Boehringer Ingelheim Says (Law360-$)
  • Fed. Circ. Backs MIT In Cell-Growing Mesh Patent Case (Law360-$)
  • Sandoz, Taro, Others Hit With Antitrust Suit Over Skin Cream (Law360-$)
  • With Final MACRA Rule Looming, Fears Remain (Medpage)

Upcoming Meetings & Events


  • Ex-Novartis CAR-T researcher joins TxCell to lead CAR-Treg research program (Fierce)
  • Top 10 Questions about Europe's MDR for Medical Device Companies (Emergo)
  • Denmark's Genmab looks to immunotherapy for cancer drug encore (Reuters)
  • EMA Opens Consultation on ICH E11 (R1) (EMA)
  • MEPs Slate EU Industry Practices In Report On Barriers To Medicines Access (Pink Sheet-$)
  • Faulty defibrillator warning (MHRA)
  • Allergan's Belkyra gains marketing approval in Sweden (PharmaLetter-$)
  • European Pharmacopoeia prepares for the future through exchange with stakeholders (GaBI)
  • Potential cost savings from use of biosimilars in the UK (GaBI)
  • Bristol-Myers Squibb Receives Positive CHMP Opinion for Opdivo (nivolumab) for the Treatment of Adult Patients With Relapsed or Refractory Classical Hodgkin Lymphoma After Autologous Stem Cell Transplant and Treatment With Brentuximab Vedotin (Press)


  • India requests 'Green Channel' for export of drugs to China (BioSpectrum)
  • India urges Japan to provide wider pharma market access (Economic Times)
  • Extrapolation of indications for biosimilars in Japan (GaBI)


  • Kurt Stoeckli to head Glenmark's global research portfolio (Economic Times)
  • Boehringer Ingelheim India and Lupin enter agreement to market diabetes drug (Economic Times)
  • NPPA asks medical devices cos again to provide data of notified devices to monitor prices (PharmmaBiz)


  • Intellipharmaceutics signs generics supply deal with Mallinckrodt (PharmaLetter-$)
  • Health Canada Defends Accessibility of Mifegymiso (Health Canada)


  • Use of biosimilar anti-TNF in Australia (GaBI)
  • Safety advisory - potential battery issues if compartment cracked (TGA)


  • Rapid development of a DNA vaccine for Zika virus (Science)
  • Florida declares new area of Zika transmission in Miami (Reuters)

Other International

  • Efforts to beat tuberculosis fall far short, WHO warns (Reuters)
  • Five in six infants undernourished, risk irreversible mental and physical damage: U.N. (Reuters)

General Health & Other Interesting Articles

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

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