Regulatory Recon: Merck Wins $2.5B From Gilead in Hep C Patent Suit Watchdog Says Actavis UK Overcharged NHS by 12,000% for Hydrocortisone (16 December 2016)

Posted 16 December 2016 | By Michael Mezher 

Regulatory Recon: Merck Wins $2.5B From Gilead in Hep C Patent Suit Watchdog Says Actavis UK Overcharged NHS by 12,000% for Hydrocortisone (16 December 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Missed yesterday's Recon? Read it here.

In Focus: US

  • Gilead Sciences Ordered to Pay $2.5 Billion in Damages to Merck & Co. (WSJ) (Reuters) (Stat) (Fortune)
  • States Sue Generic-Drug Companies Over Price-Fixing Allegations (WSJ) (NYTimes) (Reuters)
  • 'Cures,' User Fees and Automation: Woodcock Details Priorities and Challenges for 2017 (Focus)
  • G.O.P. Plans to Replace Health Care Law With 'Universal Access' (NYTimes)
  • Positive Impact Of External Sourcing On Pharma R&D Productivity (LifeSciVC)
  • How price-gouging of opioid overdose cure costs lives: 'There's never enough' (The Guardian)
  • Highlights of Drug and Biologic Related Provisions of 21st Century Cures (Part Two) (FDA Law Blog)
  • FDA Proposes New Rule on Bulk Substances Used to Compound Drugs (Focus)
  • Top health industry issues of 2017 (PwC)
  • Novartis Contest Rewards Positive Peer Review Articles About Entresto (CardioBrief)
  • Baxter to put up $625m for Claris Injectables generics biz (MassDevice) (Economic Times)
  • U.S. says Allergan's Forest units to pay $38 million to settle kickback allegations (Reuters) (DoJ)
  • Mylan launches EpiPen generic at more than 50 percent discount (Reuters)
  • Trump Promises To Repeal Obamacare; Meets With Architect Of The Law (NPR)
  • America's Next Defense Against Zika and Other Foreign Invaders (WSJ)
  • The Throwaway Scope: A Way To Ditch Superbugs? (KHN)
  • Real World Evidence: 'Hot Topic' At US FDA, But Not On Front Burner (Pink Sheet-$)

In Focus: International

  • GSK opens state-of-the-art global vaccine centre (Pharmafile)
  • Actavis UK raised drug prices 12,000 percent, watchdog finds (Reuters) (Financial Times) (The Guardian)
  • NICE Joins FDA Program to Shorten Time Between Device Approval and Insurer Coverage (Focus)
  • Nurofen maker's fine for misleading consumers increased from $1.7m to $6m (The Guardian)
  • Insider interview: NICE discusses its planned 'fast-track' appraisal process (Pharmafile)
  • Japan Joins International API Manufacturing Inspection Program (Focus)
  • EU lawmakers urge Germany to broaden access to fund for thalidomide victims (Reuters)
  • Novartis says buys Ziarco Group to expand skin care portfolio (Reuters) (Fierce)
  • Cipla to make drugs in Iran in deal with Ahran Tejarat (InPharmaTechnologist)
  • NICE again rejects Takeda's Hodgkin's lymphoma drug in draft guidance (PharmaLetter-$) (PharmaTimes)
  • Bicycle, CR UK work together on new cancer drugs (PharmaTimes)
  • Stem Cells May Be Next Frontier for Diabetes Drugmaker Novo (Bloomberg)
  • India's Aurobindo shares hit nine-month low on US price-fixing lawsuit (Reuters)
  • WHO celebrates achievements in 2016, despite global health challenges (WHO)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 December 2016 (EMA)
  • New oral treatment for rheumatoid arthritis (EMA) (Press)
  • European Medicines Agency's CHMP Recommends Merck's KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC) Whose Tumors Have High PD-L1 Expression with No EGFR or ALK Positive Tumor Mutations (Press)
  • Regulator investigating the diversion of prescription only medicines (MHRA)
  • European Commission: Entry into force of MDR, IVDR Set for Late May 2017 (Emergo)
  • The authorities are not your friend anymore; and neither are notified bodies (MedicalDevicesLegal)
  • New Medical Device Registration Requirements Issued in South Africa (Emergo)

US: Pharmaceuticals & Biotechnology

  • Patients in Research: What the Professionals Don't Get (Harvard Bill of Health)
  • Roche ending diagnostics deal with Pacific Biosciences (BioCentury)
  • Attacking Fake Medicines From All Sides (USP)
  • Lilly eases investors' jitters with strong 2017 forecast (Reuters)
  • Biogen cutting 104 jobs in Cambridge (Boston Globe)
  • Commonwealth Informatics Signs Consultation and Support Agreement with FDA (Press)
  • 21st Century Cures: Examining Provisions for Streamlining FDA Regulations for Clinical Research in Title III (National Law Review)
  • FDA's Naloxone App Prize Competition Celebrates Innovation In Search of Technological Solutions to the Opioid Epidemic (FDA Voice)
  • After FDA Hold, Agios Quickly Scraps One Anemia Drug, Turns to Another (Xconomy) (Fierce)
  • Extension of Effective Date of NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research (NIH)
  • Gifts to the Food and Drug Administration: Evaluation and Acceptance; Guidance for the Public and Food and Drug Administration; Availability (FDA)

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

  • Grünenthal Receives Breakthrough Therapy Designation From U.S. FDA for Neridronic Acid for the Treatment of CRPS (Press)
  • First human trial of tau-targeting Alzheimer's vaccine shows promise (Pharmafile)
  • Cerenis Therapeutics Receives FDA IND Approval to Begin Studies with CER-209 in NAFLD and NASH (Press)
  • ENYO Pharma SA Announces Successful Initiation of the Phase 1 Clinical Programme with EYP001, Its Lead Candidate for the Treatment of Chronic Hepatitis B Virus Infection (Press)
  • Ironshore Pharmaceuticals Announces FDA Acceptance of HLD200 New Drug Application for Treatment of ADHD (Press)

US: Medical Devices

  • Postmarket Surveillance: The Truth Is Never Simple (Part 2—Manufacturer Considerations) (MDDI)
  • StimGuard launches OAB neurostim trial (MassDevice)
  • Clarius Mobile Health gets FDA clearance for app-based, wireless ultrasound scanners (MobiHealthNews)
  • BD launches high volume syringe for biologics (MassDevice)
  • FDA denies Milestone Scientific's Compu-Flo 510(k) application (MassDevice)
  • FDA Efforts to Regulate Innovative Technologies and Facilitate Market Access (MedGadget)

US: Assorted & Government

  • US govt recovers over $4.7 billion from False Claims Act cases in FY 2016 (PharmaLetter-$) (Fortune) (WSJ)
  • Heeding Presumption Only Goes So Far In Post-Sale Warning Case (Drug and Device Law)
  • Takeda IP Suit Over Hikma Gout Flare Drug Is Reopened (Law360-$)
  • Big Hospital Operator Retreats From Health-Insurance Foray (WSJ)
  • MEDICARE: Initial Results of Revised Process to Screen Providers and Suppliers, and Need for Objectives and Performance Measures (GAO)

Upcoming Meetings & Events


  • ClearLine wins CE Mark for intravenous line device (MassDevice)
  • apceth Biopharma joins Lonza as bluebird bio cell therapy contractor (BioPharmaReporter)
  • CHMP adopts a positive opinion acknowledging that Jardiance® reduces the risk of CV death (Press)


  • Fujifilm To Expand Health Care Biz With $1.3B Wako Buy (Law360-$)
  • Daiichi Sankyo Lays Out Priorities As It Pursues Oncology Ambitions (SCRIP-$)


  • Sun Pharma completes acquisition of Ocular Technologies Sarl (Economic Times)


  • CDC Releases Preliminary Estimates of Birth Defects Following Zika Virus Infection in Pregnancy (CDC)

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

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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