Regulatory Recon: Japan Scraps Drug Price Cut Proposal NICE Rejects Zurampic for Hyperuricemia in Gout Patients (9 June 2017)

Posted 09 June 2017 | By Michael Mezher 

Regulatory Recon: Japan Scraps Drug Price Cut Proposal NICE Rejects Zurampic for Hyperuricemia in Gout Patients (9 June 2017)

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

In Focus: US

  • Personalized cancer therapies show great promise. The hitch? Manufacturing them efficiently (STAT)
  • Precision Oncology Drug Shows Power Of Cancer Genomics (Forbes)
  • Lower Drug Costs Still 'Absolute Priority' for Trump, Price Says (Bloomberg) (KHN)
  • FDA Calls to Remove Endo Opioid From US Market (Focus)
  • Qualification of Drug Development Tools: FDA Updates Process (Focus)
  • FDA Unveils List of Reusable Devices Requiring New Validation Data (Focus)
  • FBI raids controversial DNA testing company in Irvine (LA Times) (STAT) (GenomeWeb)
  • How will Novartis price its groundbreaking CAR-T med? R&D exec offers some clues (Fierce)
  • Continuous Manufacturing: Novartis' experiment in the future of drug production (Pharmafile)
  • 'Tumor agnostic' cancer drugs seen boosting wider genetic tests (Reuters)
  • A Key Republican Demands Subsidies to Calm Insurance Markets (NYTimes)
  • Zika affects 5 percent of babies with confirmed infections: CDC (Reuters) (NPR)
  • Cancer drug prices are so high that doctors will test cutting doses (Washington Post)
  • Should Free Speech Protections Include an Exception for Exclusivity-Protected Information? (FDA Law Blog)

In Focus: International

  • Teva Pharmaceutical to Nominate Four New Directors (WSJ) (Fierce)
  • Japan government scraps proposals for drug-price cuts in policy guidelines (Reuters)
  • Pharmaceutical industry responds to the political uncertainty that has followed the 2017 UK General Election result (ABPI)
  • Drug in fatal clinical trial has several off-target effects, study finds (STAT) (BioCentury)
  • NICE rejects Zurampic for hyperuricemia in gout patients (PharmaTimes)
  • Turkish Ministry Seeks Spinraza, Other Funding For SMA Patients (Pink Sheet-$)
  • J&J garners EU approval for $30bn Actelion deal (Financial Times)
  • Syrian polio outbreak hits global effort to eradicate virus (Reuters)
  • Merck Versus Merck: The Moniker Row Simmers In India (SCRIP-$)
  • A Cuban vaccine might some day turn lung cancer into a chronic disease (Miami Herald)
  • Australia Proposes New Risk-Based Approach to Medicine Variations (Focus)
  • European Regulatory Roundup: EMA to Discuss Improving Treatment of Kids With Lymphoma, Leukemia (Focus)
  • EU Non-Human Primate Opinion Is A "Tremendous Missed Opportunity" (Pink Sheet-$)

Pharmaceuticals & Biotechnology

  • Roche Pushes The Boundaries Of Cancer Immunotherapy (SCRIP-$)
  • Breaking barriers to novel analgesic drug development (Nature)
  • Saying Los Angeles lacks a great cancer center, Soon-Shiong plans to open one (STAT)
  • Merrimack poaches Ariad CMO after shake-ups for both companies (Fierce)
  • Inovio Resumes VGX-3100 HPV Cancer Program (BioCentury)
  • UCL researchers identify Huntington's disease biomarker (PharmaTImes)
  • Cyclin D3-CDK6 Levels Predict Tumor Response To CDK4/6 Inhibitors (BioCentury)
  • IDF, in partnership with Lilly, announces second phase of BRIDGES programme funding for translational research in diabetes with focus on secondary prevention (Press)
  • FDA Launches Redesigned Animal Drugs Website (FDA)

Pharmaceuticals and Biotechnology: Study Results, Filings and Designations

  • First PhIII trial of AbbVie's upadacitinib a success (PharmaTimes)
  • Astellas and Pfizer Announce Amendment to Clinical Research Protocol for Phase 3 PROSPER Trial of enzalutamide in Patients with Non-metastatic Castration-Resistant Prostate Cancer (Press)
  • Lilly to Present Late-Breaking Data for Galcanezumab and Lasmiditan at the American Headache Society Annual Scientific Meeting (Press)
  • OncoSec Granted Orphan Drug Designation from the U.S. FDA for the Treatment of Unresectable Metastatic Melanoma (Press)
  • Trulance sNDA in IBS-C accepted for review by FDA (PharmaLetter-$)
  • Clearside Biomedical highlights preliminary data from retreatment trial (Drug Delivery)
  • Baxter Announces U.S. FDA Approval and Commercial Launch of Ready-To-Use Clindamycin Injection in Saline (Press)

Medical Devices

  • Report: WannaCry ransomware attack just a symptom of med device cybersecurity vulnerabilities (MassDevice)
  • With new FDA clearances, ZIO is poised to finally add realtime, connected monitoring (MobiHealthNews)
  • Using Watson to Diagnose Skin Cancer: Interview with IBM Computer Vision Scientist, Noel Codella (medGadget)

US: Assorted & Government

  • Essure Patients Say Suit Against Bayer Belongs In State Court (Law360-$)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • EMA/FDA/Health Canada joint workshop addressing unmet needs of children with pulmonary arterial hypertension – 12 June 2017
  • Session on introduction to the EU regulatory system and the EMA for international regulators and non-governmental organisations – 18 September 2017


  • Recommendations to enhance biosimilar label transparency in Europe (PharmaLetter-$)
  • Astellas and Gedeon Richter breach ABPI code (PharmaLetter-$)


  • Kissei gets rights to develop and market avacopan in Japan (PharmaLetter-$)


  • Top five Indian pharma companies together spent over Rs 8000 crore on R&D spend in FY17 (Economic Times)
  • Kerala govt to start central generic drug supply scheme, Jan Aushadhi Stores, in all 1040 panchayats and municipalities (PharmaBiz)


  • TGA Launches SME Assist Hub (TGA) (TGA)
  • When to engage with the TGA (TGA)
  • Medical devices regulation: an introduction ((TGA)

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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