Regulatory Recon: EMA Recommends Gilead, Merck Hep C Combos China to Launch Drug Pricing Probe in June (27 May 2016)

Posted 27 May 2016 | By Michael Mezher 

Regulatory Recon: EMA Recommends Gilead, Merck Hep C Combos China to Launch Drug Pricing Probe in June (27 May 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Obama's Pointless Cancer 'Moonshot' (NYTimes)
  • NIH funds biobank to support Precision Medicine Initiative Cohort Program (NIH)
  • US sees first case of bacteria resistant to all antibiotics (Reuters) (NPR)
  • Will Precision Medicine Move Us beyond Race? (NEJM)
  • FDA Approves First Buprenorphine Implant for Opioid Addiction (Press) (FDA) (Reuters) (Focus)
  • Califf to Big Data Crowd: Flood Of New Treatments Coming (Xconomy)
  • FDA teams with Flatiron for real-world cancer data analytics project (Fierce) (Press)
  • Roche boosted by early trial success with blood cancer drug Gazyva (Reuters) (Press)
  • Ionis shares plummet as GSK scraps heart drug trial plans (Reuters)
  • AstraZeneca potassium drug delayed by manufacturing snag (Reuters) (Fierce) (In The Pipeline)
  • Happy 40th Birthday Medical Device Amendments – You're Officially Over-the-Hill (FDA Law Blog)
  • MDUFA IV: Negotiations Step Forward, But Gaps Remain (Focus)

In Focus: International

  • China regulator to launch drug pricing probe in June (Reuters)
  • EU Proposes More Structured Convergence With FDA on Pharma Regulations (Focus)
  • MDSAP Update: As Pilot Winds Down, Manufacturer Buy-in Still Lacking (Emergo)
  • At G7, Britain presses for global reward system for new antibiotics (Reuters 1, 2)
  • EMA Recommends Gilead, Merck Hepatitis C Combos (EMA) (Reuters) (Press – Merck, Gilead)
  • EU regulator's advisory panel backs AstraZeneca diabetes drug  (Reuters)
  • ANSM Releases Report on Implantable Defibrillation Leads (ANSM)
  • European Regulatory Roundup: EMA Debates Use of Single-Arm Oncology Trials (Focus)

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US: Pharmaceuticals & Biotechnology

  • FDA Officials Offer Tips On How To Improve CMC Packages To Win ANDA Approvals (Gold Sheet-$)
  • FDA Requests Comments on ICH E6(R2) Addendum (FDA)
  • FDA Extends Patent Period for Olysio (FDA)
  • GOP Reps Chide HHS On Off-Label Marketing, Urge Changes (Law360-$)
  • AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA (Pharmafile)
  • Clinical trials firm BioClinica explores sale: sources (Reuters)
  • The Scope of FDA's Proposed Revisions to the IND Regulations May Not Be Sufficient to Achieve Its Stated Goals (National Law Review)
  • ICER framework threatens to halt continued progress against multiple myeloma (PhRMA)
  • Bristol-Myers attacks cost-effectiveness study of cancer drug (BioPharmaDive) (BMS)
  • White House publishes Precision Medicine Initiative data security framework (Fierce)
  • The next generation of therapeutics for chronic kidney disease (Nature)
  • NIH study visualizes proteins involved in cancer cell metabolism (NIH)
  • Pfizer Offers Hope For Lower-Priced Cancer Drug Combos (Forbes)
  • Editing our genes to cure — not just treat — disease (CNBC)

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

  • Flexion's Zilretta data sufficient for submission (BioCentury)
  • Minerva's Shares Soar on Early Data for Schizophrenia Drug (Xconomy)
  • Sage Therapeutics Announces Completion of Enrollment for Phase 2 Proof-of-Concept Trial of SAGE-547 in Severe Postpartum Depression (Press)
  • The Medicines Company Announces Completion of Patient Enrollment in Phase 3 TANGO 1 Study of CARBAVANCE (meropenem-vaborbactam) for Treatment of Complicated Urinary Tract Infections (cUTI) (Press)
  • U.S. FDA Approves CSL Behring's AFSTYLA -- The First and Only Recombinant Factor VIII Single Chain Therapy for Hemophilia A (Press)
  • Vanda Announces FDA Approval of the Fanapt® Supplemental New Drug Application for Maintenance Treatment of Schizophrenia in Adults (Press)

US: Medical Devices

  • Centerline Biomedical wraps up pre-clinical study, looks to Series A (MassDevice)
  • Hospitals Struggle to Keep Endoscopy Safe (Medpage)
  • NEMA Publishes NEMA XR 31-2016 Standard Attributes On X-Ray Equipment For Interventional Procedures (MITA)
  • Scientific Affairs At Medical Device Firms: The Ongoing Challenge To Define Roles (Cutting Edge Info)
  • Hummi Micro-Draw Blood Transfer Device by Hummingbird Med Devices: Class I Recall - Potential for Parts to Disconnect (FDA)
  • FDA Reclassifies Diurnal Pattern Recorders to Class II (FDA)
  • Top 5 Medical Device Trends of 2016 (Master Control)
  • FDA panel backs St. Jude's Amplatzer stroke device in 15-1 vote (MassDevice)
  • Medical Device Innovation Consortium Announces Release of Draft Blueprint for Early Feasibility Study Success (Press)

US: Assorted & Government

  • J&J Seeks To Pause Hip Implant Trials After $498M Verdict (Law360-$)
  • Cellphone-Cancer Link Found in Government Study (WSJ-$)
  • Back in the Senate, Rubio Tackles Drugs (Medpage)
  • Sen. Casey Submits Bill to curb abuse of dextromethorphan (Congress)
  • Sen. Coats Submits bill to ensure prompt coverage for breakthrough devices under Medicare (Congress)

Upcoming Meetings & Events


  • EMA Acts To Stem Conflicts Over Generic Drug Dissolution Specs (Gold Sheet-$)
  • Twist In The Tale To New EU Regulations Deal (Clinica-$)
  • European Reference Network Calls on Member States to Designate Affiliate and Collaborative National Centres (ERN)
  • EU agency wants 65 pct cut in farm use of last: ditch antibiotic (Reuters)
  • Mefloquine should be last resort for military personnel, MP committee says (Pharmaceutical Journal-$)
  • Agreement Reached on Europe's Medical Device and IVD Regulations (Emergo) (EuroParl)
  • Sigh Of Relief for IVD Industry As It Gets Five Years To Comply With New EU Regs (Clinica-$)
  • SuperSonic Imagine wins Japanese clearance for Aixplorer (MassDevice)
  • Ireland: Price Cuts And A New Route to Market? (Pink Sheet-$)
  • Shire gets European nod for Revestive, shareholders approve Baxalta merger (PharmaPhorum)
  • Respiratory Motion wins CE Mark for ExSpiron minute ventilation monitor (MassDevice)
  • EFPIA welcomes TTIP progress on regulatory convergence but more ambitious outcomes are expected (EFPIA)
  • Medicines For Europe Joins Global Campaign To Fight Fake Medicines (Medicines for Europe)


  • CFDA releases 2015 Annual Report for National Medical Device Adverse Event Monitoring (CFDA)
  • INC Research expands in Japan amid 'evolution of the clinical trial landscape' (Outsourcing-Pharma)
  • Roche's lung cancer Alecensa shows satisfactory efficacy in Japanese people (BioSpecrum)
  • South Korean pharma market to reach US$20 billion by 2020 (GaBI)


  • CDSCO Offers Risk-Based Checklist for Indian Pharma Manufacturing Inspections (Focus)
  • Strides Shasun Obtains Tentative Approval For Generic HIV Drug Sustiva (24 Insight)
  • Sanofi Obtains Indian Patent For Azabicycloalkane Derivatives (24 Insight)
  • Indian Generic Pharma Companies Receive Approval For Generic Vfend (24 Insight)


  • U.S. health official says Zika not a reason to cancel Olympics (Reuters)
  • U.S. researchers estimate range of microcephaly risk from Zika infection (Reuters)

Other International

  • WHO Issues Q&A Document on International Standards for Biotherapeutics (WHO)
  • Pre-Market Registration Fees Beckon In NZ For Medtech (SCRIP-$)
  • South African Ascendis Health buys 2 pharmaceutical firms in Europe for €505 million (PharmaAfrica)

General Health & Other Interesting Articles

  • Health risks for female sex workers and their children (Reuters)
  • Girls' early puberty and breast development tied to depression (Reuters)

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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