Regulatory Recon: Merck's Newly-Approved Zepatier to Challenge Hep C Rivals on Price (29 January 2016)

Posted 29 January 2016 | By Michael Mezher 

Regulatory Recon: Merck's Newly-Approved Zepatier to Challenge Hep C Rivals on Price (29 January 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

  • FDA finds Indian drug maker Wockhardt hid failed tests (Reuters)
  • Discovering New Medicines And New Ways To Pay For Them (HealthAffairsBlog)
  • FDA Approves Zepatier to Treat HCV Genotypes 1 and 4, Priced at $54,600 (FDA) (WSJ) (Press)
  • Cancer drug target visualized at atomic resolution (NIH)
  • Obama Creates Moonshot Task Force (BioCentury) (White House)
  • E&C subcommittee to hold hearing on BPCIA (BioCentury) (E&C)
  • Drug Shortages Forcing Hard Decisions on Rationing Treatments (NYTimes)
  • Walgreens Suspends Theranos Lab Services at California Store (Reuters) (WSJ-$)

In Focus: International

  • Partnerships driving similar biologics development in India (GaBI)
  • Europe Readies For Big Changes In Device Postmarket Surveillance (Gray Sheet-$)
  • EMA Recommends Coagadex, First Specific Replacement Therapy for Rare Bleeding Disorder (EMA)
  • EMA Fast-Tracks Empliciti to Treat Multiple Myeloma (EMA) (Press)
  • Alibaba Gets Bitter Pill as Gov't Said to Scrap E-Drug System (Ciaxin)
  • Sanofi and the Iran Ministry of Health and Medical Education sign a memorandum of co-operation (Manufacturing Chemist) (Pharmafile)

US: Pharmaceuticals and Biotechnology

  • FDA's Woodcock: Generic Drug Application Backlog Will be Eliminated Before GDUFA II (Focus) (Pink Sheet-$)
  • Aspirations and Strategies for Public Health (JAMA)
  • Cinfa Biotech: How Pharmacists Can Benefit Biosimilar Development (BioProcess Online)
  • A Single Cell Shines New Light on How Cancers Develop (NYTimes)
  • FDA Approves First Drug to Improve Overall Survival in Liposarcoma (Focus) (SCRIP-$) (Press)
  • The Precision Medicine Initiative's 1st Annual Checkup (Law360-$)
  • USP Q&A: Standards for Plastic Packaging Systems for Drug Products (USP)
  • GMP Data Integrity White Paper, Part 2 (Unger Consulting)

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

  • Patient recruitment starts for MERS vaccine trial (EPR)
  • Allergan's Rapastinel Receives FDA Breakthrough Therapy Designation for Adjunctive Treatment of Major Depressive Disorder (Press)
  • Innovative Med Concepts Announces Receipt of FDA Fast Track Designation for IMC-1, a Novel Treatment for Fibromyalgia (Press)
  • OptiNose Announces FDA Approval for ONZETRA Xsail (sumatriptan nasal powder), a New Treatment for Acute Migraine (Press)
  • Priority Review for Exelixis' cabozantinib in RCC (BioCentury)

US: Medical Devices

  • Medical Device Cybersecurity Task Force To Provide "Collaborative Forum" For Industry (MedDeviceOnline)
  • Homeland Security Official: Key To Cybersecurity Is People, Not Tech (Gray Sheet-$)
  • Class I Recall: SPOTCHEM II Test Strips by Arkray: Inaccurate Blood Sugar Readings (FDA)

US: Assorted and Government

  • Roche expects cancer treatments to be spared U.S. pricing curbs (Reuters)
  • Families Press CDC for Painkiller Prescription Guidelines (WSJ-$)
  • Makers of Tainted Drug Tied to Nine Alabama Deaths Agree to Plead Guilty (NBC) (DoJ)
  • The Perils of Being a Store Clerk in an FDA-Regulated World (FDA Law Blog)
  • The Shape of (Discovery) Things To Come? (Drug and Device Law)
  • Washington's Prescription For Cheaper, And Unregulated Medicines (Forbes)
  • Lilly Continues Pricing Rhetoric Despite Backlash (SCRIP-$)
  • Tax Foundation Analysis Of Sanders Plan Only Shows Downside (Forbes)
  • Bernie Sanders' Healthcare Dreams Are Revolutionary, Unaffordable And Unachievable (Forbes)
  • Justice Department Settles with Alabama Moving Company Over Hepatitis-C Discrimination (DoJ)
  • Veracyte Receives Department of Health Clearance to Offer Lung Cancer Test in NY (GenomeWeb)

Upcoming Meetings and Events              


  • EGA: Shaping the 2020 regulatory landscape for patient needs (PharmaLetter-$)
  • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 25-28 January 2016 (EMA)
  • Novartis: Centralised manufacturing unit will harness tech, not reduce network (In-PharmaTechnologist)
  • How will biosimilar Benepali approval impact European rheumatology market? (PharmaLetter-$)
  • EU expands use of BMS' hepatitis drug Daklinza (PharmaTimes)
  • Exelixis Announces European Medicines Agency Acceptance of Marketing Authorization Application for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma (Press)


  • Industry expresses relief over DoP decision to set up separate ministry for pharma sector soon (PharmaBiz)
  • India Adds Ablation Devices To List Of Notified Medical Devices Regulated As Drugs (24 Insight)
  • MMC issues more than 60 warning letters for PCPNDT violation based on HC directive (PharmaBiz)
  • Dr Reddy's gets USFDA nod for migraine injection (Economic Times) (Press)
  • Janssen (J&J) Awarded Indian Patent For Benzimidazole Derivatives (24 Insight)
  • Unichem gets USFDA approval to sell prostate drug (Economic Times)


  • Japan approves Livanova's Kora 250 MRI-safe pacemaker (MassDevice)
  • Further capping of generics in Japan (GaBI)



  • The Rise Of The pCPA Heralds More Pricing Pressure In Canada (SCRIP-$)

Zika Virus

  • U.N. to Decide if Zika Virus is a Global Health Emergency (DD&D)
  • Zika vaccine may be ready for emergency use this year: developer (Reuters)
  • Rio mayor: No threat to Olympics from Zika virus (CBS)
  • Pregnant women in scarcity-hit Venezuela battle to dodge Zika (Reuters)

Other International

  • Prescribing similar biotherapeutic products in Latin America (GaBI)
  • Pharmacists' attitudes towards domestic generics in Afghanistan (GaBI)
  • HIV resistance to favored treatment not uncommon (Reuters)

General Health and 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

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

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