Regulatory Focus™ > News Articles > Regulatory Recon: FDA Expected to Approve New Hepatitis C Drug Today (10 October 2014)

Regulatory Recon: FDA Expected to Approve New Hepatitis C Drug Today (10 October 2014)

Posted 10 October 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Expected to Approve New Hepatitis C Drug Today (10 October 2014)

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

In Focus: US

  • FDA Approval Expected Today for Gilead's FDC Hepatitis C Drug, Harvoni (Gilead) (Forbes)
  • FDA Approves Bortezomib (Velcade) for Untreated MCL (Medscape) (Boston Globe) (Press) (BioCentury)
  • FDA Awards $16.3M Contract to Symphony Health for Outpatient/Drug Utilization Data (Press)
  • Toward predictive models for drug-induced liver injury in humans: are we there yet? (PubMed)
  • Changes Coming to CDRH’s Refuse-to-Accept Policy for 510(k)s (MDDI)
  • MMM Allograft Heart Valves Should Be Class III, FDA Panel Says (Gray Sheet-$)
  • Senators Keep Pressure on FDA Over Power Morcellator Devices (Gannett)

In Focus: International

  • First Ebola Vaccine Trial Starts in Africa (CNBC)
  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (EMA)
  • Critics applaud EU Commission 'u-turn' on EMA (PharmaTimes) (SCRIP-$)
  • EU agency backs continued use of Ariad leukemia drug (Reuters) (Press) (EMA)
  • India gives go-ahead for clutch of biosimilar clinical trials (SCRIP-$)
  • Top Five Mistakes in Clinical Protocol Design (Cato)

US: Pharmaceuticals and Biotechnology

  • FDA Approval Expected Today for Gilead's FDC Hepatitis C Drug, Harvoni (Gilead) (Forbes)
  • FDA Approves Bortezomib (Velcade) for Untreated MCL (Medscape) (Boston Globe) (Press) (BioCentury)
  • FDA Awards $16.3M Contract to Symphony Health for Outpatient/Drug Utilization Data (Press)
  • Toward predictive models for drug-induced liver injury in humans: are we there yet? (PubMed)
  • Emerging efforts for discovering new biomarkers of liver disease and hepatotoxicity (PubMed)
  • Regulatory Science Collaborations Support Emergency Preparedness (FDA)
  • J&J Unit Escapes Suit Over Birth Control Patch Clotting Risks (Law 360-$)
  • Rock-Solid Triferic Heads Toward ODAC Review (Pink Sheet-$)
  • Novartis’ Panobinostat Review Panel Could Scrutinize Survival Data (Pink Sheet-$)
  • Oregon Compounding Centers, Inc. Issues Voluntary Recall of Unexpired Sterile Products in Oregon and Washington Due to Lack of Sterility Assurance (FDA)

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

  • Priority Review for Amgen's blinatumomab BiTE (BioCentury) (Press) (RTT)
  • Vertex plans 4Q lumacaftor-ivacaftor US, EU submissions (SCRIP-$) (BioCentury)
  • Novartis' secukinumab shows strong efficacy in psoriasis Phase III trials (Pharma Letter-$) (Press)
  • Medicine Co's Orbactiv (Oritavancin) Successful in Phase 3 SOLO II Trial (Press)

US: Pharmaceuticals and Biotechnology: General

  • Elderly patients in US lack knowledge on biosimilars (GaBI)

US: Medical Devices

  • Changes Coming to CDRH’s Refuse-to-Accept Policy for 510(k)s (MDDI)
  • MMM Allograft Heart Valves Should Be Class III, FDA Panel Says (Gray Sheet-$)
  • Senators Keep Pressure on FDA Over Power Morcellator Devices (Gannett)
  • Exact Sciences Announces Final National Coverage Determination for Cologuard (Press)
  • FDA Raises Concerns With RTI Surgical Over Bone Graft, Website (Press)
  • Class 1 Recalls for Richard-Allan Scientific Devices (FDA)
  • FDA accepts IDE submission for system to address chikungunya, dengue blood safety risks (VaccineNewsDaily)
  • ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall - Delivers Higher Flow Rate than Intended (FDA)
  • Covidien Announces FDA 510(k) Clearance for Nellcor Portable SpO2 Patient Monitoring System (Press)

US: Dietary Supplements

  • In Bayer Litigation, NPA Worried Government Aiming to ‘Rewrite Federal Law on Dietary Supplements’ (NPI) (NI-USA)

US: Assorted And Government

  • Highlights from the United States Food and Drug Administration's public workshop on the development of animal models of pregnancy to address medical countermeasures in an "at-risk" population of pregnant women: Influenza as a case study (PubMed)

Upcoming Meetings

Ebola Outbreak

  • Small drugmakers try to scale up to meet Ebola crisis (WaPo)
  • First Ebola Vaccine Trial Starts in Africa (CNBC)
  • Chinese company develops Ebola treatment (FT-$)
  • Enterovirus D68 And Influenza Far More Dangerous Than Ebola In U.S., Say Top Infectious Diseases Physicians (Forbes)

Europe

  • Meeting highlights from the Pharmacovigilance Risk Assessment Committee (EMA)
  • Critics applaud EU Commission 'u-turn' on EMA (PharmaTimes) (SCRIP-$)
  • EU agency backs continued use of Ariad leukemia drug (Reuters) (Press) (EMA)
  • New EU device regulation rapporteur causes Commission stir over devices (Clinica-$)
  • PRAC recommends strengthening the restrictions on the use of valproate in women and girls (EMA)
  • IQWiG finds added benefit of Novartis’ Gilenya not proven (PharmaLetter-$)
  • Biogen Idec files for Elocta approval in Europe (PharmaLetter-$)

India

  • India gives go-ahead for clutch of biosimilar clinical trials (SCRIP-$)
  • Packaging cos oppose govt order to ban PET for pharma products (PharmaBiz)
  • Supreme Court to hear case against withdrawal of drug price cap (India Times)

Japan

Australia

  • Aussie Doctors launch campaign to ban pharmaceutical rep visits (NoAdsPlease)

Clinical Trials

  • Top Five Mistakes in Clinical Protocol Design (Cato)
  • General Regulatory And Interesting Articles
  • Scientists Coax Human Embryonic Stem Cells Into Making Insulin (NPR)

Regulatory Reconnaissance #418 – 10 October 2014

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 @AlecGaffney or send him an email at news@raps.org.

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


Categories: Recon, Regulatory News

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