Regulatory Focus™ > News Articles > Regulatory Recon: WHO Clears Broader Use of Experimental Ebola Treatments (13 August 2014)

Regulatory Recon: WHO Clears Broader Use of Experimental Ebola Treatments (13 August 2014)

Posted 13 August 2014 | By Alexander Gaffney, RAC

Regulatory Recon: WHO Clears Broader Use of Experimental Ebola Treatments (13 August 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

  • Senator Hits FDA for "Shortage" of Doxycycline (Senate) (Poughkeepsie Journal)
  • FDA Smiley Face Guidance May Force Botulinum Sponsors to Grin and Bear It (RPM Report)
  • Stem cell therapy: FDA regulatory science aims to facilitate development of safe and effective regenerative medicine products (FDA)
  • FDA's Social Media Gambit 'A Long Shot,' Says Patient Advocate (Health Leaders Media)
  • Sham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators? (Live Sciences Law Blog)
  • FDA approves donor lung preservation device that may result in more lung transplants (FDA) (AP) (Health Day) (Mass Device)

In Focus: International

  • WHO backs use of experimental Ebola drugs in West Africa (WSJ-$) (Reuters) (NPR) (BioCentury) (SciAm) (WaPo)
  • India's Top Drug Regulator, GN Singh, on Regulatory Improvements in India (Nature)
  • India Makes Clinical Research Comeback But Challenges Remain (PharmAsia-$)
  • Top Former CFDA Official Hit With Price Manipulation Charges (The Standard)
  • ICH seeks bids to replace Northrop Grumman as MedDRA contractor (Outsourcing Pharma)

US: Pharmaceuticals and Biotechnology

  • Senator Hits FDA for "Shortage" of Doxycycline (Senate) (Poughkeepsie Journal)
  • FDA Smiley Face Guidance May Force Botulinum Sponsors to Grin and Bear It (RPM Report)
  • Stem cell therapy: FDA regulatory science aims to facilitate development of safe and effective regenerative medicine products (FDA)
  • FDA discusses interim disclosure in CV outcomes trials (BioCentury)
  • FDA panel to wrangle with Spiriva Respimat's 'complex' history (SCRIP-$) (Pink Sheet-$)
  • Sham Hatch-Waxman Infringement Suits And FDA Citizen Petitions; A Potential For New Liability For Innovators? (Live Sciences Law Blog)
  • FDA's Social Media Gambit 'A Long Shot,' Says Patient Advocate (Health Leaders Media)
  • Generic Drug Industry Meets With FDA, OMB at White House (OMB)
  • A Look at FDA's New Office of Pharmaceutical Quality (FDA)
  • Health group ‘superbugged’ by antibiotic misuse (The Hill)
  • Endo, Impax Face Yet Another Suit Over Opana Pay-For-Delay (Law 360-$)

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

  • AstraZeneca's gout drug lesinurad succeeds in Phase III (Pharma Times) (Press) (Fierce)
  • Pfizer Reports Top-line Results from Postherpetic Neuralgia and Painful Diabetic Peripheral Neuropathy Lyrica Studies Conducted in China (Press)
  • Agios Pharmaceuticals Announces the U.S. FDA Grants Fast Track Designation to AG-221 for Treatment of Patients With Acute Myelogenous Leukemia That Harbor an IDH2 Mutation (Press) (Boston Globe)
  • Rigel experimental eye drug fails mid-stage study (Reuters)
  • AcelRx Tries Transparency To Reassure Investors After Zalviso ‘Complete Response’ (Pink Sheet-$)
  • IMPROVE-IT Trial Scheduled For Presentation In November (Forbes)
  • Prosensa's muscular dystrophy programme 'back on track' (PharmPhorum)

US: Pharmaceuticals and Biotechnology: General

  • GSK settles with US EPA over waste storage at US R&D site (In-Pharma)
  • Group Pushes for Testosterone Study Retraction (MedPage Today)
  • Consumer Activists Put Pressure on Retailers to Drop Triclosan (Bloomberg)

US: Medical Devices

  • FDA approves donor lung preservation device that may result in more lung transplants (FDA) (AP) (Health Day) (Mass Device)
  • Class I Recall for Edwards' IPM Wound Gel; Microbial Contamination Cited (FDA)
  • Consumers Union sends petition to FTC on hip and knee replacement warranties (Consumers Union)

US: Dietary Supplements

  • Social Media and Dietary Supplements (NPI)

US: Assorted And Government

  • New Batch of FDA Warning Letters Posted (FDA)
  • It’s Time to Make Rulemaking Really Transparent on Agency Websites (RegBlog)
  • U.S. rolls back oversight of potentially dangerous experiments (Reuters)

Ebola Outbreak

  • WHO backs use of experimental Ebola drugs in West Africa (WSJ-$) (Reuters) (NPR) (BioCentury) (SciAm) (WaPo)
  • Canada to donate its own Ebola vaccine to WHO for use in Africa (Reuters)
  • How did Liberia Get Approval to Use ZMapp's Drug? (AllAfrica)
  • EBola: A Market Failure (SCRIP-$)
  • Opting Against Ebola Drug for Ill African Doctor (NYTimes)
  • Using a Tactic Unseen in a Century, Countries Cordon Off Ebola-Racked Areas (NYTimes)
  • Ebola Drug’s Success Bolsters Approach for Other Diseases (Bloomberg)
  • More Ebola drugs may be months away (The Hill)
  • Medicines supply chain ‘overwhelmed’ by Ebola crisis (PJO)
  • Tekmira shares drop 22% as frenzy cools over Ebola drug (Market Watch)

Europe

  • Collaboration and Innovation in European Medicine Regulation (PharmTech)
  • Soliris, the world’s most expensive drug: will NICE judge it affordable? (PharmaPhorum)
  • European Medicines Agency Inching Towards Clinical Trial Transparency (Policy and Medicine)

India

  • India's Top Drug Regulator, GN Singh, on Regulatory Improvements in India (Nature)
  • India Makes Clinical Research Comeback But Challenges Remain (PharmAsia-$)
  • India Ministry Renews Push For Compulsory License Of BMS Leukemia Drug (PharmAsia-$)
  • India's CDSCO Orders Improved State-Level Drug Inspections (PharmAsia-$)
  • Exporters ask commerce ministry to reinstate mono cartons as primary level packaging for barcoding (PharmaBiz)

China

  • Top Former CFDA Official Hit With Price Manipulation Charges (The Standard)

Canada

  • Draft Guidance Document - Release of draft revised: Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions (HC)
  • Canada Streamlines Rare Disease Treatment Information, Drug Approval (Health Data Management)

Australia

  • AstraZeneca Loses Generic Crestor Challenge In Australia (Law 360-$)
  • Other International
  • ICH seeks bids to replace Northrop Grumman as MedDRA contractor (Outsourcing Pharma)
  • Korea Sets New Pharmaceutical Serialization Deadlines (TraceLink)

Clinical Trials

  • Randomized Clinical Trials and Observational Studies Are More Often Alike Than Unlike (JAMA)
  • Approach used to conduct meta-analyses may affect outcomes (MNT)

General Regulatory And Interesting Articles

  • Ensuring the Safety, Quality, and Identity of Biopharmaceutical Raw Materials (Biopharm International)
  • Confirming Antibody-Based Drugs (C&EN)

Regulatory Reconnaissance #378 – 13 August 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.


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