Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves New Plague Drug (11 May 2015)

Regulatory Recon: FDA Approves New Plague Drug (11 May 2015)

Posted 11 May 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Approves New Plague Drug (11 May 2015)

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

In Focus: US

  • FDA approves additional antibacterial treatment for plague (FDA) (SCRIP-$)
  • Opana gets FDA approval despite history of abuse, limited effectiveness in trials (JournalSentinel) (MPT)
  • FDA's Coming Off-Label Battles (Policy and Medicine)
  • FDA review challenges Vertex on crucial cystic fibrosis combo data (Fierce) (Tarius) (WSJ-$)
  • CDRH Head Makes Case for FDA Regulation of Next-Gen Sequencing (MDDI)
  • FDA approves spinal cord stimulation system that treats pain without tingling sensation (FDA) (Press)
  • Manufacturers Seek More Clarity On GMP Obligations For Combo Products (Gray Sheet-$)
  • Industry balks at paying for 21st Century Cures (BioCentury)
  • 21st Century Cures Act Markup to Begin This Week (StrengthenFDA)

In Focus: International

  • EFPIA Weighs in on Animal Testing and Animal Welfare (EFPIA)
  • EMA Releases New Veterinary Drug Recommendations (EMA)
  • DCGI to study global regulations to frame rules on online pharmacy soon (PharmaBiz)
  • Pediatricians urge crackdown on nosodes as alternative to vaccines (Globe and Mail) (Toronto Star) (CBC)
  • China looks to guidelines for drugs prescribed to children (Fierce)
  • MSF Attacks TPP Biologics Proposal (Health Affairs)

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US: Pharmaceuticals and Biotechnology

  • Opana gets FDA approval despite history of abuse, limited effectiveness in trials (JournalSentinel) (MPT)
  • FDA approves additional antibacterial treatment for plague (FDA) (SCRIP-$)
  • FDA's Coming Off-Label Battles (Policy and Medicine)
  • FDA review challenges Vertex on crucial cystic fibrosis combo data (Fierce) (Tarius) (WSJ-$)
  • Gilead Using Priority Review Voucher To Shore Up HIV Franchise (Pink Sheet-$)
  • FDA’s Influenza Watchword For 2015 Is Speed (Pink Sheet-$)
  • Inside FDA’s Debates On ‘Breakthrough’ (Pink Sheet-$) (Pink Sheet-$)
  • Additional FDA action needed to mitigate drug shortages (ModernHealthcare)
  • New Jersey Biosimilar Interchangeability Bill Introduced (Scout)
  • University of Minnesota admits missteps in second schizophrenia drug study (StarTribune)
  • California may require warnings on products containing chemical BPA (Reuters)

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

  • FDA lifts clinical hold on NeuroDerm's ND0612 to treat Parkinson's disease (PBR) (BioCentury) (Press)
  • FDA Grants QIDP and Fast Track Designations to CD101 IV, Cidara Therapeutics’ Lead Antifungal Product Candidate (Press)

US: Medical Devices

  • CDRH Head Makes Case for FDA Regulation of Next-Gen Sequencing (MDDI)
  • FDA approves spinal cord stimulation system that treats pain without tingling sensation (FDA) (Press)
  • Manufacturers Seek More Clarity On GMP Obligations For Combo Products (Gray Sheet-$)
  • How Best to Work with FDA to Navigate mHealth Regulation (mHealthIntelligence)
  • Medtech execs: Thinking about reimbursement early is key to a successful launch (MassDevice) (MDDI)
  • FDA approves Medtronic lead for tough implantations (Fierce)
  • Roche Receives FDA Approval for cobas KRAS Mutation Test (Press)
  • Invictus Gets FDA OK to Sell Device Protecting Newborns’ Skulls (Xconomy)
  • FDA Clearance for Liver Navigation System (MedGadget)

US: Dietary Supplements

  • Former FDA Deputy Commissioner Criticizes Dietary Supplement Regulation (BostonGlobe)

US: Assorted And Government

  • Industry balks at paying for 21st Century Cures (BioCentury)
  • 21st Century Cures Act Markup to Begin This Week (StrengthenFDA)
  • Weekly Regulatory Newsletter from PwC (HRI)

Upcoming Meetings and Events

Ebola Outbreak

  • State-of-the-Art Workshops on Medical Countermeasures Potentially Available for Human Use Following Accidental Exposures to Ebola Virus (PubMed)
  • US FDA Posts Advisory Committee Materials on the Development and Licensure of Ebola (Tarius)
  • Hemispherx Biopharma Europe N.V./S.A. Receives Orphan Medicine Designation by the European Medicines Agency for Ampligen to Treat Patients With Ebola Virus Disease (EVD) (Press)
  • Liberia declared Ebola-free, but outbreak continues over border (Reuters)

Europe

  • EFPIA Weighs in on Animal Testing and Animal Welfare (EFPIA)
  • EMA Releases New Veterinary Drug Recommendations (EMA)
  • EMA Releases Draft Opinion on Two Patient-Reported Outcome (PRO) Measures for Evaluating New Treatments for COPD (Press)

India

  • DCGI to study global regulations to frame rules on online pharmacy soon (PharmaBiz)
  • Sanofi Successfully Challenges NPPA Price Orders (24 Insight)

China

  • China looks to guidelines for drugs prescribed to children (Fierce)
  • China to increase health care subsidies, deepen reform (Reuters)
  • Pharmaceutical groups punished for misleading ads (Xinhua)

Canada

Australia

  • A$1.3 billion investment to list life-saving medicines in Australia (PharmaLetter-$)

Other International

  • Bad Vaccines Kill 2 Babies, Sicken 29 in Chiapas, Mexico (NBC)
  • MSF Attacks TPP Biologics Proposal (Health Affairs)
  • The ANVISA Unique Medicine Identifier (IUM) on Drug Packages (RxTrace)

Clinical Trials

  • Towards early inclusion of children in tuberculosis drugs trials: a consensus statement (PubMed)
  • Direct-acting antiviral drug approvals for treatment of chronic hepatitis C virus infection: Scientific and regulatory approaches to clinical trial designs (PubMed)

General Regulatory And Interesting Articles

  • Hunt for AIDS cure accelerates as GSK and U.S. experts link up (Reuters)

Regulatory Reconnaissance #554 – 11 May 2015

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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