Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Will Focus on Quality Hurt the Generic Drug Industry? Novartis CEO Thinks

Regulatory Reconnaissance: Will Focus on Quality Hurt the Generic Drug Industry? Novartis CEO Thinks it Will (20 March 2014)

Posted 20 March 2014 | By Alexander Gaffney, RAC

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In Focus: US

  • Quality woes point to generic drugs shake-out: Novartis (Reuters)
  • FDA approves Impavido to treat tropical disease leishmaniasis (FDA) (Pharma Letter-$) (SCRIP-$) (Reuters) (BioCentury)
  • How Sovaldi Won A Broad Label: Emerging Data Swayed Reluctant FDA (PAM-$) (PAM-$) (PAM-$) (PAM-$)
  • FDA Drug Review Shop Adding Deputy Director For Quality Management (Pink Sheet-$)
  • How the New FDA Biocompatibility Testing Guidance Could Affect You (MDDI) (Part 2) (Part 3)
  • Got A Warning Letter? 4 Tips For Digging Out (Silver Sheet-$)

In Focus: International

  • EU Publishes Annual Work Plan (EMA) (EMA)
  • France's new half-yearly reporting system for device incidents marks EU first (Clinica-$)
  • EU Clinical Trial Regulation Overhaul Nears Final Approval (Sense About Science)
  • 2.3 per cent of Indian drugs found sub-standard, US doctors raise doubts on quality (India Times)

US: Pharmaceuticals/Biotechnology

  • FDA approves Impavido to treat tropical disease leishmaniasis (FDA) (Pharma Letter-$) (SCRIP-$) (Reuters) (BioCentury)
  • Quality woes point to generic drugs shake-out: Novartis (Reuters)
  • How Sovaldi Won A Broad Label: Emerging Data Swayed Reluctant FDA (PAM-$) (PAM-$) (PAM-$) (PAM-$)
  • FDA Drug Review Shop Adding Deputy Director For Quality Management (Pink Sheet-$)
  • Some Cold Medicines May Have Higher-Than-Expected Levels of a Decongestant (NYTimes)
  • Contrary to popular belief, side-effect reports on new meds keep a steady pace, study finds (Fierce)
  • FDA Approves First Insulin Product for Use with Automatic Injection Pen in Cats and Dogs (FDA)
  • The FDA vs. the flash mob: Hard questions as parents demand unproven drugs (Fierce)
  • Opinion: Can This Boy's Life Be Saved? The answer may depend on President Obama. (Weekly Standard)
  • FDA Hearing on Generic Drug Labeling Rule Scheduled for 1 April 2014 (House)
  • Compliance Officers: Three Common Mistakes to Avoid (PCM)
  • Child responding to Chimerix's brincidofovir (BioCentury)
  • The FDA's Dilemma With The Opioid Pain Medication Zohydro ER (Forbes)
  • Ferring Pharmaceuticals Receives FDA Approval For Mixed Protocol IVF Treatment (AP)
  • NEJM on the Approval of Diclegis (NEJM)

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

  • NDA for Eagle Pharmaceuticals' Orphan Drug Ryanodex for the Treatment of Malignant Hyperthermia Accepted by FDA, Priority Review Granted (Press)
  • Arbor Pharmaceuticals Announces FDA Acceptance Of 2nd NDA (AP)
  • Positive Ph III results with Novo Nordisk's N8-GP, a long-acting hemophilia A agent (Pharma Letter-$) (SCRIP-$) (BioCentury) (Fierce)
  • GSK cancer vaccine fails again but testing continues (Reuters) (Press) (Pharma Letter-$) (Pharmafile) (PMLive) (Bloomberg)
  • Emmaus product meets in Phase III sickle cell trial (BioCentury)
  • Pfizer's Investigational Vaccine Candidate Bivalent rLP2086 Receives FDA Breakthrough Therapy Designation for Potential Prevention of Meningococcal B Disease (Press)
  • Geron Reports Myelofibrosis IST Placed on Partial Clinical Hold (Fierce) (Reuters) (Bloomberg)

US: Pharmaceuticals and Biotechnology: General

  • 13 million more Americans would take statins if new guidelines followed: Study (CBS) (Forbes) (NPR)
  • Actavis Announces Daytrana Patent Challenge Settlement (AP)
  • Oklahoma: Shortage of Drugs Delays Executions (NYTimes)

US: Medical Devices

  • How the New FDA Biocompatibility Testing Guidance Could Affect You (MDDI) (Part 2) (Part 3)
  • Got A Warning Letter? 4 Tips For Digging Out (Silver Sheet-$)
  • Warning Letter Author Answers 9 Questions (Silver Sheet-$)
  • Lessons from McKesson: Insight into FDA's Stance on Clinical Decision-Support Software (MDDI)
  • FDA Developing Accelerated Pathway For Devices for Unmet Needs, Hamburg Says (Bloomberg BNA)
  • Agency at "Cutting Edge in Terms of Review and Approval of New Products" - FDA Chief (MedicalDevicesSummit)
  • A Registry of Upper-Spine Surgical Outcomes to Guide Patient Decisions (WSJ-$)
  • A Critical Take on the De Novo Approval of Cefaly (Skeptic North)
  • Ocular Therapeutix launches Phase III trial for eye plug (Mass Device)
  • ProTom International, Inc. Receives FDA 510(k) Clearance for its Radiance 330 Proton Therapy System (Press)
  • NDS Surgical Imaging Receives FDA Clearance for Dome S6c LED Widescreen 6MP Radiology Display (Press)
  • Stryker, slowly but surely, settles 8 more metal hip lawsuits (Fierce)

US: Assorted And Government

  • FDA Historians Share Lessons From Agency's Past (FDA)
  • Enforcement Report - Week of March 19, 2014 (FDA)

Europe

  • EU Publishes Annual Work Plan (EMA) (EMA)
  • France's new half-yearly reporting system for device incidents marks EU first (Clinica-$)
  • EU Clinical Trial Regulation Overhaul Nears Final Approval (Sense About Science)
  • UK Drug Pricing: An ICER of Zero? (PharmExec)
  • European Parliament votes in favour of new Data Protection Regulation (GRE Blog)

India

  • 2.3 per cent of Indian drugs found sub-standard, US doctors raise doubts on quality (India Times)

General Regulatory And Interesting Articles

  • New regulatory pathways and incentives for sustainable antibiotics: Recent European & US Initiatives (Harvard BOH)
  • Clinical trial data sharing: from principles to practical implementation - an industry model (TOPRA)
  • IBM's Watson Attempts To Tackle The Genetics Of Brain Cancer (Forbes) (Press)

Regulatory Reconnaissance #280 - 20 March 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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


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