Regulatory Focus™ > News Articles > Regulatory Reconnaissance (4 June 2013)

Regulatory Reconnaissance (4 June 2013)

Posted 04 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

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  • With One Big Exception FDA Reviewers Back More Benign View Of Avandia Trial (Forbes) (Meeting Documents) (NYTimes) (Pharmalot) (AP) (SCRIP) (Pink Sheet)
  • FDA considering lifting Avandia REMS (BioCentury)
  • PhRMA, BIO creating PDUFA V tracking database (BioCentury)
  • FDA close to resolving all cancer drug shortages (Fierce)
  • What Makes a Breakthrough Cancer Drug? FDA's Pazdur Explains (WSJ)
  • Patients Want More than Check-the-Box Experience from FDA (BioWorld)
  • Sidney Wolfe resigns as director of Public Citizen Health  (Modern Physician) (Public Citizen)
  • Dr. William Chin to Lead PhRMA Science & Regulatory Affairs (PhRMA)
  • Asco - FDA charms industry with talk of faster approvals (EP Vantage)
  • New drugs trail many old ones in effectiveness against disease (Reuters)
  • CorePharma: GMP Confident, Ready to Relaunch After FDA Closeout Letter (In-Pharma Technologist)
  • MedWatch Celebrates 20th Anniversay (FDA)
  • Illinois Rejects Biosimilar Provisions in Legislation (GPhA)
  • Do Drugmakers Really Understand Informed Consent? Hochhauser Explains (Pharmalot)
  • Obama Administration Seeks To Loosen Antibiotic Approvals (NPR)
  • BioMarin's cancer drug success prompts launch of pivotal trial (Reuters)
  • Depomed dumping hot flash drug Sefelsa after FDA rejection (SCRIP)
  • NIH to fund clinical research network on antibacterial resistance (NIH)
  • FDA Announces AdComm for Proposed New Indications for AbbVie's Humira (FDA)
  • New Drug Applications; Approval Withdrawals: ORAFLEX; Eli Lilly and Co. (FDA)
  • Rep. Bob Latta: Protecting American families from counterfeit pharmaceuticals (The Hill) (WNWO)
  • Men's Use of Testosterone on the Rise (NYTimes)
  • NIH Details Effects of Sequester on its Operations (NIH)
  • Casey to HHS: Is Current Policy Negatively Impacting Child Transplant Recipients? (Casey)
  • NIH begins long-term efficacy study of diabetes drugs (BioCentury)
  • Integration grants available for drug-monitoring data (Fierce)
  • Pfizer, GSK Price-Fixing Suit Won't Get High Court Review (Law 360)
  • FCA First-To-File Rule Sinks Kickback Suit, 1st Circ. Says (Law 360)
  • Shire Says Patent Settlements Didn't Delay Generic Adderall (Law 360)
  • Do 'Experts' Really Need To Belittle Pharma In Order To Push New Technologies? (Forbes)
  • AstraZeneca Kills Fostamatinib Filing Chances After PhIII Failure (AZ) (Rigel) (Reuters) (PMLive)
  • With billions in dispute, Teva and Pfizer face off in Newark federal court starting Monday (Philly Pharma)
ASCO In Brief
  • Clovis soars on upbeat signs of efficacy for targeted cancer drugs (Fierce)
  • U.K. researchers report big immunotherapy flop for long-sought cancer vaccine (Fierce)
  • Eli Lilly's Alimta Fails PhIII Test (Eli Lilly)
  • Clovis stock doubles on possible ''breakthrough'' lung cancer drug (SCRIP)
  • AstraZeneca wants to challenge rivals for immunotherapy class (SCRIP)
  • More highlights from ASCO for: Eisai's Halaven; Boehringer's nintedanib; and Lilly's Alimta (The Pharma Letter)
  • ASCO Wrap-Up: Cancer News from the West Coast (Xconomy)
Medical Devices
  • Medtronic triggers summer PMA process for drug-eluting balloon (Fierce)
  • The Medical Device Amendments of 1976: The Statute That Went Awry (FDA Law Blog)
  • Relievant lands FDA green light for clinical trial of Intracept back pain therapy (Mass Device)
  • St. Jude is "feeling really good" about Durata (Mass Device)
  • Class 1 Recall for Nephron Pharmaceuticals Corp's EX Breath Atomizer (FDA)
  • Human Exposure to Radiofrequency Electromagnetic Fields (FCC)
Assorted and Government
  • Supplement Companies: How to Respond to FDA Warning Letters (Natural products Insider)
  • Internet and Social Media Guidance: Still Wondering Whether the FDA Will Meet Its Deadline (Drug and Device Law)
  • NORD: FDA's Benefit-Risk Review Templates Lack Patient Input Process (FDA News)
  • Senate Tax Reform Options Include Denying DTC Deductions (CHC)
Upcoming Meetings and Events
  • 3 June 3013: House Energy and Commerce Committee to Vote on Track and Trace, ADUFA/AGDUFA Bills Bill (E&C) (The Hill)
  • 5-6 June 2013: Two-Day Avandia Meeting (FDA)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • Revised version of application form for initial evaluation of human medicines available (EMA)
  • Pharma firms face EU fines for delaying cheaper drugs (EurActiv) (India Times) (BioSpectrum) (PMLive)
  • UK government cautious on trial transparency (Pharmafile)
  • Will Data Exclusivity Issues Blunt Biogen Idec's Assault On The European Oral MS Market? (Forbes)
  • Integrity Applications Receives CE Mark Approval for Its GlucoTrack Model DF-F Glucose Monitoring Device (Business Wire)

International: Other

  • Australia Adopts Multiple ICH Guidelines (TGA)
  • India rejects allegations of exporting counterfeit drugs (DNA India) (India Times) (India Times)
  • Indian Government Still Shy About Foreign Direct Investment (India Times)
  • FDA warning for Hospira's Indian site but Orchid impact unlikely (SCRIP)
  • Canada Approves Astellas' Xtandi for Prostate Cancer (Astellas)
  • Japan Drug Makers Resist Voluntary Disclosure Of Researcher Payments (PharmAsia News)

General Regulatory and Interesting Articles

  • Risk-based monitoring needed to boost clinical trial success (Pharma Times)

Regulatory Reconnaissance #80 - 4 June 2013

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.

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