Regulatory Focus™ > News Articles > Regulatory Reconnaissance (22 July 2013)

Regulatory Reconnaissance (22 July 2013)

Posted 22 July 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  Miss our late-Friday edition of Recon? Find it here.

In Focus: US

In Focus: International

  • Big pharma mobilising patients in battle over drugs trials data, leaked memo shows (Guardian)
  • Files Suggest GSK Graft Case in China May Expand (NYTimes)
  • Medicines shortages reported in Ireland (Pharma Letter)
  • Indian pharmaceutical groups shed copycat image (FT)
  • UAE Allows Patented API Imports to Reduce Local Generic Delay (In-Pharma Technologist)
  • Chinese Police Visit AstraZeneca Office (WSJ)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA Questions Humira Spinal Arthritis Study (MedPage Today) (Pink Sheet)
  • FDA approves Astellas' once-daily tacrolimus (BioCentury) (Astellas) (Pharma Letter) (SCRIP) (Pharma Times)
  • Study Clears Avandia of Fatal Cardiac Events (MedPage Today) (Counter: MedPage Today)
  • A Look At The First Six Shared REMS (Pink Sheet) (Pink Sheet)
  • Woodcock Pushes Standardization to Speed Rx Development, But Will Uniformity Cripple Innovation? (Pink Sheet)
  • Clinical Trial Data Release: Be Careful What You Wish For, Industry Exec Says (Pink Sheet)
  • Generic Liability Battle Shifts With FDA's Labeling Rule Even As Some Court Issues Remain Unresolved (Pink Sheet)
  • FDA Sends Warning Letter to India's Wockhardt Over Waluj Plant (India Times)
  • Boehringer Can't Shake Pradaxa Warning Label Claims (Law 360)
  • NECC Victims Seek To Sue Others For Meningitis Outbreak (Law 360)
  • Pfizer Resolves 700 Suits In Chantix Depression MDL (Law 360)
  • More Pain Doctors Require Patients to Take Urine Tests (WSJ)
  • Study: Estrogen could have prevented 50,000 deaths among women with hysterectomies (CBS)
  • Volcano Company, Issues Voluntary Worldwide/Nationwide Recall of Volcano Male Enhancement Liquid and Volcano Male Enhancement Capsules, Marketed as a Dietary Supplement, Due to Undeclared Active Ingredients (FDA)
Pharmaceuticals: General
  • Small biotechs access stock market; bubble concerns rise (SCRIP)
Medical Devices
  • The Mystery of the Missing MDR Notice (FDA Law Blog)
  • Dissent Over a Device to Help Find Melanoma (NYTimes)
  • Biosense Modifies Urinalysis App To Comply With FDA (Gray Sheet)
  • Breast Implant Makers Can Use Registries To Fulfill Post-Market Surveillance Duties (Gray Sheet)
  • Disclosing The Use Of Conflict Minerals A Challenge To Industry (Gray Sheet)
  • Brief Summary of the Dental Products Panel Meeting of 18 July 2013 (FDA)
Assorted And Government
  • Drug groups set for TPP trade clash (FT) (PharmAsia)
  • FDA Sequestration Relief Bill In House Would Free User Fees, But "Pay For" Remains Question Mark (Pink Sheet)
  • FY 14, Sequestration, and the Eshoo Initiative (Strengthen FDA)
  • Physician Payment Sunshine Act: Open Payment - Questions and Answers by Topic Category (Policy and Medicine)
  • Hedge fund chief charged for ignoring insider 'red flags' (SCRIP) (Bloomberg)
  • SCRIP's US Capitol Capsule (SCRIP)
Upcoming Meetings And Events
  • 22-23 July 2013: Arthritis Advisory Committee Meeting (FDA)
  • 23 July 2013: Meeting: Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development without the Thorough QT Study (FDA)
  • 23 July 2013: Brookings Webinar: Active Medical Product Surveillance Roundtable (FDA)
  • 24 July 2013: House Hearing on US-EU Free Trade Agreements and Regulatory Barriers (House)
  • 25 July 2013: CBER Webinar on its Direct Recall Classification Program (FDA)
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Big pharma mobilising patients in battle over drugs trials data, leaked memo shows (Guardian)
  • Fate of Biogen's Plegridy in US/EU regulators' hands (SCRIP)
  • Fifteen Years After Autism Panic, a Plague of Measles Erupts (WSJ)
  • European Medicines Agency meeting and holiday dates: 2014 (EMA)
  • Medicines shortages reported in Ireland (Pharma Letter)

Asia

  • Kyowa Kirin seeks Japan mogamulizumab OK for first-line ATL (SCRIP)
  • Indian pharmaceutical groups shed copycat image (FT)
  • Pakistan Battles Polio, and Its People's Mistrust (NYTimes)
  • UAE Allows Patented API Imports to Reduce Local Generic Delay (In-Pharma Technologist)
  • Chinese Police Visit AstraZeneca Office (WSJ)
  • AstraZeneca Employee Focus of Police Probe in China (Bloomberg)

GSK's China Scandal

  • Putting GSK's China Bribery Crisis In Context (Pink Sheet)
  • Files Suggest a Graft Case in China May Expand (NYTimes)
  • Glaxo Executive Says Changes in China to Cut Drug Prices (Bloomberg)
  • At Least Six Other MNC Drug Firms Used Travel Agency Of China Probe (PharmAsia)
  • GlaxoSmithKline contacts Serious Fraud Office over its China activities (Guardian)
  • GlaxoSmithKline says executives 'breached Chinese law' (Guardian) (Pharmafile)
  • GSK statement regarding recent meeting with Chinese authorities (GSK)
  • GSK gets to grips with China crisis in police meeting (Pharma Times)
  • Big Pharma in China: getting tougher (FT)
  • Fraud investigator linked to GSK held in China (FT)
  • GSK dismisses up to 100 sales staff in China (FT)

Other International

  • MERS-CoV not yet a public health emergency, advises emergency committee (WHO)

General Regulatory And Interesting Articles

  • Innovative technique can tell if drugs have hit their target in the human body (MNT)

Regulatory Reconnaissance #113  - 22 July 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.

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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