Regulatory Focus™ > News Articles > Regulatory Reconnaissance (15 July 2013)

Regulatory Reconnaissance (15 July 2013)

Posted 15 July 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • Roche's Erivedge Gains Conditional EU Approval (Pharmafile) (Roche) (PMLive) (Pharma Letter) (Pharma Times)
  • Progress on Complex EU Device and IVD Rules Top of Lithuania's Presidency Priorities (Clinica)
  • Diovan Data Was Fabricated, Say Japanese Health Minister and University Officials (Forbes) (Pharmalive) (Japan Today)
  • China's NDRC Requests Regulatory Transparency, Public Pharma Blacklists (PharmAsia)
  • New Rules Slow Pharmaceutical Trials in India (WSJ)
  • Did Big Pharma Team Up to Kill British Columbia's Drug Safety Watchdog? (Vancouver Sun)
  • China Accuses GlaxoSmithKline of Paying £300m in Bribes (The Guardian) (The Week)

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  • FDA approves Boehringer drug Gilotrif to treat advanced lung cancer (FDA) (Reuters) (MedPage Today) (Fierce) (Pharma Times) (Pharmafile) (MNT) (BioCentury) (SCRIP) (Pink Sheet) (Fierce) (BI) (Pharma Letter) (PMLive)
  • Actavis' Generic Opana ER Receives FDA Approval (Actavis) (Pharma Letter)
  • FDA Still Racing To Fill GDUFA-Related Openings (Pink Sheet)
  • FDA Looking to Develop a Sandwich ELISA Assay to Measure Amount of Major Allergens Present in Allergenic Extracts (FDA)
  • FDA Approves ANDAs for Caraco's Repaglinide (#077571), Vintage Pharmaceuticals' Opana/Acetaminophen Combo (#090733, 090734), Dr. Reddy's Decitabine (#203131) (FDA)
  • Lilly plans big Alzheimer's disease study after prior failures (Reuters) (Forbes)
  • FDA cancels MoxDuo advisory committee meeting (BioCentury) (FDA)
  • FDA approves Sun's generic Prandin (SCRIP) (DSN)
  • U.S. Blood Supply Threatened as Donors Face Iron Losses (Bloomberg)
  • Activists hold first gay, bisexual blood drive to get FDA to change rules (CBS)
  • Sanofi kick starts dengue vaccine production ahead of regulatory green light (Reuters)
  • Daiichi Sankyo's anti-clotting drug shows promise in Ph III CAD study (Pharma Letter)
  • Merck reports positive results for lead Alzheimer's drug (Fierce)
  • Does A Decline In Phase 1 Starts Signal A Future Pharma Productivity Gap? (Forbes)
Pharmaceuticals: General
  • Sangamo in Race to Replace Chronic Drug Treatment with Gene Therapies (Xconomy)
  • Which drugs are most advertised? (Indy Star)
Medical Devices
  • Draft Bill Aims To Clarify FDA Regulation Of Mobile Medical Apps (Gray Sheet)
  • Who should regulate mHealth? (GovHealthIT)
  • FDA permits marketing of quicker method for checking effectiveness of medical device steam sterilization (FDA)
  • Court Allows device maker to sue a doctor over the death of a patient who had used its product (AMedNews)
  • FDA green-lights NeuroMetrix pain treatment device for bed-time use (Mass Device)
  • FDA-Clearance For Empi Phoenix Muscle Stimulator - An Electrical Stimulator Designed To Help Simplify Treatment Of Muscle Atrophy (MNT)
  • Qiagen Receives FDA Approval for therascreen EGFR RGQ PCR Kit as a Companion Diagnostic for Lung Cancer Patients (Qiagen)
  • Testing Flaw May Affect Some Intuitive Devices, FDA Says (Law 360)
  • Medtronic Infusion Pump May Have Blocked Vents (MedPage Today) (Fierce) (FDA) (FDA)
  • FDA puts highest-risk label on Verathon's reusable laryngoscope recall (Mass Device)
  • Health insurance cost-cutting climate hampers new devices (Fierce)
  • BPA-Free Plastics Going On Trial In Texas (NPR)
Assorted And Government
  • A Review of the FY 14 Budget Status (Strengthen FDA)
  • Number of Annual New Drug Approvals to Treat Neglected Diseases Has Nearly Doubled Between the Early-2000s and 2009-12 (Tufts)
  • NYT Opinion: Do Clinical Trials Work? (NYTimes) (Science-Based Medicine)
  • New Study Shows Improvements In Public Perceptions Of Clinical Research And Insights Into Participant Experiences (MNT)
  • FDA Budget Advocacy at a Glance (Strengthen FDA)
  • SCRIP's Capitol Capsule: Cognitive dissonance: Federal agencies clash on Alzheimer's (SCRIP)
Upcoming Meetings And Events
  • 16 July 2013: Hearing: Reforming the Drug Compounding Regulatory Framework (House)
  • 18 July 2013: Meeting: Dental Products Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 18 June 2013: Meeting: Anesthetic and Analgesic Drug Products Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • Roche's Erivedge gains conditional EU approval (Pharmafile) (Roche) (PMLive) (Pharma Letter) (Pharma Times)
  • Progress on complex EU device and IVD rules top of Lithuania's presidency priorities (Clinica)
  • PIP breast implant scandal a boon to U.K. company (Fierce)
  • MHRA consults on proposals to end "sell through" of unlicensed herbal remedies (PJO)
  • Pfizer Announces Launch of Xeljanz in Switzerland (Pfizer)


  • Diovan Data Was Fabricated, Say Japanese Health Minister And University Officials (Forbes) (Pharmalive) (Japan Today)
  • China's NDRC Requests Regulatory Transparency, Public Pharma Blacklists (PharmAsia)
  • CFDA releases the first issue of 2013 National Medical Device Quality Announcement (CFDA)
  • Nearly 500 ethics committees registered after CDSCO made it mandatory in Feb, 2013 (PharmaBiz)
  • UAE Clears 15 Drug Makers To Import APIs For R&D, Guidelines Attached (PharmAsia)
  • New Rules Slow Pharmaceutical Trials in India (WSJ)
  • India Near Decision To Return Pioglitazone To Market With Boxed Warning (PharmAsia)
  • Why India's Actos ban has even local firms puzzled (MM&M)
  • Singapore Regulators Seize 2,000 Litres of Illegal Codeine Cough Syrup (HSA)
  • Drug Industry Set To Begin Disclosing Pharma Gifts In Japan (PharmAsia)

Asia: China Crackdown on GSK

  • China accuses GlaxoSmithKline of paying £300m in bribes (The Guardian) (The Week)
  • GSK accused of being 'ringleader' in China probe (FT)
  • GlaxoSmithKline routed China bribes through travel agencies: police (Reuters)
  • Four Glaxo China Executives Held in Criminal Investigation (Bloomberg) (PharmAsia) (PMLive)
  • China Arrested How Many Glaxo Employees? At Least 30, So Far... (Pharmalot)
  • GSK stops using travel agencies accused in Chinese probe (Reuters)
  • Analysis: China case shows war on drug costs in emerging markets (Reuters)
  • China releases GSK bribery details (Pharmafile)

Other International

  • Did Big Pharma team up to kill B.C.'s drug safety watchdog? (Vancouver Sun)

General Regulatory And Interesting Articles

  • New wonder drug? Statins may have use beyond cholesterol (CBS)
  • The Price of Pharmacovigilance: Surge of Counterfeit Drugs Prompts Patient Safety Discussion (Cutting Edge Info)

Regulatory Reconnaissance #107  - 15 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.

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