Regulatory Focus™ > News Articles > Regulatory Reconnaissance (10 July 2013)

Regulatory Reconnaissance (10 July 2013)

Posted 10 July 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • PPD Cited for Manipulating Data in China Clinical Trials by US FDA (Outsourcing Pharma)
  • FDA is Lax in Enforcing Law Regarding Prescription Drug Postmarketing Studies (MedPage Today) (Pharma Marketing Blog) (MNT)
  • Roche Abandons New Diabetes Drug Aleglitazar (NYTimes) (Pharma Letter) (Bloomberg) (Pharmalot)
  • House Announces Upcoming Hearing on the Drug Compounding Regulatory Framework (House)
  • Medtronic Issues Class 1 Recall for 11M of its MiniMed Paradigm Insulin Infusion Sets (FDA)
  • Updated Analysis Shows Patent use Codes Have Nearly Tripled Since August 2003 (FDA Law Blog)
  • Warning and NOV Letter Summary - 2d Quarter 2013 (Eye on FDA)
  • Opinion: The FDA Spent $10 Million and all I got was this Lousy T-Shirt (Drug Wonks)

In Focus: International

  • Pfizer Receives European Approval to Expand use of Prevenar 13 for Pneumococcal Disease (Reuters) (Pfizer)
  • Italian Agency Threatens Action over Drug Shortages due to Parallel Trade (SCRIP)
  • EU Pharma Industry May Ban "Tchotchkes;" Tchotchke Makers Threaten to Sue (Pharma Marketing Blog)
  • Chinese API Plant Oversight Improving, but Careful Sourcing is Key, says EMA (In-Pharma Technologist)
  • GSK Finds no Wrongdoing with Botox Marketing in China (BioCentury)
  • What Happened to Outsourcing in Asia? Regulatory Issues. (PharmExec)
  • Pakistan Pharmas Urge Activation of Drug Regulator or Some Will Move (PharmAsia)

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

US

Pharmaceuticals/Biotechnology
  • PPD Cited for Manipulating Data in China Clinical Trials by US FDA (Outsourcing Pharma)
  • FDA is Lax in Enforcing Law Regarding Prescription Drug Postmarketing Studies (MedPage Today) (Pharma Marketing Blog) (MNT)
  • Roche Abandons New Diabetes Drug Aleglitazar (NYTimes) (Pharma Letter) (Bloomberg) (Pharmalot)
  • GlaxoSmithKline files sNDAs for combination melanoma drugs (Pharma Letter) (BioCentury) (SCRIP) (Pharma File)
  • Janssen, Pharmacylics File Ibrutinib for Treatment of Two B-Cell Malignancies (Janssen) (Pharmacylics)
  • Trimel's 'no touch' testosterone gel under FDA review (SCRIP) (BioCentury)
  • Chelsea resubmits Northera NDA (BioCentury) (SCRIP)
  • FDA Approves ANDA for Roxane's Generic Dry Mouth Treatment Evoxac (Cevimeline Hydrochloride) (#091591) (FDA)
  • BIO Head: Nationwide Track and Trace System Urgently Needed (Roll Call)
  • House Announces Upcoming Hearing on the Drug Compounding Regulatory Framework (House)
  • Massachussetts Panel OKs bill to crack down on compounding pharmacies (Boston Herald)
  • Critics: Piling 7 druggists on MA pharmacist board may compound problems (Boston Herald)
  • After 2012 fungal meningitis outbreak, rules change in Idaho for compounding pharmacies (MedCity News)
  • 'At-risk' generic launches at risk following Teva court decision (SCRIP)
  • Big pharma is finding new ways to expand drug life cycle by transitioning drugs from Rx to OTC (MedCity News)
  • Oncology Drug Labels Need Patient Outcome Data: Basch Explains (Pharmalot)
  • California cancer practice fined $3.4 million for buying foreign meds (Fierce)
  • CytRx Jumps on Brain Cancer Drug Study Data (AP)
  • Cardio3 shares suffer as biotech fires back at criticism of PhII study (Fierce)
  • Idaho Recovers Nearly $420K in Drug Settlement Against Ranbaxy (AP)
  • FDA approves generic Alzheimer's disease drug (DSN)
  • FDA gives tentative approval to Mylan's generic Crestor (DSN)
  • Vermont Farm Enters Consent Decree Over Drug Residues In Cows (Food Product Design)
Pharmaceuticals: General
  • Rare Mutation Ignites Race for Cholesterol Drug (NYTimes)
  • What It Takes To Cure Drug-Resistant Tuberculosis (NPR)
  • CVS adds OTC drug interaction checker to mobile app (MobiHealth News)
Medical Devices
  • Medtronic Issues Class 1 Recall for 11M of its MiniMed Paradigm Insulin Infusion Sets (FDA)
  • TYRX Receives FDA Clearance for Fully Resorbable AIGISRx R Antibacterial Envelope (TYRX)
  • FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations - Transcript (FDA)
  • CMS Proposes Centralized Decision-making On Reimbursement For IDE Studies (Gray Sheet)
  • myAnesthesia by iMDsoft is Now Listed with the FDA (iMDsoft)
Assorted And Government
  • Updated Analysis Shows Patent Use Codes Have Nearly Tripled Since August 2003 (FDA Law Blog)
  • Warning and NOV Letter Summary - 2d Quarter 2013 (Eye on FDA)
  • FDA MedWatch Safety and Adverse Event Reporting Program Expands Patient Resources (Policy and Medicine)
  • Opinion: The FDA spent $10 Million and all I got was this lousy t-shirt (Drug Wonks)
  • Agencies hope big data investments mean big payoffs (Federal Times)
  • As Chimp Research is Phased Out, Will Other Animal Research Decline? (Bioethics Forum)
  • Theorem Clinical Research, Emergo Group Form Strategic Relationship (Emergo)
  • Intellectual Property: Insights Gained from Efforts to Quantify the Effects of Counterfeit and Pirated Goods in the U.S. Economy (GAO)
Upcoming Meetings And Events
  • 10 July 2013: Meeting of the Drug Safety and Risk Management Advisory Committee Meeting Announcement (FDA)
  • 12 July 2013: Public Meeting: Implementation of Drug Supply Chain Provisions of Title VII of FDASIA (FDA)
  • 16 July 2013: Hearing: Reforming the Drug Compounding Regulatory Framework (House)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Pfizer Receives European Approval To Expand Use Of Prevenar 13 for Pneumococcal Disease (Reuters) (Pfizer)
  • Italian agency threatens action over drug shortages due to parallel trade (SCRIP)
  • EU Pharma Industry May Ban "Tchotchkes" Outright! Tchotchke Makers Threaten to Sue (Pharma Marketing Blog)
  • CTI's Pixuvri gets NICE second chance and wins Italian OK (SCRIP)
  • Germany takes some pain out of the AMNOG (SCRIP)
  • Struggle to access NICE approved therapies highlighted (PJO)

Asia

  • Chinese API plant oversight improving, but careful sourcing is key says EMA (In-Pharma Technologist)
  • GSK finds no wrongdoing with Botox marketing in China (BioCentury)
  • What Happened to Outsourcing in Asia? Regulatory Issues. (PharmExec)
  • Pakistan Pharmas Urge Activation Of Drug Regulator Or Some Will Move (PharmAsia)
  • Japan Hypertension Society: No False Data Used In Valsartan Trials (PharmAsia)
  • Japanese Mothers Appeal To MHLW Over Rubella Vaccine Shortage (PharmAsia)

Other International

  • Canada Warns of Risk of Retinal Detachment from use of Oral Fluoroquinolones (Health Canada)
  • Aus, NZ focus on quality use of medical devices  (BioSpectrum)
  • Vertex Receives Australian Approval for KALYDECO™ (ivacaftor), the First Medicine to Treat the Underlying Cause of Cystic Fibrosis in People with a Specific Genetic Mutation (G551D) (Vertex)

General Regulatory And Interesting Articles

  • Are Clinical Trial Data Shared Sufficiently Today? (MNT)
  • Make it easier to avoid vaccines, and people will skip them (TIE)
  • France's Genethon first non-profit organization to become a pharma producer (Pharma Letter)
  • Contaminated ultrasound gel tied to outbreak of healthcare-associated infections (EurekAlert)

Regulatory Reconnaissance #104  - 10 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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