Regulatory Focus™ > News Articles > Regulatory Recon: Back from Tech Headaches Edition (11-13 June 2014)

Regulatory Recon: Back from Tech Headaches Edition (11-13 June 2014)

Posted 13 June 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Back from Tech Headaches Edition (11-13 June 2014)

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

We're back in action after a DDoS attack took our cloud-hosted RSS feed offline on Wednesday, Thursday and Friday, and website troubles took down our ability to post yesterday. Enjoy all of the news you missed in this extensive edition of Regulatory Recon. Enjoy!

In Focus: US

  • Stakeholders weigh in on incentives for drug development (BioCentury) (E&C) (Pink Sheet-$) (SCRIP-$) (E&C) (AdvaMed)
  • Federal Views Diverge On Proper Use Of Painkillers (AP)
  • Warning and Untitled Letters By Therapeutic Category – Oncology (Eye on FDA)
  • DEA Scheduling Bill Advances in House (E&C) (BioCentury) (Pitts)
  • FDA Veto Threat Centers On Opioid Language In Approps Bill (Pink Sheet-$)
  • Medtronic's CoreValve Gains New Indication For High Risk Patients (Forbes) (Mass Device) (MDDI)
  • Covidien Neurovascular Micro Catheter Receives FDA Approval (Press) (MedCity News) (Mass Device)
  • Circulatory System OKs Bard's Lutonix balloon (Mass Device) (Press)
  • What To Do If You Disagree with FDA's Classification of Your Recall (MDDI)
  • FDA Asks Court To Halt Sales By NY Diet Supplement Co. (Law 360-$)
  • Lung cancer master protocol study to start Monday (BioCentury)

In Focus: International

  • Novartis Says 10,000 Side Effect Cases Were Never Filed (Pharmalot)
  • Ex-Novartis Employee Arrested Over Drug Data (AP) (Bloomberg)
  • Industry groups slam Italian off-label rule change (Pharma Times) (Fierce) (Pharmalot) (BioCentury)
  • Sharp Scrutiny From European Medicines Agency Of Amgen And Servier Heart Drug (Forbes)
  • Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis (EMA)
  • Doubts over CDSCO claim it can assess an API supplier in 30 days (In-Pharma)
  • Drugmaker Remedy for Scandal Is More Chinese for China (Bloomberg) (Fierce)
  • Beijing Forms Panel Of Health Experts To Advise On Drug, Device Risks (PharmAsia-$) (Want China Times)

US: Pharmaceuticals and Biotechnology

  • Stakeholders weigh in on incentives for drug development (BioCentury) (E&C) (Pink Sheet-$) (SCRIP-$) (E&C) (AdvaMed)
  • Dems, Generics, PBM Hit Idea Of Longer Exclusivity To Spur Drug R&D (IHP-$)
  • Federal Views Diverge On Proper Use Of Painkillers (AP)
  • Warning and Untitled Letters By Therapeutic Category – Oncology (Eye on FDA)
  • DEA Scheduling Bill Advances in House (E&C) (BioCentury) (Pitts)
  • An Incredibly Useful Look at PDUFA Timelines (Modern Medicines)
  • Free Speech or Bribes? Feds Wrestle With Allergan Over Advice Given Docs (Pharmalot) (Fierce)
  • FDA Veto Threat Centers On Opioid Language In Approps Bill (Pink Sheet-$)
  • Pharmas off the hook for large heart safety trials of new opioid-induced constipation meds (Reuters) (Press) (Fierce) (BioCentury)
  • Nektar Shares Rise on FDA Panel Recommendation (WSJ-$)
  • Lung cancer master protocol study to start Monday (BioCentury)
  • FDA approves Bayer's Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the US (Press)
  • Review of maintenance trials for major depressive disorder: a 25-year perspective from the US Food and Drug Administration (PubMed)
  • A First? Orange Book Patent Delisting Counterclaim Denied in Litigation Over Acetaminophen Injection (FDA Law Blog)
  • How Much Does It Hurt? A Long View at Zohydro (New York Mag)
  • Govs to meet on opioid abuse (Boston Herald)
  • Healthcare groups urge passage of antibiotics bill (The Hill)
  • Paging FDA… "Drinkable Sunscreen" not FDA Approved, Being Markted (NBC)
  • FDA says compounder making drugs under unsanitary conditions (Fierce)
  • Do reps push drugs off-label? Yes, a study suggests. Does it work? Also yes. (Fierce)
  • FDA Response to Drug Shortages (FDA)
  • Supplier of unprotected foreign-made cancer drugs gets 15-month prison sentence (Fierce)
  • Global Partnerships Advance the Regulatory Science That Protects Public Health (FDA Voice)
  • EnteroMedics: A Preview of the Weight-Loss Zapper FDA Panel (The Street)
  • FDA Clears Way for Azo Gentanol and Azo Gantrisin Generics (FDA)
  • Evaluating Predictive Methods and Product Performance in Healthy Adults for Pediatric Patients, Case Study: Furosemide (FDA)
  • Fed. Circ. Ends Sales Ban On Generic Latisse (Law 360-$) (Court)
  • NC Pols Nix Planned Curbs To Suits Over FDA-Approved Drugs (Law 360-$)

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

  • Orexigen Receives Three Month Extension of FDA NB32 Review (Press) (Pharma Times) (Fierce) (Pink Sheet-$) (SCRIP-$) (Reuters) (BioCentury) (Fierce) (Xconomy)
  • With patent extension up for grabs, Shire agrees to test Vyvanse in preschoolers (Press) (Fierce) (FT-$) (Pharmalot)
  • Ranbaxy Files For U.S. Generic Approvals Without FDA-Approved Pill Plant (PharmAsia-$)
  • Lilly Liver Cancer Drug Misses Primary Endpoint (Press) (Reuters) (Fierce) (SCRIP-$)
  • GSK, Theravance Release Phase 3 COPD Results (Press) (BioCentury)
  • Otsuka Continues Tolvaptan Program After FDA Negotiations (Press)
  • Phase 3 Data Demonstrate Comparability of Epirus’ BOW015 to Remicade for Treatment of Rheumatoid Arthritis (Press)
  • Geron's cancer drug shakes off one FDA hold but remains on pause (Fierce) (Reuters)
  • ALK presents Phase III data on house dust mite SLIT-tablet (MNT)
  • Sanofi and Regeneron Announce New, Detailed Data from Positive Sarilumab Phase 3 Rheumatoid Arthritis Trial (Press)
  • AVERT Trial Demonstrates High Rates of DAS-defined Remission with Orencia (abatacept) in Combination with Methotrexate (MTX) in Adult Patients with Early Rheumatoid Arthritis (RA) (Press)
  • Oral OTEZLA (Apremilast) Showed Long-Term Clinical Benefits in Patients with Active Psoriatic Arthritis (Press)
  • AVANIR Pharmaceuticals Migraine Drug AVP-825 Meets Primary Endpoint in Phase 3 Trial (Biospace)
  • Iroko takes low dose approach to osteoarthritis pain meds to avoid adverse events (MedCity News)

US: Pharmaceuticals and Biotechnology: General

  • Cancer Patients Assail Insurer Policies on Costly Drugs (Bloomberg) (The Hill)
  • AHIP: PhRMA wants to talk about anything but drug prices (The Hill)
  • MHPA wants OMB to evaluate projected Sovaldi costs (BioCentury)
  • This Won't End Well… (Imgur)
  • What Will Happen When Biotech Drugs Go Generic? (Forbes)
  • Switching To Newer Insulin For Type 2 Diabetes Comes At A Cost (NPR)
  • Men's Health Week or Low-T Week? Critics say awareness campaign is another pharma ploy (Fierce)
  • Forest Won't Immediately Phase out Namenda XR, Would Have Forced Patients to Switch to Higher-Cost Once-Daily Formulation (Press) (Fierce)
  • Will Oregon Restrict Coverage for a Pricey Gilead Pill for Hepatitis C? (Pharmalot)

US: Medical Devices

  • Covidien Neurovascular Micro Catheter Receives FDA Approval (Press) (MedCity News) (Mass Device)
  • Medtronic's CoreValve Gains New Indication For High Risk Patients (Forbes) (Mass Device) (MDDI)
  • What To Do If You Disagree with FDA's Classification of Your Recall (MDDI)
  • FDA panel to consider first drug-eluting balloon catheter (Fierce) (Gray Sheet-$)
  • Circulatory System OKs Bard's Lutonix balloon (Mass Device) (Press)
  • FDA AdComm to Discuss EDAP Technomed's Ablatherm Integrated Imaging Device PMA (FDA)
  • AIM Act Touted As One Solution To Device Reimbursement Woes (Gray Sheet-$)
  • Cohera Medical wins FDA panel date for TissuGlu surgical adhesive (Mass Device)
  • FDA Diagnostic Office Bests ODE In Decision Times, And Communication (Gray Sheet-$)
  • Report: CDRH on Track to Improve Device Submission Review Process (FDA)
  • FDA approves Auxogyn embryo test for IVF procedures (Fierce)
  • FDA warns Instrumed on manufacturing violations at German site (Mass Device)
  • The Use of Unique Device Identifiers (UDIs) in Health Insurance Claims (Brookings)
  • Medtronic readies for 2015 drug-eluting balloon FDA approval (Fierce) (Mass Device)
  • Intuitive Wins Trial, Defeats Negligent Training Claims (Bloomberg)
  • ACLU Fights Myriad's Bid For Cancer-Test Sales Ban (Law 360-$)
  • Diabetic Supply of Suncoast, Inc. issues a Nationwide Voluntary Recall of BMB-BA006A Advocate Redi-Code+ Blood Glucose Test Strips (FDA)
  • Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error (FDA)
  • Class 1 Recall for Smiths Medical ASD's Low Dead Space Connector (FDA)
  • iHealth Align, World’s Smallest FDA Cleared Glucometer, Now Available in U.S. (MedGadget)
  • VuCOMP lands FDA nod for updated M-Vu mammography system (Mass Device) (Press)
  • Cartiva, Inc. Submits First Module of PMA Application for Cartiva SCI (Press) (Fierce)
  • Strativa Pharmaceuticals Announces FDA Approval of Nascobal (Cyanocobalamin, USP) Nasal Spray Single-Use Device (Press)
  • Boston Scientific Announces One-Year Results In The VANTAGE Clinical Study Evaluating The Vercise DBS System (Press)

US: Dietary Supplements

  • FDA Asks Court To Halt Sales By NY Diet Supplement Co. (Law 360-$)
  • Qualitas opts for direct route to market with successful NDI filing on its algal EPA ingredient (NI-USA)

US: Assorted And Government

  • HHS Posts Semi-Annual Regulatory Agenda in the Federal Register (DHHS) (Was Covered by Focus in February)
  • SCOTUS Rules FDA Regulations Don't Preempt False Advertising Claims (IHP-$) (Harvard BOH)
  • New Consortium Promotes Efficiency in Working Toward Clinical Trials (CA Healthline)
  • White House opposes House FY15 appropriations bill (BioCentury)
  • Enforcement Report - Week of June 11, 2014 (FDA)
  • New FDA MAPP on Reference Checks (FDA)

Europe

  • Industry groups slam Italian off-label rule change (Pharma Times) (Fierce) (Pharmalot) (BioCentury)
  • New UK Guidance on Software as a Medical Device (Inside Medical Devices)
  • Sharp Scrutiny From European Medicines Agency Of Amgen And Servier Heart Drug (Forbes)
  • Draft guideline on clinical investigation of medicinal products for the treatment of juvenile idiopathic arthritis (EMA)
  • EMA policy on transparency is “strikingly” similar to deal struck with drug company, say experts (PharmaGossip)
  • Important Judgement in the GMP World: EU Commission entitled to take far-reaching Decisions when GMP Deviations are found (IPQ-$)
  • Early Access – an expanding menu of options (Pharma Phorum)
  • Researchers question ‘bias’ NICE on statins (Pharmafile) (Pharma Times) (PMLive) (AllTrials)
  • NICE backs Yervoy for first-line melanoma (BioCentury) (PharmaPhorum)
  • Closing the Box? Europe Probes Patent Tax Breaks (Pharmalot)
  • EMA Publishes New Guidance for Qualified Person's Declaration on GMP Compliance of API (PharmExec)
  • A Big Wrinkle: Pfizer Advertisement for Beauty Pill Turns Ugly (Pharmalot)
  • Public consultation of the draft methodological guideline “Meta-analysis of diagnostic test accuracy studies” (EUnetHTA)
  • Bayer files for EMA approval of Eylea for macular edema secondary to BRVO (Pharma Letter-$) (Bayer)
  • Scottish Medicines Consortium makes negative recommendation for Abraxane, treatment for metastatic pancreatic cancer (MNT)
  • Nordic Nanovector' Betalutin secures orphan designation in Europe for lymphoma treatment (PBR)

India

  • Doubts over CDSCO claim it can assess an API supplier in 30 days (In-Pharma)
  • India steps up drug regulatory initiatives (Business Standard)
  • Indian pharma group sends letter to new health minister (BioCentury) (SCRIP-$)
  • Group Protests India State's Ban On Exporting Drugs Through Mail (PharmAsia-$)
  • State FDA drafting performa to help drug units for self auditing of facilities (PharmaBiz)

Japan & China

  • Novartis Says 10,000 Side Effect Cases Were Never Filed (Pharmalot)
  • Ex-Novartis Employee Arrested Over Drug Data (AP) (Bloomberg)
  • Drugmaker Remedy for Scandal Is More Chinese for China (Bloomberg) (Fierce)
  • Beijing Forms Panel Of Health Experts To Advise On Drug, Device Risks (PharmAsia-$) (Want China Times)
  • Who’s leading the ASEAN device harmonization race? (Clinica-$)
  • Sense prevails as China agrees to reg enforcement delay, but concerns remain (Clinica-$)
  • Product Registration Regime Chokes China Supplement Industry Growth (Tan Sheet-$)
  • China’s FDA warns of on-line sales of fake cancer drug (Pharma Letter-$)
  • China Reforms Lead To Monopoly Drug Buyer, Threatening MNC Profits (PharmAsia-$)

Canada

  • Health Canada lets Biolyse restore production of paclitaxel (Fierce)

Other International

  • Brazil's bureaucracy a barrier to foreign CROs (Outsourcing Pharma)
  • APIC publishes Guidance on Cleaning Validation in Active Pharmaceutical Ingredients Plants (IPQ-$)
  • Australia: BioCSL Fluvax - investigations into the cause of fevers in children under 5 years (TGA)

General Regulatory And Interesting Articles

  • 'We Did It!' Brain-Controlled 'Iron Man' Suit Kicks Off World Cup (NBC)
  • How I was asked to 'author' a ghostwritten research paper (Guardian)
  • Google to help build world's largest genomic database on autism (CBS)

Regulatory Reconnaissance #336 – 13 June 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.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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