Regulatory Focus™ > News Articles > Regulatory Reconnaissance (21 May 2013)

Regulatory Reconnaissance (21 May 2013)

Posted 21 May 2013 | By Alexander Gaffney, RAC

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

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  • Merck Insomnia Drug Suvorexant Safer at Lower Dose, FDA Staff Says (Bloomberg) (Reuters) (DD&D) (Med Page Today) (AP) (The Pink Sheet) (SCRIP Intelligence) (BioCentury)
  • Fighting Agencies May Be Tougher After High Court Ruling (Law 360)
  • Biogen Idec Submits Application to FDA for Approval of PLEGRIDY™ (Peginterferon Beta-1a) in Multiple Sclerosis (Business Wire)
  • Pfizer Discontinues Phase 3 Study of Inotuzumab Ozogamicin in Relapsed or Refractory Aggressive Non-Hodgkin Lymphoma (NHL) Due to Futility (Pfizer) (PMLive) (Pharma Times) (The Pharma Letter) (Reuters) (BioCentury)
  • 2013 FDA Drug Approval Calendar (The Street)
  • Recall of All Sterile Drug Products Made and Distributed By NuVision Pharmacy Dallas Facility: Lack Of Sterility Assurance (FDA) (FDA)
  • FDA Grants Tentative Approval to Ranbaxy's ANDA for Lamivudine; Tenofovir Disoproxil Fumarate (#202529) and Apotex's Levetiracetam (#202958) (FDA)
  • Study: New FDA regs not leading to better sunscreen (The Hill)
  • Intercell vaccine gets U.S. pediatric approval (Reuters)
  • Plan B Ruling Shouldn't Be Stayed, 2nd Circ. Told (Law 360)
  • High Court's Atty Fee Ruling May Spur More Vaccine Claims (Law 360)
  • The s**t hits the fan - FDA, INDs, and fecal microbiota transplants (Scientific American)
  • Pfizer Can't Shake Skelaxin Pay-For-Delay MDL (Law 360)
  • Depo-Provera Black Box Warning Challenged In Physician Petition (The Pink Sheet)
  • Peregrine Pharmaceuticals Reaches Agreement With FDA on a Phase III Trial Design for Bavituximab in Second-Line Non-Small Cell Lung Cancer (Board Vote) (Reuters) (SCRIP Intelligence)
  • Bayer Presents Positive Interim Results from Long-term Extension Study PATENT-2 with Riociguat (Bayer)
  • Omnicare Gets FCA Off-Label Prescription Action Trimmed (Law 360)
  • Sunovion Pharmaceuticals Inc. Announces Data Showing Latuda® (lurasidone HCl) was Associated with Low Rates of Weight and Metabolic Changes in Patients with Depressive Episodes Associated with Bipolar I Disorder (Business Wire)
  • Another FDA 'breakthrough' designation: Synageva's sebelipase alfa (SCRIP Intelligence)
Medical Devices
  • Abbott Diabetes Care: Class 1 Recall - FreeStyle InsuLinx Blood Glucose Meters - Risk of Incorrect Test Result (FDA) (MDDI) (Fierce Medical Devices)
  • Covidien Receives FDA 510(k) Clearance for Nellcor™ Pulse Oximetry Motion Claims (Boardvote) (Covidien)
  • FDA Posts Transcript of Clinical Chemistry and Clinical Toxicology Devices Panel (FDA)
  • Supreme Court takes up Medtronic, Boston Scientific patent spat (Fierce Medical Devices) (Mass Device) (Law 360)
  • Direct Flow Transcatheter Aortic Heart Valve Gets FDA Feasibility Trial OK (VIDEO) (MedGadget)
  • STENTYS Enrolls First Heart Attack Patient in Pivotal U.S. Clinical Trial (Business Wire)
Assorted and Government
  • Sequester Withholding of FDA User Fees Irks Industry (CQ Roll Call) (Mass Device)
  • FDA Docket Comments on Changes to an Approved NDA/BLA/PMA (FDA)
  • Dr. Burgess on the Floor: The EPA Continues its War on Asthmatics (Burgess)
  • OMB Signs off on FDA Export Certificates (OMB)
  • FDA GMP Inspectors Cite 70% of Dietary Supplement Firms (Natural Products Insider)
  • Bristol-Myers Is Fined For Monkey Deaths, But Will $2,600 Matter? (Pharmalot)
  • The Soprano Wanna-Bees Are Stealing More Drugs This Year (Pharmalot)
Upcoming Meetings and Events
  • 21 May 2013: First-Ever Patient Network Town Hall (FDA)
  • 21-22 May 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 22 May 2013: Markup of Senate Compounding, Track and Trace Legislation (HELP)
  • 22 May 2013: Congressional Hearing: "Food and Drug Safety, Public Health, and the Environment in China" (CECC)
  • 22 May 2013: Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee (FDA)
  • 22 May 2013: CVM's New Animal Drugs for Use in Feeds Workshop (FDA)
  • 23 May 2013: Energy and Commerce Committee Hearting, "Examining Drug Compounding" (E&C)
  • 23 May 2013: Reagan-Udall Foundation Annual Open Public Meeting (RU)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)


  • PIP attorneys plead for leniency in breast implant fraud trial (Fierce Medical Devices) (France 24)
  • Russia Working to Align Biologics Regs with International Standards (In-Pharma Technologist)
  • European Parliament Posts Nearly 1,000 Amendments to New EU Medical Device Proposal (146-296) (297-449) (450-598) (599-907) (All) (MedDevicesLegal)
  • Amendments Posted for EU IVD Proposal (75-237) (238-399) (All)
  • Australia Revises CGMPs for Human Blood and Tissue Products (TGA)
  • Upcoming ENVI Meeting on 29 May 2013 to Hear Discussion of IVD, Medical Device Proposals (ENVI)
  • Pakistan badly needs a study to assess threat from fake drugs (IHT)
  • UK first in EU to get Merck's new Schmallenberg vaccine (Reuters)
  • European Medicines Agency Starts Review of Combined Use Of Drugs That Block The Renin-Angiotensin System (CardioBrief)
  • UK tries out new model for gene testing in cancer patients (Reuters)
  • Pharmaceutical Prices Around the World in 2010 (Healthcare Economist)

General Regulatory and Interesting Articles

  • But Don't Drug Companies Spend More on Marketing? (In the Pipeline) (In the Pipeline)
  • TV ads for drugs can raise awareness but may not be right for you (Washington Post)
  • Similar Cardiovascular Risk Observed With COPD Drugs (Forbes)
  • PatientsLikeMe opens health outcomes measurement hub for researcher-patient collaboration (Med City News)
  • Rice University Students Develop Shoe Energy Harvester to Power Medical Devices (VIDEO) (MedGadget)
  • Breakup of physician, drug company relationship could improve health care, cut cost (EurekAlert)
  • Breaking Up is Hard to Do: Lessons Learned from a Pharma-Free Practice Transformation (JABFM)
  • Why Feeling Anxious about a Vaccine Makes It More Effective (and Other Benefits of Short-Term Stress) (Scientific American)
  • New Tracking of a Patient's Radiation Exposure (WSJ)

Regulatory Reconnaissance #71 - 21 May 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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