Regulatory Focus™ > News Articles > Regulatory Reconnaissance (11 September 2013)

Regulatory Reconnaissance (11 September 2013)

Posted 11 September 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

In Focus: US

In Focus: International

  • CHMP Thinking On Aubagio NAS Status Offers Useful Insights (Pink Sheet)
  • UK Antimicrobial Resistance Strategy published, includes call for antibiotic development incentives (UK) (Pharma Letter)
  • Warming Climate Begins to Taint Europe's Blood Supply With Pathogens (Scientific American)
  • India Panel Recommends CL For BMS's Sprycel Leukemia Drug (PharmAsia)
  • Contrary to reports, GSK will not leave China  (BioSpectrum) (Global Times)

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

US

Pharmaceuticals/Biotechnology
  • FDA reviewers back Roche's Perjeta in early breast cancer (Fierce) (Pink Sheet) (Reuters) (DD&D) (Xconomy) (BioCentury)
  • FDA panel supports approval of Glaxo lung drug Anoro (Reuters) (GSK) (Fierce) (Pharma Letter) (SCRIP) (Pink Sheet) (BioCentury) (MedScape) (Medpage Today)
  • DEA insists cold drug can be used in meth-making, wants restrictions (AP)
  • Opioid Indication Change Could Draw Legal Challenge From Physicians Group Seeking More Restrictions (Pink Sheet)
  • Combination Products 3.0: Applying the New FDA Regulations in 2013 (Microtest) (Pharma Manufacturing)
  • Texas woman with cancer pressuring experimental drug maker for "compassionate" access (CBS)
  • Stormy Weather Ahead: Adheris Challenges HHS's Final Rule on HIPAA/HITECH Act, May Provide Further Insight into Supreme Court's Decision in Sorrell (FDA Law Blog)
  • COPD Biomarker Qualification Consortium Submits Plasma Fibrinogen to FDA as New Biomarker (CBQC) (BioCentury)
  • 'Pay For Delay' Fight Moves To Pacts Barring Authorized Generics (IHP)
  • Pfizer Denied Interlocutory Appeal In Pay-For-Delay MDL (Law 360)
  • FDA Approves Generic Zyrtec, Epilepsy Drug Levetiracetam (FDA)
  • Dompé Announces the Food and Drugs Administration (FDA) Has Granted Orphan Drug Designation to its rhNGF-based Treatment for Retinitis Pigmentosa (Dompe)
  • Perrigo Announces FDA Approval For The Generic Equivalent To Children's Zyrtec Allergy Syrup (Perrigo)
  • Yet Another Compounding Pharmacy Recall Accounced, Related to Front Range Testing Labs (FDA) (FDA)
  • Significant Part A results for Relypsa's Phase III hyperkalemia drug (SCRIP)
  • ChemoCentryx plunges on interim diabetic nephropathy data (SCRIP) (BioCentury)
  • More Than 270 Vaccines in Biopharmaceutical Pipeline (PhRMA)
Pharmaceuticals and Biotechnology: General
  • PCORI awards $114 million for research projects (BioCentury) (PCORI)
  • Burglar admits heists at Lilly, Glaxo warehouses (Fierce)
  • Medicare Could Collect Billions Via Drug Co. Rebates: OIG (Law 360)
Medical Devices
  • US UDI rule for devices falls further behind schedule (Clinica)
  • MedTech Sector Stalled by Significant Drop in FDA Approvals, M&A Slowdown (Evaluate MedTech)
  • UnitedHealth recalls prescription records software due to glitch (Reuters)
  • New Concerns on Robotic Surgeries (NYTimes)
  • Intuitive's surgical robots slammed in another study (Fierce)
  • FDA Panel To Consider Down-Classification Proposals For Three Device Categories (Gray Sheet)
  • Medtronic seeks FDA update on all approved pacemakers and defibrillators (Mass Device)
  • Guided Therapeutics reels from latest FDA rejection (Fierce)
  • Why was J&J's latest metal hip liability trial delayed two weeks? (Fierce)
  • RTI Surgical Announces Successful Outcome to FDA Inspection of Facility Subject to Warning Letter (RTI)
  • OvuSense Ovulation Prediction Device Gets FDA Green Light in U.S. (MedGadget)
  • IntelligentMDx Receives FDA Clearance for IMDx Flu A/B and RSV for Abbott m2000 assay (Intelligent MDx)
  • Gore Receives First FDA Approval for Endovascular Repair of Aortic Dissection (Gore)
  • Consumer group demands warranties for hip, knee implants (Fierce)
Assorted And Government
  • FDA "Data Steward" Role Suggested By Industry In Lieu of Direct Release of NDA/BLAs (RPM Report)
  • Alliance: FDA FY14 budget may end up below FY13 (BioCentury)
  • Clinical study failures vary widely by clinical phase of and therapeutic class; study (Pharma Letter)
  • Conflicts of Interest Often Under-reported in Clinical Trials (MedPage Today)
  • New FDA Warning Letters Posted (FDA)
  • Social Media Still Safe for Pharma Despite AstraZeneca Twitter Fiasco (InTouch)
  • Of Conflicts and Clinical Trials: Researchers Report New Results (Science Insider)
  • Clinicaltrials.gov Database Reveals "Sausage Making" in Clinical Research (JAMA)
  • Opinion: EpiPens Should be More Widely Available in Schools (NYTimes)
  • House releases short-term spending measure (The Hill)
Upcoming Meetings And Events
  • 11 September 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 12 September 2013: Oncologic Drugs Advisory Committee Meeting  (FDA)
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 18 September 2013: ENVI Meeting, no Known Agenda as of Yet (ENVI)
  • 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • CHMP Thinking On Aubagio NAS Status Offers Useful Insights (Pink Sheet)
  • UK Antimicrobial Resistance Strategy published, includes call for antibiotic development incentives (UK) (Pharma Letter)
  • Warming Climate Begins to Taint Europe's Blood Supply With Pathogens (Scientific American)
  • Scots Aye for abilify, MabThera, Lyxumia; no to Jetrea (SCRIP)
  • EC Report on the Rapid Alert system for human Tissues and Cells (EC)

Asia

  • India Panel Recommends CL For BMS's Sprycel Leukemia Drug (PharmAsia)
  • Contrary to reports, GSK will not leave China  (BioSpectrum) (Global Times)
  • Indian Government asks pharma industry not to ignore drugs for neglected tropical diseases (PharmaBiz)
  • Gaungdong FDA Passes Plans For Re-staffing & Restructuring After CFDA (PharmAsia)
  • EU firms to China: open up, streamline, protect and talk (SCRIP)

General Regulatory And Interesting Articles

  • 3D printer makes "Robohand" prosthetics (CBS)

Regulatory Reconnaissance #151 - 11 September 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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