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

Regulatory Reconnaissance (10 December 2013)

Posted 10 December 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know:

In Focus: US

In Focus: International

  • NICE to expand medtech offering with new briefings (Pharma Times)
  • Novo Nordisk gets final EU approval for haemophilia drug (Reuters)
  • Critical Council meeting to throw more light on progress of new EU device/IVD rules (Clinica-$)
  • Brazil makes proposed outsourcing regulations available for comment (Outsourcing Pharma)
  • African countries unite for drug anti-counterfeiting initiative (Securing Industry)

US: Pharmaceuticals/Biotechnology

  • Generic Drugs Office Becomes Super; Safety Organizational Challenges Remain (Pink Sheet-$) (In-Pharma) (DSN)
  • FDA's First "Outsourcing" Partner: One of the Pharmacies it Cracked Down on Extensively (RPM Report-$)
  • Study examines drug labeling and exposure in infants (MNT) (TIE) (JAMA) (Press)
  • Approval of Takeda's Vedolizumab Supported, But Committee Differs on Indicated Population (Pink Sheet-$) (SCRIP-$) (Pharma Times) (Reuters) (Reuters) (Press) (BioCentury) (Fierce)
  • U.S. FDA panel says Oralair profile supports approval: documents (Reuters) (BioCentury)
  • BMS, AstraZeneca rare disorder drug scrutinized ahead of FDA panel (SCRIP-$) (Fierce) (BioCentury) (Reuters)
  • FDA Goes To Committee With Uncertainty About Metreleptin Efficacy For Partial Lipodystrophy (Pink Sheet-$)
  • US high court leaves intact $142 million verdict against Pfizer (Reuters)
  • Paper Labeling Industry Groups Ask OMB To Kill FDA Drug E-Labeling Rule (IHP-$)
  • First Circuit Skirts the Issue of the Scope of the False Claims Act Regarding FDC Act Violations (FDA Law Blog)
  • Merck Settles Fosamax Jaw-Injury Claims For $28M (Law 360-$) (Pharma Times) (Reuters) (Pharmalot)
  • Diary of a Hatch-Waxman Addict: Day 3,655 - What About Untimely (Late) Notice? (FDA Law Blog)
  • Ethics and Oversight in Recombinant Genetic Research (Harvard Bill of Health)
  • Lupin gets USFDA nod to market HIV drug in the US market (India Times)
  • Princeton kicks off mass meningitis vaccinations to stop outbreak (CBS)

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

  • Takeda Touts Oral Triplet Regimen With Velcade Follow-On MLN9708 (Pink Sheet-$)
  • Hospira Targets First U.S. Biosimilar Filing In 2014 (Pink Sheet-$)
  • Novartis' Tasigna tops Glivec in long-term trial (PMLive)
  • Helsinn Group And Eisai Announce FDA Acceptance Of New Drug Application For Investigational Compound Netupitant 300 mg + Palonosetron 0.50 mg (NEPA) (Press) (BioCentury)
  • FDA Grants Fast Track Designation to Navidea Biopharmaceuticals' Lymphoseek for Sentinel Lymph Node Detection in Patients with Head and Neck Cancer (Press)
  • AbbVie says 96 percent patients in oral hepatitis C study show improvement (Reuters)
  • Celgene reports PFS numbers for Revlimid in newly diagnosed MM (Press) (BioCentury)
  • Gilead reports more data, regulatory update for idelalisib (BioCentury)
  • Janssen Says Multicentric Castleman's Drug Works in Trial (Press)
  • Merck Advances Development Program for Investigational Alzheimer's Disease Therapy, MK-8931 (Press) (Reuters)
  • Sunovion Pharmaceuticals Inc. Presents Phase 3 Pooled Analysis of Once-Daily Aptiom (eslicarbazepine acetate) as Adjunctive Treatment for Partial-Onset Seizures (Press)
  • Jakafi (ruxolitinib) Continues to Show Improved Overall Survival for Patients with Myelofibrosis in Further Analyses of Phase III Data Presented at 2013 ASH (Press)
  • Four-Year Data from Baxter's Phase 3 DASISION Trial Comparing Sprycel (dasatinib) to Imatinib in First-Line Treatment of Adults with Ph+ CP-CML Presented (Press)

US: Medical Devices

  • Boston Scientific faces more questions over Watchman implant's effectiveness, risks (Mass Device) (Reuters)
  • Clots Tied to HeartMate II Pump Open Debate on Risks Patients Face in Trials (NYTimes)
  • Court in Hip Implant Litigation Finds Complaint Lacking Despite Allegations of Recall and FDA Adulteration Finding (Drug and Device Law)
  • St. Jude Halts U.S. Renal Denervation Trial, Citing Slow Patient Enrollment (Gray Sheet-$)
  • Ventana lands FDA clearance for new imaging software (Mass Device)
  • Reverse Medical Corporation Announces FDA 510k Clearance of the MVP-5 Micro Vascular Plug for Peripheral Embolization (Press)
  • American Medical Systems Receives FDA 510(k) Clearance of the RetroArc Retropubic Sling System for Treatment of Female Stress Urinary Incontinence (Press)
  • FDA Clears Mega Electronic's Android-Based eMotion ECG Mobile Monitor (MedGadget)
  • Somna Therapeutics Seeks FDA Approval for New Device to Relieve Serious Acid Reflux (MedGadget)

US: Assorted And Government

  • FDA to Partially Occupy Nuclear Regulatory Commission Building (Gazette)
  • False Claims Act Cases Could Signal Increased Whistleblower Litigation (Policy and Medicine)
  • Health IT startup gets seeded to streamline regulatory compliance for clinical researchers (MedCity News)

Upcoming Meetings And Events

  • 10-11 December: FTC Meeting on Biosimilars (FTC)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • 11 December 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 11-12 December 2013: Allergenic Products Advisory Committee Meeting (FDA)
  • 12 December 2013: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)


  • NICE to expand medtech offering with new briefings (Pharma Times)
  • Novo Nordisk gets final EU approval for haemophilia drug (Reuters)
  • Critical Council meeting to throw more light on progress of new EU device/IVD rules (Clinica-$)
  • European organisations send briefing document on Clinical Trials Regulation in Europe (AllTrials)


  • China Bans Daewoong's Cefmetazole Antibiotic Until Allowed To Inspect (PharmAsia-$)
  • India to regulate phytopharmaceuticals but experts shy away from US route (SCRIP-$)
  • China cracks down on high-priced drugs  (BioSpectrum)

Other International

General Regulatory And Interesting Articles

  • BioWorld's 7th Annual Biotech Gift Guide (BioWorld)
  • Tamiflu Residue in Environment Can Lead to Resistance in Future Viruses (Press)
  • Myth of 'anonymized' data and rise of 're-identification experts' (Fierce)
  • Why promising dementia drugs failed in clinical trials (MNT)
  • So you want to be a scientist? Your best bet for making money is the drug industry. (Washington Post)
  • Above Tire Fix-It Shop Glycart Makes Roche Leukemia Drug (Bloomberg)
  • Menstrual cramps relieved by erectile dysfunction drug (MNT) (MedCity News)
  • A personal antidepressant for every genome (Press)

Regulatory Reconnaissance #218 - 10 December 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.

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