Regulatory Recon: Experts Call for New Antibiotic Pathway, NICE Says Strensiq is Too Expensive (3 December 2015)

Posted 03 December 2015 | By Michael Mezher 

Regulatory Recon: Experts Call for New Antibiotic Pathway, NICE Says Strensiq is Too Expensive (3 December 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

In Focus: International

  • Sales reps testing patients at 'free health camps' in India (Economic Times) (EurekAlert) (The BMJ)
  • Chinese Government Agrees to Easier Market Access for Foreign Device Companies (Emergo)
  • MHRA begins to develop human factors guidance with stakeholders (MHRA)
  • Alexion's $550,000 bone drug too expensive for Britain (Reuters)
  • France First EU Country To Make Truvada Available For HIV Prevention (SCRIP-$)
  • Australia Leads The Way In Biosimilar Substitution With Inflectra Listing (SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • FDA Advisory Panel Unmoved by Gepirone Data (MedpageToday)
  • How Big Pharma Could Lose the War on Disease (Bloomberg)
  • New liver cell production method will spark end of animal testing, scientist (Outsourcing-Pharma)
  • Home-made pharmaceuticals may be possible in the near future (BioPharma-Reporter)
  • PhRMA: Direct-to-consumer advertising makes doctors and patients stronger partners (PhRMA)
  • Higher Rate of Kidney Failure Seen With Two Common Antibiotics (MPR)
  • Building a New Golden Age of Innovation in Drug Development (DD&D)

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

  • Zafgen's beloranib on full clinical hold after second death (BioCentury) (Reuters) (SCRIP-$)
  • PARADIGM Investigators Estimate Entresto Prolongs Life by 1-2 Years (CardioBrief)
  • Acorda Initiates Phase 1 Clinical Trial of CVT-427, Inhaled Therapy for Acute Treatment of Migraines (Press)
  • Portrazza (necitumumab) Approved as First-Line Therapy for Metastatic, Squamous Non-Small Cell Lung Cancer (Press)
  • InVivo Therapeutics Announces Conditional Approval for INSPIRE Pivotal Probable Benefit Clinical Study of the Neuro-Spinal Scaffold (Press)
  • Mitralign Announces Enrollment of First US Subject in Percutaneous Tricuspid Repair Study (Press)

US: Medical Devices

  • FDA: PMA approvals hit record high in fiscal 2015 (MassDevice) (Focus)
  • Breast Implants Undergo Reconstruction (NYTimes)
  • LDT Update: FDA and CMS Testify Before the House Energy & Commerce Subcommittee Following Year of Debate on Oversight of LDTs (National Law Review) (Focus)
  • Market for new heart valve device could take years to build (Reuters)
  • FDA clears Philosys Gmate glucometer for Android (MassDevice)
  • Philosys' blood glucose meter goes mobile with new FDA approval (DSN)
  • Koning's No-Compression Breast CT Scanner Approved in US (medGadget)
  • Caputron Medical Announces FDA Cleared mindGear Treatment For Depression, Insomnia, And Anxiety (MedDeviceOnline)
  • Insulet recalls OmniPods on needle deployment issue (MassDevice) (FDA)
  • FDA OKs trial for StimRelieve's facial pain device (MassDevice)
  • Zimmer Biomet wins expanded FDA safety claim for Gel-One knee injection (MassDevice)
  • Guided Therapeutics sees FDA path for LuViva cervical scanner (MassDevice)

US: Assorted and Government

  • Definition of Insanity – Expecting Certification of a Personal Injury Class Action (Drug and Device Law)
  • Ebola Crisis Passes, but Questions on Quarantines Persist (NYTimes)
  • Minnesota to add pain patients to medical marijuana program (Reuters)
  • US court rejects Sequenom bid to restore prenatal DNA test patent (Reuters)
  • Drug Importation and John McCain's Flying Pig (DrugWonks)
  • Ethicon Can't Duck Patients' Defect Claims In Mesh MDL (Law360-$)
  • Pelvic Mesh Caused Irreversible Conditions, Pa. Jury Hears (Law360-$)

Upcoming Meetings and Events              


  • Revealing the quiet revolution of 21st century healthcare (MHRA)
  • NICE snubs Alexion's Strensiq (BioCentury) (SCRIP-$)
  • Medicines and Healthcare products Regulatory Agency's staff survey results 2015 (MHRA)
  • GSK gets European approval for asthma treatment Nucala (Pharmafile)
  • UN: Polio Outbreak in Ukraine is a State of Emergency (DD&D)
  • St. Jude wins CE Mark for MR-safe Quadra Assura CRT-D (MassDevice)
  • Horizon Pharma plc Receives its First Centralized Authorization for Ravicti (PharmPro)


  • AstraZeneca Pharma India to close Bengaluru API unit (Economic Times)
  • India-Africa synergies in health sector mooted (Economic Times)
  • Final report on national drugs survey likely to come by April 2016 (PharmaBiz)


  • Japan's Astellas and U.S.-based Ironwood report PhIII success for linaclotide trials (FiercePharmaAsia)


  • Updates to the list of designated orphan drugs (TGA)

General Health & Interesting Articles

  • Is It Immoral for Me to Dictate an Accelerated Death for My Future Demented Self? (Harvard Bill of Health)
  • One Doctor's Quest To End The Plague Of Screwed-Up Medical Diagnoses (Forbes)

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

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

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