Regulatory Recon: IMS Predicts Global Drug Spending Will Hit $1.4 Trillion by 2020 (18 November 2015)

Posted 18 November 2015 | By Michael Mezher 

Regulatory Recon: IMS Predicts Global Drug Spending Will Hit $1.4 Trillion by 2020 (18 November 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

  • Global drug spending to hit $1.4 trillion in 2020: IMS (Reuters) (Pink Sheet-$)
  • Health ministry plans to revamp regulatory rules for biosimilar drugs (Economic Times)
  • Europe could recommend second biosimilar arthritis drug this week (Reuters)
  • Don't mix talks on drugs & trade pact: EU to India (Economic Times)
  • Hikma resolves FDA concerns over Portugese drug factory (Telegraph)
  • Africa’s meningitis A vaccine: how partnership replaced ‘Big Pharma’ (IRIN)

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US: Pharmaceuticals and Biotechnology

  • FDA Finalizes Guidance on Formal Meetings with Biosimilar Sponsors (Focus) (FDA)
  • FDA REMS “Platform” Model Unveiled At Public Meeting; Pilot Test Using Structured Product Labeling Is First Step (RPM Report-$)
  • Women At The Top In Biopharma: The Odds And How To Beat Them (InVivo-$)
  • CDC Says It's Time To Get Smart About Antibiotics. We've Got A Long Way To Go (Forbes)
  • FDA Drug Safety Communication: FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imaging (FDA)
  • Califf Supports Combo Products Pathway At Confirmation Hearing (Gray Sheet-$)
  • New Report Outlines Recommendations For Combating Prescription Opioid Epidemic (Forbes)

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

  • Novartis biosimilar takes aim at Amgen drug Neulasta (Reuters)
  • Merck KGaA, Darmstadt, Germany, and Pfizer Receive FDA Breakthrough Therapy Designation for Avelumab in Metastatic Merkel Cell Carcinoma (Press)
  • FDA Accepts Sandoz' Regulatory Submission For Proposed Biosimilar Pegfilgrastim (RTT News)
  • Cidara's weekly antifungal candidate rolls toward Phase II (FierceBiotech)

US: Medical Devices

  • Medtronic wins FDA nod for app-based remote pacer monitor (MassDevice) (Medtronic)
  • FDA closes out AngioDynamics NanoKnife warning letter (MassDevice)
  • Companies seek to diagnose cancer from a blood sample (STAT)
  • Simple Urine Test Could Diagnose HCV (DD&D)
  • Enzo Biochem Lands NY State Approval of HCV Quantitative Test (GenomeWeb)
  • It's A Necklace And It Could Be A Lifesaver: Wearable Health Gadgets (NPR)
  • Harnessing Genomic Data: An Interview with Ben Salisbury, V.P. of GenomOncology (medGadget)
  • Registry data shows more than 10% of TAVR patients are being treated off-label (FierceMedicalDevices)
  • Diatherix, Color Genomics Receive CAP Accreditation (GenomeWeb)
  • Visible Patient gets FDA clearance for custom 3D anatomy models, app still to come (mobihealthnews)
  • Graftys launches bone cement registry trial (MassDevice)
  • Learn From Theranos’s Mistakes: An Analysis of the Form 483s (Part I) (MDDI)
  • No Drugs, No Surgery, New Hope: Magnetic Stimulation Trial is the First to Target Depression in Teenagers (Thomson Reuters)
  • Test results of fingerprick blood vary from drop to drop (MNT)
  • Hitachi’s Scenaria SE 64 and 128 Slice CTs FDA Approved (medGadget)
  • 20 pneumococcal serotyping methods tested; concern about US healthcare quality measures (MNT)
  • Visunex wins FDA 510(k) for Panocam LT (MassDevice)
  • Nanotech-based sensor developed to measure microRNAs in blood, speed cancer detection (MNT)
  • Protein biomarkers may accelerate the future of personalized medicine for CV disease (MNT)
  • Metabolic profiles distinguish early stage ovarian cancer with unprecedented accuracy (MNT)

US: Assorted and Government

  • Sex, Drugs, and Rock & Roll (FDA Style): FDA’s Unapproved Drug Machine Continues to Dole Out Enforcement and Legal Decisions (FDA Law Blog)
  • A Garden (State) Variety Bad Idea for Drug Pricing Reform (DrugWonks)
  • White House Fact Sheet on US Commitment to Global Health Security (White House)
  • Can Pharma Clean Up Its Act on Drug Pricing? Q&A With Alnylam CEO John Maraganore (Forbes)
  • Medical Device Manufacturers as "Health Care Providers" (Drug and Device Law)
  • FDA Can Help On Drug Prices – Except When It Can't, Califf Says (Pink Sheet-$)
  • The Government Is Probably Tracking Your Painkiller Prescriptions (BuzzFeed)
  • Doctors call for warnings on pot use during pregnancy (CBS News)
  • AstraZeneca's Tagrisso to cost $12,750 for a month's supply (Reuters)

Upcoming Meetings and Events


  • New regulation will drive EU clinical trials, but are you ready for it? (Outsourcing-Pharma)
  • NICE says 'no' to personalised bowel cancer drugs (PharmaTimes)
  • Radius Health submits drug application in Europe, but says delay likely in US (Boston Business Journal)
  • NICE rejects Amgen’s Repatha in draft guidance (Pharmafile)
  • Antibiotic prescriptions in England fall after 2012 peak (Pharmaceutical Journal-$)
  • Vertex Receives Two EU Approvals for KALYDECO (ivacaftor) for People with Cystic Fibrosis (Press)
  • Moximed Announces CE Mark and First Commercial Use of AtlasTM Knee System (Press)
  • Patients should be free to choose where to access services, regulators say (Pharmaceutical Journal-$)
  • Fewer antibiotics prescribed when doctors share decision with patients (Pharmaceutical Journal-$)
  • Electrosurgery: top tips (MHRA)


  • West Bengal IPA starts KYM to combat microbial resistance, to emphasize pharmacists' role in patient counseling (PharmaBiz)
  • Accreditation of ethics committees vital for high quality research & trials for new drugs, Dr Y K Gupta (PharmaBiz)
  • Zydus gets USFDA nod for clinical trials of Sarolitazar (Economic Times)
  • Chinese aid norms curb exports of Indian drugs to markets in Africa, Asia & eastern Europe (Economic Times)
  • Govt to sell 425 generic medicines at Jan Aushadhi stores (Economic Times)

Other International

  • Lee's Pharma affiliate licenses Tragara's TG02 oncology treatment for much of Asia (FiercePharmaAsia)
  • The First Use of the Global Oral Cholera Vaccine Emergency Stockpile: Lessons from South Sudan (PLoS Medicine)

General Health and Other Interesting Articles

  • A Quiet Revolution In Organ Transplants (Forbes)
  • Whooping Cough in Infants Tied to Epilepsy Risk (NYTimes)
  • Should Doctors Worry About the Cost of Extending Life? (DrugWonks)
  • Mysterious parasite may actually be a tiny jellyfish gone awry (Washington Post)
  • AHCJ award winner tells us how she created comprehensive piece on high US drug prices (AHCJ)
  • Rebuilding Trust In Medicine: How The Public Can Interpret Differing Guidelines (HealthAffairsBlog)
  • Duchenne Muscular Dystrophy is a Stem Cell Disease (DD&D)
  • New research reveals more than half of those affected with HIV have never been diagnosed due to the fear of being tested (MNT)

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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