Regulatory Recon: FDA Clears First Liquid Biopsy Test Global Cancer Drug Spending Reaches $107 Billion (2 June 2016)

Posted 02 June 2016 | By Michael Mezher 

Regulatory Recon: FDA Clears First Liquid Biopsy Test Global Cancer Drug Spending Reaches $107 Billion (2 June 2016)

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

  • FDA warns on risk of heart infection with LivaNova's Stӧckert 3T heater-cooler (MassDevice) (FDA)
  • No Easy Way Out for Abbott as Deal Target Faces Bribery Probe (Bloomberg)
  • FDA OKs First Liquid Biopsy for Lung Cancer Mutation (MedScape) (Reuters) (GenomeWeb)  (Press 1, 2)
  • Are Things Getting Any Better in the Clinic? (In The Pipeline)
  • The Emerging Benefit Of Personalized, Phase 1 Clinical Trials In Oncology (Forbes)
  • Smart Devices Undone by Dumb Security (WSJ-$)
  • FDA approves Netspot diagnostic imaging agent to detect rare neuroendocrine tumors (FDA) (Reuters) (Press)
  • Senators Call on HHS to Increase Access to Medication Assisted Therapy to Treat Opioid Dependence (Letter)
  • Biomarker Tests for Molecularly Targeted Therapies — The Key to Unlocking Precision Medicine (NEJM)
  • The US Health Disadvantage And The Role Of Spending (Health Affairs Blog)
  • Tech VC: Messy Human Dynamics Complicate Neat Tech Solutions; Who Knew? (Forbes)
  • Fearing Drugs' Rare Side Effects, Millions Take Their Chances With Osteoporosis (NYTimes)
  • Medivation Sets Wednesday as Cutoff for Vote on Sanofi's Proposal to Remove Board (WSJ-$)
  • GSK seeks lead in triple lung drug market with 2016 filing plan (Reuters)
  • Independence of compliance reviews is questioned in drug firm settlements (Reuters)

In Focus: International

  • We're spending $107 billion on cancer drugs, but is it worth it? (Washington Post) (Reuters) (IMS)
  • Worldwide collaboration for orphan drug designation (Nature)
  • Facing rival drugs, Novartis gets win with Afinitor in Europe (Reuters)
  • AstraZeneca sells EU, Latam gout drug rights to Gruenenthal (Reuters)
  • Regulatory watch: The orphan drug pipeline in Europe (Nature)
  • NICE to research patient preferences in HTA (PharmaTimes)
  • Experts urge India to join PIC/S to enhance recognition & sustain India's global leadership in pharma generics (PharmaBiz)
  • Counterfeit medicines are a growing threat to global health, WHO meeting hears (Pharmaceutical Journal-$)
  • China graft buster raps health ministry, drug regulator (Reuters)

US: Pharmaceuticals & Biotechnology

  • Making Transparency Work: why we need new efforts to make data usable (Harvard School of Public Health)
  • Program Will Train First Responders and Hazardous Waste Workers on Infectious Disease Safety (NIH)
  • Cell therapies to drive regenerative meds market rise of 20.7% CAGR (PharmaLetter-$)
  • NantHealth Shares Price at $14 Each in IPO (WSJ-$)
  • The White House's National Microbiome Initiative: My Reflections (LifeSciVC)
  • Megafine must investigate data faking at banned API plant says US FDA (In-PharmaTechnologist)
  • Comparing cytochrome P450 pharmacogenetic information available on United States drug labels and European Union Summaries of Product Characteristics (Pharmacogenomics Journal)
  • Data support Opdivo as new standard of care in mRCC, says GlobalData (EPR)
  • Pfizer raises $5B in debt (BioCentury)
  • Unapproved Wound Care Products Flood the Market  (Medpage)
  • Abuse-Deterrent Opioids: Generics Worry Comparator Standard Impedes Approvals (Pink Sheet-$)
  • Weight Of Emergency Contraceptive Data Does Not Support Label Change (Pink Sheet-$)

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

  • FDA reviewing Radius' abaloparatide (BioCentury)
  • Dermira's drug for excessive armpit sweating succeeds in key studies (Reuters) (BioCentury)
  • Trevi Therapeutics Announces Completion of Enrollment in Phase 2/3 Study of Nalbuphine ER in Prurigo Nodularis (Press)
  • FDA Grants Orphan Drug Designation to Debiopharm International SA's IAP Inhibitor Debio 1143 in the Treatment of Ovarian Cancer (Press)
  • Viamet Receives Fast Track Designation from the FDA for VT-1129 for the Treatment of Cryptococcal Meningitis (Press)

US: Medical Devices

  • Patent Difficulties For 3-D Printed Medical Implants (Law360-$)
  • FDA approves J&J Ebola test (Philly)
  • Industry Efforts Against Device Tax Haven't Slowed Down, Despite Suspension (Gray Sheet-$)
  • Clearside Biomedical floats $50m IPO (MassDevice)
  • Philips and Yale expand research deal (MassDevice)
  • Report: Abbott audits Alere's books ahead of $6B merger (MassDevice)
  • Attn: Data Integrity Compromised (MassDevice)
  • EnteroMedics Maestro neurostim device used as 'rescue' therapy after failed surgeries (MassDevice)
  • Esco Secures FDA Clearance For Commercial Distribution of Miri(R) TL, a Proprietary Next Generation Time-lapse Embryo Incubator for IVF (Press)

US: Assorted & Government

  • FDA Looks to Cut Salt Content in Food (WSJ-$) (FDA)
  • Lawmaker wants funds for victims of tainted drug scandal (Washington Examiner)
  • Opinion: Hustling Dollars for Public Health (NYTimes)
  • The Sessions-Cassidy Bill: An ACA Alternative Spelled Out In Legislative Language (Health Affairs Blog)
  • Medicare: Utilization and Expenditures for Complex Wheelchair Accessories (GAO)
  • Expanding Medicare Would Solve Some Problems, Create New Ones (NYTimes)

Upcoming Meetings & Events


  • HTA Network Multiannual Work Programme 2016-2020 (EC)
  • EU approves second indication for subcutaneous form of Roche's rituximab (BioPharma-Reporter)
  • European Commission Grants Orphan Drug Designation to ALXN1210 for the Treatment of Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) (Press)
  • EFPIA Responds to Public Consultation on a proposal for a mandatory Transparency Register (EFPIA)
  • EFPIA Response to Transparency International UK Report (EFPIA)
  • ABPI respond to Transparency International report on pharmaceutical industry corruption (ABPI)
  • ReActiv8 Implantable Muscle Stimulator for Treating Chronic Lower Back Pain EU Cleared (medGadget)
  • Avenu Medical wins CE Mark for Ellipsys vascular access system (MassDevice)
  • European Commission approves TREVICTA (paliperidone palmitate 3-monthly injection), for schizophrenia (MNT)
  • Luminex Gets CE Marking for Aries Flu, RSV Assay (GenomeWeb)
  • Revised: European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure (EMA)
  • Revised: EMA Procedural advice for users of the centralised procedure for generic/hybrid applications (EMA)
  • Revised: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure (EMA)


  • Elekta's Leksell Gamma Knife Icon cleared for use in Japan, US (BioSpectrum)
  • Tissuemed wins China's OK for TissuePatch surgical sealant (MassDevice)
  • In First Distribution Deal, StemBioSys Teams with Funakoshi in Japan (Xconomy)
  • Fujufilm, jilted in Toshiba Medical sale, still hot to trot the M&A trail (MassDevice)


  • USFDA issues warning letter to Megafine Pharma (Economic Times)
  • Export woes of Indian pharma companies (PharmaLetter-$)
  • Govt soon to approve setting up of India's first medical device testing lab at Vadodara (PharmaBiz)
  • Sun Pharma's problems to continue for another 2-3 quarters (Economic Times)


  • Guidance on release for supply, Part 2 (TGA)

Other International       

  • Chile court orders salmon farms antibiotic use be disclosed (Reuters)

General Health & Other Interesting Articles

  • Plummeting U.S. teen birthrate hit record low in 2015: CDC (Reuters)
  • Snapshots of Life: Development in Exquisite Detail (NIH)

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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