Regulatory Recon: CMS Report Finds Theranos Tests Failed Accuracy Requirements Are Cheap Drugs Leading to Shortages? (1 April 2016)

Posted 01 April 2016 | By Michael Mezher 

Regulatory Recon: CMS Report Finds Theranos Tests Failed Accuracy Requirements Are Cheap Drugs Leading to Shortages? (1 April 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

In Focus: International

  • Drug Shortages Prompt Question: Are Some Medicines Too Cheap? (Reuters)
  • GSK to Allow Staggered Payments for EMA-Approved Gene Therapy (Financial Times) (Press)
  • WHO Sees Scientific Consensus on Zika as Cause for Disorders (Reuters)
  • European Regulatory Roundup: CHMP Adopts Guidance on VTE Treatments (Focus)
  • MHRA Updates Fee Schedule, Releases New Fees Calculator (MHRA, Calculator)
  • EMA to Continue Parallel Scientific, HTA Advice Following Successful Pilot (Focus)
  • Hundreds in Guinea Get Ebola Vaccine in Fight Against Flare-Up (Reuters)
  • Liberia Records New Ebola death, Months After End of its Outbreak (Reuters)
  • Regulator Orders Drugmaker Valeant Management to Cease Trading (Reuters)
  • EMA Committee to Tackle ATMP Evaluation, Early Access, Trials and Orphans (SCRIP-$)
  • Health Ministry Official: No problems Seen in Initial Novartis investigation, Prosecutor Begins Probe (Reuters 1, 2)
  • Drugmakers Say Japan R&D Spending at Risk After Government Forces Price Cuts (Reuters)

US: Pharmaceuticals & Biotechnology

  • 'Paradigm shift needed' in trial site selection process (Outsourcing-Pharma)
  • CDER's Axelrad to retire (BioCentury)
  • 'We thought we were curing people': Hope dims as ovarian cancer therapy fails test (STAT)
  • Impact of starting material T-cell composition on outcome of CAR T-cell therapy (StemCellAssays)
  • Making Patient Registries Count in the Research Process (Faster Cures)
  • A Multi-Sectorial Approach to Ensuring Medical Product Quality & Supply Chain Integrity (USP)
  • Array Bio stops study testing drug for ovarian cancer (Reuters)
  • Menopause hormone clot risk lower for vaginal creams and skin patches (Reuters)
  • Merger prepares for 'tidal wave' of gene therapy products (BioPharma-Reporter)
  • Forget Big Data — Let's Talk Smart Data (Geeks Talk Clinical)
  • How the biosimilars market is changing (GaBI)
  • Specialty Pricing Drugs: How Did We Get Here and Where Do We Go (Policy and Medicine)
  • Washington Post falls for April Fools spoof Pfizer pricing story (PharmaPhorum) (Reuters) (Washington Post)
  • Janssen to stop fulranumab development in osteoarthritis pain (Pharmafile)
  • Amarin agreement opens off-label promotion door (Nature)
  • New Drug Shows Promise Against Muscle-Wasting Disease (DD&D)

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

  • FDA again reviewing Dynavax's Heplisav-B (BioCentury)
  • PharmaMar's Aplidin passes Phase III MM test (BioCentury)
  • Novel Vaccine Strategy Produces Rapid and Long-term Protection Against Chikungunya Virus (ICT)
  • Pfizer Announces Positive Topline Results from Second Phase 3 Lipid-Lowering Study Evaluating Bococizumab (Press)
  • Janssen's Phase 3 Trial of Daratumumab in Multiple Myeloma Meets Primary Endpoint (DD&D)
  • Actinium gets Orphan Drug Designation for myeloid leukaemia drug (Pharmafile)
  • CEL-SCI Reports Monthly Patient Enrollment in March for Its Phase 3 Head and Neck Cancer Trial (Press)
  • Radius Health submits NDA for abaloparatide-SC to treat postmenopausal osteoporosis (PharmaLetter-$)

US: Medical Devices

  • Law And Regulation Of 3-D Printed Medical Devices (Law360-$)
  • Podcast: ISO 13485 Redo, Interview With Ex-FDA International Quality Systems Expert Kim Trautman (Gray Sheet-$)
  • FDA gives Medtronic's PillCam OK for expanded indication on major risk patients (Fierce)
  • Nexstim heads to US after accidentally treating the sham group (EP Vantage)
  • Regulators scrutinise safety of mobile healthcare apps (Financial Times-$)
  • 7 Pitfalls to Avoid in mHealth Web & App Design – White Paper (MassDevice)
  • First Patients Enrolled in Medtronic Trial in Low-Risk Aortic Stenosis Patients (Press)
  • Medtronic launches CoreValve Evolut R trial in low-risk patients (MassDevice)

US: Assorted & Government

  • Idaho governor signs biosimilars substitution bill (GaBI)
  • Comment K Case by Case – Falling Out of Favor? (Drug and Device Law)
  • Let Patients Read Their Medical Records (NYTimes)
  • Hospitals Brace for New Medicare Payment Rules (WSJ-$)

Upcoming Meetings & Events


  • First oral treatment for Fabry disease recommended for approval in the EU (EMA)
  • EMA Conditionally Approves Darzalex  to Treat Patients With Multiple Myeloma (EMA)
  • CMDh endorses revocation of authorisations for fusafungine sprays used to treat airway infections (EMA)
  • U.K. industry lobby group to write pro-pharma features with newspaper that berates it (Fierce)
  • Preparing For The New EU Medical Device Regulations — A Eudamed Sneak Peek (MedDeviceOnline)
  • IBM Plans First Watson Health European Center of Excellence in Italy (IBM)
  • New Fees for the early access to medicines scheme (EAMS) (MHRA)
  • A strong NHS needs a strong economy (GOV.UK)
  • European regulators to decide on Samsung's Remicade biosimilar (PharmaPhorum)


  • Impact of South Korea's new drug–pricing policy on market competition (GaBI)
  • Turkey Regulatory Update: Reference Pricing Ends For Cheap Drugs (PharmAsiaNews-$)
  • Establishment and Start of Operations of Malaysia Subsidiary and Umbrella Organization Covering South East and South Asia Regions (Press)


  • NPPA fix prices of 103 scheduled drug formulations under DPCO (PharmaBiz)
  • Alkem gets 8 observations from UKMHRA for Taloja plant (Economic Times)
  • Vertex Pharma Refused Indian Patent For Orkambi – Subject Of Pre-Grant Opposition (24 Insight)
  • Indian Generic Manufacturer Cipla Targeting US HIV Market (24 Insight)
  • Zydus Cadila gets USFDA nod for cancer treatment drug (Economic Times)
  • Blockbuster Hepatitis C drug now under price control (Economic Times)
  • Aurobindo Pharma gets final USFDA nod for anti-viral drug (Economic Times)


  • Australia's April Cuts Signal Earlier Price Erosion For Originator Drugs (Pink Sheet-$)


  • In war on Zika mosquitoes, Puerto Rico starting at 'square one' (Reuters)
  • U.S. study may point the way on how to beat the Zika virus (Reuters)

General Health & Other Interesting Articles

  • World's obese population hits 641 million, global study finds (Reuters)
  • Endometriosis Tied to Increased Risk for Heart Disease (NYTimes)
  • Diabetes during pregnancy linked to liver disease later in life (Reuters)
  • Longer night fasting tied to reduced breast cancer recurrence (Retuers)
  • Autism rate among U.S. children held steady 2010-2012: CDC (Reuters)

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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