Regulatory Recon: Price Hikes Continue Despite Criticism, Startup Grail to Develop NGS Cancer Diagnostics (11 January 2016)

Posted 11 January 2016 | By Michael Mezher 

Regulatory Recon: Price Hikes Continue Despite Criticism, Startup Grail to Develop NGS Cancer Diagnostics (11 January 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

  • India Attempts to Incentivize Clinical Research (24 Insight)
  • MHRA Calls for Continued Quarantine of Silimed Implants (Focus)
  • Sientra Says Medical Implants Found Safe in Independent Review (Reuters)
  • Malaria Resistant to Both Artemisinin and Piperaquine Identified in Cambodia (Pharmaceutical Journal-$)

Sponsored Content: The Regulatory Affairs Landscape has Evolved. Will You?

US: Pharmaceuticals and Biotechnology

  • PhRMA, BIO Call for Global Approach on Regulations Governing Manufacturing Changes (Focus)
  • What Biosimilar Makers Need To Know About 2016 (BioprocessOnline)
  • Biologics and Biosimilars Bits and Bytes (National Law Review)
  • Round Two at FDA for Buprenorphine Implant (MedpageToday) (SCRIP-$)
  • Pharmacy Benefit Managers Begin to Cut Ties With Specialty Pharmacies (Policy and Medicine)
  • CBER's Dozen: Novel Biologics Approved In 2015 (Pink Sheet-$)
  • Ibuprofen could provide alternative to antibiotics for uncomplicated UTIs (Pharmaceutical Journal-$)
  • Doxycycline more effective than azithromycin for chlamydia (Pharmaceutical Journal-$)
  • New USP Standards for Characterization of Therapeutic Proteins (USP)
  • Shakti Group USA LLC Recalls L.G Compounded Asafoetida Powder Because Of Possible Health Risk (FDA)

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

  • AbbVie begins late stage trials of rheumatoid arthritis drug (Pharmafile)
  • NDA for First-in-Class DMD Tx Submitted to FDA (MPR)
  • Materialise NV (ADR)(NASDAQ:MTLS) Gets NSE Letter From Food and Drug Administration (BA, GE) (Press)
  • Aquinox Announces Update on Development Program for AQX-1125 Following Meeting With FDA (Press)
  • Immune Design Receives Orphan Drug Designation From the U.S. FDA for Complementary Components of CMB305 (Press)

US: Medical Devices

  • MedSun January 2016 Newsletter (FDA)
  •  The Impact of Genetic Testing on Children: What do we know, what's missing? (Harvard Bill of Health)
  • Astora lands FDA panel date for Topas incontinence device (MassDevice)
  • SRS Medical wins FDA nod for expanded study of Spanner prostate stent (MassDevice)
  • Genalyte is taking the single fingertip blood test to the next level (yet another Theranos competitor (MedCityNews)
  • Neovasc Receives FDA Approval to add 40mm Valve Size to the TIARA-I Clinical Trial (Press)

US: Assorted and Government

  • Obama Vetoes Bill to Repeal Health Law and End Planned Parenthood Funding (NYTimes) (Reuters)
  • California Supreme Court – Presumption Against Preemption Still Around (Drug and Device Law)

Upcoming Meetings and Events              


  • BioMarin CEO, waiting on FDA on Duchenne drug, eyes Europe (Reuters)
  • Antibiotic resistance looms as serious threat to health (EurActiv)
  • Vivasure wins CE Mark for bioabsorbable vascular closure device (MassDevice)
  • Exelixis Submits Marketing Authorization Application in the European Union for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma (Press)


  • Reliance Life Sciences gets US FDA nod for Navi Mumbai plant (Economic Times)
  • Aurobindo Pharma receives USFDA nod for endometriosis treatment drug (Economic Times)
  • Cadila Healthcare Gets EIR Report From USFDA  (Economic Times)
  • Indian pharma sees relevance of 'Make in India' programme if government enables regulations and infrastructure (PharmaBiz)
  • Industry wants centre to move beyond discussions to make India a global manufacturing hub (PharmaBiz)
  • Drug maker Wockhardt on fast track of innovation (Economic Times)
  • Govt & industry anxious on TPP & TTIP which could impact manufacture & supply of drugs to 12 Pacific Rim nations (PharmaBiz)


  • Novocure seeks Japanese PMA approval for cancer treatment device (BioSpectrum)
  • As 'patent cliff' beckons, Japanese drugmakers seek lifeline with technology (FiercePharmaAsia)
  • Otsuka files for Iclusig approval in Japan, under deal with Ariad (PharmaLetter-$)
  • Gates-funded Access to Medicine Foundation to meet Japanese pharma companies (BioSpectrum)


  • Guidance Document - Biomarkers Related to Drug or Biotechnology Product Development: Context, Structure and Format of Qualification Submissions ICH Topic E16 (Health Canada)
  • Release of Draft (Step 2) ICH Guidance Document: E18: Genomic Sampling and Management of Genomic Data (Health Canada)


  • HeartWare Ventricular Assist Device AC adapters and batteries (TGA)

Other International

  • World Health Organization Doubles Cholera Vaccine Supply (NBC)
  • Ethics of Clinical Trials in Low-Resource Settings: Lessons From Recent Trials in Cancer Medicine (Journal of Global Oncology)
  • Aurobindo Pharma to build pharmaceutical factory in Saudi Arabia (Economic Times)
  • Varian ProBeam Proton Therapy System First to Receive Saudi FDA Authorization (Press)

General Health and Other Interesting Articles

  • Exercise prescriptions important for type 2 diabetes (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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