Regulatory Focus™ > News Articles > Regulatory Recon: Theranos to Appeal CMS Sanctions; EMA Reviewing First Herceptin Biosimilar (26 Aug

Regulatory Recon: Theranos to Appeal CMS Sanctions EMA Reviewing First Herceptin Biosimilar (26 August 2016)

Posted 26 August 2016 | By Michael Mezher 

Regulatory Recon: Theranos to Appeal CMS Sanctions EMA Reviewing First Herceptin Biosimilar (26 August 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

  • Lung cancer doctors eye Merck's Keytruda over Bristol's Opdivo (Reuters)
  • Theranos to appeal regulatory sanctions on its lab (Reuters)
  • The New Age of Organic Synthesis (In the Pipeline)
  • Illinois Attorney General Sues Fentanyl Drugmaker for Deceptive Off-Label Marketing (Focus)
  • Approval of Anthrax Vaccine Under FDA's Animal Rule is a Step Forward, Researchers Argue (Focus) (Nature)
  • Drug Pricing, Shame, and Shortages (Harvard Bill of Health)
  • A Simpler Way To Make A Complicated Molecule (Forbes)
  • Did You Catch That "New" Drug Product Addition to the Orange Book? (FDA Law Blog)
  • The Unintended Consequence of Congress's Ban on Designer Babies (MIT Technology Review)
  • Senators to FDA: Where are the Alternatives to Mylan's EpiPen? (Focus)
  • FDA Warns of Serious Risks for Syringe Pumps at Low Infusion Rates (Focus)
  • Mad About Epipen? Here Are Some Ideas To Actually Fix America's Drug Pricing Mess (Forbes)
  • OutFront: LGBTQ Advocate Abstaining From Sex for a Year to Donate Blood (NBC)
  • By the Numbers: Wide Variation by Specialty in Use of Generics (Medpage)
  • New Virus Breaks The Rules Of Infection (NPR)
  • Morcellation-Cancer Controversy Still Unresolved (Medpage)

In Focus: International

  • European Regulatory Roundup: When is an App a Medical Device? MHRA Explains (Focus)
  • Pharmaceutical price regulation in Saudi Arabia: a countdown to affordable biosimilars (GaBI)
  • Eisai gets new indication for Treakisym in Japan (PharmaLetter-$) (Press)
  • EMA reviewing first Herceptin biosimilar (BioCentury) (Economic Times)
  • Developing Drugs for Neglected Diseases: Gosh, Fellows, There's a Better Way (In the Pipeline)
  • Phase I Studies Drive 16% Rise In Danish Clinical Trial Applications (Pink Sheet-$)
  • Health Canada warns on hepatoxicity of Revolade (PharmaLetter-$)
  • European Medicines Agency closed 29 August 2016 (EMA)

US: Pharmaceuticals & Biotechnology

  • Denali grabs $130M more as it heads into the clinic, reveals deals (Fierce)
  • Duchenne Lessons: Advocates For Rare Spinal Disease Have Eyes on FDA (Xconomy)
  • FDA's Advisory Committees Just Can't Say "No" (Pink Sheet-$)
  • Mallinckrodt Could Be Next in Spotlight Thanks to EpiPen Scrutiny (The Street)
  • Review: Stem Cell Tx for Heart Failure Not Ready Yet (Medpage)
  • Grunenthal says anti-crush tech Endo uses for Opana ER helps prevent abuse (InPharmaTechnologist)
  • Metrion: research consortium aiming to reduce animal studies, facilitate new drug development (Outsourcing Pharma)

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

  • Intercept's new PBC liver disease treatment yields successful clinical trials (EPR)
  • Adocia scraps diabetic foot ulcer program following PhIII flop (Fierce)

US: Medical Devices

  • 10 Things I Wish I'd Known Before Writing my FDA Response Letter (GxP Lifeline)
  • Patient perspective: Why I'm not that worried about my St. Jude Medical pacemaker (MassDevice)
  • Short-seller's cybersecurity accusations push St. Jude Medical shares down (MassDevice)
  • Study: Drug-coated balloons beat plain balloon angioplasty in peripheral vessel disease (MassDevice)
  • Medtronic to cover HeartWare's cash burn by cutting back on other heart failure R&D (MassDevice)
  • Amedica wins expanded FDA indication for Valeo II spinal fusion devices (MassDevice)
  • Derma Sciences touts Medicare reimbursement win (MassDevice)
  • Insightec touts near 50% tremor score improvement in pivotal Exablate Neuro study (MassDevice)
  • Alere Recalls INRatio® and INRatio2® PT/INR Monitoring System Due to Incorrect Test Results (FDA)
  • Class 1 Device Recall Roadrunner Uniglide Hydrophilic Wire Guide (FDA)

US: Assorted & Government

  • How Expanding Medicaid Can Lower Insurance Premiums for All (NYTimes)
  • Burden of Health-Care Costs Moves to the Middle Class (WSJ)
  • Another Reason Why Medical Device Class Actions Don't Work (Drug and Device Law)

Upcoming Meetings & Events


  • Takeda says no decision yet on shutdown of Cambridge, UK unit (PMLive)
  • NICE backs non-surgical option for fibroids (PharmaTimes)
  • NHS deficit narrows in first quarter (PharmaTimes)
  • Signing of the Grant Agreement for Joint Action 3 started (EUnetHTA)


  • Quick change at the top for Shanghai Pharma as chairman quits after 3 months (Fierce)
  • Titan Medical again extends negotiations with Chinese distributor (MassDevice)


  • Medela breastpumps detachable wall plug for AC power adapter (TGA)


  • Hong Kong confirms first case of Zika virus (Reuters)
  • So Far, It Seems No One Caught Zika at the Olympics: WHO (NBC)

Other International

  • Tanzania's army of community health workers face mistrust as they roll out services (Reuters)

General Health & Other Interesting Articles

  • Illegally Made Fentanyl Seems To Be Fueling A Spike In Overdoses (NPR)
  • More Life to Be Lived (NYTimes)
  • Exposure to 9/11 disaster tied to low birthweight, preterm delivery (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.

Categories: Recon, Regulatory News

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