Regulatory Recon: Theranos Halts All But One of its Proprietary Blood Tests Under FDA Pressure (16 October 2015)

Posted 16 October 2015 | By Michael Mezher 

Regulatory Recon: Theranos Halts All But One of its Proprietary Blood Tests Under FDA Pressure (16 October 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

  • Valeant faces federal probe over patient assistance programs (Pharmalot)(WSJ-$) (Valeant Letter) (SCRIP-$)
  • FDA puts Zafgen's obesity drug trial on partial hold (Reuters)
  • FDA ‘Weirdness?’ Separate meetings for BioMarin and Sarepta DMD drugs (Pharmalot) (SCRIP-$)
  • AstraZeneca diabetes drug combination faces delay after FDA rebuff (Reuters) (Bloomberg) (AstraZeneca)
  • Hot Startup Theranos Dials Back Lab Tests at FDA’s Behest (WSJ-$)
  • How Safety Concerns About Essure Reveal A Path To Better Device Tracking (HealthAffairsBlog)
  • Identification requirements for drugs, devices begin to ramp up (PWC)

In Focus: International

  • MHRA Issues Safety Alert for Two More Silimed Products, CE Mark Temporarily Suspended (MHRA 1, 2) (Focus 1, 2)
  • Brazil's ANVISA Globalizes On Class I/II Medtech Regulations, Hikes Fees (SCRIP-$)
  • Two new Ebola cases in Guinea, WHO says (Reuters)
  • India drug industry says U.S.-led trade deal will raise prices (Reuters)
  • FDA Bans Imports From Major Indian API Manufacturer (Focus) (FDANews-$)

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US: Pharmaceuticals and Biotechnology

  • 15 Years of FDA Inspection Data: Infographic (FDAZilla)
  • Desperately Seeking Patients: New Cholesterol Drug Makers Fuel Research To Find Customers (CardioBrief)
  • Looking Back at Sutent’s Development: Problems or Not? (Science)
  • The first ‘female Viagra’ is here. Who wants it? (Washington Post)
  • Survey: Half Of Companies Throw Big Bucks At FDA-483 Observations, While Heads Roll At A Quarter Of Firms After Poor Inspection Results (Gray Sheet-$)
  • FDA to Host First Public Meeting on Biotech Regulation Overhaul (National Law Review)(FDA) (Federal Register)
  • Sherman returning to FDA (BioCentury)
  • Price Controls Restrict The RIght To Live (DrugWonks)
  • Public Citizen targets pharma "ripoffs" (BioCentury)
  • Ad Comms Update: Defining Unmet Medical Need (Parent Project Muscular Dystrophy)
  • More evidence poor cancer patients don’t join clinical trials (Reuters)
  • J&J Resumes Production at Suspended Tylenol Plant (Pharmaceutical Manufacturing)
  • FDA Cautions Consumers on the Dangers of 'Some' Imported Supplements and Nonprescription Drugs (FDA)
  • Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength (FDA)
  • FDA awards Rutgers-led research team $4.9 million to expand continuous manufacturing for pharma (FiercePharma) (PharmPro)
  • Clues to opioid abuse from state prescription drug monitoring programs (CDC)
  • Draft Recommendations for the Permitted Daily Exposures for Two Solvents, Triethylamine and Methylisobutylketone, According to the Maintenance Procedures for the Guidance Q3C Impurities: Residual Solvents (FDA)

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

  • TFS gets FDA nod for second trial (The West Australian)
  • Transition Therapeutics' Alzheimer drug effective in sub-group (Reuters)
  • Tamiflu and Relenza need a better evidence base for influenza, report finds (Pharmaceutical Journal-$)
  • PTC says DMD drug data supports U.S. approval despite trial failure (Reuters)
  • Medivir Announces That Janssen Has Started a Phase IIa Study to Evaluate the Effect of simeprevir in Combination with odalasvir and AL-335 (Press)
  • Inotek Pharmaceuticals Initiates Dosing of MATRx-1, the First Pivotal Phase 3 Clinical Trial of Trabodenoson, a Novel Treatment for Glaucoma (Press)

US: Medical Devices

  • Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices: FDA Safety Communication (FDA) (ICT)
  • More Resources Sought For Using Patient-Preference Data In Device Reviews (Gray Sheet-$)
  • Apple: ResearchKit is a pipeline for future diagnostic medical apps (MobiHealthNews)
  • The Post Market Surveillance Study (imarc)
  • Can the Expedited Access Pathway (EAP) Program Rekindle Medical Device Innovation? (Pharmaceutical Compliance Monitor)
  • Improving healthcare while curbing cost: Med-tech companies offer a solution (McKinsey)
  • Edwards SAPIEN XT Valve Receives FDA Approval For Aortic Valve-In-Valve Procedures (Press)
  • Study Shows Prestige LP(TM) Cervical Disc Patients Maintained Improved Clinical Outcomes and Patient Satisfaction Compared to Fusion at Seven Years (Medtronic)
  • Kapa Bio Lands ISO Certification (GenomeWeb)

US: Assorted and Government

  • Pharma wins lawsuit over orphan drug discounts to hospitals (Pharmalot) (FDA Law Blog) (Pink Sheet-$)
  • Going on Offense against State Deceptive Trade Practices AG Actions (Drug and Device Law)
  • Sen. Turns Up Heat As WTO Discusses Drug Patent Waiver (Law360-$)
  • Drugmaker Wants 12 Firms Booted From Pay-For-Delay MDL (Law360-$)
  • Streetwise Father Takes on Sloan Kettering to Save His Sick Son (NYTimes)
  • AHF Calls on President Obama to Withdraw Dr. Robert Califf as Nominee to Head FDA (Press)
  • Hospira: Amgen's Biosimilar Lawsuit Fatally Flawed (SCRIP-$)
  • Ferring's Muted Fertility Drug Recall Falls Within FDA Rules (Law360-$)
  • J&J's Marketing Of Risperdal For Children Slammed In Trial (Law360-$)

Upcoming Meetings and Events 


  • Prime Minister calls for pressure on drug prices in UK (PharmaPhorum)
  • Ebola drug ZMapp granted orphan designation by European Medicines Agency (Reuters) (MedCityNews) (Mapp)
  • Faster EU Drug Assessment Pathway Takes Shape: Convergence With US Breakthrough Designation On the Cards (SCRIP-$)
  • Ethical considerations in paediatric clinical trials (PharmaPhorum)
  • EU New Trade and Investment Strategy Will Boost Innovation and Patient Access  (EFPIA)
  • French Regulator Increases Scrutiny Of Compliance With EtO Standard For Residue Levels (Clinica-$)
  • Swiss approval for SOBI’s Xiapex (PharmaLetter-$)
  • NICE asks for further evidence for PCT’s DMD drug Translarna (PharmaLetter-$)
  • England’s NICE recommends Lundbeck’s Brintellix for major depressive episodes (PharmaLetter-$)
  • EFCG: ‘API’ days for Europe as Big Pharma returns in search of quality (In-Pharma Technologist)
  • CPhI report highlights potential risks in biologics supply chain outsourcing (EuropeanPharmaceuticalReview)
  • Kite Pharma Receives Positive Opinions for Orphan Drug Designation in the European Union (EU) for KTE-C19 in Three Additional Hematological Indications (Kite)
  • NICE Recommends Daklinza (daclatasvir) for Treatment of Certain Patients with Chronic Hepatitis C Genotypes 1, 3 and 4 (BMS) (SCRIP-$)


  • Unichem gets USFDA nod for hypertension treatment tablets (Economic Times)
  • Indian Court Dismisses "Misconceived" PIL On Rotavirus Vaccine (SCRIP-$)
  • Drugs Consultative Committee to review chemists' Oct 14 nationwide strike at its meeting on Oct 16 (PharmaBiz)
  • CDSCO to hold workshops on GMP for Indian drug regulators at Bengaluru & Ahmedabad (PharmaBiz)
  • India, Sweden soon to begin jt research in e-Science for life science & antimicrobial resistance in ‘One health’ perspective (PharmaBiz)


  • Antibiotic control leads to superbug drop in China (CNTV)


  • Australia’s DoH seeks feedback on biosimilars awareness project (GaBI) (Australia DoH)
  • TGA and industry presentations - Devices Sponsor Information Day, October 2015 (TGA)

Ebola Outbreak

  • UK Ebola "relapse" case takes virus specialists to uncharted waters (Reuters)
  • Sexual Transmission of Ebola Virus in Liberia Confirmed Using Genomic Analysis (ICT)

Other International

  • Pharmacovigilance compliance for biocomparables in Mexico (GaBI)
  • AngioDynamics wins S. Korean approval for NanoKnife (MassDevice)
  • Edwards-backed CardioKinetix earns South Korean approval for its cardiology catheter (FierceMedicalDevices)
  • What May Be the IP Provisions of the Trans Pacific Partnership Agreement (Patent Docs)
  • Turkey’s First Nobel Has Oncology Implications (PharmAsiaNews-$)

General Health and Other Interesting Articles

  • Researchers Find High Microbiological Contamination of Clinicians' Mobile Phones in ICUs, NICUs (ICT)

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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