Regulatory Recon: Valeant, Theranos Go on the Defensive (22 October 2015)

Posted 22 October 2015 | By Michael Mezher 

Regulatory Recon: Valeant, Theranos Go on the Defensive (22 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

  • FDA staff reviewers question safety of AstraZeneca's gout drug (Reuters) (FDA) (Pink Sheet-$) (SCRIP-$) (Law360-$)
  • Drug Makers Respond to Concerns Over Specialty-Pharmacy Use (WSJ-$)
  • Valeant Rebuts Critical Report That Pummels Stock (WSJ-$) (Pharmalot) (SCRIP-$)
  • More Trouble for Valeant Pharmaceuticals (Policy and Medicine)
  • Theranos CEO says company's underlying technology is sound (Reuters) (WSJ-$) (NYTimes)
  • Big Pharma's Darknet Drug Deal (Bloomberg)
  • The Daraprim Price Hike And A Role For Antitrust (HealthAffairsBlog)
  • FDA's Jan Welch Is ORA's First Device Director; New Acting CDRH Compliance Chief Named (Gray Sheet-$)

In Focus: International

  • Gilead Confirms It Is Developing Ebola Drug (WSJ-$) (Gilead)
  • Janssen provides free courses of anti-TB drug bedaquiline to Georgia (Pharmaceutical Journal-$)
  • Mystery deaths in Sierra Leone spread fear of Ebola relapses (Reuters)
  • IMDRF Reaffirms Device Access As Priority In Strategic Plan (Gray Sheet-$) (Focus)
  • Germany’s Boehringer denied patent on HIV drug (Economic Times)

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US: Pharmaceuticals and Biotechnology

  • Correspondence: The 21st Century Cures Act (NEJM)
  • Towards an Intramural Approach to Biomarkers (DrugWonks)
  • It's the Cost of R and D Stupid (DrugWonks)
  • New Patent Rules Pit Wall Street Against Big Pharma (Forbes)
  • FDA approves Relypsa's drug to treat high potassium levels (Reuters) (FDA)
  • Taking On The Big Guns: Life As A Boutique Biosimilar Developer (SCRIP-$)
  • Genetics help explain poor showing for GSK malaria vaccine (Reuters)
  • FDA’s Woodcock Cautions Efforts To 'Legislate A New Generation Of Biomarkers' (RPM Report)
  • Endo says most of its drugs not marketed via specialty pharmacies (Reuters)
  • Study reveals poor levels of use, availability and affordability of vital heart medicines (MNT)
  • Asthma, COPD Drug to Be Discontinued (MPR)
  • US FDA Taking Steps To Simplify Combo Product Consultations (SCRIP-$) (Focus)

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

  • Gilead Announces Phase 3 Results for Genvoya® (Elvitegravir, Cobicistat, Emtricitabine and Tenofovir Alafenamide), an Investigational Once-Daily Single Tablet Regimen for HIV (Press)
  • Biogen Reports Top-Line Results from Phase 3 Study Evaluating Natalizumab in Secondary Progressive MS (Press)
  • Elite Plans Opioid NDA Submission After Phase III Success (SCRIP-$)
  • GSK's Incruse Ellipta demonstrates efficacy against tiotropium (PharmaLetter-$)
  • Phase I Trial of Cytori Cell Therapy for Inflammatory Bowel Disease Published (Press)
  • Impax Receives FDA Approval for Generic Version of Intuniv® (Guanfacine) Extended-Release Tablets, 1 mg, 2 mg, 3 mg and 4 mg (Press)

US: Medical Devices

  • Anne Wojcicki on 23andMe’s new (and improved?) personal genome service (Washington Post)
  • Deploying New Molecular Influenza Tests in the Fight Against Antimicrobial Resistance (ICT)
  • A Randomized, Controlled Trial of Total Knee Replacement (NEJM)
  • Contextual Genomics Lands CAP Accreditation (GenomeWebs)
  • AirXpanders pivotal IDE trial meets endpoint (MassDevice)
  • Qualcomm’s Capsule wins FDA nod for patient monitoring system (MassDevice)
  • Cleaner, safer medical equipment with metallic glass coating (MNT)
  • Ariosa Diagnostics Responds to Sequenom's Petition for Rehearing En Banc (Patent Docs)
  • INSIGHTEC Submits Pre-Market Application (PMA) for FDA Approval of Exablate Neuro for Treatment of Essential Tremor (Press)

US: Assorted and Government

  • Medtronic beats NuVasive patent infringement suit (MassDevice)
  • First Amendment Notes: Amicus Briefs In Pacira & Application of IMS v. Sorrell (Drug and Device Law)
  • Can Drug Companies Survive Their Martin Shkreli Moment? (California Healthline)
  • Daiichi, Mylan Push High Court To Hear Apotex Drug IP Fight (Law360-$)
  • Obama requires training for federal employees who prescribe opioids (Modern Healthcare)
  • Horizon Pharma gets favorable ruling in Ravicti patent infringement suit (PharmaLetter-$)

Upcoming Meetings and Events              


  • Irish research hubs invent roaming reactor sensor (BioPharma-Reporter)
  • Hologic Gains CE Mark for Aptima HCV Assay (GenomeWeb)
  • Back Off! EU Associations Tell Parliament To Get Real About Genetic Testing And clearer On Apps (Clinica-$)
  • AGTC Announces Orphan Drug Designation in the European Union for Gene Therapy to Treat Achromatopsia (Press)
  • Four treatments for arthritis in children get backing from NICE (PharmaLetter-$)
  • Medtronic’s New ICDs with Atrial Fibrillation Detection Capabilities Win CE Mark in Europe (medGadget)
  • NICE recommends ezetimibe for hypercholesterolaemia (EuropeanPharmaceuticalReview)
  • Considerable added benefit found for Nulojix after kidney transplant, says IQWiG (PharmaLetter-$)


  • British medical journal Lancet to take PM Modi to task for ignoring health sector (Economic Times)
  • Sun Pharma settles patent litigation with Acorda Therapeutics (Economic Times)
  • Biocon to file up to five biosimilars in EU and US in FY 2017 (BioPharma-Reporter)


  • Japan Aims To Support Innovation But Local Pharma Wants More (PharmAsiaNews-$)


  • New medical device quality system guidelines released by Chinese regulators (MassDevice)


  • Medical devices and IVDs: Cancellations from the ARTG (TGA)

Other International

  • Hanmi’s Once Weekly Efpeglenatide Bests Liraglutide In Phase II (PharmAsiaNews-$)

General Health and Other Interesting Articles

  • Scientists Hope to Lengthen Dog Years (MIT Technology Review)
  • Prevalence of Marijuana Use Among U.S. Adults Doubles Over Past Decade (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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