Regulatory Recon: Theranos Brings in New Regulatory, Compliance Execs Valeant Gets CRL for Glaucoma Drug Over GMP Issues at Manufacturer (22 July 2016)

Posted 22 July 2016 | By Michael Mezher 

Regulatory Recon: Theranos Brings in New Regulatory, Compliance Execs Valeant Gets CRL for Glaucoma Drug Over GMP Issues at Manufacturer (22 July 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

  • Theranos hires executives in regulatory, compliance push (Reuters) (WSJ-$)
  • Patients as key partners in rare disease drug development (Nature)
  • Scangos to remain PhRMA chair for now (BioCentury)
  • Valeant receives complete response letter from FDA on glaucoma drug (Pharmafile) (Press)
  • US Sues to Block Anthem-Cigna and Aetna-Humana Mergers (NYTimes) (WSJ-$)
  • Scientists hunt 'anti-evolution' drugs in new cancer fight (Reuters)
  • Second Possible Zika Infection Is Found in Florida (NYTimes)

In Focus: International             

  • China Investigating Data Leak and Swindling of HIV Patients (NYTimes)
  • Health remains priority for work of Gates foundation in Africa (Reuters)
  • MHRA GxP Data Integrity Definitions and Guidance for Industry (MHRA)
  • Roche CEO fears hit to UK drug research from Brexit vote (Reuters) (Financial Times)
  • Gilead's universal hep C therapy Epclusa approved in EU (PMLive)

US: Pharmaceuticals & Biotechnology

  • The Proper Role of the FDA in the 21st Century (GxP Lifeline)
  • Pharmacogenetics experts establish common vocabulary in bid to advance precision medicine (MNT)
  • To Understand Data Integrity, Just Read These 6 FDA 483s (FDA Zilla)
  • The Art of the Rescue - Navigating Potential Pitfalls during Imaging Vendor Transition (BioClinica)
  • Merck Provides Regulatory Update on Biologics Licensing Application for Investigational Agent Bezlotoxumab (Press)
  • Can FDA Implement Biologics Price Competition and Innovation Act As Federal Circuit Suggested? (National Law Review)
  • Tracking Cancer In Real Time (KHN)
  • Administrative Actions for Noncompliance; Lesser Administrative Actions; Confirmation of Effective Date (FDA)
  • MenB Vax Not Fully Effective in College Outbreak (Medpage)
  • (Medpage)
  • Fears about IVF and cancer may be unfounded (Washington Post)

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

  • Transgene to Continue Phase 1/1b Study with TG1050 in Chronic Hepatitis B Patients on the Recommendation of the Trial's Safety Review Committee (Press)
  • Puma Biotechnology Announces Interim 5-Year Disease Free Survival Data from Phase III Trial of PB272 (Neratinib) in Extended Adjuvant HER2-Positive Early Stage Breast Cancer (ExteNET Trial) (Press)
  • Merck Animal Health Receives FDA Approval of BRAVECTO® (fluralaner topical solution) for Cats and Dogs (Press)
  • How Abbvie's Humira Undercuts The Drug Industry Price Defense (Forbes)

US: Medical Devices

  • FDA approves Vasorum's Celt ACD vascular closure device (MassDevice)
  • FDA panel votes in favor of Dexcom G5 dosage label expansion (MassDevice)
  • Medtronic recalls pacing leads on design standards snafu (MassDevice)
  • LifeBond wins FDA IDE clearance for LifeSeal sealant kit (MassDevice)
  • Medtronic Receives First-Ever FDA Clearance for Cement-Augmented Pedicle Screws (Press)
  • Relievant Medsystems wins FDA clearance for Intracept ablation device for low back pain (MassDevice) (Press)

US: Assorted & Government

  • General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals; Draft Guidance for Industry; Availability (FDA)
  • Practical Applications of FDA Regulations for the Indian Food Industry (FDAVoice)

Upcoming Meetings & Events

  • FDA Advisory Committee Calendar
  • FDA/Patient Workshop - Partnering with Patients on CDRH's Research Agenda for Assistive and/or Neurostimulation Devices, August 1, 2016 (FDA)


  • Do you buy medicine using online pharmacies? Share your experiences (The Guardian)
  • NICE now backs Alimta maintenance therapy (BioCentury)
  • Department of Health ministerial responsibilities (GOV.UK)
  • NICE updates safe harbor service (BioCentury)


  • India to set up Regional Biotechnology Center (BioSpectrum)


  • Doctors devise care plan for babies as Zika threat looms in U.S. (Reuters)
  • Brazil scientists find Zika traces in Culex mosquitoes in wild (Reuters)

General Health & Other Interesting Articles

  • Satirical musical about indicted pharmaceutical executive Shkreli premieres (CNBC)

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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