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Regulatory Recon: WHO Calls Emergency Meeting on Zika, CMS Says Theranos Lab Poses 'Jeopardy to Patient Health' (28 January 2016)

Posted 28 January 2016 | By Michael Mezher 

Regulatory Recon: WHO Calls Emergency Meeting on Zika, CMS Says Theranos Lab Poses 'Jeopardy to Patient Health' (28 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

  • AstraZeneca says US FDA grants Lynparza BTD for prostate cancer (Reuters)
  • Theranos lab poses 'jeopardy to patient health': regulator (Reuters) (WSJ-$) (Forbes)
  • 2016: The Year of Diversity in Clinical Trials (FDA Voice)
  • Merck lines up for a quick approval with its C. diff therapy (FierceBiotech) (Press)
  • US insurers dragging feet on covering new drugs, Novartis says (Reuters)
  • Incyte stops tests on Jakafi to treat colorectal cancer (Reuters) (Press)
  • Officials Call for Stronger Efforts to Combat Heroin, Painkiller Abuse (WSJ-$)
  • FDA approves Neos Therapeutics' long-acting ADHD drug (Reuters)
  • Manchin Will Filibuster FDA Nominee Robert Califf for Big Pharma Ties (Statement) (BioCentury)

In Focus: International

  • 10 Global Challenges For Life Sciences Cos. In 2016 (Law360-$)
  • WHO emergency committee to meet on Zika on Feb 1 (Reuters)
  • In Brazil, Researchers Launch Massive Study Into Zika Virus (NPR)
  • WHO: Zika virus 'spreading explosively,' 'level of alarm extremely high' (Washington Post)

US: Pharmaceuticals and Biotechnology

  • FDA Adds 31 New Guidances to Bioequivalence List (FDANews-$) (Focus)
  • FDA Continues Nationwide Inspections of Compounding Pharmacies; Hits 3 More with 483s (FDANews-$)
  • The Crowd-sourced Journal Watch Returns (Biotech Due Diligence)
  • Increased US FDA oversight driving recent China plant warnings (In-PharmaTechnologist)
  • Opioid Prescribing for Chronic Pain — Achieving the Right Balance through Education (NEJM)
  • FDA CDER Update 2016 (Policy and Medicine)
  • Schizophrenia's strongest known genetic risk deconstructed (NIH) (NYTimes) (MIT Technology Review)
  • Fauci: Considerable Pharma Interest In Zika Vaccine (SCRIP-$)
  • Researchers in Oregon are changing the face of gene therapy with new breakthrough (MedCityNew)
  • 3-Year Exclusivity May Not Be Worth as Much as You Think (505(b)(2) Blog)
  • Gilead Confronts New Attacks On Pricing, Patents (SCRIP-$)
  • The FDA Just Called! Are You Ready for an Inspection? (GxP Lifeline)
  • Medivation is not the first to be overturned on further review (EP Vantage)
  • Kochenderfer: 'I think the main focus of the CAR field will be autologous cells...' (FierceBiotech)
  • RBM: 'Risks are not issues,' Boehringer Ingelheim (Outsourcing-Pharma)
  • Comparative Study In COPD Pits AstraZeneca's Daliresp vs. Azithromycin (Pink Sheet-$)
  • Cosentyx to achieve blockbuster status, says GlobalData analyst (EPR)

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

  • Exelixis Announces FDA Deems New Drug Application Sufficiently Complete and Grants Priority Review for Cabozantinib as a Treatment for Advanced Renal Cell Carcinoma (Press)
  • Genticel Reports Initial Results at 12 Months From Phase 2 Trial of HPV Immunotherapeutic Candidate, GTL001 (Press)
  • STRIVE results for enzalutamide in CRPC published (EPR)
  • Medivir initiates phase IIa study of MIV-711 in knee osteoarthritis (Press)
  • CheckMate -141, a Pivotal Phase 3 Opdivo (nivolumab) Head and Neck Cancer Trial, Stopped Early (Press)
  • FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole) (Press)

US: Medical Devices

  • Do-It-Yourself Medical Devices — Technology and Empowerment in American Health Care (NEJM)
  • FDA Gives Nod to SonarMed Device For Monitoring Newborns (Xconomy)
  • Is Machine Learning the Next Big Thing in Healthcare? (Part 2) (Geeks Talk Clinical)
  • Zika Virus Rapid Diagnostics Sought By NIH As Mosquito-Borne Malady Spreads (Gray Sheet-$) (NIH)
  • Insiders' Guide To Winning In the Drug Delivery Device Market — Part 2: Regulatory Compliance (MedDeviceOnline)
  • Draft Emerging Signals Guidance – Additional Time Granted for Comments Due to an "unanticipated high-level of interest" (FDA Law Blog)
  • FDA Approves Aortica Corporation to Supply AortaFit System for Starnes' Physician-Sponsored IDE Study (Press)
  • Class 1 Recall: Thornhill Research Inc. MOVES Ventilator System Due to Battery Problem (FDA)
  • New Sapien 3 TAVR Trial Launched (Gray Sheet-$)
  • Brain tumors can be rapidly profiled with new gene test (MNT)
  • Cellulose nanogenerators could one day power implanted biomedical devices (MNT)
  • Researchers Design Wearable Sweat Sensor to Track Body's Biochemical Data (WSJ-$) (Nature)

US: Assorted and Government

  • The Health Care Delusion Hillary And Trump Share (Forbes)
  • J&J to Pay $120 Million in Its First Big Mesh Settlement (Bloomberg)
  • Picking Up The Pieces Of "Cures": Senate Process Resets Focus On 2017 (RPM Report-$)
  • Massachusetts official challenges Gilead's hepatitis C drug prices (Reuters)
  • NH-ISAC, EHNAC team up on healthcare cybersecurity efforts (FierceHealthIT)
  • Trailblazer Amarin Continues to Blaze New Trails: ANDA Paragraph IV Litigation Dismissed (FDA Law Blog)
  • Shire Expert Opinions Draw Fire In Adderall Antitrust Suit (Law360-$)
  • Drug-Pricing Help Wanted: Wyden, Grassley Seek Public Input On Policy Ideas (Pink Sheet-$)

Upcoming Meetings and Events              


  • French Trial Tragedy: Dosing Continued After Volunteer Hospitalized (SCRIP-$)
  • EU Wants Report On Fitness Of Supplementary Protection Certificate System (SCRIP-$)
  • HTA Core Model® gets an update – open for use by anyone (EUnetHTA)


  • India's drugs for domestic use fall short in quality tests, task force says (FiercePharmaAsia)
  • Grunenthal Denied Indian Patent For Use Of Tapentadol To Treat Osteoarthritis Pain (24 Insight)
  • India gets kudos for TB testing regime (FiercePharmaAsia)
  • Maharashtra FDA to issue AADHAR linked e-signed licenses for medicines for first time in India (PharmaBiz)
  • India Reschedules Export Track And Trace Plan (SCRIP-$)
  • Leverage tracking technologies for safety in pharma supply chain (PharmaBiz)


  • Summary Safety Review - GALEXOS (simeprevir) - Assessing the Potential Risk of Severe Liver Problems (Health Canada)
  • Avioq, Inc. Obtains Health Canada Approval for Screening of Cadaveric Organ and Tissue Donors with the Avioq® HTLV-I/II Microelisa System, Expands Already Approved FDA and CE-IVD Claims (Press)


  • De-Risking China For Foreign Life Science Investors (Start-Up)

Zika Virus

  • Teen in Los Angeles County tested positive for Zika after travel abroad (Reuters)
  • Portugal has five mild cases of Zika virus, all after Brazil trips (Reuters)
  • LATAM Airlines offers refunds to pregnant travelers to Zika-hit region (Reuters)
  • Caught off-guard by Zika, Brazil struggles with deformed babies (Reuters)
  • Four Zika cases found in New York among returning travelers (Reuters)
  • UW-Madison Researchers Find Zika Virus in Colombia, Look for Ways to Stop It (ICT)

Other International

  • Libya's health needs can't wait for unity government, minister says (Reuters)
  • UN officials call for pauses in Syrian conflict to vaccinate children (PharmaceuticalJournal)

General Health and Other Interesting Articles

  • First Laser Measurements of Magnetic Fields of Single Nerves (MIT Technology Review)
  • Pope Francis Said to Bless Human-Animal Chimeras (MIT Technology Review)
  • Young women with melanoma tanned indoors earlier and more often (CBS)
  • Irregular Heartbeats? Coffee May Not Be So Bad for You (NYTimes)
  • Study: HIV can hide and grow in 'sanctuaries' in body after it's undetectable in blood (Washington Post)

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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