Regulatory Recon: FDA Panel Split Over Alere Diabetes Diagnostic EMA Recommends Suspending Drugs Over Data Integrity Issues at Semler (25 July 2016)

Posted 25 July 2016 | By Michael Mezher 

Regulatory Recon: FDA Panel Split Over Alere Diabetes Diagnostic EMA Recommends Suspending Drugs Over Data Integrity Issues at Semler (25 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

  • US Says Florida Network Defrauded Medicare and Medicaid of Over $1 Billion (NYTimes) (DoJ)
  • A Grim First: New York City Reports Baby Born With a Zika-Related Defect (NYTimes)
  • Obama signs into law opioid addiction bill to protect newborns (Reuters)
  • Bloodlines: Rivals look to create 'off-the-shelf' treatment (Financial Times)
  • Gene therapy: A controversial cure (Financial Times)
  • What Are the Top 20 Priciest Medicare Prescription Drugs? (NYTimes)
  • A Big Bet That Gene Editing Will Cure Human Disease (MIT Technology Review) (The Gardian)
  • FDA Panel Divided Over Diagnostic HbA1c Test (Medpage)
  • Senators Question AstraZeneca Over Attempt to Delay Generic Crestor Competition (Letter)
  • Expanded Access Updates (JAMA)
  • Olympus Told U.S. Executives No Broad Scope Warning Needed Despite Superbug Outbreaks (KHN)
  • Healthcare earnings calendar for the week of July 25th (Loncar Blog)
  • J&J's Acclarent to pay $18m over off-label marketing charges (MassDevice) (Pink Sheet-$)
  • Recent Developments in Off-Label Promotion (Harvard Bill of Health)
  • Interventional Cardiology And The Rejection Of Science (CardioBrief)
  • Merck Receives Breakthrough Therapy Designation from FDA and PRIME Status from EMA for Investigational Ebola Zaire Vaccine (V920) (Press)

In Focus: International             

  • China launches nationwide inspection of vaccines (Reuters)
  • Flawed studies at Semler Research Centre calls for suspension of medicines, EMA recommends (EMA) (Pharmafile) (Reuters) (Economic Times)
  • Global rate of new HIV infections hasn't fallen in a decade (Nature)
  • Abbott in trouble over death of a sales representative (Economic Times)
  • Health Canada Clarifies Performance Targets, Reports Decline in MDL Submissions (Emergo)
  • Eight medicines recommended for approval; use of Truvada extended to include PrEP against HIV-1 infection  (EMA) (BioCentury 1, 2) (Pharmafile 1, 2)
  • Lessons from Brexit (Nature 1, 2) (PharmaLetter-$)
  • Manchester: EU Commissioner Moedas reassures UK researchers and launches €8.5bn EU work programme for 2017 (European Commission)

US: Pharmaceuticals & Biotechnology

  • Uncle Sam Wants You — Or at Least Your Genetic and Lifestyle Information (NYTimes)
  • CA State Senator Says Higher Drug Prices to Blame for  CoveredCA Rate Increase (Press)
  • Tracking genetic changes in West Nile Virus that could affect its spread and the ability of blood donor screening tests, future treatments, and vaccines to work effectively (FDA)
  • Final Guidance: Implementation of Acceptable Full-Length and Abbreviated Donor History Questionnaires and Accompanying Materials for Use in Screening Donors of Source Plasma (FDA)
  • FDA Updates List of Recognized Standards (FDA)
  • Unlikely Bedfellows: SEC Penalties When Industry Fails to Disclose FDA Recommendations for Clinical Trials (Policy and Medicine)
  • Pennsylvania Governor Wolf Signs Bill Facilitating Patient Access to Interchangeable Biologic Medicines (BIO)
  • California initiative aims to capture cancer data in real time (Fierce)
  • Tainted Meds Versus No Meds at All: The FDA's Compromise (Bloomberg)
  • SRSLY: The Female Viagra: 0.5 Satisfying Sexual Events Per Month if You Don't Pass Out (ProPublica)
  • Biogen needs to fill pipeline or rethink strategy (EP Vantage)
  • Malaria drug may help in cancer fight, early research finds (Reuters)
  • Puma files, and the battle begins (EP Vantage)
  • FDA Adjustment to Orphan Drug Review May Indicate Increased Scrutiny of Designations (National Law Review)
  • OPDP Issues Just Two Enforcement Letters in First Half of 2016 (Coalition for Healthcare Communication)
  • Teewinot gets US patent for bioreactor used to make synthetic cannabinoid APIs (BioPharma-Reporter)

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

  • FDA Lifts GenVec Clinical Hold (Press)
  • AbbVie and Bristol-Myers Squibb Announce Oncology Clinical Collaboration to Evaluate the Combination of Rova-T plus Opdivo and Opdivo + Yervoy Regimen (Press)
  • FDA grants fast-track status to Morphochem's antibiotic ahead of start of PhII (Fierce)
  • Boehringer Ingelheim stops LUX-Head & Neck 2 and 4 trials following pre-planned analysis from independent Data Monitoring Committee (Press)
  • Ocular Therapeutix Receives Complete Response Letter from FDA for its NDA for DEXTENZA for the Treatment of Post-Surgical Ocular Pain (Press)
  • Spark Therapeutics and Pfizer gain FDA Breakthrough designation for hemophilia B treatment (PharmaLetter-$)
  • UCB and Amgen submit biologics license application for Romosozumab to the U.S. FDA (MNT)
  • Tobira Therapeutics Announces Clinically and Statistically Significant Improvement in Liver Fibrosis From Phase 2b CENTAUR NASH Trial at One Year (Press)

US: Medical Devices

  • Two New Draft Guidances Outline FDA's Proposed Approach to Regulatory Oversight of Next Generation Sequencing Diagnostic Tests (FDA Law Blog)
  • Physical Medicine Devices; Reclassification of Iontophoresis Device Intended for Any Other Purposes (FDA)
  • Do-it-yourself brain stimulation has hidden risks (Reuters) (NYTimes)
  • Molecular Test to Guide CML Therapy OK'd (Medpage)
  • Class 1 Device Recall CareFusion, SnowdenPencer, DiamondFlex (FDA)
  • Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) Recalls Flush Angiographic Catheter Due to Tip Separation (FDA)
  • 4 Products Coming Down the Pike at St. Jude Medical (MDDI)
  • Asuragen's QuantideX® qPCR BCR-ABL IS Kit Receives FDA Premarket Clearance for Monitoring Minimal Residual Disease in Chronic Myeloid Leukemia (Press)

US: Assorted & Government

  • Bauman Jurisdictional Limits Dismember Three More Misjoined Multi-Plaintiff Complaints (Drug and Device Law)

Upcoming Meetings & Events


  • Earnings Season Appears Not At Home To Brexit (SCRIP-$)
  • Concept paper on revision of the current guideline on the summary of product characteristics for antimicrobial products (EMA)
  • Extension of time limit for submitting Drug Master Files and Active Substance Master Files before submitting application (SwissMedic)
  • Adaptation of the form Manufacturer information and new form Responsible Person Declaration (SwissMedic)
  • NICE recommends Lonsurf (BioCentury)
  • AZ frustrated with Tagrisso NICE delay, calls for reform (Fierce)
  • Greek government and pharmaceutical industry work together on solutions to benefit patients (PharmaLetter-$)
  • MHRA approves Sanofi Pasteur MSD's four-strain influenza vaccine for UK use (Pharmafile)


  • Takeda Said to Explore Sale of Chemicals Unit to Raise Cash (Bloomberg)
  • PMDA July Newsletter: ICH Meeting in Lisbon, Japan-Korea Joint Symposium on Medical Products (PMDA)d


  • Drug overcharging case: Supreme Court directs Cipla to pay Rs 175.07 crore (Economic Times)
  • Low-cost cancer treatment should be priority: Amitabh Kant (Economic Times)
  • India yet to adopt WHO blueprint for epidemic-prone diseases (Economic Times)
  • World Bank giving assistance for new vaccines for infants: Government (Economic Times)
  • Why private hospitals make you buy costly drugs (Times of India)


  • S1: Regulatory Testing Paradigm of Carcinogenicity in Rats - Status Report (Health Canada)
  • Q3D Notice: Health Canada recommendations for implementation of the ICH Harmonised Guideline for Elemental Impurities (Q3D) for new and marketed products (Health Canada)


  • Summer Travel and the Zika Virus (NYTimes)
  • While Zika Spreads in US Congress Goes On Vacation (Forbes)
  • Florida tests more than 200 residents in Zika probe (Reuters)

Other International

  • Libyan health crisis sharpens as resources dwindle (Reuters)

General Health & Other Interesting Articles

  • Should Doctors Game The Transplant Wait List To Help Their Patients? (NPR)

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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