Regulatory Recon: Obama Expected to Sign Bill on Zika, FDA Panel Votes Against Clovis NSCLC Drug (13 April 2016)

Posted 13 April 2016 | By

Regulatory Recon: Obama Expected to Sign Bill on Zika, FDA Panel Votes Against Clovis NSCLC Drug (13 April 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

  • FDA panel votes against approving Clovis's cancer drug on current data (Reuters) (SCRIP-$) (Medpage) (WSJ-$)
  • CRISPR: Pursuit of profit poisons collaboration (Nature)
  • Sen. Franken pushes Medtronic, FDA for Infuse study details (Star Tribune) (Franken)
  • FDA Allows First Switch From Batch to Continuous Manufacturing for HIV Drug (Focus) (FDA)
  • Pfizer must face revived Celebrex, Bextra safety lawsuit (Reuters) (Law360-$)
  • FDA finds Epigenomics appealing (EP Vantage)
  • Commander-in-Chief of War on Cancer Assesses 'Moonshot' (Medpage Today)
  • Largest Study Yet Shows Mother's Smoking Changes Baby's Epigenome (NIH)
  • Obama expected to sign bill on Zika drug development: White House (Reuters 1, 2)
  • Top Democrat, blasts Valeant CEO, Congress Puts Contempt Charges on Hold (Reuters) (STAT)
  • Valeant Pharmaceuticals' Prescription For Disaster (Forbes)
  • Woodcock Says Drug Development Paradigm Needs To Change, But Not At FDA (InsideHealthPolicy)
  • Lifting the Patent Barrier to New Drugs and Energy Sources (NYTimes)
  • Federal Court Applies PMA Preemption to a Device Approved under the FDA's Humanitarian Device Exemption (Drug and Device Law)
  • The Extinction Invention (MIT Technology Review)
  • Sean Parker's $250 Million Bet on Hacking the Immune System to Beat Cancer (MIT Technology Review) (NYTimes) (Wired)
  • At A Conference On Cancer, Patients Take Notes Like Their Lives Depend On It (Forbes)

In Focus: International

  • Singapore HSA Simplifies Import Declaration Rules for Medical Devices (Emergo)
  • Saudi FDA To Cut Drug Approval Time With Abridged Reviews (SCRIP-$)
  • MSF Calls on Congress to Stop 'Unacceptable'  TPP (MSF)
  • Brazil's confirmed, suspected microcephaly cases fall to 4,949 (Reuters)
  • Nestlé Develops Foods to Treat Diseases (WSJ-$)
  • Medivation Said to Have Rebuffed Sanofi Takeover Approach (Bloomberg)
  • China says 202 detained in vaccine scandal (Reuters)
  • Croatia/Canada Begin Information Exchange On Pharma GMP Under EU Mutual Recognition Agreement (SCRIP-$)
  • APAC's Diversity A Key Challenge But Demand Will Keep Growing, says APACMed CEO (Clinica)
  • Building Learning Health Systems to Accelerate Research and Improve Outcomes of Clinical Care in Low- and Middle-Income Countries (PLOS)

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US: Pharmaceuticals & Biotechnology

  • Preparing For The Zero Moment Of Truth: Managing Early Awareness In Rare Disease Drug Commercialization (In Vivo-$)
  • CDER Brand Name Reviews: Predictability Returns To Process (RPM Report-$)
  • Generic Drug Helps Multiple Sclerosis Damage in Mid-Stage Trial (Bloomberg)
  • Personalised dosing technology shows promise for transplant patients (Pharmaceutical Journal-$)
  • Celgene to commercialize Juno CD19 program (Outsourcing-Pharma)
  • The Association between Sulfonylurea Use and All-Cause and Cardiovascular Mortality: A Meta-Analysis with Trial Sequential Analysis of Randomized Clinical Trials (PLOS)
  • Roche: Bispecific and complex mAbs driving process development (BioPharma-Reporter)
  • With Latest Startup, Harvard's Verdine Again Aims at Elusive Targets (Xconomy)
  • Antibiotic Resistance Genes are Increasing, New Research Shows (ICT)
  • US 'foots the bill' for global biopharma innovation, says ITIF (In-PharmaTechnologist)
  • Four Takeaways From The National Rx Drug Abuse And Heroin Summit (Forbes)
  • Pill attaches to GI tract lining for slow release (In-PharmaTechnologist)
  • Breakthrough Designation Can Be 'Lever' For Manufacturing Evolution, FDA Says (Pink Sheet-$)
  • Sekisui XenoTech expands cell- and tissue-based product catalog (Outsourcing-Pharma)
  • Regeneron Looks To Use CRISPR Inside/Outside The Liver With Intellia Pact (Pink Sheet-$)

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

  • Lumicell Successfully Completes Phase 2a Feasibility Study (Press)
  • AmpliPhi Biosciences Presents Data Showing Bacteriophage Product Candidate Kills Pseudomonas aeruginosa Isolates from Cystic Fibrosis Patients (Press)
  • Telesta Therapeutics Corporate Update - Type A Meeting with the FDA Scheduled (Press)
  • Bio Products Laboratory, Ltd Announces FDA Submission of Biologics License Supplement for Gammaplex 10% (Press)
  • DURECT Announces FDA Acceptance of REMOXY NDA, PDUFA Date of September 25, 2016 (Press)
  • TGV-Inhalonix Receives Orphan Drug Status for its Novel Antibiotic to Treat Resistant Infections in Cystic Fibrosis (Press)
  • Merck Announces FDA Acceptance of Biologics License Application for Investigational House Dust Mite Sublingual Allergy Immunotherapy Tablet (Press)
  • FDA Accepts Supplemental Biologics License Application (sBLA) for KEYTRUDA (pembrolizumab) in Recurrent or Metastatic Head and Neck Cancer, and Grants Priority Review (Press)
  • Head-to-head study demonstrating Giotrif (afatinib) significantly improved clinical outcomes compared to Iressa (gefitinib) in EGFR mutation-positive advanced non-small cell lung cancer published in The Lancet Oncology (Press)
  • Noveome Debuts with Top-Line Data from Three Phase 1 Clinical Trials (Press)
  • Appili Receives Orphan Drug Designation from FDA for ATI-1501 (Press)

US: Medical Devices

  • Structuring the Medtech Supply Chain for Growth (MDDI)
  • Poor Positioning Responsible For Most Clinical Image Deficiencies, Failures (FDA)
  • Med Device: How to Address the Documentation Burden of Design Control (GxP Lifeline)
  • In Rural States Policy Changes To Improve Access To Home Dialysis Are Vital (Health Affairs Blog)
  • Seventh Sense aims to upend blood testing as Theranos struggles (Boston Business Journal)
  • Toshiba partners with UCI to study potential brain damage in HS football players (MassDevice)
  • Biotronik wins FDA nod for BioMonitor 2 (MassDevice)
  • IBM Aims To Make Brain Implant To Predict, Stop Seizures (MedDeviceOnline)
  • St. Jude Hopes Its PFO Occluder Gets RESPECT At May FDA Panel (Gray Sheet-$)
  • Qbtech receives FDA clearance for online test that assesses ADHD (mobihealthnews)
  • Eos Imaging wins FDA nod for spineEos 3D planning solution (MassDevice)
  • RenovaCare, Inc. Completes Engineering, Research, and Studies Required to File 510(k) Submission to the FDA for its Novel Medical-Grade Liquid Spray Device (Press)

US: Assorted & Government

  • News About Obamacare Has Been Bad Lately. How Bad? (NYTimes)
  • Medicare 'hospital star rating' may correspond to patient outcomes (Reuters)
  • FDA Warning Wire: Hospital In Mayo Clinic Network Scolded (Law360-$)
  • Supplemental Brief Filed in the Case of Zubik v. Burwell (DoJ)
  • Avalere: Patients could pay more for Part D biosimilars (BioCentury)
  • FDA's New Sanitary Transportation Regulations Focus on Safety (FDA Law Blog)

Upcoming Meetings & Events


  • Draft guideline on the sterilisation of the medicinal product, active substance, excipient and primary container (EMA)
  • Draft European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) Vision and Strategy 2016-2020 (EMA)
  • Two more cancer indications for Bristol-Myers Opdivo OKed in Europe (PharmaLetter-$) (Pharmafile)
  • How To Align APEC And EU Cross-Border Transfer Rules (Law360-$)
  • Companies Dive Into French Stress Test Of Future EU Trial Procedures (SCRIP-$)
  • UK's first holistic clinical trial to help improve life for cancer sufferers and survivors (MNT)
  • Marketing authorisations granted in March 2016 (MHRA)
  • Parallel import licences granted in March 2016 (MHRA)
  • EU safety experts say cherry insecticide could carry health risk (Reuters)
  • UK's Version of EFPIA Disclosure: Bred with the Sunshine Act in Mind (Policy and Medicine)
  • EFPIA Disclosure "Sunshine Act – Lite" (Policy and Medicine)
  • TULSA-PRO Whole Prostate Ablation System Cleared in Europe (medGadget)


  • Chinese Anti-Bribery Law May Be Changing (Law360-$)
  • China wants investors to fund innovation (PharmaLetter-$)
  • Japan's MHLW slated to review Nippon Boehringer high blood pressure combo (Fierce)
  • Asia a "New Frontier" for pharma sector growth in advanced drug delivery market (PharmaLetter-$)


  • Quality issues not behind sight loss in off-label Avastin use in India (Fierce)
  • Orchid Pharma antibiotic API plant passes US FDA inspection (In-PharmaTechnologist)
  • NPPA Using Third-Party Data To Set Ceiling Prices For Essential Medicines (24 Insight)
  • Fixed Dose Combination Drug Approvals In India (24 Insight)
  • Indian pharmaceutical market registers lowest growth of 6.4% in March 2016 (PharmaBiz)
  • CDSCO issues circular to pharma industry for assessing views on switch over to veg capsules from gelatin based capsules (PharmaBiz)
  • Confusion prevails amongst retailers over sale of banned FDCs as Delhi HC granted stay to several cos (PharmaBiz)



  • Nurofen maker deserves $6m fine for false claims, court told (The Guardian)


  • House Agrees To Priority FDA Review For Zika Treatments (Law360-$)
  • Johns Hopkins Hackathon Draws Innovative Solutions for Zika Virus (ICT)

Other International

  • NZ's PHARMAC to fund Sensipar; consult on Sirturo, Sylvant (PharmaLetter-$)
  • The Future of the RTS,S/AS01 Malaria Vaccine: An Alternative Development Plan (PLOS)
  • Mobile Phones As Surveillance Tools: Implementing and Evaluating a Large-Scale Intersectoral Surveillance System for Rabies in Tanzania (PLOS)
  • The Impact of Hotspot-Targeted Interventions on Malaria Transmission in Rachuonyo South District in the Western Kenyan Highlands: A Cluster-Randomized Controlled Trial (PLOS)
  • Investing in treatment for depression and anxiety leads to fourfold return (WHO)
  • Protein Sciences and Orygen Biotecnologia to license Flublok influenza vaccine for Brazil (PharmaLetter-$)
  • Improving Treatments for Post-Ebola Syndrome Sufferers (ICT)

General Health & Other Interesting Articles

  • For Native Americans, Health Care Is A Long, Hard Road Away (NPR)
  • Science fairs are as flawed as my solar-powered hot dog cooker (STAT)

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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