Regulatory Recon: FDA Approves Genetically Engineered Salmon After 19 Year Review (19 November 2015)

Posted 19 November 2015 | By Michael Mezher 

Regulatory Recon: FDA Approves Genetically Engineered Salmon After 19 Year Review (19 November 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

In Focus: International

Sponsored Content: Get the Story Straight

  • When you want to bring a product to market, you must create messaging early and implement it consistently. Our case study illustrates how to:
    • Better understand & communicate your messages
    • Identify associated issues
    • Increase submission efficacy
    • Improve credibility with reviewers
    • Download ECG's free case study

US: Pharmaceuticals and Biotechnology

  • US plans to require trial consent publication (Outsourcing-Pharma)
  • PDUFA VI: FDA Proposes Expanding Sentinel, Real-World Safety Data Sources (Pink Sheet-$)
  • Merck & Co. weeks away from filing first antibacterial mAb (BioPharma-Reporter)
  • Broken Market for Old Drugs Means Price Spikes Are Here to Stay (Bloomberg)
  • One-Third of US Children Have Not Received All Recommended Childhood Vaccines, Study Finds (ICT)
  • Study Could Result in New Strategies For Treating Juvenile Cancer (NBC News) (WSJ-$)
  • Allergan CEO Brent Saunders: Here's What I Really Think About R&D (Forbes)
  • Radius CEO Says Drug Application Delayed for `Work-Life Balance' (Bloomberg)

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

  • Sandoz applies for pegfilgrastim biosimilar in the United States (Biosimilar News) (SCRIP-$) (Law360-$)
  • Panel: Telesta Bladder Cancer Drug Targeted Wrong Patients (SCRIP-$) (Press)
  • Gilead Addresses HCV Vulnerability With Strong Genotype 3 Data (Pink Sheet-$)
  • NeuroVive Pharmaceutical: NeuroVive reports favourable safety evaluation in Phase II acute kidney injury study (Press)
  • Destiny Pharma Drug Granted QIDP Designation for Staph Infections (MPR)
  • Pfizer's Phase 3 Xalkori NSCLC trial meets primary objective (EPR)
  • Tetraphase lays out path to drug approval despite Phase 3 trial fail (Boston Business Journal)
  • Triphase Accelerator Corporation Announces FDA Orphan Drug Designation for Marizomib in Malignant Glioma (Press)
  • FDA Grants Orphan Drug Designation to Researcher's Potential CF Treatment (University of Cincinnati)
  • Pledpharma Reports Constructive Meeting With FDA And Presents New Follow-Up Data (Press)
  • Study Finds That Ebola Vaccine is Safe and Stimulates Strong Immune Response (ICT)
  • FDA-Approved Drug Protects Against Ebola in Mouse Model (ICT)
  • Teva Reports Positive Top-Line Results from Phase III Trials Evaluating Fluticasone Propionate/Salmeterol and Fluticasone Propionate Multidose Dry Powder Inhalers (MDPIs) in Patients with Asthma (Press)
  • AmpliPhi Signs Clinical Trial Agreement with University of Adelaide to Conduct a Phase I Trial of Bacteriophage Therapy for Treating Staphylococcus aureus Infections (Press)

US: Medical Devices

  • Podcast: US medical device distribution (MassDevice)
  • FDA Manages High-Risk Devices Nervously (MDDI)
  • Meridian Receives FDA Clearance for New Molecular Whooping Cough Test Claims (Press)
  • Printers and the Evolution of Mammography (FDA)
  • Medtronic launches connected app for pacemaker patients, but patients can't see the data (MobiHealthNews)
  • Hearables, Wristables and Eyewearables! (Geeks Talk Clinical)
  • Laser delivery will allow painless, needle-less vaccines (In-PharmaTechnologist)
  • Visaris Americas Receives FDA Clearance Prior to Portfolio Launch at North America's Largest Industry Conference (Press)
  • St. Jude Medical Announces FDA Approval of the Proclaim Elite SCS System (Press)

US: Assorted and Government

  • Reps. urge increased NIH funding (BioCentury) (Letter)
  • Price looms as major hurdle in hepatitis C eradication (Reuters)
  • Prescription Drugs And The Slowdown In Health Care Spending (HealthAffairsBlog)
  • Common Ground On Pricing And Access (RPM Report-$)
  • FTC, Profs Urge 3rd Circ. To Revive Pay-For-Delay Complaint (Law360-$)
  • NY Doc Gets Almost 4 Years In $100M Test-Referral Scheme (Law360-$)
  • Value-Based Cancer Care (NEJM)

Upcoming Meetings and Events              


  • NICE OK's restricted use of Bayer's prostate cancer drug (PharmaTimes)
  • NHS drug spending rises by 8% to £15.5bn in England (Pharmaceutical Journal)
  • Merck criticises NICE 'no' to personalised bowel cancer drugs (Pharmafile)
  • ECDC survey shows increasing threat of antibiotic resistance (EPR)
  • IQWiG finds further benefit for nivolumab, but not for Xultophy (PharmaLetter-$)
  • EMA approves Sobi's Xiapex for concurrent treatment of palpable cords (PharmaBiz)
  • England and Wales lag behind other countries for paediatric insulin pump use (Pharmaceutical Journal)
  • UK pharmacy regulator concerned by plans for EU-wide professional registration (Pharmaceutical Journal)


  • NPPA warns cos of penal action for failing to register under IPDMS by Dec 15 (PharmaBiz) (Economic Times)
  • Price controls loom for generic drugs in India next year (FiercePharmaAsia)
  • LA based law firm Lundin Law charges Dr. Reddy's of making false claims about financial performance (Economic Times)
  • Patient Loans For Medicines: Lessons From India (SCRIP-$)


  • Drug Trial Brings China Closer to Getting Access to HCV Antivirals (HCPLive)
  • Fresenius opens China design center (MassDevice)
  • CFDA proposes revised good clinical practices (Lexology)
  • China FDA Announces Implementation Scheme to Improve the Drug Approval System (Ropes & Gray)


  • Final decisions and reasons of decisions by a delegate (Medicines) of the Secretary to the Department of Health - November 2015 (TGA)

Other International

  • Global task force tackles problem of untreatable cancers and disease relapse (MNT)
  • FDA Clears First Bangladesh Rx Supplies From Beximco Site (SCRIP-$)

General Health and Other Interesting Articles

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.

Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.


Most Viewed Articles