Regulatory Recon: Sanofi Uses Priority Review Voucher on Diabetes NDA, FDA Approves Gout Drug Zurampic (23 December 2015)

Posted 23 December 2015 | By Michael Mezher 

Regulatory Recon: Sanofi Uses Priority Review Voucher on Diabetes NDA, FDA Approves Gout Drug Zurampic (23 December 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

  • Hillary Clinton Calls for $2 Billion in Alzheimer's Research, Cure by 2025 (WSJ-$) (Reuters)
  • AstraZeneca gets US approval for gout drug Zurampic (Reuters) (FDA)
  • Government panel backs preventive statin use by adults 40 and over (Reuters)
  • Sanofi Uses Priority Review Voucher for Diabetes Drug NDA (Reuters) (Press)
  • New blood thinner 'antidote' to help doctors move past warfarin (Reuters)
  • FDA Approval Could Turn A Free Drug For A Rare Disease Pricey (NPR)

In Focus: International

  • Comprehensive Amendments of German Drug Laws upcoming (National Law Review)
  • Biosimilars driving down price of biological drugs (Pharmaceutical Journal)
  • Sanofi gets Philippines' approval to market dengue vaccine (Economic Times)
  • World Health Organization to Review Merck's Investigational Ebola Vaccine for Emergency Use Assessment and Listing (Merck)

US: Pharmaceuticals and Biotechnology

  • 2015 – A Blockbuster Year (Thomson Reuters)
  • GDUFA II: Inspection Information Takes Center Stage (Pink Sheet-$)
  • The Role Of Big Pharma In Neglected Diseases (Forbes)
  • GSK's new $32,500 asthma med costs at least 2X too much, U.S. pricing watchdog says (FiercePharma) (ICER)
  • Using Quality by Design to Improve Manufacturing (GxP Lifeline)
  • Patients Fear Spike in Price of Old Drugs (NYTimes)
  • Delayed prescription strategy can reduce antibiotic use (Reuters)

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

  • Kamada's rabies drug succeeds in trial (Reuters)
  • Adamas says lead drug meets late-stage study goals (Reuters)
  • pSivida shares soar as eye drug/device passes its first PhIII test (FierceBiotech)
  • Baxalta and Momenta announce Humira biosimilar met primary endpoint in PK study (BiosimilarNews)
  • Seattle Genetics and Bristol-Myers Squibb Announce Initiation of Phase 1/2 Clinical Trial of ADCETRIS® (Brentuximab Vedotin) in Combination with Opdivo (Nivolumab) in Relapsed or Refractory Non-Hodgkin Lymphoma (Press)

US: Medical Devices

  • FDA still seems reluctant to regulate mobile health apps (MedCityNews)
  • Biotronik wins 2 FDA clearances: Iperia MRI-safe ICD and Astron peripheral stent (MassDevice)
  • LabStyle's Dario glucose monitor wins FDA 510(k) (MassDevice)
  • FDA denies Materialise's 510(k) bid for knee guide (MassDevice)
  • FDA grants PMA nod to Medtronic for Real-Time Revel insulin mgmt system (MassDevice)

US: Assorted and Government

  • US signs up 8.2 million people so far for insurance on (Reuters)
  • Risk of Eye and Skin Injuries from Hand-held Laser Pointers (FDA)
  • Introducing the New Pennsylvania Learned Intermediary Jury Instructions (Drug and Device Law)
  • Legislators Want GAO Studies on Non-Biologic Complex Drugs & FDA Inspections, and Want a Raft of Documents as Questions are Raised About ANDA Review Efficiency (FDA Law Blog)

Upcoming Meetings and Events              


  • Elusive EU Clinical Trial Rules Slip Again -This Time To Late 2018 (SCRIP-$)
  • EMA 'Disappointed' With Use Of Art. 58 Procedure For Non-EU Drugs (SCRIP-$)
  • European Medicines Agency Accepts Fanaptum (iloperidone) Marketing Authorization Application for the Treatment of Schizophrenia in Adults (Press)
  • CHMP Thumbs Up For Bayer's Hemophilia A Product (SCRIP-$)


  • What Is An Essential Medicine? Indian Gov't Seeks Feedback On Access (24 Insight)
  • Lupin gets USFDA nod to market Potassium Chloride capsules (Economic Times)
  • Suven Life gets patent for neuro-degenerative drug  (Economic Times)
  • Natco settles patent litigation with Celgene on cancer drug  (Economic Times)
  • NPPA once again extends date to register under IPDMS for cos till Jan 15, 2016 (PharmaBiz)
  • Study report by regulatory officer shows lack of control by health ministry is reason for failure of KSDP to cater to needs of state (PharmaBiz)


    Other International

    • Colombia's President Santos legalizes use of medical marijuana (Reuters)

    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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