Regulatory Recon: Sen. Franken Introduces Bill to Add Zika to Priority Review Voucher Program, UN Calls for WHO Reform (9 February 2016)

Posted 09 February 2016 | By Michael Mezher 

Regulatory Recon: Sen. Franken Introduces Bill to Add Zika to Priority Review Voucher Program, UN Calls for WHO Reform (9 February 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

  • Sen. Franken Introduces Bill to Add Zika to Priority Review Voucher Program (Bill) (Statement)
  • FDA Delays Decision on Duchenne Drug but Accepts Info From Sarepta (STAT) (Reuters) (SCRIP-$) (Press)
  • Novartis Sets Heart-Drug Price With Two Insurers Based on Health Outcome (Reuters)
  • Obama Asks Congress for $1.8 Billion to Combat Zika Virus (NYTimes) (WSJ-$) (Focus)
  • Sientra Says it Will Resume Selling Breast Implants in US (Reuters) (FierceMedicalDevices) (Letter)
  • Why it Took Years for FDA to Warn About Infections Tied to Scopes (Los Angeles Times)
  • Pharma Industry has More in Common With Shkreli Than it Likes to Admit (STAT)
  • FDA Moves to Crack Down on Unproven Stem Cell Therapies (STAT)
  • Colorado Introduces Drug Price Transparency Bill (Bill)

In Focus: International

  • First Medtech Trilogue Under Dutch Presidency Suffers Setback (Clinica-$)
  • WHO to Assess Impact of Biological Qualifier Scheme (SCRIP-$)
  • The World Health Organization's Critical Challenge: Healing Itself (Reuters)
  • In Five Years, US FDA Rejected 13,334 Indian Products (Economic Times)
  • Sierra Leone Discharges Last Known Ebola Patient (Reuters)
  • NICE Rebuffs Sanofi Cholesterol Drug but Backs Amgen's (Reuters) (BioCentury)

Sponsored Content: The Ohio State University Masters of Applied Clinical and Preclinical Research

US: Pharmaceuticals & Biotechnology

  • US FDA Guidance Sheds Light On Human Factor Studies For Combination Products (SCRIP-$)
  • The US Biosimilars Pathway: Key Questions (Biologics Blog)
  • Therapy Focus – Phase III proves tough for IPF (EP Vantage)
  • Health policy: Putting a price on cancer (Nature-$)
  • FDA Panel Backs Vortioxetine for Cognitive Dysfunction in MDD (Medscape)
  • Sarepta's Duchenne Treatment Likely Making Progress At FDA (Pink Sheet-$)
  • FDA Discusses Upcoming DMF Electronic Filing Requirements  (Registrar Corp)
  • Association Of Clinical Research Organizations Launches Real World Data Video Series (ACRO)
  • Are We Poised for a Neuroscience Research Renaissance?  Maybe (LifeSciVC)
  • Drug Product Quality Dashboard Taking Shape at FDA in Wake of OPQ Integration and Expanding Knowledge Base (IPQ)
  • FDA's API DMF Assessment Timelines Improve as eCTD Use Increases and OPQ's New API Review Structure Takes Hold (IPQ)
  • FDA Generics Office Overcomes Challenges to Meet Year 3 GDUFA Goals (IPQ)
  • 'Safe' social network LinkedIn emerges as popular marketing tool for pharma (FiercePharmaMarketing)
  • Valeant, AstraZeneca played the Super Bowl ad game, but did they win? (FiercePharmaMarketing)
  • #BIOCEO16 Fireside Chat with Senator Chuck Schumer (BIO)
  • Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays (FDA)
  • Peptide antiviral "a real step forward" in search for flu treatment (Pharmaceutical Journal-$)

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

  • AstraZeneca's Durvalumab/Tremelimumab Combo Holds Its Own In NSCLC (Pink Sheet-$)
  • Novocure's Phase 3 Pivotal Trial Results in Newly Diagnosed Glioblastoma Selected For ASCO's Clinical Cancer Advances 2016 Report (Press)
  • ADC Therapeutics Doses First Patient in Phase I Trial of ADCT-301 Trial in Acute Myeloid Leukemia (Press)
  • Seres Therapeutics Announces Publication of Positive SER-109 Phase 1b/2 Study Results in The Journal of Infectious Diseases (Press)
  • FDA Accepts for Review Otsuka and Lundbeck's sNDA Filing for Labeling Update of REXULTI (Brexpiprazole) for Maintenance Treatment of Schizophrenia (Press)
  • Mersana plans human trials of first cancer drug by this summer (Boston Business Journal)

US: Medical Devices

  • FDA wants answers from Medtronic, St. Jude on leadless pacers (MassDevice)
  • FDA Lays Out Requirements For Diagnostic Radiology Display 510(k)s (Gray Sheet-$) (Focus)
  • Artificial mesh marginally better than tissue repair for vaginal prolapse (OnMedica)
  • Planned Protocol Deviations- Should Sponsors Notify FDA? (Medical Device CRO Blog)
  • BioArchitects' Patient Specific Titanium Implants Cleared by FDA (medGadget)
  • FDA Clears Validation Testing For Automated Endoscope Reprocessors (Gray Sheet-$)
  • Cartiva, Angel Medical win FDA PMA review dates (MassDevice)
  • Spectranetics wins FDA nod for Bridge occlusion balloon (MassDevice)
  • LifeWatch™ Receives FDA Clearance for Its Continuous Vital Signs Monitoring Service (Press)

US: Assorted & Government

  • The Real Losers In The Zombie Versus Vampire Lab Company Court Battle (CardioBrief)
  • Hawaii's Big Island declares emergency over dengue fever infections (Reuters)
  • Once Again, the VA Turns Down Navy Vets for Agent Orange Benefits (ProPublica)
  • An Update on the Nomination of FDA Commissioner Robert Califf (Policy and Medicine)
  • Pfizer announces executive leadership team for Allergan merger (In-PharmaTechnologist) (Pink Sheet-$)
  • Injunctive Relief Claims Lead to Defense Opportunities (Drug and Device Law)
  • Eisai Says That the Recently Enacted IRTNMTA Should Result in a Longer PTE for FYCOMPA Patent (FDA Law Blog)
  • Treasury Dept.  Finds Johnson & Johnson in Violation of Trade Embargo to Sudan (National Law Review) (OFAC)

Upcoming Meetings & Events  


  • Cancer drug Apealea submitted to EMA (PharmaLetter-$)
  • ABPI: Are we 'over' regulation? (ABPI)
  • Brothers sentenced for the illegal sale of medicines (MHRA)
  • EMA-EUnetHTA meeting summary, November 23, 2015, Copenhagen, Denmark (EUnetHTA)


  • IPA contends USTR's anti-India comments in 2016 Special 301 submission to USTR (PharmaBiz)
  • Roche's Anadys Pharmaceuticals Refused Patent For Hepatitis C Treatment (24 Insight)
  • Drug prices to rise slightly on removal of duty relief (Economic Times)
  • Dr Reddy's: Will resolve issues raised by USFDA in a timely manner (Economic Times)
  • Pharma sector hiring expected to see 20% growth in 2016: Report (Economic Times)


  • Japan takes aim at ballooning drug prices as costs strain health budget (Japan Times)


  • Updating medicine ingredient names (TGA)
  • AmpliPhi Biosciences Announces Award of Federal Research Grant from Australia to its Collaboration Partner, Westmead Institute (Press)


  • Updated Guidance: Post-Notice of Compliance (NOC) Changes: Safety and Efficacy Document (Health Canada)

Zika Virus

  • Zika Goes Mainstream as Industry Scrambles to Respond (Thomson Reuters)
  • CDC Emergency Operations Center moves to highest level of activation for Zika response (CDC)
  • Zika expert: 'Microcephaly may just be the tip of the iceberg.' (Washington Post)
  • NIH Seeks Research Applications to Study Zika Virus in Pregnancy, Developing Fetus (ICT) (NIH)
  • Brazilian studies aim to unravel Zika's link to birth defects (Reuters)
  • Interview: WHO Focuses On Zika-Linked Microcephaly Cases (NPR)
  • US health official: Widespread Zika vaccine not likely to be available for years (Reuters)

Other International

  • Korea Steps Up Reimbursement For Serious Diseases (PharmAsiaNews-$)

General Health & Other Interesting Articles

  • New Lyme-disease-causing bacteria species discovered (CDC) (Reuters)
  • Tick genome reveals secrets of a successful bloodsucker (NIH)
  • Opening Up About Depression (NYTimes)
  • More evidence there may be no such thing as 'fat and fit' (Reuters)
  • Scientists uncover the brain mechanism that makes you sigh (Washington Post)
  • Why I hid my happy, healthy daughter's medical diagnosis from her for as long as I could (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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