Regulatory Recon: FDA Panel to Review Risks With Abbott Dissolving Stent, Price of Brand Name Rx Drugs Doubled Since 2011 (15 March 2016)

Posted 15 March 2016 | By Michael Mezher 

Regulatory Recon: FDA Panel to Review Risks With Abbott Dissolving Stent, Price of Brand Name Rx Drugs Doubled Since 2011 (15 March 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 to review Roche's bladder cancer drug on priority basis (Reuters) (Press)
  • FDA to Prioritize Generic Drug Applications for 'Sole-Source' Products (Focus) (Bloomberg)
    Express Scripts: US drug spending rose 5.2 percent in 2015 (Reuters)
  • J&J to Stop Selling Automated Sedation System Sedasys (WSJ-$)
  • FDA advisers to weigh risks of Abbott's dissolving stent (Reuters) (Gray Sheet-$) (MDDI)
  • T-Cell Pioneer Carl June Acknowledges Key Ingredient Wasn't His (MIT Technology Review)
  • The End of Prescriptions as We Know Them in New York (NYTimes)
  • Price of branded prescription drugs in the US doubles in 5 years (Financial Times-$)
  • Senators ask FDA, CMS to address waste of excess drug (BioCentury) (Letter)
  • Congress Should Allocate Money to Fight Zika (NYTimes)
  • Alere receives grand jury subpoena from US DoJ (Reuters)

In Focus: International

US: Pharmaceuticals & Biotechnology

  • FDA's Biosimilars Workload: 57 Development Programs, $81M Spent in First Three Fiscal Years (Focus)
  • Cancer And Arthritis Drugs Drive Up Spending On Medicines (NPR)
  • STAT goes to court to unseal records of OxyContin maker (STAT)
  • Will The Bernie Sanders $3 Billion Prize For New HIV/AIDS Drugs Stimulate Innovation? (Forbes)
  • Biosimilar User Fee Talks Reach Starting Line As Report Shows Growing FDA Workload (Pink Sheet-$)
  • Additional 505(b)(2) Benefits: Selective Safety Data Collection (The 505(b)(2) Blog)
  • CAR-T meeting – To hit solid tumours use a supercar (EP Vantage)
  • Sandoz Sued for Cutting Short BPCIA "Patent Dance" for Neulasta Biosimilar (Biologics Blog)
  • FDA panels to discuss KemPharm's pain candidate (BioCentury)
  • John Grisham book turns spotlight on futuristic cancer treatment (Reuters)
  • Oxytrol For Women Exclusivity Ends Not With Competition, But Label Warning Change (Pink Sheet-$)
  • SENDing data to meet new FDA standards (Outsourcing-Pharma)
  • Decoding the molecular ties between vascular disease and Alzheimer's (NIH)
  • Scientists find gene fault that raises schizophrenia risk 35-fold (Reuters)
  • Orexigen buys U.S. obesity pill rights from partner Takeda (Reuters)
  • Financial burden of cancer can harm quality of life (Reuters)
  • HIV drug might block skin cancer's path to resistance (OnMedica)
  • There's a new theory about why some cancer therapies fail. It's about timing. (Washington Post)
  • Incentivizing ADF Opioids (DrugWonks)
  • The Five Facts About Drug Pricing HHS (and the media) Missed (DrugWonks)
  • Plant-based vaccines poised to challenge $4bn seasonal flu shot market (BioPharma-Reporter)
  • FDA National Direct to Consumer Advertising Survey – Again (Policy and Medicine)
  • Proposed Revised Vaccine Information Materials for Polio and Varicella Vaccines (FDA)
  • Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services To Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry (FDA)

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

  • Celator stock soars after leukemia treatment shows survival benefit (Reuters) (Press)
  • Lilly Announces Change to Primary Endpoint of EXPEDITION3 Study (Press)
  • FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection (Press)
  • Lundbeck starts Lu AF35700 Phase III programme in treatment-resistant schizophrenia (EPR)
  • Aeglea BioTherapeutics Announces FDA Acceptance of its Investigational New Drug Application for AEB1102 for the Treatment of Hematological Malignancies (Press)

US: Medical Devices

  • FDA Sends Three Letters Over Unapproved Zika Diagnostics (Focus)
  • Digital health takes a back seat to medical devices in pediatric pitch event at SXSW (MedCityNews)
  • Palo Alto Health Sciences raises $1.9M for FDA-cleared sensor, tablet-based system for panic disorder (mobihealthnews)
  • Three Bills Affecting FDA Medical Device Oversight Advance in US Senate (Emergo)
  • Musclebound "Bio-bots" Move Around in Response to Light (MIT Technology Review)
  • FDA Announces Public Workshop on LC/MS-Based IVD Test Validation, Requests Comments (GenomeWeb)
  • CardiacAssist Receives FDA 510(k) Clearance For Its TandemLung Oxygenator (Press)

US: Assorted & Government

  • Georgia state lawmakers OK new insurance rules for cancer drugs (Reuters)
  • Changes in Leadership for FDA's Foods and Veterinary Medicine Program (FDA)
  • Everything Old is New Again—FDA Request for Comments on Medical Device Refurbishing, Servicing, and Similar Activities (FDA Law Blog)
  • Good Things Sometimes Come in Big Packages: Mirena Daubert Rulings Favor the Defense -- Big Time (Drug and Device Law)
  • Embarrassing New GAO Report On Hospital Safety Has Two Surprising Bright Spots (Forbes)

Upcoming Meetings & Events


  • Classification of Ibuprofen Seven Plus 200mg/5ml Oral Suspension (MHRA)
  • Curing the UK Cancer Drugs Fund (BioCentury)
  • British Science Week: showcasing uses of genomics in healthcare (GOV.UK)
  • Interscope EndoRotor Cleared In Europe for More Efficient Polyp Removal (medGadget)


  • Lupin receives nine observations from USFDA for Goa plant (Economic Times)
  • Indian court grants temporary relief to Abbott, Glenmark in drug ban case (Reuters)
  • Industry may move court to challenge health ministry's order banning 344 FDC drugs (PharmaBiz)
  • P&G stops selling Vicks Action 500 Extra in India after ban (Retuers)
  • Delhi High Court stays Corex ban on Pfizer's petition (Economic Times)
  • Regulatory authority should have given at least 15-30 days timeframe to recall 344 FDCs: Dr BR Jagashetty (PharmaBiz)
  • Aurobindo Pharma gets final USFDA nod for osteoporosis drug (Economic Times)
  • KDPMA works aggressively with Karnataka govt for approval of a Pharma Park in state (PharmaBiz)
  • Glenmark Pharma gets final USFDA nod for migraine drug (Economic Times)


  • Health Canada Details New Confidential Info Disclosures in Draft Guidance (Focus)
  • PTC Therapeutics to file new Phase III data for genetic muscle disorder drug in Canada (Pharmafile) (Press)
  • Health Canada Medical Device Licensing Performance on Target in Late 2015 (Emergo)


  • Consultation: Draft clinical evidence guidelines - Medical devices (TGA)

Zika Virus

  • The Poignant Cry Of Babies With Birth Defects Linked to Zika (NPR)
  • CDC sleuths descend on Puerto Rico to unearth mysteries of Zika (STAT)

    General Health & Other Interesting Articles

    • Is the US ready for the next big pandemic? (PRI)
    • How I Helped Solve The 2001 Anthrax Case (Forbes)
    • The Unfolding of Polio (NYTimes)
    • Girls on most effective birth control may unwisely skip condoms (Reuters)
    • New SARS-like Virus is Poised to Infect Humans (ICT)

    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

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