Regulatory Recon: Does an FDA Safety Program Contribute to Surging Drug Prices (6 October 2015)

Posted 06 October 2015 | By

Regulatory Recon: Does an FDA Safety Program Contribute to Surging Drug Prices (6 October 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

  • EMA Sees Increase in Early Dialogue with Biosimilar, New Drug Developers (Focus)
  • Final TPP Agreement Draws Ire from Both Sides over Biologics Exclusivity (Focus) (NYTimes) (BioPharma-Reporter) (BioPharmaDive) (Forbes)
  • EU Regulators Tackle "Significant Benefit" Criteria For Orphan Drugs (Pink Sheet-$)
  • ICH issues guidance on GMP for APIs, industry appreciates it as move to observe high quality standards (PharmaBiz)

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US: Pharmaceuticals and Biotechnology

  • Electronic Common Technical Document Technical Conformance Guide (FDA)
  • GPhA’s Davis comments on Trans-Pacific Partnership talks (DSN)
  • AAMI/FDA Summit Offers Broader View of Risk Management (ICT)
  • Did Biopharma Really Lose In TPP Trade Deal? (SCRIP 1, 2-$)
  • Meet The Company Giving Patients Access To Unlicensed Medicines (SCRIP-$)
  • GSK, Merck use social media to learn how patients use drugs outside the lab (MobiHealthNews)
  • Gene Therapy for Visually Impaired Shows Promise (WSJ)
  • Want to improve medication adherence? Educate patients now (MedCityNews)
  • Flu jab linked to fewer hospitalisations (OnMedica)
  • Infection Control Experts Announce Recommendations to Reduce Overuse in Medicine (ICT)

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

  • Akebia Reaches Agreement with FDA and EMA on Vadadustat Global Phase 3 Program (Press)
  • Baxalta and Momenta target Humira with a Phase III biosimilar trial (FierceBiotech) (BiosimilarNews)
  • Turing announces first IND application for new brain disorder drug(MedCityNews)
  • Oncobiologics announces bevacizumab biosimilar meets primary and secondary endpoints in Phase I clinical trial (BiosimilarNews)
  • Osiris Announces Initiation of a Phase III Trial for a New Investigational Drug, OTI-15-01, for the Treatment of Chronic Diabetic Foot Wounds (Press)
  • FDA Clears CorPath® System for Robotic-assisted Radial Access PCI Procedures (Press)
  • Inspirion Delivery Technologies Receives FDA Approval for an Opioid Analgesic (
  • Compass Biomedical Announces FDA Drug Master File Acceptance for PLUS™ Human Platelet Lysate (Press)
  • FDA grants priority review for HCV treatment Daklinza sNDAs (EuropeanPharmaceuticalReview)
  • Exelixis Announces Positive Overall Survival Results from Phase 3 Pivotal Trial of Cobimetinib in Combination with Vemurafenib in Patients with BRAF V600 Mutation-Positive Advanced Melanoma (Press)

US: Medical Devices

  • FDA approves expanded indication for medical device to treat a form of brain cancer (FDA)
  • FDA Enthusiastic about Mobile Health Data (MDDI)
  • 2015 Medtech Company of the Year Finalists (MDDI)
  • Industry, Regulators Hail Public-Private Partnerships as Key to Device Innovation (ICT)
  • FDA asks duodenoscopes makers to study success of cleaning guide (Reuters) (MassDevice) (Focus)
  • FCC + FDA: Working together to regulate digital health (MedCityNews)
  • How an unknown designer created the first home pregnancy test in 1967 (Washington Post)
  • FDA Approves Bioabsorbable Polymer Stent (MedpageToday)

US: Assorted and Government

  • FDA Off-Label Promotion Policy Is 'Daunting Challenge' For Congress (Pink Sheet-$)
  • Bristol-Myers Squibb Pays $14M Over Alleged China Bribes (Law360-$) (Focus)
  • A Court’s Contempt for the Government in Bayer (FDA Law Blog)
  • Prograf Class Cert. Makes Case Unworkable, 1st Circ. Hears (Law360-$)
  • J&J Wins 1st Trial Over Prosima Pelvic Mesh (Law360-$)
  • Another Decision Applying Bartlett Preemption to All Drugs (Drug and Device Law)
  • For Vaccines, Public Health Protection Trumps Religious Freedom (Again) (Harvard Bill of Health)
  • Medical Device Makers See Opening In Repeal Of Obamacare Tax (Forbes)

Upcoming Meetings and Events              


  • EBR Systems Receives CE Mark For World's First Wireless Cardiac Pacing System For Heart Failure (MedDeviceOnline)
  • Industry Welcomes the European Commission Commitment to a Sustainable and Competitive Off-Patent Biologics Market (EFPIA)
  • NHS England Innovative Drug Scorecard Paints Unbalanced, Unclear Access Picture (SCRIP-$)
  • Cell Therapy begins European marketing authorization process for stem cell therapy Heartcel (PharmaLetter-$)


  • UK MHRA completes inspection of Wockhardt's Chikalthana plant (Economic Times)
  • Chemists and druggists to shut nation-wide on October 14 (Economic Times)
  • CDSCO to meet state DCs to review compliance of WHO-GMP norms by drug units (PharmaBiz)
  •  India, UK health regulators sign MoU to boost public (Economic Times) (Focus)
  •  India-EU FTA: PM Narendra Modi conveys concerns on ban of 700 drugs (Economic Times)
  • Indian Contract Manufacturing: Prospects And Pains (SCRIP-$)


  • Japanese flu vaccine makers pump up prices 50%, drawing flak as peak season hits (FiercePharmaAsia)


  • Preparation of Drug Master File (DMF) in "Non-eCTD Electronic-Only" Format (Health Canada)


  • Australia and the Trans-Pacific Partnership: what we do and don't know (The Guardian)
  • Changes to Australia’s Reimbursement System: Potential Effects on Medical Device Companies (Emergo)

Other International

  • New Self-Positioning Transcatheter Mitral Valve Developed by National University of Singapore (medGadget)
  • MSF: TPP agreement could swell healthcare costs (PMLive)
  • Dengue Epidemics Linked to High Temperatures During Strong El Nino Season (ICT)
  • Statement on the 7th meeting of the IHR Emergency Committee regarding the Ebola outbreak in West Africa (WHO)

General Health and Other Interesting Articles

  • Scientists create blueprint for developing ‘exercise in a bottle’ drug that promises to transform your workout (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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