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Regulatory Recon: FDA Rejects Expanded Label for CF Drug Kalydeco, EMA Says Faulty Device in Trial Doesn't Impact Xarelto Safety (5 February 2016)

Posted 05 February 2016 | By Michael Mezher 

Regulatory Recon: FDA Rejects Expanded Label for CF Drug Kalydeco, EMA Says Faulty Device in Trial Doesn't Impact Xarelto Safety (5 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

In Focus: International

  • Gilead Moves To Block Harvoni Infringer In India (SCRIP-$)
  • EMA concludes defective device in ROCKET study does not impact Xarelto's safety (EMA)
  • Prostate cancer: NICE issues full guidance for Xofigo (MNT)
  • Where do OECD countries stand in the "war against cancer" (OECD)
  • Biosimilar etanercept offered at 47% discount in Norway (GaBI)
  • MSF Open Letter to ASEAN Governments: Don't trade away health (MSF)
  • Lab criticized as slow to act in fatal French drug trial (Reuters)
  • Final WHO Biosimilar Naming Proposal Resembles FDA Approach (Biologics Blog)

US: Pharmaceuticals and Biotechnology

  • Building a Modern Generic Drug Review Process (FDA Voice)
  • Hit with a storm of protest, LifeSci Advisors apologizes for its J.P. Morgan party (FierceBiotech)
  • Data Integrity and Enforcement Actions (Unger Consulting)
  • 2015 505(b)(2) NDA Approvals (The 505(b)(2) Blog)
  • Major shift ahead in how FDA regulates drug quality (PWC Health Research Institute)
  • Lilly's tadalafil fails DMD Phase III (BioCentury) (SCRIP-$)
  • What drives operational performance in clinical R&D? (Nature-$)
  • Leverage Centralized Risk-Based Monitoring Tactics To Preserve Data Quality And Highlight Potential Problem Areas (Cutting Edge Information)
  • NIH researchers identify striking genomic signature shared by five types of cancer (NIH)
  • The Promise of Umbrella, Basket and N-of-1 Clinical Trials in Cancer (Thomson Reuters)
  • Is It Time To Ditch Tdap As A Routinely Recommended Teen Vaccination? (Forbes)

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

  • FDA Acknowledges Receipt of Resubmission of Shire's New Drug Application for Lifitegrast for Dry Eye Disease in Adults (Press)
  • OSE Pharma Announces U.S. Initiation of Atalante 1, the Company's Global, Pivotal Phase 3 Trial for Tedopi® Immunotherapy in Non-Small Cell Lung Cancer (Press)
  • Biosimilars Forum Issues Statement Regarding House Energy & Commerce, Subcommittee on Health Biosimilars Hearing, Launch of New Biosimilars Education Initiative (Press)
  • Positive phase III results for cetuximab and infliximab copy biologicals (GaBI)
  • Dipexium Pharmaceuticals Reaches 75% Enrollment Milestone in Pivotal Phase 3 Clinical Trials (Press)
  • FDA Grants Breakthrough Therapy Designation to Immunomedics for Sacituzumab Govitecan for the Treatment of Patients With Triple-Negative Breast Cancer (Press)

US: Medical Devices

  • FDA Extends Deadline for Some UDI Requirements for Medical Devices (Focus)
  • FDA to Finalize LDT Guidance Amid Uncertainty on Number of Genetic Tests Impacted (GenomeWeb)
  • Class II medical device labelers may now open FDA UDI database accounts (MassDevice)
  • Medtronic wins expanded PMA for CoreValve (MassDevice)
  • Draft Guidance Announces List of High Priority Devices for Human Factors Review (FDA Law Blog)
  • FDA approves Medtronic's Amplia, Compia MRI-safe CRT-Ds (MassDevice) (Press)
  • Medtronic's iPro(TM)2 Professional CGM Shows Benefits for People with Type 2 Diabetes (Press)
  • Edwards CEO Touts Increased Adoption of TAVR Program (MedDeviceOnline)
  • Cerapedics touts IDE bone graft trial results (MassDevice)

US: Assorted and Government

  • Hit with a storm of protest, LifeSci Advisors apologizes for its J.P. Morgan party (FierceBiotech) (BioCentury)
  • GAO Recommends Better Monitoring of Federal Marijuana Enforcement Priorities; DOJ and DEA Officials Report on Marijuana Enforcement (FDA Law Blog)
  • The 2016 Open Enrollment Tally: 12.7 Million Selected Plans, 1 Million More Than 2015 (HealthAffairsBlog)
  • Illumina Cambridge Ltd. v. Intelligent Bio-Systems, Inc. (Fed. Cir. 2016) (Patent Docs)

Upcoming Meetings and Events


  • Companies Welcome Steps Towards Early Pan-EU HTA Talks (SCRIP-$)
  • Mafia behind most EU pharma cargo theft: €30m worth of drugs stolen each year says expert (In-PharmaTechnologist)
  • Dutch EUC Presidency priorities in the field of pharmaceuticals (PharmaLetter-$)
  • Orphan Drug Designation for acute spinal cord injury treatment (EPR)
  • EU Regulators Ramp Up Safety Monitoring Efforts For Biologicals (SCRIP-$)
  • FreeStyle Libre flash Glucose Monitor Gets Rid of Pinpricks, Now Approved for Kids in EU (medGadget)


  • India's Pharmaceutical Market to Skyrocket from $20B to $55B by 2020 (DD&D)
  • Celgene settles Revlimid patent litigation with Natco Pharma (GaBI)
  • US Recall Of Levofloxacin Manufactured By Lupin Pharma (24 Insight)
  • Yeda Research Denied Patent In India, Granted US Patent Term Adjustment (24 Insight)


  • Japan Announces Proposed Plan to Reduce Biosimilar and Generic Drug Prices (BigMoleculeWatch)


  • Interim impact assessment of the Therapeutic Goods Administration annual charge exemption (ACE) scheme (TGA)

Zika Virus

  • Inadequate testing thwarts efforts to measure Zika's impact (Reuters)
  • CDC Issues Zika Advisory for Pregnant Women and Sex Partners (NYTimes) (STAT)
  • Tropical Tonga declares Zika outbreak after five cases confirmed (Reuters)
  • Indian firm announces breakthrough for Zika (BioSpectrum)

Other International

  • New Zealand Signs Off on TPP While Protestors Hit PhRMA HQ (FDANews-$)

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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