Regulatory Recon: Roche Hemophilia Drug Scores FDA Breakthrough Designation (4 September 2015)

Posted 04 September 2015 | By Michael Mezher 

Regulatory Recon: Roche Hemophilia Drug Scores FDA Breakthrough Designation (4 September 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 and @RAPSorg on Twitter.

In Focus: US

  • Roche hemophilia drug wins fast-track FDA designation (Reuters) (Press) (FierceBiotech)
  • How FDA Could Change the Way it Approves Drugs (FiveThiryEight)
  • PDUFA 101 (The Catalyst)
  • Biosimilars Council Chief Answers 6 Questions About Biosimilars in the US (BioPharmaDive)
  • Biosimilar Prices Bode Well For Innovation (DrugWonks)
  • FDA warns iPhone ECG maker Cardiac Designs (MassDevice)
  • Spending User Fees: Biomarker Research, Drug-Device Combos? (SCRIP-$)

In Focus: International

  • Life-extending cancer drugs to be axed by NHS (The Guardian)
  • How to apply for orphan designation (EMA)
  • FDA’s New China Director Looks To Strengthen CFDA Ties (PharmAsiaNews-$)
  • Japan hits Pfizer with business improvement order after ADR reporting failures (In-Pharma Technologist)
  • Brazilian Medical Device Registration and BGMP Fees Set for Major Increase (Emergo)

US: Pharmaceuticals and Biotechnology

  • ‘Paternalistic’ FDA? Anti-vaxxer genetic activists? Watch the battle lines of consumer-driven precision medicine (MedCityNews)
  • Hospira/Celltrion: Don't Let U.S. Biosimilar Law's Questions 'Percolate'  (SCRIP-$)
  • Big Pharma: The Moment of Dread Is Here (WSJ-$)
  • New Rules For A New Era Of Research: The Case For Updating The “Common Rule” (RPM Report-$) (Focus)
  • Extent of data breaches in pharmaceutical sector revealed (EuropeanPharmaceuticalReview)
  • Zarxio 15% Price Discount To Neupogen In US Tracks European Strategy (Pink Sheet-$)
  • Sandoz's Zarxio: Interactive Timeline of Regulatory, Legal And Commercial Milestones (Pink Sheet-$)
  • Amgen's Plea To Stop Zarxio Launch Denied; Next Move? (SCRIP-$)
  • Novartis finally gets to roll out inaugural biosim Zarxio. What will payers and docs do? (FiercePharma)
  • Regeneron scientists score rare disease breakthrough with excess bone growth discovery (BioPharmaDive)
  • Researchers Report Long-Term Remissions in First Personalized Cell Therapy Trial (DD&D)
  • Kardashian's FDA infraction shows policing pharma social media isn't easy (FiercePharmaMarketing)
  • Patient-Reported Outcomes: Looking to FDA Guidances to Drive Submissions (Cutting Edge Info)

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

US: Medical Devices

  • C.R. Bard downplayed serious problems related to blood-clot device (FierceMedicalDevices)
  • Manufacturers, Suppliers Offer Perspectives On Supplier Quality Program (Gray Sheet-$)
  • Paralyzed Man Walks Thanks to Exoskeleton Combined with Spinal Cord Stimulation (medGadget)
  • Focus Diagnostics Receives FDA Clearance to Add Genital Swab Claim to Moderate Complexity Simplexa™ HSV 1 & 2 Direct Molecular Test (Press) (GenomeWeb) (FierceDiagnostics)
  • Presbia to Complete Second Stage Enrollment in the US FDA Pivotal Study of Presbia Flexivue Microlens (Press)
  • Expanded OpenFDA Interface Aims To Improve Device Analysis, App Development (Gray Sheet-$)

US: Assorted and Government

  • Legislature OKs 'Right-To-Try' Bill, Sends Measure to Brown (CaliforniaHealthline)
  • HRSA Issues Long-Awaited 340B Mega-Guidance; HP&M Issues Summary (FDA Law Blog) (BioPharmaDive)
  • NIH backs research to put genomic data into electronic medical records (FierceMedicalDevices)
  • Approval of New Animal Drug Applications (FDA)
  • Hayman Capital’s Kyle Bass Vows to Continue Drug-Patent Challenges (WSJ-$)
  • Health Care Rules Proposed to Shield Transgender Patients From Bias (NYTimes) (WSJ)
  • House Panel Investigating Blood Thinner’s Safety (FDANews-$)
  • Motrin Plaintiffs Say Bartlett Doesn't Block All Defect Claims (Law360-$

Upcoming Meetings and Events              




  • Sildenafil Found in Illegal Hongkong Tianli Biological 'Power' tablets (TGA)


  • Aurobindo Pharma gets USFDA nod for generic hypertension tablets (Economic Times)
  • Glenmark gets USFDA nod for fungal infections treatment drug (Economic Times)
  • Glenmark Pharmaceuticals completes phase I clinical trials for antibody (Economic Times)

    Other International

    • Singapore researchers get access to AstraZeneca drug compounds (BioSpectrum)
    • What's the Big Challenge in Winning In Emerging Markets? (MDDI)
    • Pharma market bets on ASEAN in focus ahead of economic pact (FiercePharmaAsia)

    General Health and Other Interesting Articles

    • How Innovation Got One Man Killed: A Cautionary Tale (MDDI)
    • Lyme Deaths From Heart Inflammation Likely Worse Than We Thought (Forbes)
    • Targeting protein aggregation for the treatment of degenerative diseases (Nature-$)
    • Dissecting fibrosis: therapeutic insights from the small-molecule toolbox (Nature-$)
    • Bees self-medicate to protect against parasites (FierceAnimalHealth)

    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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