Regulatory Recon: WHO Weighs in on Biosimilar Naming (1 July 2015)

Posted 01 July 2015 By Alexander Gaffney, RAC

placeholder+image

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

A quick note from your editor: After five wonderful years working at RAPS, my last day will be on 2 July 2015. More on that here. You have my sincerest thanks for your readership over the years.

Regulatory Recon will live on under a new editor.

In Focus: US

  • Congress Moves to Block Human Embryo Editing, FDA Approval of INDs (SciAm)
  • Must FDA-Regulated Companies "Allow" FDA To Conduct Warrantless Inspections? (FDA Law Blog)
  • FDA takes action against unapproved prescription ear drop products (FDA) (FDA)
  • Clarity on How Pharmaceutical Companies Can Communicate Data Could Spur Investment in Evidence Generation (Avalere) (Forbes)
  • OxyContin maker drops out of FDA meeting to review newer, abuse-deterrent tablet (AP) (Pink Sheet-$) (SCRIP-$) (Law 360-$) (Fierce)
  • ​​U.S. doctors, hospitals reap $6.5 billion from drug and device makers: report (Reuters) (Bloomberg) (WSJ-$) (CMS)
  • Cardiology Societies Urge Registry For Left-Atrial Appendage Closure Devices (Gray Sheet-$) (Fierce)
  • Lawmakers want public to see new tanning beds rules (The Hill)

In Focus: International

  • WHO Biosimilar Naming Policy Supports Use of Qualifiers (WHO) (BioPharma-Reporter)
  • EMA: Electronic application becomes mandatory today (EMA)
  • Drugmakers draw up plans to ease medicine shortage in Greece (Guardian) (EFPIA) (Fierce)
  • New EU logo to help patients avoid online sellers of fake medicines (EC) (EMA)
  • China Joins Global Regulatory Coalition Amid Calls For Reforms (PharmAsia-$)
  • Assessing the relative efficacy of new drugs: an emerging opportunity (Nature)

Sponsored: Master of Science In Orthopaedic Regulatory And Clinical Affairs

  • Grace College is located near Warsaw, Indiana, the "Orthopaedic Capital of the World," headquarters for Zimmer-Biomet, DePuy-Synthes, Orthopediatrics, and numerous suppliers. Two accelerated masters programs at Grace College support critical functions in the design, manufacturing, marketing, and distribution of medical devices.  The ORCA program focuses on regulatory and clinical affairs. The MDQM program emphasizes device quality management. Classes are accelerated, offered in weekend and evening formats, and taught by industry professionals. Instruction is live-streamed for remote participation.
  • http://www.grace.edu/orca

US: Pharmaceuticals and Biotechnology

  • U.S. Congress Moves to Block Human Embryo Editing, FDA Approval of INDs (SciAm)
  • Must FDA-Regulated Companies "Allow" FDA To Conduct Warrantless Inspections? (FDA Law Blog)
  • FDA takes action against unapproved prescription ear drop products (FDA) (FDA)
  • Clarity on How Pharmaceutical Companies Can Communicate Data Could Spur Investment in Evidence Generation (Avalere) (Forbes)
  • OxyContin maker drops out of FDA meeting to review newer, abuse-deterrent tablet (AP) (Pink Sheet-$) (SCRIP-$) (Law 360-$) (Fierce)
  • How Drug Cos. Can Minimize Risks Of 'Right To Try' Laws (Law 360-$)
  • 'Right to Try' May Be Hard to Implement (HealthNewsFlorida)
  • New Report on Benefits of Cancer Medicines That Emerge After FDA Approval (PhRMA)
  • House bill would force FDA to ease up on social media (Fierce)
  • Amarin Not Backing Down In Free Speech Suit Against FDA (Law 360-$)
  • Opioid REMS Role Debated as Heroin Overdoses Spike (PainMedicineNews)
  • Access barrier created by distinguishable names for biosimilars, GPhA says (DSN)
  • Prepare Now for DSCSA Serialization (PharmaManufacturing)
  • FDA deputy Califf's consulting reported (BioCentury)
  • Doomsday AMR scenarios lurk: What's FDA, others doing? (SCRIP-$)
  • FDA, Gates Foundation call for improved global access to veterinary drugs (Fierce)
  • FDA on its Latest Operation PANGEA (FDA)

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

  • Genentech PDUFA Date for Cobimetinib NDA Pushed Back (Press)
  • Innocoll AG Announces Qualified Infectious Disease Product (QIDP) Designation for Cogenzia for the Adjunctive Treatment of Moderate and Severe Diabetic Foot Infection (Press)
  • Sembragiline misses AD endpoint (BioCentury)
  • Roche and Evotec's Alzheimer's drug ineffective (PMLive)
  • Aridis Pharmaceuticals Receives FDA Fast Track Designation for Aerucin for Treating Hospital-Acquired and Ventilator-Associated Pneumonia (Press)

US: Pharmaceuticals and Biotechnology: General

  • ​​U.S. doctors, hospitals reap $6.5 billion from drug and device makers: report (Reuters) (Bloomberg) (WSJ-$) (CMS)
  • California bill limits school vaccine exemptions (Reuters) (NYTimes)
  • How Much?! Feds Wants Novartis to pay $3.35B For Kickback Schemes (Pharmalot)

US: Medical Devices

  • Cardiology Societies Urge Registry For Left-Atrial Appendage Closure Devices (Gray Sheet-$) (Fierce)
  • Lawmakers want public to see new tanning beds rules (The Hill)
  • DOJ calls off investigation of Abiomed's Impella marketing (Fierce)
  • MX Orthopedics Receives FDA Clearance on the dynaMX™ Compression Staple Featuring Malleable Nitinol Technology (Press)
  • Lancet Publication of Sham-Controlled Clinical Trial Shows Pulmonx's Zephyr Endobronchial Valves Deliver Significant Benefit to Emphysema Patients (Press)

Upcoming Meetings and Events

Europe

  • EMA: Electronic application becomes mandatory today (EMA)
  • Drugmakers draw up plans to ease medicine shortage in Greece (Guardian) (EFPIA) (Fierce)
  • New EU logo to help patients avoid online sellers of fake medicines (EC) (EMA)
  • Draft reflection paper on viral safety of plasma-derived medicinal products with respect to hepatitis E virus (EMA)
  • Facilitating the development of advanced therapies (EMA)
  • A lot of promise but a long way to go: an initial assessment of the EU adaptive pathways pilot (SCRIP RA-$)
  • European standard on usability engineering of medical devices updated to address legacy products (SCRIP RA-$)
  • Early advice: making the most of a mixed offering (SCRIP-$)
  • BioLight Obtains EU CE Mark for CellDetect Non-Invasive Test for Detecting Recurrence of Bladder Cancer (Press)
  • GlySure Secures CE Mark and Launches World's First Continuous Intravascular Glucose Monitoring System (Press)

China

  • China Joins Global Regulatory Coalition Amid Calls For Reforms (PharmAsia-$)

Australia

  • Clinical trials: New online form for CTN scheme (TGA)

Other International

  • WHO Biosimilar Naming Policy Supports Use of Qualifiers (WHO) (BioPharma-Reporter)
  • CorGENIX ReEBOV Antigen Rapid Test Kit approved by WHO for emergencies (MedGadget)

General Regulatory And Interesting Articles

  • Assessing the relative efficacy of new drugs: an emerging opportunity (Nature)
  • Will iPhones Change Medicine--by Turning Us All into Subjects? (SciAm)
  • Beware of animal diseases as biological weapons, health experts say (Reuters)
  • Plastic surgeons from different countries prefer different breast shapes (Reuters)

Regulatory Reconnaissance #587 – 1 July 2015

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? Email news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

Share this article:

Categories: Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, News

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Regulatory Exchange: Latest Updates From the Community