Regulatory Focus™ > News Articles > Regulatory Recon: Biosimilar Humira Passes Critical Head-to-Head Trial (9 October 2014)

Regulatory Recon: Biosimilar Humira Passes Critical Head-to-Head Trial (9 October 2014)

Posted 09 October 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Biosimilar Humira Passes Critical Head-to-Head Trial (9 October 2014)

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

In Focus: US

  • Amgen declares a head-to-head PhIII win for Humira biosimilar (Fierce) (AP) (PharmaTimes) (Pink Sheet-$) (Press) (BioCentury)
  • FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device (Forbes) (Press) (Reuters) (WSJ-$) (Mass Device)
  • IBM, Oracle Prod Congress To Clarify FDA's Health IT Powers (Law 360-$) (Bloomberg)
  • Covidien Seeks Participation In FDA-CMS Parallel Review Program (Gray Sheet-$)
  • Durbin, Blumenthal Press FDA to Investigate ‘Amp’ Stimulant in Dietary Supplement (NPI)
  • CEOs Fear FDA’s ‘Breakthrough’ Program Is Too Popular For Its Own Good (Pink Sheet-$)
  • Safety Advocates Seek Stronger Warnings on Chantix (AP) (Fierce) (Pharmalot)
  • Pharma Import Alert: FDA Working Towards Consistency, Better Decision Making (Pink Sheet-$)
  • Flare Up: Takeda Challenges FDA Approval of 505(b)(2) Application for Colchicine Capsules (FDA Law Blog)

In Focus: International

  • EMA Releases Mid-Year Statistics Report (EMA)
  • Report: Medical Device Authority May be Returning to DG Sanco (Twitter)
  • Two plead guilty in Polish drug bribery case (Reuters)
  • Catarina Andersson Forsman Appointed Director General of the Swedish Medical Products Agency (NewsDesk)
  • NICE denies two drugs in new MS guidance (PMLive)
  • Seven-fold fee hike to classify product has German IVD industry in a spin (Clinica-$)
  • Indian Supreme court hearing on clinical trials enters crucial phase (PR Watch)

US: Pharmaceuticals and Biotechnology

  • CEOs Fear FDA’s ‘Breakthrough’ Program Is Too Popular For Its Own Good (Pink Sheet-$)
  • FDA AdComm to Consider Novartis' Panobinostat and Rockwell's Triferic (Tarius) (BiOCentury) (Myeloma Beacon)
  • Safety Advocates Seek Stronger Warnings on Chantix (AP) (Fierce) (Pharmalot)
  • Pharma Import Alert: FDA Working Towards Consistency, Better Decision Making (Pink Sheet-$)
  • Flare Up: Takeda Challenges FDA Approval of 505(b)(2) Application for Colchicine Capsules (FDA Law Blog)
  • FDA's FY2014 Generic Drug GDUFA Data (FDA)
  • Experts See Strong Upside in FDA’s Reorganization of Inspectorate (FDA News-$)
  • Endo, Impax Face Another Pay-for-Delay Lawsuit Over Generic Opana ER (FDA News-$)
  • FDA approves Uceris rectal foam (BioCentury)
  • Hospira Recalls Vancomycin Due to "Unctrolled Storage During Transit" (FDA)
  • A Drug Shortage of… Injectable Dextrose? (FDA)
  • Gerresheimer adjusts earnings forecast lower in wake of FDA crackdown (Fierce)

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

  • Amgen declares a head-to-head PhIII win for Humira biosimilar (Fierce) (AP) (PharmaTimes) (Pink Sheet-$) (Press) (BioCentury)
  • FDA Grants Priority Review for Genentech’s Lucentis in Diabetic Retinopathy (Press) (SCRIP-$)
  • Lefamulin Designated QDIP and Fast Track Status for Bacterial Infections (MPR) (BioCentury)
  • New gene therapy treatment showing promise against 'bubble boy' disease (Reuters) (WSJ-$)
  • Setback for Shire's NDA Submission for ADHD Drug SHP 465 (Press)

US: Pharmaceuticals and Biotechnology: General

  • VA Getting Sovaldi Drug at Half Sticker Price (CNBC)
  • ​Men Dominate List of Doctors Receiving Largest Payments From Drug Companies (The Upshot)
  • Dogs, hogs and dairy cows: 'Animal pharm' catches Wall Street's attention (Reuters)
  • Prescription Database Privacy Case Heads For Legal Showdown (InformationWeek)

US: Medical Devices

  • FDA Panel Gives Cautious Endorsement To Novel Boston Scientific Device (Forbes) (Press) (Reuters) (WSJ-$) (Mass Device)
  • IBM, Oracle Prod Congress To Clarify FDA's Health IT Powers (Law 360-$) (Bloomberg)
  • Covidien Seeks Participation In FDA-CMS Parallel Review Program (Gray Sheet-$)
  • CDRH, ORA Plan Specialized Field Force, And To Build On “Case for Quality” (Gray Sheet-$)
  • FDA and the Cybersecurity Community: Working Together to Protect the Public Health (FDA)
  • The Benefits of Unique Device Identification throughout the Health Care System (Pew)

US: Dietary Supplements

  • Durbin, Blumenthal Press FDA to Investigate ‘Amp’ Stimulant in Dietary Supplement (NPI)
  • Recall DMAA Analog While FDA Evaluates Safety – CRN, Researchers (Tan Sheet-$)
  • GNC stops sale of two supplements in wake of news story (USA Today)
  • Regulatory status of caffeine in the United States (PubMed)

US: Assorted And Government

  • FDA Enforcement Report - Week of October 7, 2014 (FDA)
  • NIH funds research consortia to study more than 200 rare diseases (NCATS)
  • Upcoming Panel will Highlight The Successes of The NCATS Tech Transfer Model (BIO)

Upcoming Meetings

Ebola Outbreak

  • Defusing panic over Ebola by understanding R-nought (AHCJ)
  • Canadian Ebola Vaccine License Holder Moving Ahead with Safety Trial (AP)
  • Playing 'God' in the time of Ebola: Who gets care? (SCRIP-$)

Europe

  • EMA Releases Mid-Year Statistics Report (EMA)
  • Report: Medical Device Authority May be Returning to DG Sanco (Twitter)
  • Two plead guilty in Polish drug bribery case (Reuters)
  • Catarina Andersson Forsman Appointed Director General of the Swedish Medical Products Agency (NewsDesk)
  • Netherlands' Medicines Evalation Board Working to Make Info on Products More Accessible (MEB)
  • NICE denies two drugs in new MS guidance (PMLive)
  • Seven-fold fee hike to classify product has German IVD industry in a spin (Clinica-$)
  • EU GMP Inspectors find 26 GMP Deficiencies at Chinese API Manufacturer Hebei Dongfeng Pharmaceuticals (ECA)
  • UK MHRA announces new collaboration in the development of advanced therapies (PharmaLetter-$)

India

  • Indian Supreme court hearing on clinical trials enters crucial phase (PR Watch)
  • Will a U.S.-India Working Group do the Bidding of the Pharma Industry? (Pharmalot)
  • Local Indian Regulators Want Price Controls on Some Medical Devices (PharmaBiz)

China

  • Mazor granted CFDA approval for surgical guidance system (Press)

Canada

  • Health Canada’s Draft Guidance on Cell Therapy Studies Aims for Early Identification of Risks, Delivery (FDA News-$)

Other International

  • WHO 4th International Meeting of World Pharmacopoeias (EDQM)
  • Drug Quality and the Heart of Darkness (Morning Consult)

Clinical Trials

  • Hospital bottom lines: Why clinical trial enrollment is abysmal (MedCity News)

General Regulatory And Interesting Articles

  • The Regulatory Convergence: RAPS 2014 Recap (DocuLabs)
  • AdvaMed Lifetime Achievement Award 2014: Earl Bakken (YouTube)
  • Do-It-Yourself Flu Vaccine? Study Shows it Works (AP)
  • New Report Shows Past Drug Failures Aid in the Fight Against Cancer (PhRMA)
  • Nerve Implants Let Patients Feel Through Artificial Fingers (NBC)

Regulatory Reconnaissance #417 – 9 October 2014

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 @AlecGaffney or send him an email at news@raps.org.

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


Categories: Recon, Regulatory News

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