Regulatory Focus™ > News Articles > Regulatory Recon: NICE Approves World's Most Expensive Drug for Use (28 January 2015)

Regulatory Recon: NICE Approves World's Most Expensive Drug for Use (28 January 2015)

Posted 28 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: NICE Approves World's Most Expensive Drug for Use (28 January 2015)

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

In Focus: US

  • TransCelerate adds two members, appoints chair (BioCentury) (Press)
  • Clinical Trial Network For Antibiotics Included In President’s FY 2016 Budget (Pink Sheet-$)
  • Hospira 'committed to quality' as total recall count hits 40 since 2012 (In-Pharma)
  • House Panel Takes Up DEA Drug Approval, Enforcement Bills (Law 360-$) (E&C)
  • Will Promoted Video Pave the Way for Drug and Medical Device Promotion on Twitter? (Epstein Becker Green)
  • It's Official: The Device Industry Finds FDA Greatly Improved (MDDI)
  • Myriad Settles Breast Cancer Test Patent Suit With Ambry (Law 360-$) (Patent Docs) (NYTimes)
  • FDA approves Abiomed's Impella RP (Mass Device) (MedPage Today) (Reuters)
  • Senators to Call for Creation of a Single Food Safety Agency (Senate)

In Focus: International

  • NICE approves world’s most expensive drug, Alexion's Soliris (Pharmafile) (SCRIP-$) (BioCentury)
  • Free, Online and Useful Regulatory Tools (Polaris)
  • MHRA Launches New Website (MHRA)
  • Drop high-risk device scrutiny proposal, electromed industry tells Council (Clinica-$)
  • International regulators keen to work with Indian regulators (PharmaBiz)
  • Ebola: which are the leading vaccine candidates? (BioPharma Reporter)

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US: Pharmaceuticals and Biotechnology

  • TransCelerate adds two members, appoints chair (BioCentury) (Press)
  • Clinical Trial Network For Antibiotics Included In President’s FY 2016 Budget (Pink Sheet-$)
  • Hospira 'committed to quality' as total recall count hits 40 since 2012 (In-Pharma)
  • House Panel Takes Up DEA Drug Approval, Enforcement Bills (Law 360-$) (E&C)
  • Will Promoted Video Pave the Way for Drug and Medical Device Promotion on Twitter? (Epstein Becker Green)
  • New Labeling Rule Will Help, but Can’t Compensate for Scant Information on Drug Safety in Pregnancy (Thomson Reuters)
  • An Early Test Of Antitrust Ramifications Of FDA's REMS (Law 360-$)
  • Biologics and USP’s General Chapters on Container Closure Systems (HC Packaging)
  • Analysis rejects linkage between testosterone therapy, cardiovascular risk (Press)

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

  • Amgen Submits Applications In The US And Europe For Kyprolis (carfilzomib) For The Treatment Of Relapsed Multiple Myeloma (Press)
  • RestorGenex Granted Orphan Drug Designation for RES-529 for Treatment of Glioblastoma Multiforme (Press)

US: Pharmaceuticals and Biotechnology: General

  • US to Fund GAVI With $1Billion Pledge Through 2019 (White House) (SCRIP-$)
  • Breyer turns down generic firms’ plea for access to Copaxone ruling (SCOTUSblog)

US: Medical Devices

  • It's Official: The Device Industry Finds FDA Greatly Improved (MDDI)
  • Myriad Settles Breast Cancer Test Patent Suit With Ambry (Law 360-$) (Patent Docs) (NYTimes)
  • FDA approves Abiomed's Impella RP (Mass Device) (MedPage Today) (Reuters)
  • St. Jude Medical Announces FDA Approval of FlexAbility Ablation Catheter (Press) (Mass Device)
  • United States Food and Drug Administration perspectives on the update to the objective performance criteria for surgically implanted heart valve prostheses. (PubMed)
  • Beyond Law Enforcement: The FTC’s Role In Promoting Health Care Competition And Innovation (Health Affairs)
  • Report: Many medical imaging tests performed in U.S. are unnecessary (CBS)

US: Dietary Supplements

  • Senators to Call for Creation of a Single Food Safety Agency (Senate)

US: Assorted And Government

  • House Judiciary Committee passes bill on rule-making reform (The Hill)
  • Obama's 'precision medicine' plan to boost research, but faces hurdles (Reuters)
  • NIH launches tool to advance Down syndrome research (NIH)

Upcoming Meetings

Ebola Outbreak

Europe

  • NICE approves world’s most expensive drug, Alexion's Soliris (Pharmafile) (SCRIP-$) (BioCentury)
  • MHRA Launches New Website (MHRA)
  • Drop high-risk device scrutiny proposal, electromed industry tells Council (Clinica-$)
  • Drug manufacturers propose alert system to mitigate medicine shortages (Pharm-Journal)

India

  • International regulators keen to work with Indian regulators to bridge gaps & strengthen regulatory set-up (PharmaBiz)
  • India: 30-63% of Rs 10,000 crore existing medical devices faulty (India Times)

Australia

  • TGA Warns About Battery Failure in InterStim Neurostimulation Devices (TGA)

General Regulatory And Interesting Articles

  • Free, Online and Useful Regulatory Tools (Polaris)
  • Bill Gates dismisses criticism of high prices for vaccines (Guardian)
  • To Protect His Son, A Father Asks School To Bar Unvaccinated Children (NPR)

Regulatory Reconnaissance #481 – 28 January 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? 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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