Regulatory Focus™ > News Articles > Regulatory Recon: Vertex' Orkambi Gets FDA Nod, Indication Covers Half of CF Patients (6 July 2015

Regulatory Recon: Vertex' Orkambi Gets FDA Nod, Indication Covers Half of CF Patients (6 July 2015)

Posted 06 July 2015 | By Michael Mezher 

Regulatory Recon: Vertex' Orkambi Gets  FDA Nod, Indication Covers Half of CF Patients (6  July 2015)

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

In Focus: US

  • FDA Approves Vertex' Orkambi for Cystic Fibrosis ( FDA) ( NYTimes) ( Washington Post) ( SCRIP-$)
  • Court Rules Patents for Medicines Co.’s Anticlotting Drug Invalid ( WSJ) ( Pharma Letter-$) ( SCRIP-$) ( Press
  • Guidance on FDA Decision to Push Back Track and Trace Enforcement ( FDA)
  • PhRMA Calls FDA Regulations are 'Outdated' and Discourage Development and Dissemination of Economic Data ( The Catalyst)
  • Second Circuit Appellate Court Weighs In on Pharmaceutical “Product Hopping” ( National Law Review)
  • NIH funding boost trimmed in 21st Century Cures bill ( BioCentury) ( SCRIP-$)
  • Risk-Based Inspections Might Actually Be Hurting Compliant Firms ( Pink Sheet-$)
  • Theranos gets first FDA clearance, emerges from secrecy ( MedCityNews)

In Focus: International

  • Australia Ditches Paper, Accepts eCTD and Non-eCTD Electronic Submissions without paper copies ( TGA)
  • Greek 'no' vote puts pharma in tricky position ( PMLive) ( EFPIA)
  • Lee Takes India Compulsory License Fight To Saxagliptin ( PharmAsiaNews-$)
  • Delhi High Court Upholds BMS' Patent for Cancer Drug Dasatinib ( Economic Times)
  • Biosimilar Use and Funding in Norway ( GaBI)
  • Guideline on influenza vaccines – submission and procedural requirements ( EMA)

US: Pharmaceuticals and Biotechnology

  • The Drug Supply Chain Security Act Implementation: Product Tracing Requirements for Dispensers-Compliance Policy ( FDA)
  • PhRMA Calls FDA Regulations are 'Outdated' and Discourage Development and Dissemination of Economic Data ( The Catalyst)
  • FDA Approves Vertex' Orkambi for Cystic Fibrosis ( FDA) ( NYTimes) ( Washington Post) ( SCRIP-$)
  • Court Rules Patents for Medicines Co.’s Anticlotting Drug Invalid ( WSJ) ( Pharma Letter-$) ( SCRIP-$) ( Press)
  • Risk-Based Inspections Might Actually Be Hurting Compliant Firms ( Pink Sheet-$)

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

  • Pfizer Announces FDA Acceptance for Review of New Drug Application for A Once-Daily Formulation of XELJANZ ( Press)
  • New obesity drug gives 6 kg extra weight loss in trial ( MedicalNewsToday)
  • HIV vaccine from J&J starts human trials ( PMLive) ( Reuters)
  • Bosutinib is well-suited for older patients with chronic myeloid leukemia ( MedicalNewsToday)
  • Erythropoietic protoporphyria: Phase III SCENESSE studies published ( MedicalNewsToday)

US: Pharmaceuticals and Biotechnology: General

  • NIH funding boost trimmed in 21st Century Cures bill ( BioCentury) ( SCRIP-$)
  • FDA ‘Monster’ Patent Reg: Brands, Generics Each Want More Options To Pick Fights ( Pink Sheet-$)

US: Medical Devices

  • FDA Expands Proteus Digital Health's Clearance to Include Measuring Medication Adherence ( MobiHealthNews)
  • Theranos gets first FDA clearance, emerges from secrecy ( MedCityNews)

US: Assorted and Government

  • NIH funding boost trimmed in 21st Century Cures bill ( BioCentury)
  • Biosimilars substitution bill become law in Texas ( GaBI)
  • Second Circuit Appellate Court Weighs In on Pharmaceutical “Product Hopping” ( National Law Review)

Upcoming Meetings and Events

Europe

  • Biosimilar Use and Funding in Norway ( GaBI)
  • Guideline on influenza vaccines – submission and procedural requirements ( EMA)
  • Hospira Wins French Biosimilar Drug Tender at 45 Percent Discount ( Reuters)
  • Zentiva's Abilify Generic Authorized in Europe ( EC) ( EMA)
  • Cystic fibrosis gene therapy trial offers hope of treatment ( MedicalNewsToday) ( BioCentury)
  • Studies confirm regorafenib benefit in pre-treated metastatic colorectal cancer ( MedicalNewsToday)
  • Staff cuts and accelerated access: MHRA’s plan for 2016 ( In-Pharma Technologist)
  • Expert clinical advice – MHRA medical devices independent review ( MHRA) ( Report)
  • IQWiG re-examination finds indication of added benefit in certain patients for Gilenya ( PharmaLetter-$) ( IQWiG)

Canada

  • Development of a Regulatory Framework for Mandatory Reporting by Healthcare Institutions ( Health Canada)

India

  • Lee Takes India Compulsory License Fight To Saxagliptin ( PharmAsiaNews-$)
  • Delhi High Court Upholds BMS' Patent for Cancer Drug Dasatinib ( Economic Times)
  • NPPA seeks details of price movement of certain ortho implants ( Economic Times)

Japan

Ebola Outbreak

  • Recurrence of Ebola transmission in Liberia ( WHO)

General Regulatory and Interesting Articles

  • Mount Sinai has multi-layered approach to health apps ( MedCityNews)
  • The US just recorded its first confirmed measles death in 12 years ( Washington Post)

Regulatory Reconnaissance #589 – 6 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? Find him on Twitter at @Michael_Mezher 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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