Regulatory Focus™ > News Articles > Regulatory Recon: House Passes 'Cures' Act, Heads to the Senate (13 July 2015)

Regulatory Recon: House Passes 'Cures' Act, Heads to the Senate (13 July 2015)

Posted 13 July 2015 | By Michael Mezher 

Regulatory Recon: House Passes 'Cures' Act, Heads to the Senate (13 July 2015)

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

In Focus: US

  • US House passes 'Cures' Act to Speed New Drugs to Market (Reuters) (NYTimes) (WSJ-$) (Kaiser) (MedCityNews) (PharmaLetter-$)
  • Cures Act Could Have a Bumpy Ride in Senate (Pink Sheet-$) (SCRIP-$)
  • Draft Guidance on Labeling and Safety Testing of Heparin-Containing Devices (FDA)
  • Purdue Pharma and GlaxoSmithKline Could be First to use Apple's ResearchKit (BuzzFeed)
  • After Approval, Pricing of Novartis’ Entresto Gets the Spotlight (PharmaPhorum) (Pink Sheet-$)
  • Why Pricing Orkambi Below Kalydeco is a Savvy Strategy for Vertex (Pink Sheet-$)  
  • FDA Warns ASCEND Therapeutics for Omitting Risk Info in Promotional Materials (FDANews) (FDA)
  • FDA Boosts its Heart-Attack Warning On NSAIDs, Sows Confusion (NPR)
  • Did DOJ Embrace 2nd Circuit's Caronia Ruling In Amarin's Off-Label Challenge? (Forbes)

In Focus: International

  • European Medicines Agency says started review of HPV vaccines (Reuters) (PharmaLeter-$) (EMA)
  • How to Improve the Availability of Veterinary Vaccines in Europe (EMA)
  • New EU project seeks to fill cracks in medtech regulatoy system (Clinica-$)
  • Speedy NICE nod for Daiichi's bloodthinner Lixiana (PharmaTimes) (PharmaLetter)
  • How Lee Pharma’s Compulsory License Request Could Bring Down Modi’s “Make in India” Campaign (24Insight)
  • Almac's New Asia Pacific packaging Site Gets OK From Singapore's HSA (Outsourcing-Pharma)

US: Pharmaceuticals and Biotechnology

  • Purdue Pharma and GlaxoSmithKline could be the first two drugmakers to use Apple's ResearchKit (BuzzFeed)
  • After Approval, Pricing of Novartis’ Entresto Gets the Spotlight (PharmaPhorum) (Pink Sheet-$)
  • Why Pricing Orkambi Below Kalydeco Is A Savvy Strategy For Vertex (Pink Sheet-$)
  • FDA Warns ASCEND Therapeutics for Omitting Risk Info in Promotional Materials (FDANews) (FDA)

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

US: Pharmaceuticals and Biotechnology: General

  • FDA Boosts Its Heart-Attack Warning On NSAIDs, Sows Confusion (NPR)
  • Biosimilar makers slam proposed Medicare/Medicaid billing code changes (BioPharma-Reporter)
  • Did The DOJ Embrace The 2nd Circuit's Caronia Ruling In Amarin's Off-Label Challenge? (Forbes)
  • Maker of Costly Drug Spent Heavily on Hospitality for Doctors (Roll Call)

US: Medical Devices

  • An Inside Look At The Theranos Direct-To-Consumer Experience (Forbes)
  • FDA Clearance for joimax EndoLIF On-Cage: 3D-Printed Fusion Implant (Press)
  • 21st Century Cures: Select Device Provisions (Gray Sheet-$)
  • RIVANNA Gets FDA Clearance for Accuro Device (Press)
  • ApiFix Finds Scoliosis Improvement in Follow-Up Study (Press)

US: Assorted and Government

  • U.S. House passes 'C21st Cures' bill to speed new drugs to market (Reuters) (NYTimes) (WSJ-$) (Kaiser) (MedCityNews) (PharmaLetter-$)
  • Cures Act Could Have a Bumpy Ride in Senate (Pink Sheet-$) (SCRIP-$)
  • President Lends Tepid Support To 'Cures' Bill, But Questions Funding (Gray Sheet-$)
  • CMS proposes Part B reimbursement rule for biosimilars (BioCentury)
  • Congressional Briefing on Implementation of Biologics Price Competition Act (Press)

Upcoming Meetings and Events

Europe

  • European Medicines Agency says started review of HPV vaccines (Reuters) (PharmaLeter-$) (EMA)
  • How to Improve the Availability of Veterinary Vaccines in Europe (EMA)
  • New EU project seeks to fill cracks in medtech regulatoy system (Clinica-$)
  • Speedy NICE nod for Daiichi's bloodthinner Lixiana (PharmaTimes) (PharmaLetter)
  • Study Demonstrates Accuracy of GlySure Continuous Intravascular Glucose Monitoring System in Critically Ill Patients (Press)

India

  • How Lee Pharma’s Compulsory License Request Could Bring Down Modi’s “Make in India” Campaign (24Insight)
  •  TSDCA books over 100 blood banks for violation of safety norms (PharmaBiz)
  • Delhi High Court sets aside cap on condom prices (Economic Times)

China

  • China to build biotech research lab in Pakistan (BioSpectrum)
  • Expert view: Chinese healthcare industry entering a 'new normal'? (SCRIP-$)

Australia

  • Medicines Australia urges Parliament to legislate the Medical Research Future Fund (PharmaLetter)

Ebola Outbreak

  • Ebola Assays Compared in Head-to-Head Analysis; BioFire Test Deemed Advantageous (GenomeWeb)
  • Liberia update: New information from genetic sequencing (WHO)
  • Pledges of $3.4 billion for Ebola recovery made at United Nations (Reuters)
  • Africa's Ebola outbreak not yet run its course: U.N. envoy (Reuters)

Other International

  • When COFEPRIS Will Accept ISO 13485 in Lieu of EIRs for US devices Seeking Expedited Mexico Registration (MassDevice)
  • Almac's New Asia Pacific packaging Site Gets OK From Singapore's HSA (Outsourcing-Pharma)
  • Green Cross Begins Clinical Trials for Hepatitis Drug in South Korea (BioSpectrum)
  • General Regulatory and Interesting Articles
  • How to avoid getting duped by bad research, in 5 case studies (Vox)
  • Should Doctors And Drugmakers Keep Their Distance? (NPR)
  • Behind Sunscreens' Confusing Figures (WSJ-$)
  •  
  • Regulatory Reconnaissance #594 – 13 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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe