Regulatory Recon: ‘Cures’ Bill to Give Small Percentage of Drugs Added Exclusivity (24 June 2015)

Posted 24 June 2015 By Alexander Gaffney, RAC

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

In Focus: US

  • 21st Century Cures would extend exclusivity for 15% of drugs (BioCentury) (Pink Sheet-$) (CBO) (SCRIP-$)
  • An analysis of the attrition of drug candidates from four major pharmaceutical companies (Nature)
  • Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development (Tufts CSDD)
  • How To Get 270 Approvals At Once? – Stealth's Rare Disease Strategy (Pink Sheet-$)
  • Federal Government Makes it Easier to Obtain Marijuana for Medical Research (Federal Register)
  • Department of Justice (DOJ) will conduct its first "eight-factor analysis" of cannabidiol (Senate)
  • A Bill Would Prevent Drug Makers From Frustrating Generic Rivals (Pharmalot)
  • Google Reveals Health-Tracking Wristband Intended for Use in Clinical Trials (Bloomberg) (PharmaPhorum) (Pharmafile)
  • FDA Speeding up its Approvals of Complex Devices (MDDI)
  • FDA to Weigh Risks and Benefits in Approving Investigational Device Exemptions (FDA Law Blog)
  • Medtronic recalls Covidien Shiley tracheostomy tubes (MassDevice) (Press) (FDA)
  • 'Cures' Would Cost FDA $872 Million, Device Provisions A Big Chunk (IHP-$) (FDAnews-$)

In Focus: International

  • TTIP trade talks will 'force' FDA-EMA to sync regs, says biopharma (In-Pharma)
  • India to open drugs database to global regulators (India Times)
  • IPA wants Regulatory Affairs Science as academic discipline for higher education in pharmacy (India Times)
  • MHRA Launches New Regulatory Blog (MHRA)
  • Solution 'desperately required' for 'serious problem' with medtech standards in EU (Clinica-$)
  • ANALYSIS: next steps to move EU medtech regulations forward and key player views (Clinica-$)
  • NICE asks for more evidence from dry eye treatment maker (Pharmafile) (PMLive) (PharmaTimes)

US: Pharmaceuticals and Biotechnology

  • A Bill Would Prevent Drug Makers From Frustrating Generic Rivals (Pharmalot)
  • 21st Century Cures would extend exclusivity for 15% of drugs (BioCentury) (Pink Sheet-$) (CBO) (SCRIP-$)
  • An analysis of the attrition of drug candidates from four major pharmaceutical companies (Nature)
  • Profiles of New Approaches to Improving the Efficiency and Performance of Pharmaceutical Drug Development (Tufts CSDD)
  • How To Get 270 Approvals At Once? – Stealth's Rare Disease Strategy (Pink Sheet-$)
  • Edible Marijuana Labels Often Have Potency Wrong, Study Says (NYTimes) (JAMA) (JAMA) (Reuters) (Forbes)
  • Federal Government Makes it Easier to Obtain Marijuana for Medical Research (Federal Register)
  • Department of Justice (DOJ) will conduct its first "eight-factor analysis" of cannabidiol (Senate)
  • FDA Goes On Offense In Amarin's Free Speech Suit (Law 360-$)
  • Pondering PDUFA & Other Policy Drivers (YourEncore)
  • Comparative Risk Assessment of Formulation Changes in Generic Drug Products: A Pharmacology/Toxicology Perspective (PubMed)
  • Human Immunodeficiency Virus (HIV) Organ Policy Equity (HOPE) Act Safeguards and Research Criteria for Transplantation of Organs Infected With HIV (NIH)
  • Allergan Pulled 'Hard Switch' To Block Generics, Unions Say (Law 360-$)

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

  • AbbVie hepatitis C cocktail succeeds in late-stage study (Reuters)
  • Alcobra's genetic disorder drug fails in mid-stage trial (Reuters)
  • Hope And Hype For New Type Of Antidepressant (Forbes)
  • OptiNose Announces Positive Results of Phase III Trial for OPN-375 (Press)

US: Pharmaceuticals and Biotechnology: General

  • ​​PhRMA Gives ASCO's Cancer Drug Value Framework Cautious Support (PhRMA)
  • California Caps What Patients Pay For Pricey Drugs. Will Other States Follow? (KHN)
  • High Prescription Drug Costs a Major Concern for Voters (Morning Consult)

US: Medical Devices

  • Google Reveals Health-Tracking Wristband Intended for Use in Clinical Trials (Bloomberg) (PharmaPhorum) (Pharmafile)
  • FDA Speeding up its Approvals of Complex Devices (MDDI)
  • FDA to Weigh Risks and Benefits in Approving Investigational Device Exemptions (FDA Law Blog)
  • Medtronic recalls Covidien Shiley tracheostomy tubes (MassDevice) (Press) (FDA)
  • No Precision Medicine Dollars For FDA Molecular Dx Development In House Bill (Gray Sheet-$)
  • MIT's New Non-Profit To Gauge Digital Health Products' Value (MDO)
  • Medical Device Firm Advanced Cooling Therapy Receives FDA De Novo Clearance for Esophageal Cooling Device to Cool and Warm Patients (Press)
  • Torax Medical wins FDA nod for MRI compatible Linx (MassDevice)
  • April 2015 PMA Approvals (FDA)

US: Assorted And Government

  • 'Cures' Would Cost FDA $872 Million, Device Provisions A Big Chunk (IHP-$) (FDAnews-$)
  • Congress Has To Beat The Clock For 21st Century Cures Act (Law 360-$)
  • Senate spending bill to boost NIH funds, cut CDC's (SCRIP-$)

Upcoming Meetings and Events

Ebola Outbreak

  • NIH Expands Testing of Ebola Drugs and Vaccines Into New Countries (WSJ-$)

Europe

  • MHRA Launches New Regulatory Blog (MHRA)
  • Solution 'desperately required' for 'serious problem' with medtech standards in EU (Clinica-$)
  • ANALYSIS: next steps to move EU medtech regulations forward and key player views (Clinica-$)
  • NICE asks for more evidence from dry eye treatment maker (Pharmafile) (PMLive) (PharmaTimes)
  • Draft questions and answers on sodium in the context of the revision of the guideline on 'Excipients in the label and package leaflet of medicinal products for human use' (CPMP/463/00 Rev.1) (EMA)
  • AveXis Gains Orphan Drug Designation From the European Medicines Agency for Gene Therapy Treatment in Spinal Muscular Atrophy (Press)

India

  • India to open drugs database to global regulators (India Times)
  • IPA wants Regulatory Affairs Science as academic discipline for higher education in pharmacy (India Times)

Australia

  • Expert review of medicines and medical devices regulation - first report released (TGA)

Other International

  • TTIP trade talks will 'force' FDA-EMA to sync regs, says biopharma (In-Pharma)
  • Leveraging benefit-risk information to achieve better outcomes (Deloitte)

General Regulatory And Interesting Articles

  • Airing, a Hoseless Micro-CPAP, Hoping to Become a Reality (MedGadget)
  • Pot For Parasites? Pygmy Men Smoke Out Worms (NPR)
  • Report: Viagra Doesn't Cause Melanoma But The Viagra Lifestyle Might (Forbes)
  • The 'smart' insulin patch that might one day replace injections for diabetic patients (WaPo)
  • Can placebo pills help cancer survivors manage fatigue? (CBS)

Regulatory Reconnaissance #582 – 24 June 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.

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