Regulatory Focus™ > News Articles > Regulatory Recon: 21st Century Cures Act Unanimously Approved by House Committee (22 May 2015)

Regulatory Recon: 21st Century Cures Act Unanimously Approved by House Committee (22 May 2015)

Posted 22 May 2015 | By Alexander Gaffney, RAC

Regulatory Recon: 21st Century Cures Act Unanimously Approved by House Committee (22 May 2015)

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

In Focus: US

  • House committee approves 21st Century Cures Act (Reuters) (Gray Sheet-$) (Press) (Pink Sheet-$) (BioCentury) (SCRIP-$) (The Hill) (E&C)
  • FDA: Here's Why oncology drugs fail to gain US regulatory approval (Nature-$)
  • FDA was warned years ago about superbugs in medical scopes (USA Today) (USA Today)
  • FDA Strengthens Testing Requirements for Blood, Blood Products (FDA) (Law 360-$)
  • How State Right-To-Try Laws Create False Expectations (Health Affairs)
  • FDA’s Deadline To Update “Off Label” Policy (RPM Report-$)
  • Novartis' Summer Blockbuster LCZ696 Gains A Name, Skips An Advisory Panel (Forbes)
  • USP demands public standards for dietary supplements (Press)

In Focus: International

  • EMA's CHMP Recommends Eight New Medicines for Approval (EMA)
  • EMA confirms suspension of GVK Bioscience's drugs over flawed studies (Reuters) (EMA)
  • Industry calls for global alignment of qualification and validation guidelines (In-Pharma)
  • EMA Confirms Cardiovascular Risks With High-Dose Acetaminophen Uptake (EMA)
  • AMR a development challenge, not just a health security risk: India (India Times)
  • Bristol-Myers Faces a Compulsory License for an AIDS Drug in Peru (Pharmalot)

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US: Pharmaceuticals and Biotechnology

  • FDA: Here's Why oncology drugs fail to gain US regulatory approval (Nature-$)
  • FDA Strengthens Testing Requirements for Blood, Blood Products (FDA) (Law 360-$)
  • How State Right-To-Try Laws Create False Expectations (Health Affairs)
  • FDA’s Deadline To Update “Off Label” Policy (RPM Report-$)
  • Electronic Study Data Submission; Data Standards; Study Data Standardization Plan Recommendations (FDA)
  • Novartis' Summer Blockbuster LCZ696 Gains A Name, Skips An Advisory Panel (Forbes)
  • FDA Advisory Committee to Review GlaxoSmithKline’s Mepolizumab for Severe Eosinophilic Asthma (Tarius)
  • ‘Confusion’ Clogs Sunscreen TEA Proposals, ‘Radio Silence’ On NSURE Progress – Woodcock (Pink Sheet-$)
  • For Q1 and Q2 Determinations, OGD Nixes “The Price is Right” Process! (Lachman)
  • Physician groups urge FDA to ensure patient safety with greater transparency in biosimilar labeling (Biosimilar News)
  • Chinese Drug Manufacturer Boai NKY Pharma Put on Import Alert for GMP Problems (FDA)
  • OPDP finds fault with Rapaflo website (MM&M) (Pink Sheet-$)
  • Apotex recalling generic Zyprexa because the antipsychotic may be too weak (Fierce)
  • Calif. Justices Urged To Reconsider Pay-For-Delay Ruling (Law 360-$)
  • Hospira recalls solution marked as heparin (Fierce)

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

  • Sarilumab meets Phase III RA endpoints (BioCentury)
  • Otonomy's ear drug fails mid-stage trial, shares slide (Reuters)
  • Bluebird's gene therapy continues to show promise in early study (Reuters) (BioCentury) (SCRIP-$)
  • FDA Grants Orphan Drug Designation to Aura Biosciences’ Novel Treatment for Uveal Melanoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • Sanderson Farms CEO Resists Poultry-Industry Move to Curb Antibiotics (WSJ-$) (Fierce)

US: Medical Devices

  • FDA was warned years ago about superbugs in medical scopes (USA Today) (USA Today)
  • Cook Medical Joins Medical Device Single Audit Program Pilot (Press)
  • Is It Time to Reconsider Your Trial Design? (MDDI)
  • National Medicare Analysis Opened For Watchman Device (Gray Sheet-$)

US: Dietary Supplements

  • USP demands public standards for dietary supplements (Press)
  • Trade Org Says Ingredient Suppliers Should Follow Dietary Supplement Regulations (NPI)

US: Assorted And Government

Upcoming Meetings and Events

Europe

  • EMA's CHMP Recommends Eight New Medicines for Approval (EMA)
  • EMA confirms suspension of GVK Bioscience's drugs over flawed studies (Reuters) (EMA)
  • Industry calls for global alignment of qualification and validation guidelines (In-Pharma)
  • EMA Recommends Approval of Amgen's New Cholesterol Drug Repatha (EMA) (Reuters)
  • EMA recommends Imbruvica for the treatment of Waldenstrӧm’s macroglobulinaemia (EMA)
  • BMS Receives Positive CHMP Opinion for Opdivo for the Treatment of Advanced Squamous NSCLC (Press) (EMA)
  • MSD Receives Positive CHMP Opinion for Keytruda for the Treatment of Advanced Melanoma (Press) (EMA) (Reuters)
  • EMA recommends Unituxin to prolong survival in young patients with high-risk neuroblastoma (EMA)
  • EMA Confirms Cardiovascular Risks With High-Dose Acetaminophen Uptake (EMA)
  • Omidria Receives Positive Opinion from European Medicines Agency's Committee for Medicinal Products for Human Use (Press)
  • Bayer's Stivarga wins appeal to stay on CDF (PharmaTimes) (Pharmafile)
  • A boost for patient safety in the EU: What about the member states? (EurActiv)

India

  • AMR a development challenge, not just a health security risk: India (India Times)

Japan

  • Japan Prices Sovaldi Well Below U.S. (PharmAsia-$)

Australia

  • Australian eCTD submissions, version 3.0 (TGA)
  • GMP clearance application process improvements (TGA)

Other International

  • Gilead's Sovaldi faces renewed advocacy CL pressure, this time for China and Russia (Fierce)
  • Bristol-Myers Faces a Compulsory License for an AIDS Drug in Peru (Pharmalot)
  • Rational rollout of new medicines for diseases of poverty (AEI)

General Regulatory And Interesting Articles

  • Debunking The Five Big Myths About 'Big Pharma' (Forbes)
  • No, Pharmascolds Are Not Worse Than The Pervasive Conflicts Of Interest They Criticize (Forbes)

Regulatory Reconnaissance #563 – 22 May 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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