Regulatory Focus™ > News Articles > Regulatory Recon: 21st Century Cures Bill Clears House Subcommittee (15 May 2015)

Regulatory Recon: 21st Century Cures Bill Clears House Subcommittee (15 May 2015)

Posted 15 May 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: 21st Century Cures Bill Clears House Subcommittee (15 May 2015)

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

In Focus: US

In Focus: International

  • Indian court bars Glenmark from selling Merck drug copies (Reuters)
  • German government poised to tackle growing antibiotic resistance (EurActiv)
  • Australia to adopt EMA’s biosimilars guidelines (GaBi)
  • TPP Draft Seeks to Limit Use of Compulsory Licensing (KEI)
  • ICH door closes on new industry members ahead of reforms (SCRIP RA-$)

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US: Pharmaceuticals and Biotechnology

  • Generic ADHD Drug Maker Locks Horns With FDA (Pharmalot)
  • FedEx Seeks Dismissal of Federal Drug Indictment  (AP) (Bloomberg) (Law 360-$) (Fierce)
  • Clinical Trial System Needs Radical Change, FDA’s Califf Says (Pink Sheet-$)
  • Branded Pharma Groups Attack Proposed REMS Reforms (HealthAffairs)
  • Lessons learned from two years of breakthrough therapy designation (Health360)
  • Sunscreen TEA ‘Confusion’ Clogs Ingredient Proposals – Woodcock (Tan Sheet-$)
  • Actavis says Warner Chilcott unit held talks to settle U.S. probe (Reuters)
  • FDA Approves TREXIMET (sumatriptan and naproxen sodium) for Use in Pediatric Patients (Press)
  • Postmarketing safety of biologics and biological devices (PubMed)
  • Sens. Feinstein, Grassley Urge DOJ, HHS to Facilitate Cannabidiol Research (Senate)

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

  • Teva says chronic migraine drug is ready for phase III (PMLive)
  • Amgen's migraine drug shows promise in Phase II (PharmaTimes)
  • New Keytruda data show responses in diverse tumor types (BioCentury)
  • The ASCO roundup: Thumbs down for Puma, up for Roche, mixed for Bristol-Myers (Fierce)
  • NewLink continues cancer vaccine Ph III trial with interim data under wraps (Fierce)
  • FDA Grants Orphan Drug Designation To GlycoMimetics’ GMI-1271 For Treatment of Acute Myleogenous Leukemia (AML) (Fierce)

US: Pharmaceuticals and Biotechnology: General

  • Biosimilars Forum says CMS coding issues could discourage US biosimilar adoption (BioPharma-Reporter)
  • Calif. Moves Closer To Banning Vaccine 'Personal Belief' Exemptions (NPR) (Reuters)

US: Medical Devices

  • Study: Diagnostics not keeping pace with personalized medicine (MM&M) (Press)
  • Parsing Pros And Cons Of FDA's Expedited Access Pathway (Law 360-$)
  • The Dos and Don'ts of IVD Clinical Trials (MDDI)
  • Scope makers won't testify but say they are working with FDA on superbug (LATimes)
  • Medtronic's leadless pacemaker and MRI-safe defibrillator present positive trial data at cardiology conference (Fierce) (MassDevice)
  • Sunlamp Products & UV Lamps: 3 Months to Submit 510(k)s to FDA (Registrar Corp)
  • FDA Classifies Recall of HeartWare HVAD Device as Class 1 (FDA)

US: Assorted And Government

Upcoming Meetings and Events

Europe

  • German government poised to tackle growing antibiotic resistance (EurActiv)
  • Underperformance of EU medtech industry overseers pinpointed in joint assessment initiative (SCRIP RA-$)
  • Medtronic vein closure device recalled in Europe, Asia right around time of its U.S. launch (Fierce)
  • UK in talks with albumin suppliers over imminent shortages (SCRIP-$)

India

  • Indian court bars Glenmark from selling Merck drug copies (Reuters)
  • 3 years on, probe into Bhopal's drug trials case still incomplete (India Times)

China

  • China’s New Dietary Supplement Law Goes into Effect in October. But Will It Solve the Problems? (Nutritional Outlook)

Australia

  • Australia to adopt EMA’s biosimilars guidelines (GaBi)

Other International

  • TPP Draft Seeks to Limit Use of Compulsory Licensing (KEI)
  • ICH door closes on new industry members ahead of reforms (SCRIP RA-$)
  • Saudi Arabia Tightens Regulation of Drug Imports, Exports (FDAnews-$)

Clinical Trials

  • Antiquated clinical trial industry ripe for change from innovation, experts say (Outsourcing Pharma)

General Regulatory And Interesting Articles

  • Bacteria May Be Remaking Drugs in Sewage (Scientific American)
  • Viagra may help cure malaria, research suggests (Popular Science) (Study)
  • Sanofi is Prioritizing Implementation of Coordinated Lifecycle Management Processes for Automation Systems to Head Off Manufacturing Breakdowns (IPQ-$)

Regulatory Reconnaissance #558 – 15 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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