Regulatory Focus™ > News Articles > Regulatory Recon: EU's Clinical Trial Regulation is Here (29 May 2014)

Regulatory Recon: EU's Clinical Trial Regulation is Here (29 May 2014)

Posted 29 May 2014 | By Alexander Gaffney, RAC

Regulatory Recon: EU's Clinical Trial Regulation is Here (29 May 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

In Focus: International

  • EU Clinical Trials Regulation Published for Adoption by Member States (EMA) (BioCentury) (Regulation)
  • UK patent changes could attract more new drug trials (SCRIP-$)
  • Italy Seeks $1.6 Billion Over Roche, Novartis Eye Drugs (Bloomberg)
  • India's Pharma & Health Ministries Together? Drug Cos Worry (Businessworld)
  • CFDA’s Fast-Track Orphan Drug Effort Spurs Domestic Firms To In-License (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

  • Boehringer Ingelheim to Pay $650 Million to Settle Pradaxa Lawsuits (BI) (NYTimes) (Pink Sheet-$) (Pharmafile) (Fierce) (SCRIP-$) (Law 360-$) (BioCentury) (PharmPro) (Forbes)
  • House Appropriators Ask For New Economic Analysis Of FDA's Generic Labeling Rule (IHP-$)
  • Drugs Can Reach Patients Faster and Cheaper, FDA Chief Says (Bloomberg)
  • FDA Sticks To Hard Line On Abuse-Deterrent Opioids (Pink Sheet-$) (Reuters)
  • FDA and Pan American Partners Work to Strengthen Regulatory Systems (FDA)
  • Michigan Introduces Biosimilar Substitution Bill (MI House)
  • FDA Approval Summary: Erlotinib for the First-Line Treatment of Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Exon 19 Deletions or Exon 21 (L858R) Substitution Mutations (The Oncologist) (Full)
  • US FDA approves Eisai’s Aloxi for children and extends exclusivity (Pharma Letter-$) (Eisai)
  • Can there be more than one level of drug quality? (Drug Wonks)
  • Judge Sends Abuse-Resistant OxyContin Patents To Trial (Law 360-$)
  • DEA Loosens Grip on Marijuana Research (Harvard BOH)
  • Steps toward harmonization for clinical development of medicines in pediatric ulcerative colitis-a global scientific discussion (PubMed) (PubMed)
  • Trimel Receives FDA Approval for Natesto Nasal Gel to Treat Men with Low Testosterone (Press)
  • Nuvo Research announces U.S. FDA approval of third-party generic of PENNSAID 1.5% (Press)

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

  • Mallinckrodt New Drug Application For MNK-155 Accepted For Review By FDA (Press) (DD&D) (SCRIP-$) (PharmPro)
  • Rockwell's iron replacement drug Triferic under FDA review (SCRIP-$) (BioCentury)
  • Adamis Submits New Drug Application to FDA for Its Epinephrine Pre-Filled Syringe (PipelineReview)
  • US: Pharmaceuticals and Biotechnology: General
  • Insurers Push to Rein In Spending on Cancer Care (WSJ-$) (Fierce) (BioCentury)
  • Top 10 best-selling cancer drugs of 2013 (Fierce)
  • Pregnancy Woes: Why Did The Price Of My Progesterone Skyrocket? (WBUR)
  • R&D productivity: Drug approvals don’t tell the whole story (In-Pharma)

US: Medical Devices

  • FDA Approves CardioMEMS' Novel Implanted Sensor To Monitor Heart Failure (FDA) (Forbes) (Press) (NYTimes) (Gray Sheet-$) (Fierce) (Mass Device) (MDDI) (AP)
  • FzioMed Oxiplex Dispute Panel Postponed So CDRH Can Review More Data (Gray Sheet-$) (Mass Device)
  • 8 Traits of a Good Document Control System (MedDevSummit)
  • Is Your Complaint Management Process Effective? (MedDevSummit)
  • EDAP outlines road to FDA approval for prostate cancer ultrasound therapy (Mass Device)
  • Company Looking to Bring New Type of Condom to Market (LA Weekly)
  • Cantel Medical and OsteoSymbionics Announce FDA 510(k) Clearance of ClearShield Implant Using Novel REVOX® Sterilization Process (Press)
  • Dem proposes studying health effects of menstrual products (The Hill)

US: Dietary Supplements

  • GNC Evades False Ad Action Over Amino Acid Supplements (Law 360-$)

US: Assorted And Government

  • FDA's Chief Information Officer Counting Down on Twitter… is openFDA close to Launch? (Twitter)

Europe

  • EU Clinical Trials Regulation Published for Adoption by Member States (EMA) (BioCentury) (Regulation)
  • UK patent changes could attract more new drug trials (SCRIP-$)
  • Italy Seeks $1.6 Billion Over Roche, Novartis Eye Drugs (Bloomberg)
  • EMA “look, but don’t touch” terms of use for clinical study data are impracticable, says IQWiG (Pharma Letter-$)
  • NICE gives negative guidance on Janssen’s Stelara for psoriatic arthritis (Pharma Letter-$)
  • Don't combine sartans and ACE-inhibitors, says EU's CHMP (SCRIP-$)

India

  • India's Pharma & Health Ministries Together? Drug Cos Worry (Businessworld)
  • An open letter to PM Narendra Modi for an effective drugs regulator to revive the sector (India Times)
  • New India Pharma Minister Proposes Lowering Key-Drug Prices 25%-40% (PharmAsia-$)
  • CDSCO to come out with clean basket of FDCs in eight months (PharmaBiz)
  • Government mulls bringing cancer, AIDS drugs under price control (India Times)

Japan & China

  • CFDA’s Fast-Track Orphan Drug Effort Spurs Domestic Firms To In-License (PharmAsia-$)
  • GSK salesmen want ‘bribes’ reimbursed (FT-$)

Other International

  • ICH Releases Agenda for Upcoming Meeting (ICH)
  • Australia: Annual charges for manufacturing licences (TGA)

General Regulatory And Interesting Articles

  • Hidden Novel Proteins Found That May Aid Against Disease (Bloomberg)
  • Now You Can See Which Diseases Are Trending At The Doctor's Office (Fast Company)

Regulatory Reconnaissance #327 – 29 May 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email atnews@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