Regulatory Focus™ > News Articles > Regulatory Recon: Should FDA Have Approved Triclosan for Use in Toothpastes? (11 August 2014)

Regulatory Recon: Should FDA Have Approved Triclosan for Use in Toothpastes? (11 August 2014)

Posted 11 August 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Should FDA Have Approved Triclosan for Use in Toothpastes? (11 August 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

  • Colgate’s Unseen FDA Pages Flag Concerns Over Triclosan (Bloomberg)
  • First US biosimilar MAb on the horizon as Celltrion files Remsima (SCRIP-$) (Press)
  • FDA approves J&J diabetes drug Invokamet (Pharma Times) (Press) (SCRIP-$)
  • FDA’s New Biosimilars Guidance: Liberal Criteria Opens the Door to More Exclusivities Being Awarded (FDA Law Blog)
  • Four unanswered questions about the looming LDT regulations (Fierce)
  • U.S. emergency labs ready to work on Ebola drugs if asked (Reuters)
  • Clinical trial to start soon on GSK Ebola vaccine (Reuters) (Fierce) (Pharmafile)

In Focus: International

  • EU approval for Bayer’s Eylea in diabetic macular oedema (PharmaPhorum) (Pharma Times) (Press)
  • EMA Accepts Application for Pfizer's New Pneumococcal Vaccine Indication (Press) (BioPharma Dive)
  • AstraZeneca Sees Cost-Obsession Behind NICE’s Rejection Of Iressa (Pink Sheet-$)
  • Supreme Court stays Bombay High Court drug price order in favour of Pfizer (India Times) (India Times)
  • Group seeks standardization for what clinical trials must measure (Nature)

US: Pharmaceuticals and Biotechnology

  • Colgate’s Unseen FDA Pages Flag Concerns Over Triclosan (Bloomberg)
  • First US biosimilar MAb on the horizon as Celltrion files Remsima (SCRIP-$) (Press)
  • FDA approves J&J diabetes drug Invokamet (Pharma Times) (Press) (SCRIP-$)
  • FDA’s New Biosimilars Guidance: Liberal Criteria Opens the Door to More Exclusivities Being Awarded (FDA Law Blog)
  • Are Biosimilars Ready For Primetime? (Morning Consult)
  • Eisai Sues FDA To Reclaim Lost Exclusivity For 2 Drugs (Law 360-$) (FDA Law Blog)
  • FDA Approves Takeda's Velcade (bortezomib) Retreatment in Patients with Multiple Myeloma (Press)
  • The revival of Phage Therapy to fight Antimicrobial Resistance (AMR) – Part III: What about patent protection and alternative incentives? (Harvard BOH)
  • FDA Conducting Testing on DILI and Biomarker Development (FDA)

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

  • Genentech submits sBLA for Lucentis for diabetic retinopathy (BioCentury) (Press) (Press) (SCRIP-$)
  • Results Show Anthrax Vaccine is Potent with Rapid Onset (Press)
  • Mirati Therapeutics Receives Orphan Designation from FDA for Mocetinostat in Diffuse Large B-Cell Lymphoma (Press)
  • FDA Assigns PDUFA Goal Date for Salix's RELISTOR for Opioid-induced Constipation (Press)

US: Pharmaceuticals and Biotechnology: General

  • US Capitol Capsule: Allocating scarce drugs: Quandary beyond Ebola (SCRIP-$)

US: Medical Devices

  • Four unanswered questions about the looming LDT regulations (Fierce)
  • Medicare finalizes coverage for MitraClip (Mass Device)
  • July 2014 510(k) Clearances (FDA)

US: Assorted And Government

  • Medical Marijuana Research Hits Wall of U.S. Law (NYTimes)
  • Retrophin CEO Under Fire for Twitter Faux Pas (The Street)

Ebola Outbreak

  • U.S. emergency labs ready to work on Ebola drugs if asked (Reuters)
  • Clinical trial to start soon on GSK Ebola vaccine (Reuters) (Fierce) (Pharmafile)
  • Spanish Ebola Patient Gets Experimental Drug (PharmPro)
  • GSK plays down progress of Ebola vaccine (Pharma Times)
  • HHS Publishes Declaration of Emergency Use of Ebola Diagnostics Device (HHS)
  • Sarepta Therapeutics urges government to approve its Ebola drug (BIoPharma Dive)
  • Statement by Commissioner Borg on the Ebola outbreak in West Africa (EU)
  • US Defense Threat Reduction Agency contracts with NewLink Genetics for Ebola vaccine (MedCity News)
  • Industry an Effective Partner in Preparing for Biological Threats (Roll Call)
  • Vaccine against Ebola will not be available before 2015: WHO (India Times)
  • Investors Pump Prospects Of Unproven Ebola Treatments (NPR)
  • Frustration, suspicion over lack of Ebola drugs in West Africa (CBS)
  • UTMB receives over $6 million to develop treatment for deadly Ebola and Marburg viruses (Press)

Europe

  • EU approval for Bayer’s Eylea in diabetic macular oedema (PharmaPhorum) (Pharma Times) (Press)
  • EMA Accepts Application for Pfizer's New Pneumococcal Vaccine Indication (Press) (BioPharma Dive)
  • AstraZeneca Sees Cost-Obsession Behind NICE’s Rejection Of Iressa (Pink Sheet-$)
  • Clinigen backs white paper calling for recognition of early access schemes (Pharma Letter-$)
  • Belgian pharma trade body issues recommendations on domestic drug shortages (Pharma Letter-$)
  • A Look at Pharmaceutical Lobbying in the EU (HAI-PDF)

India

China

Other International

  • Russia may restrict drug imports from Western countries (Pharma Letter-$)

Clinical Trials

  • Group seeks standardization for what clinical trials must measure (Nature)

General Regulatory And Interesting Articles

  • For $12,000, a company grafts a patient’s cancer into rodents and tests drugs on them. (MIT TR)
  • NIST project works to standardize identification of CHO, rat cell lines (BioPharma Reporter)
  • GE-funded NGO aims to repair developed-world medical devices in the developing world (Fierce)
  • Will Human Factors Engineers Have a Role in Medtech’s Future? (MDDI)
  • Layered Thin-Film Drug Delivery System Could Supply Medicine Internally For Up To A Year (MedGadget)

Regulatory Reconnaissance #376 – 11 August 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.

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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