Regulatory Focus™ > News Articles > Regulatory Recon: US Setting Up Group on Experimental Ebola Treatments (8 August 2014)

Regulatory Recon: US Setting Up Group on Experimental Ebola Treatments (8 August 2014)

Posted 08 August 2014 | By Alexander Gaffney, RAC

Regulatory Recon: US Setting Up Group on Experimental Ebola Treatments (8 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

  • U.S. administration setting up group on experimental Ebola drugs (Reuters)
  • The rise of the seemingly serious but “just for entertainment purposes” medical app (MobiHealthNews)
  • Where Have All the 510(k) Rescission Letters Gone? (MDDI)
  • Medtronic lands FDA wins for new CRT-Ds and quadripolar lead (Mass Device) (Press)
  • Pfizer confronts surge of lawsuits over Lipitor (Reuters)
  • US Refuses Nigeria's Request for ZMapp Drug (IBT)
  • Doctors' 'conflict of interest' database gets delayed (The Hill)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • U.S. administration setting up group on experimental Ebola drugs (Reuters)
  • Pfizer confronts surge of lawsuits over Lipitor (Reuters)
  • Generics production predicted to return to the USA due to quality concerns (Pharma Letter-$)
  • When it Comes to Expanded Access, What's the Difference Between and Ebola Patient and a Cancer Patient? (Valley News)
  • Ebola: US Refuses Nigeria's Request for ZMapp Drug (IBT)
  • CDC Chief Warns Against 'False Hopes' on Ebola Drugs (NBC-Autoplay Video) (SCRIP-$)
  • In Ebola Outbreak, Who Should Get Experimental Drug? (NYTimes)
  • The revival of Phage Therapy to fight Antimicrobial Resistance – Part II: What about patent protection and alternative incentives? (Harvard BOH)
  • FDA Researchers Build Partnerships to Advance Innovations (FDA)
  • Work group passes epidural steroid injection consensus in response to FDA warning (Healio)
  • Teva Comments on Receipt of First Paragraph IV Notice for COPAXONE 40 mg/mL (glatiramer acetate injection) Formulation (Press)

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

  • MediVector said to be planning submission for Ebola (BioCentury)
  • Emergent submits BLA for anthrax treatment (BioCentury)
  • Eisai Announces Top-Line Phase Iii Trial Results Of Eribulin In Patients With Advanced Non-Small Cell Lung Cancer Following At Least Two Prior Regimens (Press)
  • Collegium's abuse-deterrent oxycodone meets in Phase III (BioCentury)
  • US Tresiba resubmission 'ahead of schedule' (SCRIP-$)
  • Orexigen Thinks Contrave On The Verge Of Approval, Again (Pink Sheet-$)
  • Bone marrow disorder treatment garners FDA fast track status for CTI BioPharma (MedCity News) (MM&M) (Fierce)
  • PI-88 misses in interim analysis for hepatitis virus-related HCC (BioCentury)
  • US Contracts With Company to Make Treatment for Smallpox Vaccine Complications (Press)

US: Pharmaceuticals and Biotechnology: General

  • Doctors' 'conflict of interest' database gets delayed (The Hill)
  • Reimbursement Bar for Orphan Drugs Rising (MM&M)
  • Why the federal government classifies marijuana like heroin (Vox)

US: Medical Devices

  • The rise of the seemingly serious but “just for entertainment purposes” medical app (MobiHealthNews)
  • Where Have All the 510(k) Rescission Letters Gone? (MDDI)
  • Medtronic lands FDA wins for new CRT-Ds and quadripolar lead (Mass Device) (Press)
  • Only about 0.1% of mHealth apps are FDA-approved (Becker's)
  • Sen Carper: We must secure radiological material (The Hill)

US: Dietary Supplements

  • FDA Recalls Supplement After Finding DMAA (FDA) (FDA) (FDA)

US: Assorted And Government

  • FDA 101: An Overview of FDA's Regulatory Review and Research Activities (FDA)

Europe

  • Drugs watchdog condemns Roche for high price of breast cancer therapy (Guardian) (Pharmafile) (Pharma Letter-$)
  • Roche to appeal NICE 'no' to breast cancer drug Kadcyla (Pharma Times) (SCRIP-$) (Pink Sheet-$) (PMLive) (Bloomberg)
  • Cancer Drugs Fund seems to help pharmaceuticals giant Roche most (Guardian)
  • European Medicines Agency accused of censoring researchers over drug safety analyses (PJO)
  • Medicines regulator consults on which medicines should carry anti-counterfeit features (PJO)
  • U.K. cost-effectiveness watchdog bars access to AstraZeneca's Iressa (Fierce)
  • EMA concept paper focuses on quality control with animal tests (Outsourcing Pharma)
  • Alnylam Receives Orphan Drug Designations in the European Union for ALN-AT3, an RNAi Therapeutic in Development for the Treatment of Hemophilia (Press)
  • European Medicines Agency Accepts Application Seeking New Indication For Prevenar 13®1 For Prevention Of Pneumococcal Pneumonia In Adults (Press)

India

  • How Much? Gilead Will Charge $900 for Sovaldi in India (Pharmalot) (Fierce) (Forbes)
  • Bangladesh Drug Administration Director Jailed (PharmAsia-$)
  • India’s CDSCO outlines procedures for state inspections of manufacturers (In-Pharma)

China

Japan

  • Japan’s First Committee On Drugs Recommends Novel Insomnia Drug (PharmAsia-$)

Other International

  • WHO declares Ebola epidemic an international health emergency (Reuters) (WHO) (NPR) (SCRIP-$)

Clinical Trials

  • Drug Supply Shortages in Clinical Trials, Part 1 (BioClinica)

General Regulatory And Interesting Articles

  • Ebola Vaccine Possible, but Many Doubts Persist (NYTimes)
  • Five Steps to Data Integrity (PharmExec)
  • Is the gut microbiome a potential cause and therapeutic target for autoimmune diseases like multiple sclerosis? (Press)

Regulatory Reconnaissance #375 – 8 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.


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