By John Leavitt, Ph.D. Nerac Analyst
Originally Published: July 21, 2014
When I saw an obit for Hilary Koprowski recently, I was surprised that it did not mention his benchmark work with “monoclonal antibodies” or “hybridomas.” Read more
The Cloning of Human Embryonic Stem Cells…and Human Beings?
By John Leavitt, Ph.D. Nerac Analyst
Originally Published July 21, 2014
Recently we read in the NY Times of a successful cloning of human embryonic stem cells by Oregon Health and Sciences University researchers led by Professor Shoukhrat Mitalipov. Read more
The Holy Grail of Cancer Research – A Protein That Enables Aggressive Tumor Growth and Metastasis
By John Leavitt, Ph.D. Nerac Analyst
Originally Published July 21, 2014
Such a protein appears to be described in a paper published in the journal Molecular Cancer Therapeutics in February 2014 by Heinz-Josef Lenz at the Keck School of Medicine of the University of Southern California in collaboration with colleagues at the University of Graz in Austria. Read more
Environmental Responsibility in Cosmetics: The Case of Microbeads
By Stephenie Smulligan-Maldanis, Nerac Analyst
Brilliant, white teeth and clear skin: it seems like Americans are in constant pursuit of youth and beauty. Read more
Telemedicine: A Tool for Reducing the Cost of Delivering Medicine
By Roz Sweeney, Ph.D., Nerac Analyst
Originally Published: July 21, 2014
Global economic weakness beginning in 2008, along with an aging population, has intensified the need to reduce healthcare costs. There is a general consensus that the rate of increase in healthcare spending is not sustainable. Since 2009, the annual rate of healthcare spending increases have dropped in the United States; however, it is not clear if this is a temporary phenomenon, or if spending increases will resume to previous levels as the economy improves. Read More
Modest Impact on Personalized Medicine Expected from Recent SCOTUS Rulings
By Roz Sweeney, Ph.D. Nerac Analyst, The recent Supreme Court decision on the Association for Molecular Pathology v. Myriad Genetics case was the culmination of much litigation on the validity of patent protection for the genomic sequences of BRCA1 and BRCA2. Myriad Genetics’ patents on these two genes gave it the exclusive right to offer genetic […]
The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements
By Donna Mitchell-Magaldi, Nerac Analyst, On March 20, 2010, the revised Guideline; MedDev 2.7.1 Rev 3 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies became a requirement for obtaining and maintaining a CE Mark for all classes of devices marketed in the European Union. An important component of the MedDev 2.7.1 Rev 3 is the […]
The Costs of Regulatory Noncompliance in the Medical Device Industry: Is it Worth the Gamble?
By Donna Mitchell-Magaldi, Nerac Analyst,
The global medical device market was valued at $350 billion dollars in 2012 (Mddonline.com, 2012).
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Cost Reduction Technologies: An Expanding Market for Medical Technology Companies
By Roz Sweeney, Ph.D. Nerac Analyst, Healthcare payers, both in the United States and Europe, have been striving to reduce costs in recent years, and this trend is expected to continue. To address this emphasis on cost-reduction, medical device companies are becoming increasingly interested in the market for technologies that reduce costs to the overall healthcare […]
Clinical Literature Evaluations to Support Medical Device Marketing
By Roz Sweeney, Ph.D. Nerac Analyst,
Comprehensive evaluations of the clinical and technical literature serve a variety of purposes for medical device companies.
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