US

3D printing of drugs: “the possibilities seem endless”

The possibilities do seem endless, but the Guardian asks whether the 3D printing of medications is safe. They speculate how the pharmacies might change if drugs were printed in local pharmacies, to exact and personalized formulations. The FDA has already given the go-ahead for Spritam levetiracetam (a drug used to control epilepsy) and the hope is to follow with […]

The Contrasting Medicines Regulatory Environments of China and the Western World

For purposes of anticounterfeiting and pharmacovigilance, “in our world of economic unions and free trade agreements, a country’s drug regulations are only as good as its weakest import partner”.

 

Peter J. Harris and Ian C. Shaw (2015) The Contrasting Medicines Regulatory Environments of China and the Western World, Pharmaceutical Medicine, First online: 16 October 2015 : http://link.springer.com/article/10.1007/s40290-015-0117-3/fulltext.html

 

Note: the reference list […]

On the White House Precision Medicine Initiative

From the White House Blog:

The Precision Medicine Initiative: Data-Driven Treatments as Unique as Your Own Body
http://www.whitehouse.gov/blog/2015/01/30/precision-medicine-initiative-data-driven-treatments-unique-your-own-body

Includes also link to the White House plan and a video about precision medicine.

The title of the blog, as well as the three examples provided, illustrate how ‘precision medicine’ involves digital technology (not just genomics):

“• The drug ivacaftor treats the underlying cause […]

On innovation, policies, economic returns – the cases of antibiotics , new and transformative drugs

In the current issue of Health Affairs :

February 2015; Volume 34, Issue 2 Biomedical Innovation
http://content.healthaffairs.org/content/34/2.toc

Outterson, K., J. H. Powers, G. W. Daniel and M. B. McClellan (2015). “Repairing The Broken Market For Antibiotic Innovation.” Health Affairs 34(2): 277-285. http://content.healthaffairs.org/content/34/2/277.abstract

“…Good public health practices curb inappropriate antibiotic use, making return on investment challenging in payment systems based on sales volume. We […]

NEWS: Obama’s Precision Medicine Initiative

Obama calls for major new personalized medicine initiative

http://www.reuters.com/article/2015/01/21/usa-obama-genomics-idUSL1N0V000N20150121

On the rise of the “translational state” – The State commitment to accelerating the commercial translation of biomedical research

Hogarth, S. “Neoliberal technocracy: Explaining how and why the US Food and Drug Administration has championed pharmacogenomics.” Social Science & Medicine. Available online 15 January 2015 – In Press, Accepted Manuscript
http://www.sciencedirect.com/science/article/pii/S0277953615000313

Abstract:
“By 2004 the FDA had emerged as a champion of pharmacogenomics as an exemplar for novel approaches to drug development. This was made clear in 2004 when […]

McKinsey report: A digital prescription for pharma companies

Patients are changing, Governments are moving… “Pharmaceutical and medical-device companies have been slow to adopt digitization. Here are five reasons they should get moving…”

for digitally enabled healthcare…

 

The report is here: http://www.mckinsey.com/insights/health_systems_and_services/a_digital_prescription_for_pharma_companies

 

December 6th, 2014|Business, Medicine|0 Comments|

On medicines supply – Drug shortages in European countries

A new paper on the problem of drug shortages and the sustainability of the medicine market:

Drug shortages in European countries: a trade-off between market attractiveness and cost containment?

by Kim Pauwels, Isabelle Huys, Minne Casteels and Steven Simoens
BMC Health Services Research, 2014, 14 :438

http://www.biomedcentral.com/1472-6963/14/438
Abstract

Background
Drug shortages are a global problem. While extensively studied in the United States, numbers about drug […]

October 1st, 2014|Regulation, Value|0 Comments|