Category Archives: Uncategorized

Subscribe to Uncategorized RSS Feed

More Than 25% of New Molecular Entities Approved in 2016 Are Personalized Medicines

fda
The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug Administration (FDA). Personalized Medicine at FDA, 2016 Progress Report (Report). Personalized medicines are new drugs, agents or therapeutic biologics where … Continue reading this entry

New Report Outlines 5 Year Plan to Achieve Cancer Moonshot

federal_eagle1
The Cancer Moonshot Task Force has just released its 5 year plan for implementing President Obama’s “Cancer Moonshot” program (“Report”). The initiative, announced during President Obama’s 2016 State of the Union Address, is a national effort to dramatically accelerate efforts to prevent, diagnose and treat cancer that take advantage of recent advances in molecular medicine … Continue reading this entry

Breakthrough Business Solutions to Advance Personalized or Precision Medicine

16.11832_BPM_blog-ad
In today’s era of unprecedented opportunities and complexity within personalized medicine, it has become critical innovators in the space to adopt a collaborative approach with outside experts in order to quickly and affordably bring new products and services to market. And, as it turns out, collaboration may also be the key to achieving mainstream clinical … Continue reading this entry

FDA Issues Guidance on Use of Public Human Genetic Variant Databases and Their Use in Personalized Medicine

fda
Next Generation Sequencing (NGS) permits the analysis of millions of genetic variants at a time and has proven to be invaluable for the development of personalized or precision medicine. Analysis of whole genomes is providing insight into the diagnosis, prediction and treatment of disease, and will continue to do so as more genetic information is collected and … Continue reading this entry

Supreme Court Declines Sequenom Review

testtube
Last week the United States Supreme Court denied Sequenom’s petition to review the Federal Circuit’s holding in Sequenom Inc. v. Ariosa Diagnostic Inc., 788 F.3d 1371 (2015) that claims directed to detecting fetal DNA in maternal blood were invalid for failing to recite patent eligible subject matter. Therefore by default, the Court let stand the … Continue reading this entry

Data Transmission, Personalized Medicine, and Privacy

healthcare_IT
Health care analytics make use of patient data to inform treatment decisions and is increasingly moving front and center in personalized medicine. For example, the President’s Precision Medicine Initiative (see post of January 26, 2016) has rolled out a program to collect health data from one million volunteers to inform and guide future research. Consumers … Continue reading this entry

Federal Circuit Invalidates Another Diagnostic Patent

testtube2
In Ariosa Diagnostics, Inc. v. Sequenom, Inc., Slip Op. 2014-1139, 2014-114 (Fed. Cir. June 12, 2015), the U.S. Court of Appeals for the Federal Circuit held that Sequenom’s U.S. Patent No. 6,258,540 (the ‘540 Patent) was invalid under 35 U.S.C. § 101, for failing to claim patent-eligible subject matter. The Court’s decision is yet another application … Continue reading this entry