Personalized Medicine

News & Analysis as of

When it comes to personalized medicine (or precision medicine!), there seem to be more questions than answers

Over the course of four days at the BIO 2015 Convention, there were at least half a dozen sessions and countless speakers directly and peripherally addressing issues of personalized medicine, including reimbursement,...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

Will Personalized Medicine Survive Alternative Payment Models?

There is no doubt that health care costs in the United States are rising. According to a recent study published by the U.S. Department of Health and Human Services, personal health care expenditures in the United States...more

Federal Circuit Holds Sequenom Diagnostic Method Patent Invalid Under 101

On Friday, June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., affirming the district court's finding that Sequenom’s claims are invalid under 35 USC § 101. The court's...more

Divided Infringement Challenges for Personalized Medicine

On remand from the U.S. Supreme Court, the U.S. Court of Appeals for the Federal Circuit last month held in Akamai Tech. Inc. v. Limelight Networks Inc. that “direct infringement liability of a method claim under 35 U.S.C....more

An Update on 21st Century Cures Legislation

Last week the Personalized Medicine Coalition held its 11th Annual State of Personalized Medicine luncheon in Washington, D.C. U.S. Representative Michael Burgess, a member of the House Energy and Commerce Committee...more

The Double-Edged Sword: Genomic Profiling in Drug and Chemical Litigation

Since completion of the Human Genome Project, genomic profiling and the related advent of personalized medicine have become a hot topic. Many predicted this new genomic information would lead to targeted drug treatments that...more

Washington Healthcare Update

This Week: House E&C Releases Discussion Draft of 21st Century Cures Legislation Ahead of Legislative Hearing... FDA Finalizes Biosimilar Guidance Documents... CMS Updates Wage Index and Payment Rates for the Medicare Hospice...more

California's Bet on Precision Medicine

California sees opportunities in personalized medicine. Earlier this month, Governor Brown announced the creation of a two year initiative – California Initiative to Advance Precision Medicine to “begin building...more

Genetics-based medical treatment is not without problems

Many doctors and politicians are hailing genetics-based medical treatments as the future of medicine. With the personalized attention this medical approach allows, patients are expected to soon receive the best possible care...more

Waiting on Sequenom

As I write this there’s a voice in my head saying, “Be careful what you wish for!” but it has been five months since Sequenom was argued at the Federal Circuit, and the court has yet to issue its decision. In the meantime,...more

Perspectives on the President’s Precision Medicine Initiative

President Obama’s “precision medicine initiative” earmarked over $200 million from his proposed 2016 budget to “bring us closer to curing diseases like cancer and diabetes – and to give all of us access to the personalized...more

The ACLU, Working for the Man

The ACLU championed its efforts in the AMP v. Myriad case as being another instance of the group fighting for the rights of the many and the powerless against corporate America and the oligarchical few. In a paradox, it now...more

What Does President Obama's $215 Million "Precision Medicine Initiative" Mean for Genetic Privacy?

We have all heard about the burgeoning opportunities tied to the development of precision medicine (also called “personalized medicine”), which includes the use of an individual’s genetic information to design targeted...more

Details Emerge for President’s Precision Medicine Initiative

Personalized medicine has a friend in high places. President Obama recently announced an initiative to support “precision” or personalized medicine. In very general terms, the President stated during his 2015 State of the...more

President Obama Revisits Interest in Personalized Medicine

President Obama announced during his 2015 State of the Union Address that he is launching a new “precision” or personalized medicine initiative to advance personalized, effective therapies for the American public. As reported...more

Healthcare & Life Sciences Private Equity Deal Tracker: Assurex Health Secures $30 Million in Financing

Assurex, headquartered in Mason, Ohio, is a personalized medicine company specializing in helping physicians determine the right medication for individual patients with behavioral health disorders....more

Another Patent Challenge for Personalized Medicine

The U.S. Supreme Court’s recent trilogy of patent-eligibility decisions (Prometheus, Myriad and Alice) have called into question the validity of many U.S. patents on diagnostic medical methods. Nevertheless, legal battles...more

Privacy Issues in the Sharing of Genetic Information

Scientific breakthroughs and technological advancements have led to the emergence of personalized medicine — a practice based on the use of an individual's genetic profile to guide health care decisions made about the...more

Unlocking the Promise of Personalized Medicine: Reimbursement, Coverage, and Clinical Utility

AmerisourceBergen, in connection with the Business of Personalized Medicine Summit, released “Unlocking the Promise of Personalized Medicine: Perspectives on Reimbursement, Coverage, and Clinical Utility” (“Report“). The...more

Considering Sex-Specific Variation for Personalized Medicine

Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more

Managing IP Risk in the Age of Personalized Medicine

As discussed on Foley’s Health Care Law Today blog, personalized medicine treatment trends and innovations are leading diagnostic and therapeutic companies to form complex arrangements and partnerships with the ultimate goal...more

The Future of Coverage and Payment for Personalized Medicine Diagnostics

The past decade has seen incredible progress for the scope and impact of personalized medicine. Just ten years ago, tamoxifen and trastuzumab were among the few drugs that were routinely paired with a companion diagnostic...more

Personalized Medicine Today: PMC Issues Fourth State of the Industry Report

Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the...more

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more

41 Results
|
View per page
Page: of 2

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×