News & Analysis as of

Personalized Medicine Pharmaceutical Industry

FDA Offers Guidance on Streamlined Development of Treatments for Rare Bacterial Infections

by Knobbe Martens on

On August 1, 2017, the U.S. Food and Drug Administration released its draft guidance titled Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases, detailing proposals...more

Cleveland Clinic Decision Highlights Catch-22 Of Personalized Medicine Patents

by Foley & Lardner LLP on

The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized...more

Forget Bigger Data – Personalized Medicine Needs Smarter Data to Reach its Full Potential

by Foley & Lardner LLP on

The advent of big data has helped enable the growth of personalized medicine. But if machine learning and analytics are to truly help transform health care, it won’t be through bigger data, but through harmonized, smarter...more

New Report Outlines 5 Year Plan to Achieve Cancer Moonshot

by Foley & Lardner LLP on

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...more

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

by Foley & Lardner LLP on

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

USPTO Releases Patent Eligibility Update

by Foley & Lardner LLP on

On May 4, 2016, the USPTO released a “May 2016 Subject Matter Eligibility Update” (“Update”) providing guidance to patent examiners on formulating a subject matter eligibility rejection and evaluating an applicant’s response...more

Life lines: Life sciences M&A and the rise of personalised medicine

by Reed Smith on

The second report in our Deal Dimensions series, written in collaboration with Mergermarket and launched today, reveals that 94 per cent of life sciences companies are planning an acquisition in the next year, with more than...more

Three Pressing Challenges for Personalized Medicine

by Foley & Lardner LLP on

Personalized medicine can be described as the science of targeted therapies. Advances in diagnostic and molecular medicine have made it possible to more precisely identify alternative treatment options for patients based on...more

[Event] 2015 Business of Personalized Medicine Summit - Oct. 7, San Francisco, CA

by Foley & Lardner LLP on

Just as with patient treatments, one size does not fit all when it comes to companies involved in personalized medicine. Each is unique in its mission, culture, and capabilities, and so it should come as no surprise that each...more

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

by Foley & Lardner LLP on

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

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

by Dentons on

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

by Faegre Baker Daniels on

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

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

by Foley & Lardner LLP on

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

FDA FY2012 Drug Approvals Equal FY2011 Mark

Last month, the U.S. Food and Drug Administration released its annual report on innovative drug approvals, noting that the agency approved 35 novel medicines in FY 2012. The 35 approvals equaled the number of approvals for...more

Getting the Best Medical Care: a Newsletter from Patrick Malone - January 2013

In This Issue: - Six Things to Think About as Technology Advances - For More Information - Recent Health Care News You Should Know About - Check Out Our Previous Tips - Deep Thoughts for the New Year: Ethical...more

Personalized Medicine: An Industry Report

by Foley & Lardner LLP on

Increasingly, the development of new pharmaceuticals utilize genetic information to stratify patient subpopulations and/or predict efficacy and adverse events – the development paradigm of personalized medicine....more

16 Results
|
View per page
Page: of 1
Cybersecurity

"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 using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*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.