Personalized medical intervention is in a transformative phase as artificial intelligence algorithms are increasingly deployed to tailor treatments for individual patients based on their unique characteristics. Developers...more
The expansion of artificial intelligence (“AI”) applications in healthcare (“Healthcare AI”) has made recent headlines, from the transformation of clinical diagnostics with increased accuracy, to use of personalized medicine...more
GenAI, or Generative AI, has seen a surge in patenting activity with China leading the way in filing patent applications for this technology. The landscape analysis by WIPO reveals Tencent, Ping An Insurance Group, and Baidu...more
Between 2014-2023, China has filed more patent applications (38,000) covering Generative AI (GenAI) technology than another other country, six times more than second place United States, as reported by the World Intellectual...more
In part one of our series "FemTech: how this growing industry can build trust, protect privacy and redress healthcare inequity… one app at a time", we take an introductory look at the industry, and offer some...more
On December 8, 2023, the U.S. Food and Drug Administration (FDA) approved two new gene therapies for the treatment of sickle cell disease. The first, Casgevy™ (exagamglogene autotemcel (exa-cel)), is the first-ever approved...more
Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more
On March 31, 2023, Governor Andy Beshear signed Senate Bill 47 making medical marijuana use and sale legal in Kentucky, effective January 1, 2025. Kentucky now joins at least 37 other states that have legalized medical...more
The Personalized Medicine Coalition (PMC) recently released its annual report on the progress of precision medicine as measured by precision medicine FDA approvals in 2022 (“Report”). As summarized in the Report, 2022...more
With the health care industry under pressure to improve patient outcomes while controlling costs, artificial intelligence (AI) and machine learning (ML) are quickly becoming indispensable tools. These technologies show...more
As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more
Precision or personalized medicine seeks to find the right treatment for each patient at the right time based on the patient’s genes, proteins and other personal characteristics. The approach has been successfully used to...more
Last week I reported on The Personalized Medicine Coalition’s (PMC) recently released PERSONALIZED MEDICINE AT FDA: The Scope & Significance of Progress in 2021(2021 Report) that surveyed U.S. Food and Drug Administration...more
The Personalized Medicine Coalition (PMC) released PERSONALIZED MEDICINE AT FDA: The Scope & Significance of Progress in 2021(2021 Report), its recent survey of U.S. Food and Drug Administration (FDA)-approved personalized...more
Editor’s Note: In a new white paper, summarized below, Manatt Health partners with Tia to reveal how women would advise the next President of the United States, regardless of who it is, on their healthcare priorities for the...more
On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward...more
On August 26, 2020, the U.S. Food and Drug Administration approved Foundation Medicine, Inc.’s Foundation One® Liquid CDx, a quantitative next-generation sequencing (NGS) test that can detect mutations using circulating...more
Does payer coverage of genomic testing drive utilization? That is the question The Personalized Medicine Coalition (“PMC”) asked and answered in its recent report “Understanding Genomic Testing Utilization and Coverage in the...more
Editor’s Note: The U.S. primary healthcare system does not effectively meet women’s needs during the teen and young adult years and/or as they age and transition through later stages of life. In a new report prepared in...more
The United States Patent and Trademark Office (USPTO) published the latest revision to its Manual of Patent Examining Procedure (MPEP) on June 30, 2020. According to the Executive Summary, in this revision, nearly all of the...more
On April 27, 2020, Representatives Fred Upton (R-Michigan) and Diana DeGette (D-Colorado) released a “concept paper” to build on the success of the 21st Century Cures Act (Pub. L. 114-255) and improve the country’s...more
...The Personalized Medicine Coalition (“PMC”) recently published its 2020 Spring Newsletter that examines the landscape and outlook for personalized medicine as COVID-19 prompts new discussions about the effect of COVID-19...more
The U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), recently published rules implementing...more
Personalized medicine selects the best therapy or course of treatment for each patient based on diagnostic testing. In one aspect, personalized medicine uses pharmacogenetic testing to provide information regarding: 1) how an...more
In Advisory Opinion 20-02, the Office of Inspector General (OIG) approved certain lodging and travel assistance offered by a pharmaceutical manufacturer to patients being administered a drug manufactured by the pharmaceutical...more