On December 12, 2019, an outbreak of a severe pneumonia broke out of Wuhan, China. The causative agent of the outbreak was determined to be a coronavirus, an enveloped positive- and single-stranded RNA virus that infects vertebrates. The newly discovered
Personalized Medicine Bulletin
The Personalized Medicine Bulletin, published by Foley & Lardner LLP, focuses on legal and regulatory developments related to precision and personalized medicine. It covers topics such as FDA approvals of personalized therapies, gene and cell-based treatments, diagnostic testing systems, and emerging technologies in biomanufacturing and gene editing. The bulletin also addresses government initiatives and funding programs supporting precision medicine research, including NIH and White House efforts. Additionally, it discusses intellectual property issues like patent programs for cancer immunotherapy and regulatory guidance impacting the development and commercialization of personalized medical products.
Latest from Personalized Medicine Bulletin - Page 2
All of Us Research Workbench Open for User Feedback
The National Institutes of Health recently opened its data platform for user feedback of its “All of Us Researcher Workbench.” Researchers are now able to use the initial datasets obtained from nearly 350,000 participants in the All of Us research…
Improving 21st Century Cures Act: Personalized Medicine and COVID-19
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 surveillance and testing capabilities urgently…
Adjusting to Alice: USPTO’s View of Its Examination Guidelines
In 2014, the U.S. Supreme Court’s Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014) (“Alice”) held that technologies that merely implemented an abstract idea with a generic computer were not eligible for patent protection. As a result, the…
Personalized Medicine Coalition Releases Spring 2020 Newsletter Amid COVID-19
“As the emergence of COVID-19 grips the global psych, policymakers and citizens will increasingly turn to thought leaders in health and medicine for answers about how to equip our health systems to respond to medical challenges in a new era.…
Utilization of Natural Phenomenon Found Patent Eligible
In Illumina, Inc. v. Ariosa Diagnositcs, Inc., (Fed. Cir. Slip Op. 2019-1419, March 17, 2020) the Federal Circuit held that process claims that exploit the discovered size differences between fetal and maternal DNA in serum or plasma are patent…
Collaborative Review of Scientific Evidence Announced By FDA
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 individual’s genes affect that person’s response to medications;…
Collaborative Review of Scientific Evidence Announced By FDA
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 individual’s genes affect that person’s response to medications;…
2019 FDA Precision Medicine Approvals: Progress At FDA
On February 21, 2020, the Personalized Medicine Coalition (PMC) released its annual “Personalized Medicine At FDA: The Scope and Significance of Progress in 2019” (Report) that monitors FDA approvals of precision medicine therapies and diagnostic assays.
Notable Developments…
2020 Business of Personalized Medicine Summit: Break Through to Solutions in the Birthplace of Biotechnology
By LexBlog
How are businesses across the health care and life sciences spectrum collaborating to capitalize on the commercial promise of personalized medicine? Find out at the 2020 Business of Personalized Medicine Summit — join us at Oyster Point in South San…