Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is manufactured by Pfizer Inc. and BioNTech SE. It consists of two doses taken three weeks apart, and …›
“We are finally starting to see into the future, understanding the ways COVID-19 is changing the future of FDA regulatory process and advancing innovation to meet the needs of today’s patients. Thanks to all the attendees for such amazing questions and contributions!” commented …›
On November 17, 2020, FDA issued the long-awaited first emergency use authorization (EUA) for a COVID-19 diagnostic test for self-testing at home. The test, the Lucira COVID-19 All‑In‑One Test Kit, can be conducted completely at home by anyone age 14 or over, by collecting …›
The U.S. Food and Drug Administration (FDA) is showing its dedication to the advancement of digital health technology with two recent announcements: a new Digital Health Center of Excellence and an update on its Software Precertification Program. Manufacturers developing mobile medical devices, …›
MoFo & GSAS Harvard Biotech Club’s new course, “Legal Topics for Scientists, Entrepreneurs, and Start Ups,” started on November 11, with more than 100 life sciences graduate students, post-docs, and industry professionals. The Harvard Biotech Club is a student organization that seeks to bridge …›
The GSAS Harvard Biotech Club and Morrison & Foerster course on Legal Topics for Scientists, Entrepreneurs, and Start Ups features a combination of lectures and interactive workshops and is designed for students, post-docs, entrepreneurs, and investors with life sciences and tech backgrounds to learn …›
During our fifth Patent Law Course session offered by Morrison & Foerster and GSAS Harvard Biotech Club , Steve Rowles, firmwide co-chair of the Emerging Companies & Venture Capital Group, chair of MoFo’s San Diego Corporate Group, and managing partner of the San Diego …›
Morrison & Foerster Research Analyst Christine Lentz contributed to the writing of this article. The House of Representatives recently passed a proposed bill that encourages treatments for rare pediatric diseases by prolonging the authority of Health and Human Services to issue priority review vouchers. H.R.4439, …›
“What can be a better day to talk about the complex CRISPR/Cas9 patent landscape than the big day that the Nobel Prize was awarded to pioneers of this revolutionary technology? The story of the continuing dispute on the fundamental CRISPR/Cas9 patents offers a lot …›
In this third installment of a six-part Patent Law Course offered by Morrison & Foerster and GSAS Harvard Biotech Club, MoFo partner and head of the firm’s China Life Sciences Group Janet Xiao taught a class on the value, protection, and legal issues involved …›