Podcast: Non-binding Guidance: Examining FDA’s Enforcement Authority Over Stem Cell Clinics and Compounders
Policy Announcements - On September 6, 2024, the People’s Republic of China’s (PRC) National Development and Reform Commission and the PRC Ministry of Commerce issued the “Special Administrative Measures for Foreign...more
On August 14, 2024, the U.S. Food and Drug Administration (FDA) approved a colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, NIKTIMVO (axatilimab-csfr) developed by Incyte Corporation (and in-licensed from...more
In a long-awaited milestone in the gene therapy space, the Food and Drug Administration (FDA) approved two gene therapies to cure sickle cell disease (SCD). Soon thereafter these approvals, a key licensing agreement was...more
Share on Twitter Print Share Back to top On December 8, 2023 the U.S. Food and Drug Administration (FDA) approved Casgevy and Lyfgenia, both cell-based gene therapies for the treatment of sickle cell disease in patients 12...more
The use of artificial intelligence (AI) to advance stem cell therapy has produced exciting results, with a key role in driving recent growth and innovation. Separated into three parts, this article provides an overview the...more
Iowa AG Brenna Bird filed a lawsuit against Biologics Health, LLC and Summit Partners Group, LLC, d/b/a Summit Health Centers, as well as their co-owners, for allegedly violating the Iowa Consumer Fraud Act, the Door-to-Door...more
Cultured meat and its introduction into our grocery stores and restaurants is on the horizon. The FDA has established a premarket consultation process which allows companies who would like to market cultured meat in the U.S....more
Last year, a federal court in California ruled against the U.S. Food and Drug Administration (FDA) in a matter where the government alleged that a stem cell clinic’s products should be regulated as new drugs. The decision...more
Speaking at the World Stem Cell Summit hosted by the Regenerative Medicine Foundation, Hogan Lovells partners Mike Druckman, Ernesto Algaba, Mandi Jacobson, Lu Zhou, Mikael Salmela, Charlotte Damiano, and Lowell Zeta, along...more
Last week, the Food and Drug Administration (FDA) authorized a fourth coronavirus vaccination, approving a new shot developed by Novavax. Unlike the Pfizer and Moderna products, this vaccine does not use messenger RNA...more
A major step forward in using Artificial Intelligence (AI) for scientific discovery in the field of stem cell research was recently reported, reflecting the continued growth of the technology and stressing the need for...more
Here are last week’s curated AG and federal regulatory news stories highlighting key areas in which state and federal regulators’ decisions are having an impact across the US: •Connecticut AG Tong Doesn’t Want to Hear...more
Washington AG Robert Ferguson has sued Seattle-based US Stemology, LLC and its owners (collectively, “Stemology”) for allegedly violating Washington’s Consumer Protection Act by deceptively marketing and providing stem cell...more
At the Food and Drug Law Institute’s 2021 annual conference, Dr. Peter Marks, the director of FDA’s Center for Biologics Evaluation and Research, commented on progress that has been made using FDA’s Regenerative Medicine...more
Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell...more
COVID-19- NAAG: Airline Industry Customers Deserve Stronger Consumer Protections- •The National Association of Attorneys General (“NAAG”) sent a letter to congressional leaders urging Congress to strengthen consumer...more
In a move welcomed by industry, the Food and Drug Administration (FDA) has granted six additional months of enforcement discretion to manufacturers of certain human cell, tissue, or cellular or tissue-based products (HCT/Ps)....more
COVID-19- Attorney General to Congress: Let States Help Battle COVID-19-Related Medicaid Scams- •Citing the growing number of COVID-19-related scams, Kansas AG Derek Schmidt urged Congress to expand the authority of states...more
Lawmaking in the COVID Era - The legislature adjourned Friday June 26 at 8:41 p.m. Sort of. After holding what was nearly the longest and certainly the strangest session in history – half of it remotely – the legislature has...more
SARS-CoV-2, the virus that causes COVID-19, is a novel coronavirus never before seen in humans. To date, it has caused 60,000 deaths in the United States – 56,000 of those in the last month alone. There does not yet exist an...more
Divided House committee approves Act 250 compromise - After more than a year of work, the House Natural Resources Committee voted 6-3 to approve sweeping changes to Vermont’s landmark land-use law, including a provision...more
Push to end surprise medical billing - The Senate Finance Committee heard from providers and health insurers on S.309, a bill that prohibits certain provisions in contracts between health insurers and health care...more
The U.S. Food and Drug Administration (FDA) has issued three letters (one warning letter and two untitled letters) over the last two months of 2019 directed at four different companies focused on the processing, distributing,...more
Following up on our first post in this year-end series that discussed medical device regulatory activities at the Food and Drug Administration (FDA), the Mintz FDA team’s second year-end post will provide an overview of 2019...more
The 2020 Legislative Session will begin its 60-day trek to completion on Tuesday, January 14, 2020. The following is a sample of bills that have been filed. We encourage you to review these bills, and contact us with specific...more