Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Yours, Mine and Ours (not yet!): An Update on the Patentability of Human Genes -
On January 11, 2026, the FDA issued two news releases putting forward reforms to the chemistry, manufacturing, and control requirements for cell and gene therapy products, one titled FDA Increases Flexibility on Requirements...more
On November 13, 2025, the Genetic Technology (Precision Breeding) Regulations 2025 (“2025 PB regulations”) took effect, completing the United Kingdom’s (UK’s) post-Brexit framework for gene-edited plants. The Regulations...more
This article is the third in our new series, “Trends in Cell, Tissue, and Gene Therapies,” which aims to help you stay informed about the broad array of legal and regulatory issues affecting companies operating in the...more
On Wednesday, the U.S. Food and Drug Administration (FDA) published three new draft guidances that aim to offer greater clarity to sponsors of cell and gene therapies (CGTs) on issues related to clinical trial design,...more
In 2025, Life Sciences and Health Care (LS&HC) companies face rapidly evolving regulatory paradigms that create transactional risks and require daily monitoring. After more than 70 national elections in 2024, the dust hasn’t...more
In the legal industry, handling business transactions is part of our daily routine. Managing the transfer of personal data during acquisitions, sales, mergers or bankruptcy proceedings has become second nature to us. We...more
On June 18, 2025, the U.S. Food and Drug Administration (“FDA”) announced an immediate review of new clinical trials that export American citizens’ biological materials to countries of concern, such as China, for genetic...more
To illustrate just how creative phishing campaigns have become, on January 30, 2019, it was reported by multiple credit unions that Bank Secrecy Act officers at credit unions around the country received emails that appeared...more
Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product's success or failure could cost you millions of dollars....more