Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
Episode 230: Innovations in Cancer Treatment with Dr. Ray DuBois of MUSC Hollings Center
Medical Device Legal News with Sam Bernstein: Episode 18
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 169: Shirley Paddock, Senior VP of Clinical Development, Syneos Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 168: Christine Harhaj, Senior Director of Advocacy & Strategic Alliances, PhRMA
Podcast: Unpacking FDA's Final Clinical Decision Support Guidance - Diagnosing Health Care
Podcast: Post-Dobbs - Considerations for Clinical Trials and Research - Diagnosing Health Care
Podcast - Talking Sickle Cell Trait with NFL Wide Receiver Ty Montgomery and Dr. Anjulika Chawla, MD, FAAP
Product Launching in the Era of COVID-19 - Diagnosing Health Care Podcast
JONES DAY PRESENTS® Digital Health and Clinical Research: Understanding Regulatory Regimes
JONES DAY PRESENTS® The Impact of Digital Health on Research and Clinical Trials
Nota Bene Episode 75: Clinical Trial Disclosures on the World Map with TrialScope Chief Strategy Officer Thomas Wicks
Podcast: Non-binding Guidance: SEC Disclosure Issues for Life Sciences Companies
Life Sciences Quarterly (Q3 2019): SEC Enforcement and Class Actions Regarding FDA Communications
Podcast: Non-binding Guidance: Real-World Evidence in Drug Development and FDA Submissions
Passage of Federal Right-to-Try law poses risks and opportunities for patients and the biopharmaceutical industry
Life Sciences Quarterly (Q4 2017): The Use of Social Media and Mobile Applications
Case Name: Jazz Pharms., Inc. v. Avadel CNS Pharms., LLC, Nos. 2024-2274, 2024-2277, 2024-2278, 2025 WL 1298920 (Fed. Cir. May 6, 2025) (Circuit Judges Lourie, Reyna, and Taranto presiding; Opinion by Lourie, J.) (Appeal from...more
The U.S. Food & Drug Administration (FDA) has approved certain GLP-1 drugs for commercialization and use, including liraglutide (Victoza®), semaglutide (Ozempic®, Wegovy®), and tirzepatide (Mounjaro®, Zepbound®). Although...more
The burgeoning field of psychedelic medicine, which suffered a major setback last year when the Food and Drug Administration (FDA) rejected an application to approve the use of midomafetamine (MDMA) to treat post-traumatic...more
Femtech stands at an exciting inflection point. What was initially perceived as a niche category focused on period-tracking apps has evolved into a comprehensive ecosystem addressing women's health needs with individualized...more
Developing a medical product, such as a medical device, comes with important milestones that can cause a project to sink or swim. One major milestone is amassing the clinical data needed to support pre-market submissions....more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more
Mitral regurgitation is the most common form of valvular heart disease and affects around 10% of Americans over 75. It occurs when the mitral valve, which is located between the left atrium and the left ventricle, doesn’t...more
Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA? This month it is: how big...more
Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device. Recruitment for...more