Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Podcast: Dietary Supplements – Navigating the Regulatory Maze – Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 164: Emily Chee, US General Manager of Novartis Gene Therapies
Podcast: Direct Access Laboratory Testing - Future FDA Proposed Regulations on LDTs - Diagnosing Health Care
Medical Device Legal News with Sam Bernstein: Episode 14
Medical Device Legal News with Sam Bernstein: Episode 11
Medical Device Legal News with Sam Bernstein: Episode 10
Medical Device Legal News with Sam Bernstein: Episode 9
Medical Device Legal News with Sam Bernstein: Episode 8
Venable’s BiologicsHQ Monthly Injection – June 2024...more
Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...more
2022 heralded the next chapter for biosimilars in the United States, including U.S. Food and Drug Administration approval of biosimilars in new therapeutic areas, additional interchangeable designations, and litigation...more
Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more
The Patent Trial and Appeal Board (“PTAB”) regularly tracks statistics regarding administrative trials conducted under the processes created by the America Invents Act (“AIA”), which provide insight into recent trends...more
As we close out another calendar year, we look back at the top legal developments of 2019 that could influence the market for biologics and biosimilars. These five major court decisions will likely impact the legal strategy...more
In Coalition For Affordable Drugs VI, LLC v. Celgene Corp. (2015-01096, -01102, -01103), the PTAB granted Patent Owner Celgene’s request for rehearing of a final written decision that had found the challenged claims invalid...more
It’s time for an update on Kyle Bass’s efforts to rid America of the pharmaceutical patents that support high priced drugs. Between February and September 2015, at least eleven investment funds organized by J. Kyle Bass and...more
The biologics industry has been eagerly awaiting the Federal Circuit’s ruling on Sandoz Inc.’s (“Sandoz”) appeal from the United States District Court for the Northern District of California’s dismissal of its declaratory...more