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
HHS Policy Changes, Supreme Court Rulings, and the DOJ-HHS False Claims Act Working Group
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 246: The Next Generation of Treatment for Alzheimer's and Parkinson’s with Neal Goodwin and Pawel Krysiak of Jaya Bio
AI Today in 5: August 11, 2025, The ACHILLES Project Episode
False Claims Act Insights - Bitter Pills: DOJ Targets Pharmacies for FCA Enforcement
Key Discovery Points: BYOD Case Law Covering Subpoenas and Employee Handbooks
Daily Compliance News: June 23, 2025, The Is Walmart Cool Edition
Taking the Pulse: A Health Care & Life Sciences Video Podcast | Episode 239: Understanding the 340B Pricing Program with Chuck Melendi of Disruptive Dialogue
Unexpected Paths to IP Law with Dan Young and Colin White
Navigating Legal Strategies for Covering GLP-1s in Self-Insured Medical Plans — Employee Benefits and Executive Compensation Podcast
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
AGG Talks: Cross-Border Business Podcast - Episode 28: How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
How Life Sciences Companies Can Create a Culture of Compliance When Expanding to the U.S. Market
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 231: Advancing the Life Sciences Industry with Kendalle O’Connell of MassBio
Compliance Program Effectiveness: Keep it Streamlined and Strategic
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Podcast — Drug Pricing: 2025 J.P. Morgan Healthcare Conference Takeaways and Outlook
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
The Israel Competition Authority (ICA) conducted a thorough investigation of the S. Schestowitz Group, an Israeli company in the food and consumer goods sector, due to suspicions the company operated a cartel in the food...more
The evidentiary burden on plaintiffs to have a case certified—i.e., the “some basis in fact” standard—has been described as a “low bar” in countless cases. Plaintiffs cite the “low bar” in trying to certify their cases, and...more
Welcome back to the Class Action & MDL Roundup! This edition covers notable class actions from the fourth quarter of 2024. In this edition, an overdue audiobook suit is shelved, an old case gets new reps and new...more
Invega Sustenna® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., Civ. Nos. 18-734, 19-16484, 2024 WL 5135666 (D.N.J. Dec. 17, 2024) (Cecchi, J.) Drug Product and Patent(s)-in-Suit:...more
On December 17, 2024, the Competition Tribunal (the Tribunal) issued reasons for its decision to dismiss an application for leave to bring a private abuse of dominance action against a major pharmaceutical manufacturer. JAMP...more
The US Food and Drug Administration (FDA) issued draft guidance, providing recommendations to sponsors who are considering submitting a non-interventional study (i.e., an observational study) to FDA to support the...more
Robins Kaplan Secures Historic $12.2 Million Settlement in a Section 1983 Jail Deliberate Indifference Case - Scott County Jail officials failed to report detained man’s injuries and allowed video evidence to be deleted. ...more
Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more
MEDTRONIC, INC. v. TELEFLEX INNOVATIONS S.A.R.L. Before Moore, Lourie, and Dyk. Appeal from the Patent Trial and Appeal Board - Summary: Federal Circuit confirms low bar for evidence corroborating prior inventorship...more
MASSACHUSETTS - First Circuit Holds Failure-To-Warn Claims Against Drug Manufacturer Preempted By Federal Food, Drug, And Cosmetic Act Because Animal Studies Cited By Plaintiffs Did Not Demonstrate Risks Beyond Those In...more
AURIS HEALTH, INC., v. INTUITIVE SURGICAL OPERATIONS, INC., Before Dyk, Prost, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB). Summary: Evidence of generic industry skepticism cannot, by itself, form...more
Pharmacy benefit managers (PBM) audits are becoming increasingly dangerous for independent pharmacies. While the role of the PBM was initially to reduce costs for all parties involved, abusive PBM practices have led to the...more
Multidistrict litigation is often criticized for enabling plaintiffs to file meritless cases and then hide in large inventories, hoping to be swept up in a settlement (whether global or otherwise) before the case is...more
Kathryn Isted In Harbor Healthcare System, L.P. v. United States, 5 F.4th 593 (5th Cir. 2021), the court of appeals ruled that the district court abused its discretion in refusing to exercise its equitable jurisdiction over a...more
Editor’s Note: On September 16, 2020, HaystackID shared an educational webcast designed to inform and update legal and data discovery professionals on the complexities of eDiscovery support in pharmaceutical industry matters...more
Update: On November 10, 2021, the Minister rejected Janssen’s second request for data protection for SPRAVATO, which was submitted following the coming into force of the Canada-United States-Mexico Agreement (CUSMA). The...more
If you’re marketing any pharmaceutical or medical device, the Food and Drug Administration (FDA) has its eye on you. More accurately, the FDA has its eye on your website and social media, checking to see what you’re claiming...more
On September 30, 2020, the Federal Court dismissed an application by Catalyst Pharmaceuticals Inc (Catalyst) and KYE Pharmaceuticals Inc (KYE) (collectively, the applicants) for an interlocutory injunction to stay the...more
The District Court for the Northern District of West Virginia recently found method of treatment claims directed to treating a specific disease at a specific dose invalid for lack of written description based on the context...more
Applying basic scientific principles to exclude an expert’s unfounded and unsupported opinions, the U.S. District Court for the Northern District of California has granted summary judgment to the maker of the antipsychotic...more
We are excited to bring you issue 76 of our International Products Law Review with insights and updates on all aspects of products law. In this issue, we explore what businesses need to consider when making climate-related...more
As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their generic o-desmethyl-venlafaxine (ODV) succinate products (Pfizer’s PRISTIQ) until expiry of...more
I previously wrote about the standing issue addressed in Amerigen Pharmaceuticals v. UCB Pharma GMBH. In this article, I look at the lead compound analysis that led the USPTO Patent Trial and Appeal Board (PTAB) to uphold the...more
In United States v. Scully, 16-3073-cr (Pooler, Lynch, Cogan[1]), the Second Circuit vacated the defendant’s conviction for various offenses, including mail and wire fraud, conspiracy to defraud the United States, the sale of...more
Last week, in United States v. Scully, the Second Circuit vacated the conviction of a distributor of pharmaceutical products on misbranding charges due to evidentiary issues surrounding his advice-of-counsel defense at trial....more