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?
Depo-Provera, a birth control injection containing the hormone medroxyprogesterone acetate, has been widely used for decades as a convenient contraceptive option. For many women, the Depo shot offered an alternative to daily...more
Pharmaceutical companies play a critical role in the healthcare system. They research, develop, and supply the drugs that patients need to manage and recover from all types of medical conditions—from antiviral medications...more
Welcome back to the Class Action & MDL Roundup! This edition covers notable class actions from the first quarter of 2025. In this edition, two UK actions fail to clear a low bar, a movie isn’t a video, and spam isn’t...more
On June 17, 2025, Regeneron Pharmaceuticals, Inc. (“Regeneron”) filed another complaint against Amgen Inc. (“Amgen”) under the BPCIA, alleging that Amgen’s aflibercept biosimilar, PAVBLU®, infringes U.S. Patent No. 12,331,099...more
What types of eye injuries does Ozempic/Wegovy cause? Ozempic/Wegovy are two of the most common weight-loss medications known as GLP-1 drugs. Other GLP-1 drugs include Mounjaro, Rybelsus, Saxenda, Victoza, Trulicity, and...more
What is a meningioma and what types of injuries qualify? Depo-Provera has many known side effects. However, the current Depo-Provera litigation mainly involves a “signature injury” that was not properly warned against by...more
The legal landscape surrounding Depo-Provera, a long-acting injectable birth control, has entered a pivotal phase. With the growing number of lawsuits alleging that the drug caused serious brain tumors known as meningiomas,...more
On April 22, 2025, the U.S. District Court for the Northern District of West Virginia entered a Stipulation and Order Vacating Permanent Injunction and Dismissing All Claims and Counterclaims with Prejudice in In re:...more
The costs of an intracranial meningioma diagnosis can be substantial. Not only can this diagnosis lead to a lifetime of medical bills and other costs, but it can drastically reduce patients’ quality of life as well....more
For decades, women have trusted Depo-Provera, a birth control injection manufactured by Pfizer, as a convenient and effective contraceptive option. However, recent research has uncovered alarming health risks associated with...more
Women across the country are taking legal action against Pfizer, the manufacturer of Depo-Provera, alleging that the company failed to warn about the risks of developing meningiomas — generally non-cancerous but potentially...more
Note: This post addresses two Federal Circuit decisions issued on January 29, 2025. Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more
West Virginia Attorney General (AG) Patrick Morrisey announced a total $17 million settlement agreement with pharmaceutical companies, Pfizer and Ranbaxy after more than a decade of litigation regarding the companies’ alleged...more
As we ring in the new year, it is time, once again, to reflect on some of the most significant legal developments for drug and device companies this year. Below is a brief recap and assessment of a few of the top developments...more
There are four pending BPCIA litigations brought by Amgen against biosimilar companies seeking to market denosumab biosimilars. Two of the four cases are pending in the District Court for the District of New Jersey before...more
On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv)....more
As we previously reported, the Judicial Panel on Multidistrict Litigation recently granted Regeneron Pharmaceutical’s (“Regeneron”) motion to establish a multi-district litigation (“MDL”) for its aflibercept BPCIA litigation....more
The Committee Notes to the newly implemented amendments to Federal Rule of Evidence 702 make clear that the “[j]udicial gatekeeping” of expert evidence is “essential.” Federal courts in New York have played an important role...more
The first bellwether trial in the nationwide litigation over the copper IUD Paragard is scheduled to go to trial in Georgia in October 2024. More than 2,200 lawsuits have been filed against Teva Pharmaceutical and...more
Hosted by American Conference Institute, the 28th Annual Conference on Drug & Medical Device Litigation returns for another exciting year with curated programming and networking opportunities with 400+ industry...more
European Commission Orders Unprecedented Unwinding Of Illumina’s Acquisition of GRAIL. For the first time, the European Commission has ordered reversal of a consummated transaction, Illumina Inc.’s 2021 acquisition of GRAIL...more
Join American Conference Institute at the 6th Annual Summit on Controlled Substances – Regulation, Litigation, and Enforcement on March 14-15, 2023, in Washington. Hear from leading stakeholders, discuss your most pressing...more
As an organization representing many target defendants in mass tort MDLs, including some of the largest MDLs on the federal docket, the Product Liability Advisory Council is uniquely positioned to serve as a voice for the...more
Zofran (ondansetron) has often been used to combat nausea during pregnancy. It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks –...more
Earlier this year, we discussed the Eastern District of Pennsylvania’s decision to enter a Lone Pine order – that is, a case management order that requires all plaintiffs to produce evidence establishing specific elements of...more