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?
On August 1, 2025, a UK Court of Appeal upheld the validity of Moderna’s European Patent No. 3,590,949 (“EP’949”) in a dispute with Pfizer and BioNTech. The decision affirmed a July 2024 UK High Court ruling finding that...more
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
Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more
On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. (“Alnylam”) and Pfizer, Inc. (“Pfizer”)—concluding that Pfizer’s...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
On May 22, 2025, the CAFC affirmed the PTAB’s (Board) Final Written Decisions in Pfizer’s IPR2021-00925 and IPR2021-00926 finding all challenged claims of uniQure’s U.S. Patent No. 9,982,248 (“the ’248 patent”) unpatentable...more
Partner Dan Shores will present a webinar titled "mRNA Patent Wars Update: Litigations Expand and Key Rulings Expected in 2025" for Medmarc, the leading expert in the products liability risks facing medical technology and...more
Recent scientific research has revealed that women who used the Depo-Provera birth control shot may be five times more likely to develop a form of brain tumors known as meningioma....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
As we previously discussed, beginning in 2022, a series of patent infringement lawsuits were filed against Moderna and collaborators Pfizer+BioNTech seeking damages based on their respective sales of the Spikevax® and...more
On April 3, 2025, GlaxoSmithKline (GSK) and Pfizer filed a stipulation to dismiss with prejudice GSK’s litigation in the United States District Court for the District of Delaware....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
For decades, Depo-Provera has been presented as a game-changing contraceptive—a quick injection every three months that promised simplicity and effectiveness. For millions of women worldwide, it seemed like the perfect...more
The U.K. Competition Appeal Tribunal (CAT) has imposed its own fines on Pfizer and Flynn Pharma for abusing their dominant positions by charging excessive and unfair prices for phenytoin sodium, an anti-epilepsy drug, after...more
To date, 2024 has not yet seen the type of mega-merger (Pfizer/Seagen) or level of agency enforcement (Sanofi/Maze or Amgen/Horizon) as 2023. But two notable investigations — one still active — show the Federal Trade...more
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
PFIZER INC. v. SANOFI PASTEUR INC. - Before Lourie, Bryson, and Stark. Appeal from the Patent Trial and Appeal Board....more
Last week, the Federal Circuit handed down its opinion in Pfizer Inc. v. Sanofi Pasteur Inc., affirming the Patent Trial and Appeal Board's (PTAB) determination that all claims of U.S. Patent No. 9,492,559 challenged in...more
Despite increasingly aggressive rhetoric from the agencies, 2022 was largely characterized as “business as usual” in the antitrust world. In contrast, 2023 featured a significant step up in enforcement activity, including...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
The FTC’s Amgen/Horizon Lawsuit Ends With a Whimper - We covered the FTC’s investigation into (and litigation challenging) Amgen’s $28.3 billion acquisition of rare disease specialist Horizon Therapeutics in our Q1 and...more
FDA grants interchangeable designation to Pfizer’s adaliumumab biosimilar – On October 5, 2023, Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an...more
GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC (collectively, “GSK”) recently filed suit in the District of Delaware against Pfizer, Inc. alleging that Pfizer’s respiratory syncytial virus (“RSV”) vaccine ABRYSVO...more
Partner Dan Shores will present a webinar titled "The mRNA/Lipid Nanoparticle Competitive and Litigation Landscape" for Medmarc, the leading expert in the products liability risks facing medical technology and life sciences...more