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?
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
With volatile market conditions and recent FDA shakeups, biotech companies are increasingly focused on bolstering cash runways and accelerating R&D efforts. But fierce competition for financing has some biotechs turning to...more
On June 9, 2025, biosimilar manufacturers Samsung Bioepis and Alvotech announced separate deals to expand their respective offerings in Japan and Europe. ...more
On May 19, Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active immunization against COVID-19 in adults 65 years and older and individuals 12 through 64...more
While M&A activity slowed in the first quarter of 2025, including in life sciences, there have been plenty of noteworthy developments in the antitrust space in the first 100 days of the Trump administration....more
On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of...more
Last year was a surprisingly big one for legal decisions impacting the biotechnology transactions and licensing space. Given that most biotech deals are subject to confidential alternative dispute resolution, it is unusual...more
The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A)....more
Integrating AI tools into drug discovery introduces a mix of opportunities and challenges for startups and large pharmaceutical companies. These challenges often center on intellectual property (IP) risks, licensing...more
Duality Biologics and GSK enter into an exclusive option agreement to exploit gastrointestinal cancer target, DB-1324 - On December 4, 2024, Duality Biologics (“DualityBio”), a clinical-stage biotech company focusing on...more
On October 3, 2024, Teva Pharmaceuticals and mAbxience, a Fresenius Kabi majority-owned group, announced a new global licensing agreement for the development of an anti PD-1 oncology biosimilar candidate, further...more
Recently, the Delaware Chancery Court and the Third Circuit issued three significant decisions on key issues affecting licensing and M&A transactions in the life sciences industry....more
This is the first of two articles focused on 2023 life sciences deals in China. The second article, which is coming soon, looks at trends in M&A. In 2023, there were 240 reported life sciences licensing deals in China,...more
On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (“J&J”) regarding Bmab 1200, Biocon’s proposed biosimilar to STELARA....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
Generative AI (GenAI) surged to the forefront of corporate agendas and public policy debates last year, promising to boost productivity and innovation. What’s in store for AI in 2024?...more
Hosted by American Conference Institute, the 2nd Annual Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities returns for another exciting year with curated programming that will highlight leveraging...more
Precedential and Key Federal Circuit Opinions - 1. PARKERVISION, INC. v. VIDAL [OPINION] (2022-1548, 12/15/2023) (Prost, Wallach, and Chen)* - Chen, J. The Court affirmed the PTAB’s determination that the patent...more
ACI’s 6th Annual Life Sciences IP Due Diligence Summit is devoted to providing corporate and IP counsel with expert strategies for assessing, valuing, and commercializing IP assets when conducting strategic IP due diligence –...more
Please join McDermott for our highly anticipated Life Sciences Dealmaking Symposium! Now in its 12th year, the Symposium offers a unique platform for education, insight sharing, purposeful networking and strategic...more
Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceuticals Co., Ltd. to commercialize Tonghua Dongbao’s three insulin biosimilars (insulin...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Alvotech and Teva Pharmaceuticals, Inc. announced that they reached a settlement and license agreement with Johnson & Johnson regarding AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab) in the United States....more
As the industry readies itself for the January 2023 pilgrimage to the J.P. Morgan Healthcare Conference (JPM) and Biotech Showcase in San Francisco, our market-leading life sciences and health care industry team has prepared...more
On October 25, 2022, JSR Life Sciences and Blau Farmaceutica announced that Similis Bio, JSR Life Sciences’s business unit focused on biosimilar development, has signed its first development and license agreement with Blau...more