United States: Life Sciences, Biotechnology & Nanotechnology

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
Benesch Healthcare Dialysis & Nephrology Digest No. 79
Benesch Healthcare Partner Jason Greis recently joined the BackTable Vascular & Interventional Podcast to discuss the growing scrutiny surrounding Medicare audits and what physicians and medical practices should know. During the conversation, he examined common audit triggers, the increasing use of artificial intelligence in audit activities, compliance and documentation best practices, and strategies for responding to audits and navigating the appeals process.
United States Healthcare
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Benesch Friedlander Coplan & Aronoff LLP
Article
Fresenius Acquires Remaining 45% Stake In MAbxience For Up To €750 Million
Fresenius SE & Co. KGaA has completed its acquisition of the remaining 45% stake in mAbxience Holding S.L., a biosimilar manufacturer, for up to €750 million. The transaction makes mAbxience a wholly owned subsidiary within Fresenius Kabi's Biopharma business, providing the company with greater control over its biosimilar value chain from development through commercialization.
United States Healthcare
GP
Goodwin Procter LLP
Curated
Rethinking Expert Testimony: The Case For Concurrent Evidence
Expert testimony is often the center of gravity in life sciences and technology disputes because patent, licensing and other commercial cases often turn on specialized scientific or technical questions. Yet the traditional method of presenting expert testimony—one side presents its expert, the expert is examined and cross-examined and, days later, the opposing expert goes through the same process—is not always well suited to resolving these questions. By the time the second expert addresses a point made by the first, the tribunal is comparing testimony delivered at different times, in response to different questions and sometimes using different terminology or assumptions. And much of what the experts have to say is really not in dispute.
United States Litigation
J
JAMS
Article
Janssen Granted Preliminary Injunction Against Golimumab Biosimilar
A federal court in Delaware has granted Janssen's motion for a preliminary injunction against Accord BioPharma and Bio-Thera Solutions, halting the manufacture, sale, and importation of their golimumab biosimilar BAT2506 in the United States. The injunction requires Janssen to post a $98.8 million bond while the underlying patent dispute continues through litigation and inter partes review proceedings at the USPTO.
United States Healthcare
GP
Goodwin Procter LLP
Article
STADA And SBP Group Launch Biosimilars Partnership
STADA and Sino Biopharmaceutical Limited have formed a strategic partnership to develop and commercialize biosimilar medications across Europe and neighboring regions. The collaboration focuses on bringing biosimilar alternatives to market, beginning with a pembrolizumab biosimilar targeting multiple cancer indications, with plans to expand into additional oncology and immunology treatments.
United States Healthcare
GP
Goodwin Procter LLP
Curated
Rethinking Expert Testimony: The Case For Concurrent Evidence
Expert testimony is often the center of gravity in life sciences and technology disputes because patent, licensing and other commercial cases often turn on specialized scientific or technical questions. Yet the traditional method of presenting expert testimony—one side presents its expert, the expert is examined and cross-examined and, days later, the opposing expert goes through the same process—is not always well suited to resolving these questions. By the time the second expert addresses a point made by the first, the tribunal is comparing testimony delivered at different times, in response to different questions and sometimes using different terminology or assumptions. And much of what the experts have to say is really not in dispute.
United States Litigation
J
JAMS
Article
Behavioral Health Leaders Need A Margin Mindset As Disruption Sweeps The Sector
Behavioral health providers face mounting pressures from declining reimbursement rates, regulatory complexity, and severe workforce shortages that threaten operational sustainability. While demand for behavioral health services is projected to outpace supply for the next decade, only operators who build lean, efficient models rather than pursue pure expansion will capture the rewards.
United States Healthcare
A
AlixPartners
Article
Federal Circuit Denies En Banc Rehearing In Teva v. Eli Lilly, Preserving Precedent For Method-of-Treatment Patent Claims
The Federal Circuit's denial of Eli Lilly's en banc petition in Teva v. Eli Lilly solidifies a critical distinction between method-of-treatment claims and composition claims under Section 112. This precedential decision upheld a $177 million jury verdict and established that when a claimed method involves a well-known genus that is not itself the invention, the written description and enablement requirements focus on whether the method works, not on structural diversity within the genus.
United States IP
FH
Foley Hoag LLP
Curated
Rethinking Expert Testimony: The Case For Concurrent Evidence
Expert testimony is often the center of gravity in life sciences and technology disputes because patent, licensing and other commercial cases often turn on specialized scientific or technical questions. Yet the traditional method of presenting expert testimony—one side presents its expert, the expert is examined and cross-examined and, days later, the opposing expert goes through the same process—is not always well suited to resolving these questions. By the time the second expert addresses a point made by the first, the tribunal is comparing testimony delivered at different times, in response to different questions and sometimes using different terminology or assumptions. And much of what the experts have to say is really not in dispute.
United States Litigation
J
JAMS
Article
Trends In 2026 M&A Dealmaking
Life sciences M&A activity surged in the first half of 2026 with 86 transactions totaling $196 billion, marking a 141% increase over the previous year and the strongest start since 2019. The resurgence is driven by an impending patent cliff threatening $305 billion in revenue, abundant dry powder on pharma balance sheets, and attractive target valuations. With companies increasingly focused on de-risked Phase II and beyond assets, and private equity emerging as optimization partners, the industry is positio
United States Finance
BS
Ballard Spahr LLP
Article
Bipartisan House Bill Would Direct Secretary Of Commerce To Develop Prioritized Action Plan For Biomanufacturing
Representatives Bob Latta and Debbie Dingell have introduced the BEDROCK Act, legislation aimed at strengthening American biomanufacturing competitiveness and reducing dependence on China. The bill would designate a Commerce Department official to lead efforts, assess supply-chain vulnerabilities, develop action plans, and streamline federal commercialization processes to help scale domestic production of biologically-manufactured products.
United States Government
BC
Bergeson & Campbell
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