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
Stopping Disputes Before They Derail Innovation: The Emerging Role Of Life Sciences Dispute Review Boards
The American Arbitration Association has introduced Life Sciences Dispute Review Boards to help pharmaceutical, biotech, and medical device companies resolve technical disagreements before they escalate into costly formal disputes. These standing panels of neutral experts can address complex issues in licensing, R&D, and manufacturing agreements, but they involve recurring costs and strategic considerations around confidentiality, privilege, and the admissibility of recommendations in later proceedings.
United States Litigation
GP
Goodwin Procter LLP
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
B
Benesch Friedlander Coplan & Aronoff LLP
Article
Ultragenyx’s FAYUVI Becomes First FDA-Approved Treatment for Sanfilippo Syndrome Type A
Ultragenyx Pharmaceutical has received FDA approval for FAYUVI, a groundbreaking one-time gene therapy designed to halt or slow the progression of mucopolysaccharidosis type IIIA (MPS IIIA), also known as Sanfilippo syndrome type A. This marks the first-ever treatment capable of addressing the underlying cause of this ultra-rare, fatal neurodegenerative disorder that has previously had no disease-modifying therapeutic options.
United States Healthcare
GP
Goodwin Procter LLP
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
Pharmaceutical Policy In Motion Continued: The Trump Administration’s Second Wave Of Drug Pricing Deals
The Trump administration's most-favored-nation pricing initiative has expanded to include nine additional mid-sized pharmaceutical manufacturers, bringing the total coverage to 89% of the brand drug market. These new agreements focus on Medicaid pricing discounts aligned with international rates, while manufacturers commit billions to U.S. manufacturing and research in exchange for exemptions from future pricing mandates and potential tariffs.
United States Healthcare
M
Mintz
Article
Inside The Pharma Scouting Engine: Lessons From LSX Boston's Pharma Partnering Workshop
Two experienced pharma business development leaders from Novo Nordisk and Takeda reveal the multidisciplinary screening process that determines which biotech partnerships advance beyond initial evaluation. The discussion demystifies pharma's scouting methodology, partnership readiness requirements, and the critical factors that cause promising engagements to stall or succeed.
United States Healthcare
AO
A&O Shearman
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
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
Key Trends In 2026 Life Sciences Patent Prosecution
Recent developments in patent law are creating significant uncertainty for life sciences companies. The USPTO's evolving stance on obviousness-type double patenting, increasingly stringent enablement requirements following Amgen v. Sanofi, and the Supreme Court's clarification of skinny-label protections in Hikma v. Amarin are fundamentally reshaping how pharmaceutical and biotechnology companies must approach patent strategy and generic competition.
United States IP
BS
Ballard Spahr LLP
Article
Changes To PTAB And Takeaways For Life Sciences Stakeholders
The Patent Trial and Appeal Board has undergone significant procedural changes since early 2025, consolidating institution authority under the Director and expanding grounds for discretionary denial of inter partes review proceedings. These shifts have resulted in dramatically lower institution rates and increased uncertainty for patent challengers, fundamentally altering the landscape for life sciences companies seeking to invalidate or defend patents through PTAB proceedings.
United States IP
BS
Ballard Spahr LLP
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
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