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
New Federal Policy Prohibits Certain Gain-of-Function Research And Restricts Certain International Projects
The U.S. government has released a sweeping new policy that prohibits federal funding for "dangerous gain-of-function research" and establishes unprecedented oversight requirements for life sciences research involving biological agents. Research institutions must now evaluate all proposed and ongoing federally funded projects against expanded risk criteria, implement new review structures, and monitor even non-federally funded research...
United States Healthcare
BS
Butler Snow LLP
Article
Reclaiming Store Labor In Canada | Putting Hours Back On The Sales Floor
Explore cutting-edge insights on legal technology, AI-driven clinical research reform, pharmaceutical manufacturing reshoring challenges, cryptocurrency malware threats, and strategic data center investment opportunities. Discover how evolving regulatory frameworks, infrastructure constraints, and digital transformation are reshaping industries from healthcare to construction joint ventures.
United States Strategy
AC
Ankura Consulting Group LLC
Article
Accord BioPharma Announces FDA Approval Of Pegfilgrastim Biosimilar
Accord BioPharma has secured FDA approval for ENNUMO, its second pegfilgrastim biosimilar referencing Amgen's NEULASTA, positioning the company as the only U.S. provider offering two distinct pegfilgrastim biosimilars alongside a short-acting G-CSF biosimilar. With eight pegfilgrastim biosimilars now approved by the FDA, the competitive landscape for these infection-reducing cancer treatments continues to expand. This approval strengthens Accord's biosimilar portfolio in the oncology supportive care market.
United States Healthcare
GP
Goodwin Procter LLP
Article
Federal Circuit: Provisional Application Must Support Later Claims
The Federal Circuit addressed whether a patent claiming priority to a provisional application can maintain that earlier filing date when the provisional disclosed a C2-C12 alkyl substituent but the issued patent broadened the claim to C1-C12 alkyl. This case examines the written description requirement and its impact on priority dates in pharmaceutical patent disputes, particularly where an intervening public disclosure by a competitor falls between the two filing dates.
United States IP
LD
Lerner David
Article
Patenting Plants In Europe And The UK
Patent protection for plant-related inventions in Europe is available despite specific exclusions in the European Patent Convention. While plant varieties and essentially biological breeding processes are excluded, many innovations in modern plant biotechnology remain patentable. Success depends on strategic claim drafting to avoid exclusions while securing commercially valuable protection for transgenic, gene-edited, and technically produced plants.
United States IP
JA
J A Kemp LLP
Article
Holland & Knight Health Dose: July 14, 2026
This comprehensive healthcare policy update examines Congress's return from recess with a focus on bipartisan healthcare legislation, including remote patient monitoring expansion, prior authorization reform, and ACA premium tax credit extensions. The analysis covers regulatory developments from CMS and FDA, including significant changes to hospital outpatient payment systems, 340B drug pricing policies, and the launch of Medicare's GLP-1 Bridge program.
United States Healthcare
HK
Holland & Knight
Article
"Patenting RNA Therapeutics in the Age of AI: What Companies Must Get Right Early"
Artificial intelligence is revolutionizing RNA drug discovery and fundamentally altering the patent strategies required to protect these innovations. As AI becomes increasingly integrated into RNA therapeutics development, biotechnology companies face new challenges around inventorship, obviousness, and enablement that demand early consideration in the research process. This analysis explores how companies can adapt their intellectual property approaches to secure robust patent protection while navigating t
United States IP
MG
Marshall, Gerstein & Borun LLP
Article
Harrow Re-Launches BYOOVIZ (Ranibizumab-nuna) In The United States
Harrow has launched BYOOVIZ (ranibizumab-nuna), the first FDA-approved ophthalmic biosimilar, following an exclusive commercialization agreement with Samsung Bioepis after Biogen's exit from the U.S. market. This marks the beginning of Harrow's partnership to commercialize Samsung Bioepis's ophthalmology biosimilar portfolio, which also includes OPUVIZ, a biosimilar referencing EYLEA.
United States Healthcare
GP
Goodwin Procter LLP
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