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
Feeling Deflated From Inflated Prices: Ahold Delhaize Pays $40 Million In First Drug Pricing Fraud Case Settled Under The Second Trump Administration
Earlier this month, the U.S. Department of Justice (DOJ) announced a $40 million settlement with Ahold Delhaize USA, Inc. (Ahold Delhaize) to resolve allegations that the company violated the False Claims Act (FCA) by reporting inflated “usual and customary” prescription drug prices on claims submitted to Medicare Part D, Medicaid, and TRICARE.
United States Healthcare
AP
Arnold & Porter
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
FDA Expands Indication For Vertex’s CASGEVY To Children Aged Two Years And Older
Vertex Pharmaceuticals has secured FDA approval to expand CASGEVY's indication to children as young as two years old with sickle cell disease or transfusion-dependent beta thalassemia, making it the first CRISPR-based gene-editing therapy available for this younger patient population. The approval, reviewed under the FDA's Commissioner's National Priority Voucher pilot program, follows recent European data presentations demonstrating efficacy and safety in pediatric patients. This expansion allows clinician
United States Healthcare
GP
Goodwin Procter LLP
Article
OECD Publishes Policy Paper On Anticipatory Governance For Responsible Innovation In Synthetic Biology
The OECD has published a comprehensive policy paper examining how member countries are adapting their governance frameworks to support responsible innovation in synthetic biology. The analysis reviews national strategies, policy instruments, and governance initiatives across five key dimensions, revealing emerging practices while highlighting uneven implementation across jurisdictions. Drawing on examples from multiple countries, the paper identifies policy considerations for strengthening anticipatory gove
United States Healthcare
BC
Bergeson & Campbell
Article
Janssen Files BPCIA Complaint Against Alvotech Related To Golimumab Biosimilar
Janssen Biotech has initiated patent infringement litigation against Alvotech in the Eastern District of Virginia, asserting 14 patents related to manufacturing processes for proposed golimumab biosimilars AVT05 SC and AVT05 IV. The complaint seeks to delay FDA approval until patent expiration and requests injunctive relief to prevent commercialization by Alvotech and its partner Teva Pharmaceuticals.
United States IP
GP
Goodwin Procter LLP
Article
Building Strong Chemical Genus Claims In An Evolving § 112 Landscape
Broad chemical genus claims represent valuable pharmaceutical patent assets, yet face increasing judicial scrutiny under written description and enablement requirements. Recent Federal Circuit and Supreme Court decisions have reinforced that broader claims demand more robust supporting disclosures, requiring applicants to carefully consider specification strategies when seeking expansive chemical claim coverage.
United States IP
BB
Baker Botts LLP
Article
Federal Court Hands Major Win To Tissue Product Manufacturers – FDA’s HCT/P Classification Decision For Umbilical Cord–Derived Product CORDGRAFT Rejected
A federal court has overturned the FDA's classification of an umbilical cord-derived tissue product, ruling that the agency misapplied its own "minimal manipulation" standard by focusing solely on the tissue's function in the donor rather than its potential benefits to recipients. The decision could reshape the regulatory landscape for tissue banks, regenerative medicine companies, and HCT/P manufacturers by making it easier for structural tissue products to qualify for less burdensome Section 361 regulator
United States Healthcare
B
Benesch Friedlander Coplan & Aronoff LLP
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