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.

Xbrane Enters Into Conditional Financing Deal Related To Ranibizumab Biosimilar

As we have previously reported, on June 21, 2023, the FDA accepted Xbrane's sBLA for LUCAMZI, a proposed ranibizumab biosimilar to Genentech's LUCENTIS (ranibizumab).

United States Healthcare

GP

Goodwin Procter LLP

Our Key Takeaways From The 2025 Licensing Executives Society Annual Meeting

The Licensing Executives Society (LES) held its annual meeting this week in Boston, bringing together intellectual property (IP) licensing professionals across disciplines...

United States IP

BS

Ballard Spahr LLP

Replay: Wearables Webinar Series, Part 1: Update On FDA Regulation On Wearables (Video)

A replay of "Wearables Webinar Series, Part 1: Update on FDA Regulation on Wearables" is now available for viewing.

United States Healthcare

DM

Duane Morris LLP

AI-Enabled Tech Faces Dual Hurdles In FDA Regulation, Patent Law

Artificial intelligence is reshaping health care by powering medical devices and diagnostic tools that are increasingly precise, adaptive, and data driven.

United States IP

MG

Marshall, Gerstein & Borun LLP

Inside The FDA: Insights From Former Regulators

United States Healthcare

WL

WIT Legal

Using AI Responsibly: Balancing Innovation With Privacy

United States Privacy

HI

Harness IP

Survey On Assessment Of Health And Environmental Hazards And Risks Of Surface-Treated Nanomaterials Will Close October 31, 2025

United States Environment

BC

Bergeson & Campbell

Royalty Monetizations: The "What, Why, When, Who And How" For Universities, Non-Profit Institutions And Life Sciences Companies

United States Healthcare

FH

Foley Hoag LLP

Semler Scientific AndCipria Pay $37 Million To Resolve Medical Device Fraud Allegations

United States Healthcare

MS

Miller Shah

Senate Passes 2026 NDAA Including BIOSECURE Act Amendment

United States Healthcare

RG

Ropes & Gray LLP

Part II: Recent Changes In Jury Dynamics And How To Prepare Your Expert Accordingly (Podcast)

United States Consumer

HK

Holland & Knight

What To Watch: Human Cell And Tissue Product Regulation

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Assessing The Impact Of The Long-Stay Antipsychotic Measure On Access To Patient-Centered Care

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

The PBM Effect: Regulatory And Market Implications For Life Sciences Companies And Healthcare Providers

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

District Court Rejects Exclusive Backstop In Chapter 11 Plan

United States Insolvency

PR

Proskauer Rose LLP

Control, Creativity, Closure: The Mediation Advantage

United States Litigation

J

JAMS

Tariffs, Contracts And The Negotiation Imperative: Why The Old Playbook Won't Work

United States International

J

JAMS

Why Direct Student-Athlete Payments Create An Immigration Crisis For Universities

United States Immigration

Gs

Green and Spiegel

Resolving Construction Conflicts Efficiently: A Guided Mediation Approach

United States Litigation

J

JAMS

Amgen And Biocon Settle Denosumab BPCIA Case

On September 30, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen...

United States IP

GP

Goodwin Procter LLP

FDA Approves Celltrion's Aflibercept Biosimilar

On October 9, 2025, the FDA approved Celltrion's aflibercept biosimilar, EYDENZELT® (aflibercept-boav) referencing Regeneron's EYLEA® (aflibercept).

United States Healthcare

GP

Goodwin Procter LLP

Ohio's PBM Regulation Passed By House Of Representatives

In a previous article, Buchanan Ingersoll & Rooney discussed three pending bills in Ohio that would regulate Pharmacy Benefit Managers (PBMs), including House Bill 229.

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

The New (And Politically Improved?) BIOSECURE Act

Regular readers of the ML Strategies blog are familiar with the legislative wrangling that surrounded the BIOSECURE Act as drafted (and re-drafted) in the last Congress.

United States Healthcare

M

Mintz

FDCA: Fifth Circuit End-Run Suggests State Law Private Right Of Action

United States Healthcare

FL

Foley & Lardner

Advances In Plant Biotechnology Improving Health And Well-Being

United States IP

JA

J A Kemp LLP

BIOSECURE Included In Draft National Defense Authorization Act Of 2026

United States Healthcare

GP

Goodwin Procter LLP

EPO To Allow Color And Greyscale Patent Drawings: What U.S. Companies Need To Know

United States IP

BT

Barnes & Thornburg LLP

Celltrion Announces Launch Of AVTOZMA® (Tocilizumab-anoh) Intravenous Formulation In The United States

United States Healthcare

GP

Goodwin Procter LLP

Connecting Innovators In Life Sciences With Jennifer Hawks Bland (Podcast)

United States Healthcare

C

Crowley Law LLC

Kashiv BioSciences Omalizumab Biosimilar Application Submitted To FDA, Accepted By EMA

United States Healthcare

GP

Goodwin Procter LLP

Biogen Ordered To Pay Genentech $88.3 Million In Past Royalties On Cabilly Patents

United States IP

GP

Goodwin Procter LLP

Aflibercept BPCIA Multi-District Litigation Updates

United States Healthcare

GP

Goodwin Procter LLP

The Continued Rise Of Royalty Deals In Life Sciences

United States Healthcare

GP

Goodwin Procter LLP

Kashiv BioSciences Omalizumab Biosimilar Application Submitted To FDA, Accepted By EMA

On September 26, Amneal Pharmaceuticals, Inc. announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ADL-018, a proposed biosimilar...

United States Healthcare

GP

Goodwin Procter LLP

Biogen Ordered To Pay Genentech $88.3 Million In Past Royalties On Cabilly Patents

On September 30, 2025, the U.S. District Court for the Northern District of California ordered Biogen MA, Inc.

United States IP

GP

Goodwin Procter LLP

Aflibercept BPCIA Multi-District Litigation Updates

The aflibercept multi-district litigation consists of multiple actions consolidated in the Northern District of West Virginia, with Regeneron Pharmaceuticals, Inc. ("Regeneron") filing suit under the Biologics...

United States Healthcare

GP

Goodwin Procter LLP

The Continued Rise Of Royalty Deals In Life Sciences

Volatile equity markets and costly debt are fueling interest in monetization transactions. Data, recent deals, and increasing interest suggest the model is set to endure.

United States Healthcare

GP

Goodwin Procter LLP

Key Considerations For Food Safety Recalls

United States Healthcare

SJ

Steptoe LLP

FDA Approves Seventh Denosumab Biosimilar: Richter And Hikma's Enoby And Xtrenbo

On September 29, 2025, Gedeon Richter Plc. and Hikma Pharmaceuticals Plc. along with its wholly owned subsidiary Hikma Pharmaceuticals USA Inc. announced that the FDA approved their biosimilar denosumab products Enoby and Xtrenbo, referencing Prolia and Xgeva respectively.

United States Healthcare

GP

Goodwin Procter LLP

State Of Capital Markets For Public Companies: A Comprehensive Look At The Technology, Clean Energy, And Life Sciences Sectors In 2025

As a Silicon Valley corporate lawyer advising high-growth companies and their boards, I have seen firsthand how capital strategy, disclosure, governance, and litigation risk all intersect.

United States Commercial

FL

Foley & Lardner

Healthcare AI In The United States — Navigating Regulatory Evolution, Market Dynamics, And Emerging Challenges In An Era Of Rapid Innovation

The use of artificial intelligence (AI) tools in healthcare continues to evolve at an unprecedented pace, fundamentally reshaping how medical care is delivered, managed, and regulated across the United States.

United States Healthcare

JW

Jones Walker

The Trump Administration Continues To Make Drug Pricing Moves, Announces First MFN Agreement

Lowering drug prices for American patients continues to be a key area of focus and activity for the Trump administration. In May, the President issued the "Delivering Most-Favored-Nation...

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

President Trump's Recent Post Concerning CBD And Potential Implications

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

USDA's Spring 2025 Unified Agenda Includes Rules Regarding Biotechnology Products And Bioengineered Foods

United States Healthcare

BC

Bergeson & Campbell

Life Sciences And Medtech Policy Update: Key Things To Know Q4 2025

United States Healthcare

GP

Goodwin Procter LLP

Increased Enforcement And Seizure Activity Of Nicotine Vaping Products

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Benesch's Dental/DSO Intelligence Monthly Report: September 2025

United States Healthcare

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Benesch Friedlander Coplan & Aronoff LLP

From Stents To Grafts: FDA Guidance On PFAS In Medical Devices

United States Healthcare

D

Dechert

Department Of Health And Human Services Links Prenatal Tylenol Use To Autism: Expanding Litigation Risks For Manufacturers, Retailers, Distributors, And Clinicians

United States Healthcare

MB

Mayer Brown

New Mexico Poised To Be First Jurisdiction To Impose Labeling Requirements On All Products Containing PFAS

United States Environment

BD

Beveridge & Diamond

Commerce Opens Section 232 Investigations On PPE/medical Equipment And Robotics/industrial Machinery

United States International

CH

Clark Hill

Responsible AI In Healthcare: Balancing Innovation With Compliance

United States Healthcare

AC

Ankura Consulting Group LLC

U.S. Chemical & Life Science Patents Q3 – 2025 Newsletter

United States IP

HI

Harness IP

Innovative Insights: Legal Updates In Life Sciences | Third Quarter 2025

United States Healthcare

JD

Jones Day

National Security Investigation: Imports Of Personal Protective Equipment, Medical Consumables, And Medical Equipment, Including Devices

United States International

BI

Buchanan Ingersoll & Rooney PC

US Initiates Investigation Of Imported PPE, Medical Gear

United States International

CL

Cassidy Levy Kent

General Court Annuls Additional Year Of Marketing Protection For Biogen's Tecfidera

United States Healthcare

AO

A&O Shearman

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Highlighted Content

Plausibility At The EPO – An Update On G2/21

United States Healthcare

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Dehns

Infringement Of Repurposed Drug Patents And Skinny Labelling – Where Does The Balance Lie In The United States Today?

United States Healthcare

D

Dehns

Infringement Of Repurposed Drug Patents And Skinny Labelling – Where Does The Balance Lie In Europe Today?

United States Healthcare

D

Dehns

How Good Does A Copy Need To Be?

United States Healthcare

D

Dehns

Supplementary Protection Certificates – European Patent Term Extensions

United States Healthcare

D

Dehns

How Much Experimental Data Is Needed For Patent Applications In Europe?

United States Healthcare

D

Dehns

Implications Of The Genetic Technology (Precision Breeding) Bill On The Life Science IP Sector

United States Healthcare

D

Dehns

Protection For Plant Varieties In Europe And The UK Post-Brexit

United States Healthcare

D

Dehns

Best Practice For Invention Harvesting

United States Healthcare

D

Dehns

ADR And Diversity In The Life Sciences Sector

United States Commercial

J

JAMS

Latest Videos

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Non-binding Guidance: The Administration's Focus On Direct-to-Consumer Prescription Drug Advertising (Podcast)

RG

Ropes & Gray LLP

Inside MedTech Translation Challenges: Ensuring Multilingual Regulatory Compliance

Moringside

Critical Medical Device Series: Part VI Navigating Innovation: The FDA's Role In Regulating Medical Technology (Video)

AP

Arnold & Porter

Leveraging Technology To Create A Next Generation Academic Medical Center In Austin (Video)

AM

Alvarez & Marsal

Life Science Dealmaking Trends 2025 (Video)

M

Mintz

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