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.

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

Pharmacy Benefit Managers (PBMs) occupy a powerful and increasingly scrutinized position within the U.S. drug distribution and reimbursement system.

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

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

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

Strengthening Your Hiring Process (Video)

United States Law Practice

OK

Offit Kurman

From Conflict To Clarity: Why The ADR Experience Matters In Successful Resolution

United States Litigation

J

JAMS

What Honeybees Have Taught Me About Dispute Resolution

United States Litigation

J

JAMS

Unpacking A Busy Last Week For US ESG Disclosure And Compliance

United States Commercial

RG

Ropes & Gray LLP

Fair Use In AI Training: What Is Considered "Transformative?" (Podcast)

United States Technology

LB

Lewis Brisbois Bisgaard & Smith 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

Steptoe partners Joseph Dages, Ryan Poscablo, and Anthony Anscombe and associate Emma Howard authored an article titled "Key Considerations for Food Safety Recalls," which appeared in Food Safety Magazine.

United States Healthcare

SJ

Steptoe LLP

FDA Seeks Stakeholder Feedback On AI-Enabled Medical Device Performance

The U.S. Food and Drug Administration (FDA) is offering an opportunity for stakeholders to provide feedback to "advance a broader discussion among the AI healthcare ecosystem."

United States Healthcare

KM

Katten Muchin Rosenman LLP

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

In this episode of Non-binding Guidance, Greg Levine and Josh Oyster, partners in Ropes & Gray's life sciences regulatory and compliance practice group, are joined by Kellie Combs, partner and chair...

United States Media & IT

RG

Ropes & Gray LLP

FDA Seeks Input On Real-World Performance Of AI-Enabled Medical Devices: What Biotech And MedTech Innovators Need To Know

United States Healthcare

CM

Crowell & Moring LLP

Podcast - Part I: Going From Young Associate To Veteran Lawyer

United States Litigation

HK

Holland & Knight

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

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

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

United States Healthcare

JW

Jones Walker

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

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

President Trump's Recent Post Concerning CBD And Potential Implications

As reported in the Washington Post, Reuters and Marijuana Moment, President Trump posted a video on Truth Social endorsing Medicare coverage of hemp-derived cannabidiol (CBD)...

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

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

On September 4, 2025, the Office of Management and Budget (OMB) published the Trump Administration's Spring 2025 Unified Agenda.

United States Healthcare

BC

Bergeson & Campbell

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

Expected New Drug Pricing Model: We anticipate the Centers for Medicare & Medicaid Services (CMS) to release a significant proposed new drug pricing model through its Innovation Center...

United States Healthcare

GP

Goodwin Procter LLP

Increased Enforcement And Seizure Activity Of Nicotine Vaping Products

As indicated in our previous post, the US Food and Drug Administration (FDA) and the Department of Justice (DOJ) created a joint task force including the Bureau of Alcohol, Tobacco, Firearms...

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

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

United States Healthcare

B

Benesch Friedlander Coplan & Aronoff LLP

Responsible AI In Healthcare: Balancing Innovation With Compliance

Artificial intelligence (AI) is rapidly transforming the healthcare and life sciences industry, from accelerating drug discovery to personalizing treatment plans and optimizing clinical trials.

United States Healthcare

AC

Ankura Consulting Group LLC

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

We are pleased to share the Q3 edition of our Chemical and Life Science Patents Newsletter. Along with USPTO updates and US Chem and life science case law practice tips...

United States IP

HI

Harness IP

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

Pharmaceutical companies are increasingly concerned about the prospect that the Food and Drug Administration (FDA) will be delayed in its consideration of pending New Drug Applications (NDAs) and Biologics Licensing Applications (BLAs).

United States Healthcare

JD

Jones Day

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

On September 2, 2025, the U.S. Department of Commerce's Bureau of Industry and Security (BIS) initiated an investigation to determine the effects on the national security of imports of personal protective equipment...

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

Development Of Therapeutic Protein Biosimilars - Can Startups Content With The "State Of The Art" Standard?

United States Healthcare

IG

IR Global

AstraZeneca Doubles Down: Pharmacies Face Escalated Requests For Farxiga® Dispensing Records

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Healthcare Companies Must Act Quickly After CMS Launches $50 Billion Rural Health Transformation Program

United States Healthcare

FH

Foley Hoag LLP

Corresponding Responsibility: Why Pharmacies Must Take It Seriously — And How A Mock DEA Audit Can Protect Your Business

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

USTR Seeking Public Input As USMCA Review Gets Underway

United States International

W

WilmerHale

Navigating Work Requirements With AI-Driven Eligibility And Enrollment Solutions Under H.R. 1

United States Healthcare

AM

Alvarez & Marsal

New World Screwworm Invasion Threatens U.S. Livestock, Raising Economic And Legal Alarms

United States Healthcare

SH

Shook, Hardy & Bacon

Alvotech Files PGR Against Regeneron High-Dose Aflibercept Patent

United States IP

GP

Goodwin Procter LLP

FDA In Flux — September 2025 Newsletter

United States Healthcare

M

Mintz

HHS OIG Flags Explosive Part B Spending On Skin Substitutes Signaling Heightened Fraud, Waste, And Abuse Risk And Imminent Payment Reform

United States Healthcare

B

Benesch Friedlander Coplan & Aronoff LLP

FDA Updates Guidance On Development Of Therapeutic Protein Biosimilars: Comparative Analytical Assessment & Other Quality-Related Considerations

United States Healthcare

GP

Goodwin Procter LLP

Medical Wearables Under The Microscope: U.S. Regulatory, Data Privacy And Cybersecurity Perspectives

United States Healthcare

AO

A&O Shearman

Drug And Medical Device Regulation Under The Trump Administration

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

D

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

Welcome: Judith Hasko (Video)

W

WilmerHale

Conversations With Anthony Caporrino: Unlock The Potential Of Life Sciences (Video)

AM

Alvarez & Marsal

Navigating Health Tech: Regulations For AI/ML In Medical Devices And Software (Video)

M

Mintz

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