Worldwide: 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.

Virtual And Digital Health Digest – October 2025

This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2025 from the the United Kingdom, and European Union.

United States Healthcare

AP

Arnold & Porter

CRLs Unveiled: Converting FDA Transparency Into A Market Advantage

With the FDA's disclosure of 200 Complete Response Letters (CRLs), leadership teams now have an unprecedented insight into regulatory decision-making to glean patterns...

United States Healthcare

AM

Alvarez & Marsal

Holland & Knight Health Dose: October 28, 2025

In a notable development, a group of moderate Republican members of the U.S. House of Representatives sent a letter to Speaker Mike Johnson (R-La.), urging him to initiate negotiations on extending the APTCs but only after the government has reopened

United States Healthcare

HK

Holland & Knight

ATA EDGE 2025 Policy Conference

On December 10-12, Foley partners Nathaniel Lacktman, Nathan Beaver, T.J. Ferrante, and Aaron Maguregui are speaking in the American Telemedicine Association's (ATA) EDGE 2025...

United States Healthcare

FL

Foley & Lardner

Replay: Wearables Webinar Series, Part 2: Cybersecurity And Data Privacy Concerns For Wearables (Video)

United States Privacy

DM

Duane Morris LLP

NIH New Patent Licensing Policy

United States IP

TC

Thompson Coburn LLP

AI In Health Care And Biotechnology: Promise, Progress, And Challenges

United States Healthcare

FL

Foley & Lardner

Recent Rulings Highlight Risk To Japanese Drugmakers In Settling Pharmaceutical Litigations

United States Healthcare

JB

Jenner & Block

Payers, Providers, And Patients – Oh My!: AI In Healthcare – Key Policy Developments And State Laws

United States Technology

CM

Crowell & Moring LLP

Xbrane Enters Into Conditional Financing Deal Related To Ranibizumab Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

Our Key Takeaways From The 2025 Licensing Executives Society Annual Meeting

United States IP

BS

Ballard Spahr LLP

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

United States Healthcare

DM

Duane Morris LLP

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

United States IP

MG

Marshall, Gerstein & Borun LLP

Inside The FDA: Insights From Former Regulators

United States Healthcare

WL

WIT Legal

AMTL's AICP Files Second Case Against TSMC, Its Advanced Memory Amends Against SK Hynix

United States IP

RC

RPX Corporation

USCIS Announces Changes To The Naturalization Test

United States Immigration

Gs

Green and Spiegel

California Privacy Violations Result In $1.35 Million Fine!

United States Privacy

KM

Klein Moynihan Turco LLP

District Court Invalidates Patents For Bridge Cheating Detection Software Under § 101

United States IP

JM

Jeffer Mangels Butler & Mitchell LLP

Federal Court Blocks Enforcement Of Texas Proxy Advisor Disclosure Law

United States Commercial

SM

Sheppard Mullin Richter & Hampton

Using AI Responsibly: Balancing Innovation With Privacy

As artificial intelligence (AI) is increasingly adopted to innovate, it is essential to consider privacy implications of using AI tools to collect, analyze and/or use sensitive personal data...

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

The European Union (EU) Observatory for Nanomaterials (EUON) has contracted the Nanotechnology Industries Association (NIA) and Yordas Group to undertake a study on the assessment of health and environmental hazards and risks of surface-treated nanomaterials.

United States Environment

BC

Bergeson & Campbell

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

Are you a university or non-profit who's curious about the ways to unlock the potential of your incoming life sciences product royalty streams? In our comprehensive guide...

United States Healthcare

FH

Foley Hoag LLP

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

Semler Scientific Inc. ("Semler Scientific") and Bard Peripheral Vascular Inc. ("Bard Inc.") have agreed to pay nearly $37 million to settle allegations that they violated the False Claims Act ("FCA")...

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

Amgen And Biocon Settle Denosumab BPCIA Case

United States IP

GP

Goodwin Procter LLP

FDA Approves Celltrion's Aflibercept Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

Ohio's PBM Regulation Passed By House Of Representatives

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

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

Life sciences companies aggrieved by competitor activity believed to be in violation of the Federal, Food, Drug, and Cosmetic Act (FDCA) have been consistently unsuccessful...

United States Healthcare

FL

Foley & Lardner

Advances In Plant Biotechnology Improving Health And Well-Being

United States IP

JA

J A Kemp 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 Seeks Stakeholder Feedback On AI-Enabled Medical Device Performance

United States Healthcare

KM

Katten Muchin Rosenman LLP

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

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

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

United States Healthcare

B

Benesch Friedlander Coplan & Aronoff LLP

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

United States Healthcare

D

Dechert

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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

See more

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

Life Science Dealmaking Trends 2025 (Video)

M

Mintz

Welcome: Judith Hasko (Video)

W

WilmerHale

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

AM

Alvarez & Marsal

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