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.

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

Strengthening Your Hiring Process (Video)

United States Law Practice

OK

Offit Kurman

Still On The Fence About Hiring A Lawyer? Here's Why Timing Matters (Video)

United States Law Practice

C

Crowley Law LLC

The Changes To The English Arbitration Regime: What Parties To International Construction Disputes Need To Know

United States Litigation

J

JAMS

Unpacking A Busy Last Week For US ESG Disclosure And Compliance

United States Commercial

RG

Ropes & Gray LLP

Control, Creativity, Closure: The Mediation Advantage

United States Litigation

J

JAMS

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

DentalForum USA is an event series tailored specifically for DSOs, group practices and dental industry vendors.

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

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

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

The U.S. Department of Commerce today published notice that it has launched an investigation into whether imports of personal protective equipment...

United States International

CL

Cassidy Levy Kent

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

Eight companies marketing generic human medicinal products in the EU have each succeeded in persuading the General Court that a decision of the European Commission to grant...

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

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

The One Big Beautiful Bill Act (H.R. 1 or OBBBA) was signed into law on July 4, 2025 introducing significant changes to Medicaid policies and operations.

United States Healthcare

AM

Alvarez & Marsal

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

Aresurgence of the New World Screwworm (NWS), a parasitic pest eradicated from North America in the 1960s...

United States Healthcare

SH

Shook, Hardy & Bacon

Alvotech Files PGR Against Regeneron High-Dose Aflibercept Patent

On September 17, 2025, Alvotech USA Inc. and Alvotech hf. ("Alvotech") filed a Petition for Post Grant Review of U.S. Patent...

United States IP

GP

Goodwin Procter LLP

FDA In Flux — September 2025 Newsletter

Welcome to FDA In Flux – A Mintz newsletter tracking rapid changes in policy and agency actions that impact medical, life sciences, and consumer product investment decisions and development strategies.

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

Antitrust In Life Sciences—key European Developments For Pharma Companies

Worldwide Anti-trust

AO

A&O Shearman

Historic UPC Court Of Appeal Decision Changes The Landscape For European Generics

European Union IP

AO

A&O Shearman

Recent Federal Developments For September 2025

Worldwide Energy

BC

Bergeson & Campbell

NIH Prepares To Launch AI Initiative Transforming Medical Imaging Data Analysis And Advancing Personalized Medicine

United States Healthcare

FL

Foley & Lardner

Mintz IRA Update — Redesigning Part D For CY 2026

United States Healthcare

M

Mintz

Mintz IRA Update — Under Pressure: The Trump Administration's Drug Pricing Executive Orders

United States Healthcare

M

Mintz

Monthly Federal Developments Memorandum

Worldwide Energy

BC

Bergeson & Campbell

PhRMA's 2025 Policy Agenda And The Industry's Crossroads With The IRA And Drug Pricing Reform

United States Healthcare

M

Mintz

European Commission's Call For Evidence On The Revision Of The MDR/IVDR

United States Healthcare

AP

Arnold & Porter

How Stock Transfer Restrictions In Stockholder Agreements Shape Ownership And Control

United States Commercial

C

Crowley Law LLC

FDA On The Offense! Targeting Pharmaceutical Company Drug Advertising In Wave Of Enforcement Actions

United States Healthcare

FL

Foley & Lardner

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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

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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