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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.

How To Leverage Licensing To Grow Your Life Sciences Or Tech Startup

Too often, early-stage founders overlook licensing because it seems like something only the big players do. But if you've built something novel...

United States IP

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Crowley Law LLC

Biocon Regulatory Approval Updates In The U.S. And Europe: Insulin Aspart And Denosumab

On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection)...

United States Healthcare

GP

Goodwin Procter LLP

Bio-Thera Announces Acceptance Of BLA For BAT2506 Referencing Johnson & Johnson's SIMPONI® (Golimumab)

On July 16, 2025, Bio-Thera Solutions, Ltd. announced that the U.S. Food and Drug Administration had accepted its Biologics License Application for its golimumab biosimilar, BAT2506, referencing Johnson & Johnson's SIMPONI®.

United States Healthcare

GP

Goodwin Procter LLP

DOJ False Claims "Working Group" Update

CYMI over the holiday week (present company included), the U.S. Department of Justice (DOJ) announced a re-energized partnership with the U.S. Department of Health and Human Services (HHS)...

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

California Supreme Court Strengthens Forum Selection Clause Enforcement

United States Commercial

CH

Clark Hill

FDA-Regulated Products Supply Chain Disruptions: Industry Perspective (Podcast)

United States Healthcare

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BakerHostetler

Updates And News From The Bakerhostetler Life Sciences Team

United States Healthcare

B

BakerHostetler

Amgen And Accord BioPharma Settle Denosumab BPCIA Case

United States Healthcare

GP

Goodwin Procter LLP

Midyear Update On Recent OIG Activity For Life Sciences Legal And Compliance Professionals (Part 1)

United States Healthcare

PB

Porzio, Bromberg & Newman

Health-e Law Episode 18: AI In Clinical Research: Opportunities, Risks, And The Road Ahead With Bill Kish And Dr. Brad Pruitt Of Kenosha AI (Podcast)

United States Technology

SM

Sheppard Mullin Richter & Hampton

Texas Enacts Responsible AI Governance Act Adding To Patchwork Of AI Laws

United States Technology

SM

Sheppard Mullin Richter & Hampton

European Commission Fines Alchem In First Cartel Case Involving A Pharmaceutical API

United States Healthcare

AO

A&O Shearman

The 340B Drug Pricing Program: Navigating Challenges In Healthcare Access

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

New Rules To Impact Texas Pharmacies

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

ALERT: Key Tax Provisions Provided For In "One Big Beautiful Bill Act"

United States Employment

DP

Dilworth Paxson LLP

U.S.-China Trade Relations: An Update On Tariffs

United States International

BG

Braumiller Law Group, PLLC

CTPAT: An Anchor For Weathering The Trade Storms

United States International

BG

Braumiller Law Group, PLLC

2025 Trade Policy Agenda Provides Rationale For Trump Tariff Actions

United States International

BG

Braumiller Law Group, PLLC

Workplace Violence: Why Employers Can't Afford To Ignore The Warning Signs

United States Employment

OK

Offit Kurman

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

The U.S. Food and Drug Administration, Center for Devices and Radiological Health (FDA) plays a pivotal role in shaping the future of medical technology innovation, particularly through its pre-market and post-market regulatory oversight.

United States Healthcare

AP

Arnold & Porter

GLP-1 Receptor Agonists: Clinical Trial Considerations

The U.S. Food & Drug Administration (FDA) has approved certain GLP-1 drugs for commercialization and use, including liraglutide (Victoza®), semaglutide (Ozempic®, Wegovy®), and tirzepatide (Mounjaro®, Zepbound®).

United States Healthcare

FL

Foley & Lardner

The Big, Beautiful Webinar Series - Part One: An Introduction To The One Big Beautiful Bill Act (Video)

These webinars will explore the provisions of the One Big Beautiful Bill Act that impact healthcare organizations. Part 1 of the series will summarize the bill and provide a foundation for future discussions...

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

FDA Issues Warning Letter Classifying Wearable Blood Pressure Monitor As A Device

Essentially, FDA deemed the BPI feature to constitute a device because of the relationship between measuring blood pressure and diagnosing high or low blood pressure.

United States Healthcare

DM

Duane Morris LLP

Neural Data Privacy Regulation: What Laws Exist And What Is Anticipated?

United States Privacy

AP

Arnold & Porter

AI-llowed Or Infringing? Are AI Research Tools Protected Under The Safe Harbor?

United States Healthcare

AP

Arnold & Porter

DOJ-HHS Announces False Claims Act Working Group, Emphasizes Healthcare Fraud Enforcement Priorities

United States Healthcare

GP

Goodwin Procter LLP

Why 340B Data Must Be Part Of CMS's Medicaid Pharmacy Surveys

United States Healthcare

JW

Jones Walker

Looking At The Challenges Of AI In Life Sciences

United States Healthcare

C

Crowley Law LLC

Building The Future Of Biopharmaceutical Manufacturing: Insights From BioNJ Manufacturing Briefing 2024

United States Healthcare

C

Crowley Law LLC

Looking At The Challenges Of AI In Life Sciences

United States Healthcare

C

Crowley Law LLC

No Rest For The Caretakers: Health Care Industry In Crosshairs For Expanded False Claims Act And Criminal Enforcement Activity

United States Healthcare

KL

Herbert Smith Freehills Kramer LLP

CBP Rescinds PGA Filing Exemption For Certain Low-Value FDA-Regulated Products

United States International

CM

Crowell & Moring LLP

Cybersecurity Challenges And Data Protection Strategies For Life Sciences And Tech Companies

United States Technology

C

Crowley Law LLC

Looking At The Challenges Of AI In Life Sciences

How AI Is Shaping Life Sciences: Challenges, Risks and Future Prospects...

United States Healthcare

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Crowley Law LLC

No Rest For The Caretakers: Health Care Industry In Crosshairs For Expanded False Claims Act And Criminal Enforcement Activity

The health care industry – already bracing for the financial impact of Medicaid cuts – faces another hard truth: This administration isn't slowing the pace of health care fraud enforcement.

United States Healthcare

KL

Herbert Smith Freehills Kramer LLP

CBP Rescinds PGA Filing Exemption For Certain Low-Value FDA-Regulated Products

In a CSMS message posted July 9, 2025, U.S. Customs and Border Protection (CBP) announced that, effective immediately, all shipments of products regulated by the U.S. Food and Drug Administration (FDA) must be subject to FDA-review upon importation.

United States International

CM

Crowell & Moring LLP

Cybersecurity Challenges And Data Protection Strategies For Life Sciences And Tech Companies

As generative AI rapidly becomes the backbone of industries like life sciences and other technology, the value of data has soared. Unfortunately, so have the risks associated with it.

United States Technology

C

Crowley Law LLC

AI In Biotech Research: Boon Or Bane?

United States Healthcare

C

Crowley Law LLC

BPCIA Litigation: Key District Courts And Judges Shaping The Biologics Landscape

By analyzing a decade's worth of BPCIA filings, we have gained insight into how venue strategy, repeat players, and specialized counsel are shaping the contours of this complex...

United States Healthcare

WL

WIT Legal

Lupin And Zentiva Reach Agreement To Commercialize Certolizumab Pegol Biosimilar

On July 9, 2025, Lupin Limited and Zentiva Group announced a license and supply agreement to commercialize Lupin's biosimilar of Certolizumab Pegol across multiple global markets.

United States Healthcare

GP

Goodwin Procter LLP

Trump Administration Bolsters FCA Health Care Fraud Enforcement With New DOJ-HHS Working Group

Emphasizing its commitment to enforcing the False Claims Act (FCA) and combating health care fraud, the Trump Administration recently instituted a DOJ-HHS False Claims Act Working Group...

United States Healthcare

PD

Phelps Dunbar LLP

Episode 36: Let's Talk Compliance: The Risks And Pitfalls Of Health Care Supply Chain Compliance (Podcast)

And so when you think about having that multi-disciplinary approached to third-party risk management, you really want to think about who is going to be on a committee, those individuals that really should be part of that committee structure.

United States Healthcare

FL

Foley & Lardner

Patents And The FDA: Four Critical Considerations Medical Device Companies Must Know To Successfully Introduce New Products Into The Market

United States IP

OK

Offit Kurman

Navigating AI In Business, Biotech, And Beyond

United States Technology

IG

IR Global

DOJ And HHS Announce New False Claims Act Enforcement Group

United States Healthcare

DM

Duane Morris LLP

Recent Federal Developments For July 2025

United States Healthcare

BC

Bergeson & Campbell

NASEM Will Hold July 17 Webinar On Nanotechnology R&D Infrastructure: Then And Now

United States Healthcare

BC

Bergeson & Campbell

Consumer Compass: Navigating The Consumer Products Legal Landscape | Mid-Year 2025

United States Healthcare

GT

Greenberg Traurig, LLP

Recent FDA Actions Pose Big Changes And Questions For Health And Food Industries

United States Healthcare

HK

Holland & Knight

Private Equity's Plan B: Navigating The Exit Drought With Continuation Funds

United States Commercial

FF

Farrell Fritz, P.C.

Federal Circuit Sides With J&J In Patent Battle Over Schizophrenia Drug Regimen

United States IP

RP

Reavis Page Jump LLP

No More Baby Steps: FDA Call To Action To Enhance Recall Communications For Infant Formula, Baby Foods, And Foods Intended For Children

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

MDEP Receives 11 CUU Proposals For Products Containing Intentionally Added PFAS Scheduled For Prohibition In 2026, Recommends Two For CUU Determinations

United States Environment

BC

Bergeson & Campbell

Safeguarding Innovation: Minimizing Risk In AI Partnership For Life Sciences

United States Technology

LE

Leason Ellis

Gender-Affirming Care: Key Takeaways From FTC's July 2025 Workshop On Unfair Or Deceptive Trade Practices

United States Healthcare

FL

Foley & Lardner

The Patent Eligibility Restoration Act And Life Sciences Innovation

United States IP

FL

Foley & Lardner

EPA Appoints Former ASA Government Affairs Director As OCSPP DAA For Pesticides

United States Environment

BC

Bergeson & Campbell

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

AM

Alvarez & Marsal

Welcome: Judith Hasko (Video)

W

WilmerHale

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

M

Mintz

Intellectual Property Partner Jason Murata In Conversation With The Hsu Untied Podcast (Video)

AV

Axinn Veltrop & Harkrider

Consumer Health: What To Know About Recent Trends In Digital Health (Video)

AP

Arnold & Porter

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