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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.

UPC: CE Marking For A Medical Device As A Trigger For "Imminent Infringement", Refining The Standard On Imminence, Urgency, And Territorial Scope

The UPC has granted a preliminary injunction effective for Germany, France, Italy, the Netherlands and Ireland against a Chinese medical device manufacturer and its Dutch subsidiary over the infringement of a patent for implantable occlusion devices.

Worldwide Healthcare

AO

A&O Shearman

FDA Approves Lupin's Pegfilgrastim Biosimilar, ARMLUPEG

Lupin Limited announced on December 1 that it received FDA approval for its biosimilar product, ARMLUPEG (pegfilgrastim-unne).

United States Healthcare

GP

Goodwin Procter LLP

Navigating Maritime Drug Enforcement: Implications For Commercial Shipping And Cargo Security

U.S. agencies have intensified maritime drug-interdiction efforts, expanding enforcement under the Maritime Drug Law Enforcement Act and increasing pressure on commercial vessels targeted by drug traffickers.

United States Transport

HK

Holland & Knight

The Power And Gratification Of Giving Back: How Purpose, Character, And Service Drive Fennemore's Culture Forward

As we enter the holiday season—a natural time for reflection—we're reminded not only of celebration but of the many people in our communities who are facing hardship.

United States Real Estate

FL

Fennemore

National Advertising Division Puts Compounded GLP-1 Advertising On A Diet

United States Media & IT

PL

Polsinelli LLP

FDA Publishes New Draft Guidance On Reducing Animal Testing In Nonclinical Safety Studies

United States Healthcare

HK

Holland & Knight

Food Litigation Watch: State Ingredient Warnings, Color-Additive Bans, And "Ultra-Processed" Claims

United States Healthcare

BD

Beveridge & Diamond

Advancing Medicaid Reentry Initiatives: Early Implementation Successes

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Access Unlocked Part 2: FDA Launches TEMPO Pilot To Advance Digital Health Under CMMI's ACCESS Model

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

2026 Legislative And Regulatory Outlook

United States Transport

HK

Holland & Knight

Food Venture Financing News – Weekly Issue No. 263

United States Healthcare

DW

Davis Wright Tremaine

CMS Announces ACCESS (Advancing Chronic Care With Effective, Scalable Solutions) Model

United States Healthcare

FH

Foley Hoag LLP

Cigna To Join TrumpRx Fertility Drug Expansion Program

United States Healthcare

HB

Hall Benefits Law

FDA Withdraws "Standardized" Asbestos Testing Proposal For Talc-Containing Cosmetics, With Intent To Reexamine And Reissue

United States Healthcare

WR

Wiley Rein

Importing Steel Into Mexico A Pillar Of Compliance For Suppliers Trading With Mexico

United States International

BG

Braumiller Law Group, PLLC

FBI's Most Recent Gambling Arrests Suggest Sports-Betting Regulations Are Effective

United States Media & IT

DM

Duane Morris LLP

The Empty Chair At Johannesburg: What It Says About US Power

United States International

SJ

Steptoe LLP

Top 5 Takeaways From "Advanced Mediation Strategies For Handling The Toughest Situations"

United States Litigation

J

JAMS

Visa Turbulence: Navigating Your H-1B Future In A Shifting U.S. Landscape (Video)

United States Immigration

Gs

Green and Spiegel

Highlights: CMS's Proposed Rule For Medicare Part C & D (CY 2027 NPRM)

On November 26, 2025, the Centers for Medicare & Medicaid Services published its Proposed Rule for the Medicare Program; Contract Year 2027 Policy and Technical Changes to the Medicare Advantage Program, Medicare Prescription Drug Benefit Program, and Medicare Cost Plan Program for public comment.

United States Healthcare

CM

Crowell & Moring LLP

Holland & Knight Health Dose: December 3, 2025

Following a brief Thanksgiving holiday break, U.S. Congress faces just a handful of legislative days before year-end, and the next two weeks promise a crowded calendar as lawmakers race to meet major deadlines.

United States Healthcare

HK

Holland & Knight

Bipartisan AGs Urge Shopify To Filter Out E-Cigarette Sellers From Its Platform

California AG Rob Bonta and the City of New York were joined by a bipartisan coalition of 24 AGs in sending a letter to Shopify Inc., urging the company...

United States Consumer

CO

Cozen O'Connor

EC Adopts Strategic Framework For A Competitive And Sustainable EU Bioeconomy

The European Commission (EC) announced on November 26, 2025, that it adopted a new Strategic Framework for a Competitive and Sustainable EU Bioeconomy, "charting a way forward to build a clean, competitive and resilient European economy."

United States Energy

BC

Bergeson & Campbell

Happy Holidays? CMS Contract Year 2027 Medicare Advantage And Part D Proposed Rule Has Winners And Losers

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

FDA's Biosimilar Playbook: Merging Biosimilarity With Interchangeability

United States Healthcare

JD

Jones Day

FDA Guidance On Biosimilars Highlights Glycosylation Profiling And Increases The Strategic Value Of Patents Covering Antibodies Defined By Glycosylation

United States Healthcare

FL

Foley & Lardner

CMMI Launches Voluntary Payment Model For Qualifying Chronic Conditions With Tech-Enabled Care

United States Healthcare

HK

Holland & Knight

ACCESS Unlocked: CMS's Bold New Model For Tech-Enable Chronic Care Management

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Health Headlines: November 2025

United States Healthcare

GP

Goodwin Procter LLP

What To Watch: Continued DTC Advertising Enforcement

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

US-UK Pharmaceutical Pricing Deal: UK Agrees Increase In Amounts It Can Pay For Innovative Medicines And Reduction Of Rebate Rates

United States Healthcare

AP

Arnold & Porter

UPC Holds CE Marking Approval Is Evidence Of Imminent Infringement And Starts The Clock Running Where Considering Any (Unreasonable) Delay In A PI Application

United States IP

KL

Herbert Smith Freehills Kramer LLP

FDA's Tobacco Civil Money Penalty Authority, Cont'd: Not Backing Down

United States Healthcare

HP

Hyman, Phelps, & McNamara

What To Watch: Continued DTC Advertising Enforcement

Just before Thanksgiving, the Food and Drug Administration's ("FDA's") Office of Prescription Drug Promotion ("OPDP") silently published three untitled letters...

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

US-UK Pharmaceutical Pricing Deal: UK Agrees Increase In Amounts It Can Pay For Innovative Medicines And Reduction Of Rebate Rates

The UK and US governments have announced that they have reached an agreement on pharmaceutical pricing and tariffs.

United States Healthcare

AP

Arnold & Porter

UPC Holds CE Marking Approval Is Evidence Of Imminent Infringement And Starts The Clock Running Where Considering Any (Unreasonable) Delay In A PI Application

The UPC's Hamburg Local Division (LD) has granted a preliminary injunction (PI) preventing Lepu Medical Technology (Beijing) Co from offering, placing on the market or using...

United States IP

KL

Herbert Smith Freehills Kramer LLP

FDA's Tobacco Civil Money Penalty Authority, Cont'd: Not Backing Down

A few months ago, we blogged about a Texas U.S. District Court's Wulferic ruling that FDA's civil monetary penalty (CMP) provision for tobacco products contained...

United States Healthcare

HP

Hyman, Phelps, & McNamara

CMS Releases The Proposed 2027 Medicare Advantage And Part D Rules

United States Healthcare

M

Mintz

California Regulators Move Toward Classifying All P,p'-Bisphenol Chemicals As Causing Reproductive Toxicity Under Proposition 65

A new California initiative aims to classify all p,p'-bisphenol chemicals, including ethers and esters of p,p'-bisphenols, bisphenol AF...

United States Energy

SH

Shook, Hardy & Bacon

Financing And Exit Strategies In Life Sciences: Aligning Capital With Compliance And IP Value

Financing and exit transactions in the life sciences industry differ fundamentally from those in traditional technology or manufacturing sectors.

United States Healthcare

DM

Duane Morris LLP

Essentials For Co-Manufacturer Agreements

As food and beverage brands begin to scale, they will often look to partner with a contract manufacturer (co-man), to increase production or expand into new product categories.

United States Consumer

LL

Loeb & Loeb LLP

What 340B Hospitals Need To Know About CMS's CY 2026 OPPS Final Rule

CMS's recently published CY 2026 OPPS Final Rule will affect 340B covered entities in two key ways starting Jan. 1, 2026. First, CMS will conduct a Drug Acquisition Cost Survey to collect NDC-level pricing data...

United States Healthcare

PL

Polsinelli LLP

Clark v. Sweeney (No. 25.-52)

United States Litigation

WD

Wiggin & Dana

Supreme Court Update: Clark v. Sweeney (No. 25.-52) And Pitts v. Mississippi (No 24-1149)

United States Litigation

WD

Wiggin & Dana

Recent Updates Transforming Plan Sponsor Relationships With Pharmacy Benefit Managers

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

2026 Physician Fee Schedule Final Rule: FMV And Bona Fide Service Fee Implications

United States Healthcare

AC

Ankura Consulting Group LLC

ACA Files Suit Challenging Colorado Law That Omits Medical Debts From Credit Reports

United States Finance

BS

Ballard Spahr LLP

State PBM Oversight Has Been Growing But Enforcement Still Falls Short: Why Pharmacies Must Step Up

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Bridging The Gap: Maine's New Law Empowers Pharmacies And Pharmacists To Improve Rural Access To Medications

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Kentucky Pharmacies: Prepare For USP Changes In The New Year

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

D. Mass. Patent Litigation Update: October 2025

United States IP

FH

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Can A Chemically Synthesised Medicine Be Authorised As A Generic Of A Biological Medicine? And Who Can Challenge This?

United States Healthcare

AP

Arnold & Porter

BsUFA IV Is Coming: FDA Calls For Public Input

United States Healthcare

HP

Hyman, Phelps, & McNamara

"Implications" All The Way Down: Third Circuit Ruling Brings More "Implicit Misrepresentations" Within Scope Of Healthcare Fraud

United States Healthcare

AP

Arnold & Porter

Senators Introduce Better Food Disclosure Act

United States Healthcare

SH

Shook, Hardy & Bacon

CMS Releases CY 2026 Hospital OPPS And Ambulatory Surgical Center Final Rule

United States Healthcare

HK

Holland & Knight

Medical/Commercial Activities And Interactions: Benchmarking And Compliance Insights

United States Healthcare

PB

Porzio, Bromberg & Newman

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Highlighted Content

The Nexus Of Trade And Food Security Amid Global Conflicts

United States International

BG

Braumiller Law Group, PLLC

Any Comments On FDA's New Proposed Rule On Prior Notice Regulations?

United States International

BG

Braumiller Law Group, PLLC

World Trade And Invasion, One Year Later – Are We On The Brink Of A New World Order?

United States International

BG

Braumiller Law Group, PLLC

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

Latest Videos

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The Exploration Crisis: Why Oil & Gas Companies Are Finding Less While Demand Keeps Growing (Video)

AM

Alvarez & Marsal

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

RG

Ropes & Gray LLP

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

AP

Arnold & Porter

Live From Workplace Horizons 2025: What's Hot In ERISA — Forfeiture And Tobacco Surcharge Class Actions (Video)

JL

Jackson Lewis P.C.

Concerns For Employers Surrounding Employee Drug And Alcohol Testing Policies (Video)

FS

Foster Swift Collins & Smith

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