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.

How Clinical Trial Translation Drives Global Engagement For Patient Recruitment

Recruiting patients for global clinical trials is challenging, and language barriers are often the biggest hurdle.

United States Healthcare

Moringside

Bio-Thera And Intas Expand Golimumab Biosimilar Partnership To India

On March 23, 2026, Bio-Thera Solutions announced an expansion of its existing partnership with Intas Pharmaceuticals for BAT2506, its golimumab biosimilar...

United States Healthcare

GP

Goodwin Procter LLP

Board Of Pharmacy Enforcement Is Accelerating: What Pharmacies And Industry Stakeholders Need To Do Now

State Boards of Pharmacy are no longer operating as passive, complaint-driven regulators. Across the country, enforcement activity has become more aggressive, more coordinated and far more data-driven.

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

English High Court Rules No SPC Based On Authorisation Of Monotherapy A Where A+B Was Authorised First

In Laboratorios Leon Farma SA v The Comptroller General of Patents ([2026] EWHC 663 (Ch)), the High Court of England and Wales has reached an important conclusion relating...

United States IP

JA

J A Kemp LLP

FDA Announces Public Hearing And Opportunity To Comment On National Priority Voucher Pilot Program

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Federal District Court Blocks Texas AG Ken Paxton From Enforcing Conspicuous Warning Label Requirement For Food Products Containing 44 Listed Ingredients

United States Healthcare

SJ

Steptoe LLP

Health-E Law Episode 23: The Future Of Brain Tech With Dr. Newton Howard (Podcast)

United States Healthcare

SM

Sheppard, Mullin, Richter & Hampton LLP

OIG Issues Favorable Advisory Opinion On Clinical Trial Cost-Sharing Subsidies

United States Healthcare

BT

Barnes & Thornburg LLP

Healthcare Regulatory & Compliance Summit 2026 Recap

United States Healthcare

BB

Bass, Berry & Sims

Congress Seeks Answers On Most-Favored-Nation Drug Pricing Agreements And Their Impact On Medicaid

United States Healthcare

M

Mintz

Breaking Barriers: Mastering FDA Regulations, National Security, And Tariffs To Expand Your MedTech Company To The U.S.

United States Commercial

BI

Buchanan Ingersoll & Rooney PC

Pharmaceuticals: M&A Revival

Worldwide Commercial

KL

Herbert Smith Freehills Kramer LLP

Unintended Consequences: GAO Report Questions Impact Of Exercising March-In Rights For Drug Pricing

United States Healthcare

JD

Jones Day

Developments In Securities Fraud Class Actions Against U.S. Life Sciences Companies

United States Commercial

D

Dechert

Monitoring The Hormuz Strait And The Subsequent Trade Volatility

United States International

BG

Braumiller Law Group, PLLC

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

United States International

SJ

Steptoe LLP

Sanctions Update: March 9, 2026

Worldwide International

SJ

Steptoe LLP

Signed, Sealed, But Not Delivered? Don't Wonder About Taxes Under New Postal Service Rules

United States Tax

N

Nossaman LLP

Colorado "Opt-Out" Litigation – Petition For Rehearing En Banc And Amicus Briefs In Support

United States Finance

BS

Ballard Spahr LLP

BIOSECURE And The Shift To Secure Biotech Supply Chains

The BIOSECURE Act, enacted on December 18, 2025, introduces new parameters for biotechnology companies seeking US government funding and procurement.

United States Healthcare

SR

McDermott Will & Schulte

PBM Reform 2026: What Recent Legislation Means For The Industry (Video)

PBM reform 2026 is reshaping how PBMs and plan sponsors operate, as Congress and federal agencies introduce new compliance requirements and enforcement standards.

United States Healthcare

M

Mintz

CMS Issues Additional Guidance On The Organ Donation Process

The Centers for Medicare & Medicaid Services' (CMS) 2026 Organ Procurement Organization (OPO) Guidance reinforces existing donor-process safeguards while signaling increased...

United States Healthcare

HK

Holland & Knight

Antibody-Drug Conjugates

In our January Newsletter (here) we reported on the non-precedential Federal Circuit decision in Daiichi Sankyo Co. v. Seagen Inc., Fed. Cir. Dec 02, 2025...

United States IP

OM

Oblon, McClelland, Maier & Neustadt, L.L.P

EDPB/EDPS Joint Opinion On The European Biotech Act Proposal: Key Data Protection Implications For Pharma And Life Sciences

European Union Healthcare

AP

Arnold & Porter

FDA Moves To Streamline Biosimilar Development: The Implications For Regulatory And IP Strategy

United States IP

SA

Skadden Arps Slate Meagher & Flom

Pharmacokinetics Not Laws Of Nature In Disguise

United States Healthcare

HK

Holland & Knight

Federal Circuit Refuses To Construe "Configured For" As More Than "Capable Of"

United States IP

OM

Oblon, McClelland, Maier & Neustadt, L.L.P

The Doctrine Of Inherency In The Context Of An Obviousness Analysis

United States IP

OM

Oblon, McClelland, Maier & Neustadt, L.L.P

FDA Proposes New Evidence Playbook For Individualized Therapies

United States Healthcare

SR

McDermott Will & Schulte

Most-Favored Nation Drug Pricing: What U.S. Pricing Initiatives Mean For International Commercial Contracts

United States Healthcare

AP

Arnold & Porter

FDA Issues Draft Guidance For Responses To Form 483 Drug CGMP Inspections

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Patenting AI Discoveries In Life Sciences: Overcoming Eligibility, Disclosure, And Inventorship Challenges

United States IP

TS

Taft Stettinius & Hollister

Essential Reading For Plant IP Enthusiasts: Nador Cott Protection SAS V Asda Stores Limited – [2026] EWHC 553 (Pat)

United States IP

JA

J A Kemp LLP

The Doctrine Of Inherency In The Context Of An Obviousness Analysis

In this board decision, the Patent Trial and Appeal Board (PTAB) reversed the Examiner's rejections of claims 22, 54-56, and 60-62 in US 16/765,024.

United States IP

OM

Oblon, McClelland, Maier & Neustadt, L.L.P

FDA Issues Draft Guidance For Responses To Form 483 Drug CGMP Inspections

On March 9, 2026, the Food and Drug Administration (FDA) published a draft guidance, "Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection."

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Patenting AI Discoveries In Life Sciences: Overcoming Eligibility, Disclosure, And Inventorship Challenges

The pharmaceutical and biotechnology industries face transformative opportunities through artificial intelligence and machine learning integration.

United States IP

TS

Taft Stettinius & Hollister

Essential Reading For Plant IP Enthusiasts: Nador Cott Protection SAS V Asda Stores Limited – [2026] EWHC 553 (Pat)

On 12 March 2026, the High Court of England and Wales delivered a landmark judgment regarding the scope of Plant Variety Rights in Nador Cott Protection SAS v Asda Stores Limited.

United States IP

JA

J A Kemp LLP

FDA User Fee Act Reauthorization: What Happens Next And Positioning For Possible Reform

United States Healthcare

HK

Holland & Knight

Regulatory Horizons: What Life Sciences Companies Should Know About The BIOSECURE Act (Podcast)

Today's topic is a big one: the BIOSECURE Act, signed into law on December 18, 2025, as part of the FY 2026 National Defense Authorization Act.

United States Healthcare

B

BakerHostetler

Consumer And Policy Objectives Underpin Enforcement In Key Sectors

A key theme of antitrust enforcement throughout 2025 has been a distinct focus on strategic sectors identified as critical for economic growth and supply chain resilience. As individuals and governments alike seek to reduce their expenditure, antitrust scrutiny has zeroed in on areas of importance to consumers and of significant public spending.

United States Anti-trust

AO

A&O Shearman

Genetic Testing Under The Microscope: OIG Reports Surge In Medicare Lab Spending

A new January 2026 report from the Office of Inspector General of the U.S. Department of Health and Human Services (OIG) shows that Medicare Part B...

United States Healthcare

AP

Arnold & Porter

West Virginia Insurance Commissioner Assesses $1.5 Million Penalty For PBM Compliance Violations

On March 2, 2026, West Virginia's insurance commissioner entered an administrative order, agreed to by Express Scripts Administrators LLC...

United States Healthcare

DM

Duane Morris LLP

Skinny Labels, Larger Risks: Supreme Court Considers Induced Infringement Standards In Hikma v. Amarin

United States IP

FH

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

Eastern District Of Pennsylvania Dismisses Putative Securities Class Action Against Pharmaceutical Company As Time-Barred

United States Commercial

AO

A&O Shearman

Cognitive Dissonance II: Oral Arguments At Second Circuit In Quincy Bioscience's Brain Health Dietary Supplements Case

United States Criminal

M

Mintz

Understanding The Anti-Kickback Statute

United States Healthcare

MS

Miller Shah

Back To The Well: FDA's Draft Guidance On New Clinical Investigation Exclusivity

United States Healthcare

AV

Axinn Veltrop & Harkrider

AI Is Transforming Life Sciences. The Oversight Structures Are Still Catching Up.

United States Healthcare

WD

Wiggin & Dana

NDSee You In 2033: FDA's 12‑Digit NDC Is Coming

United States Healthcare

AF

ArentFox Schiff

AI In Healthcare: What We Learned At ViVE 2026 (And What It Means For Your Organization)

United States Technology

SM

Sheppard, Mullin, Richter & Hampton LLP

Are You Tracking The Right NSPM-33 Research Security Program Deadline—or Just The Popular One?

United States Healthcare

B

BakerHostetler

FDA Accepts Dr. Reddy's Laboratories' BLA For Abatacept Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

HHS Asks The Public: How Can Federal Action Help Accelerate AI Use In Clinical Care?

United States Healthcare

SM

Sheppard, Mullin, Richter & Hampton LLP

2025 Year In Review: Life Sciences Licensing & Collaboration Deals

United States Healthcare

GP

Goodwin Procter LLP

New Referral To The Enlarged Board Of Appeal Expected Regarding Claim Interpretation In The Context Of Added Subject Matter

United States IP

JA

J A Kemp LLP

FDA Announces A Single Pivotal Trial As The New Default Standard For Drug Approval

United States Healthcare

AF

ArentFox Schiff

Janssen Files BPCIA Complaint Against Bio-Thera And Accord Related To Golimumab Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

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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

PBM Reform 2026: What Recent Legislation Means For The Industry (Video)

M

Mintz

Leaders In Law: Life Sciences And Technology Transactions With Jekkie Kim (Podcast)

W

WilmerHale

Pay Transparency + The Power Of Preventive Strategies: Episode 3 — Pivoting Toward Preparation In The Life Sciences (Video)

JL

Jackson Lewis P.C.

Episode 37: Chanda Center For Health: Reimagining Access To And Delivery Of Long-term Disability Care (Podcast)

FL

Foley & Lardner

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

RG

Ropes & Gray LLP

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