United States: 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.

Artificial Intelligence In Clinical Decision-Making: Regulatory Roadmap And Reimbursement Strategies

Artificial intelligence is rapidly transforming clinical medicine, with AI-powered tools increasingly being used for diagnostic imaging interpretation, clinical decision support, predictive analytics and treatment planning.

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

FDA's Support For Onshoring Drug Manufacturing And Increasing Oversight Of Foreign Facilities

Since 2000, pharmaceutical manufacturing has increasingly moved offshore. Today, approximately 53% of brand drug products and 69% of generics have at least one manufacturer outside the United States.

United States Healthcare

JD

Jones Day

Return Of The BIOSECURE Act: What Life Sciences Companies Need To Know

House advances BIOSECURE Act as part of NDAA legislation.

United States Healthcare

PL

Polsinelli LLP

Commissioner's National Priority Voucher Program And Coverage Considerations

On June 17, 2025, FDA Commissioner Marty Makary launched a new priority review pilot program intended to accelerate FDA review for drug and biologic companies supporting U.S. national interests.

United States Healthcare

JD

Jones Day

CMS Indefinitely Suspends Off-Cycle Revalidation Deadline For Skilled Nursing Facilities

United States Healthcare

HK

Holland & Knight

When Is An Approval Not An Approval? Before 1962.

United States Healthcare

HP

Hyman, Phelps, & McNamara

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

Worldwide Healthcare

AO

A&O Shearman

Algorithm Bias In Medicine

United States Healthcare

WE

Wilson Elser Moskowitz Edelman & Dicker LLP

Aligning United States Core Childhood Vaccine Recommendations With Best Practices From Peer, Developed Countries (Trump EO Tracker)

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Delaware District Court Judge Maintains View That The Operative Complaint Cannot Provide Requisite Knowledge For Post-Suit Indirect Or Willful Infringement In A Lawsuit

United States IP

AG

Akin Gump Strauss Hauer & Feld LLP

FDA Publishes New Draft Guidance On Reducing Animal Testing In Nonclinical Safety Studies

United States Healthcare

HK

Holland & Knight

BIOSECURE Act Included In Final Draft NDAA Compromise Text

United States Healthcare

GP

Goodwin Procter LLP

Virtual And Digital Health Digest – November 2025

European Union Healthcare

AP

Arnold & Porter

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

United States Healthcare

WR

Wiley Rein

How I Learned To Love Mediator's Proposals - Why Modern Mediation Sometimes Calls For A Guiding Hand

United States Litigation

J

JAMS

What Honeybees Have Taught Me About Dispute Resolution

United States Litigation

J

JAMS

Back To School 2025: Title IX Updates And How ADR Can Help Universities Resolve Disputes (Podcast)

United States Litigation

J

JAMS

Early Mediation: Is Your Case A Likely Candidate?

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

OECD Policy Brief Explores Biotechnology Investment And Regulatory Policy Landscapes In The EU And United States

On November 23, 2025, the Organisation for Economic Co-operation and Development (OECD) published a policy brief entitled "Boosting biotechnology innovation through agile regulation and finance instruments."

Worldwide Healthcare

BC

Bergeson & Campbell

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

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

Amgen, Hikma, And Gedeon Settle Denosumab BPCIA Case

On November 24, 2025, the U.S. District Court for the District of New Jersey entered a Consent Judgment and Injunction resolving the denosumab BPCIA litigation between Amgen...

United States Healthcare

GP

Goodwin Procter LLP

Ankura Powers One Of The Largest Medical Device Mass Tort Settlements In U.S. History: Transvaginal Mesh Claims Administration

United States Healthcare

AC

Ankura Consulting Group LLC

FDA's Biosimilar Playbook: Merging Biosimilarity With Interchangeability

United States Healthcare

JD

Jones Day

NSCEB Publishes Paper On Accelerating American Innovation

United States Healthcare

BC

Bergeson & Campbell

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

New Medical Device And IVD Registration And Transparency Requirements To Apply In 2026

United States Healthcare

AP

Arnold & Porter

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

United States Energy

SH

Shook, Hardy & Bacon

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

United States Healthcare

DM

Duane Morris LLP

Sector Focus: AI-Driven Tech, Healthcare And Financial Services Lead Dealmaking

United States Finance

D

Dechert

New Medical Device And IVD Registration And Transparency Requirements To Apply In 2026

On 27 November 2025, the European Commission published a notice in the Official Journal confirming that the first four modules of the European database on medical devices (EUDAMED) are fully functional.

United States Healthcare

AP

Arnold & Porter

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

Sector Focus: AI-Driven Tech, Healthcare And Financial Services Lead Dealmaking

In a market where competition for fundraising is fierce, it has become essential for GPs to differentiate their propositions to LPs. Sector specialization has been a pathway to delivering this differentiation.

United States Finance

D

Dechert

Congress Introduces Bill To Create National Biomanufacturing Center Of Excellence

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

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

On Nov. 21, 2025, the Centers for Medicare & Medicaid Services (CMS or Agency) released the calendar year (CY) 2026 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center...

United States Healthcare

HK

Holland & Knight

Medical/Commercial Activities And Interactions: Benchmarking And Compliance Insights

At the October 2025 Pharmaceutical and Medical Device Ethics and Compliance Congress, principals Jennifer A. Romanski and Michelle D. Axelrod participated in a session entitled...

United States Healthcare

PB

Porzio, Bromberg & Newman

Virtual And Digital Health Digest (October/November 2025)

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

Worldwide Healthcare

AP

Arnold & Porter

Formycon Announces New Dupilumab Biosimilar Candidate

On November 17, 2025 Formycon AG ("Formycon") announced development of a dupilumab biosimilar, FYB208, referencing Regeneron and Sanofi's DUPIXENT.

United States Healthcare

GP

Goodwin Procter LLP

Increased Federal Enforcement Of Illicit Ends Products

Worldwide Healthcare

BI

Buchanan Ingersoll & Rooney PC

European Commission Approves Alvotech's And Teva's Denosumab Biosimilars

European Union Healthcare

GP

Goodwin Procter LLP

FDA Issues First Draft Guidance In The Countdown To QMSR

United States Healthcare

HP

Hyman, Phelps, & McNamara

DOJ Expands Health Care Fraud Strike Force To Massachusetts As Health Care Enforcement Remains An Administration Priority

United States Criminal

LS

Lowenstein Sandler

Critical Medical Device Series: Part X Balancing Risk And Innovation: Fraud And Abuse Trends For MedTech (Video)

United States Healthcare

AP

Arnold & Porter

FDA Approves Accord BioPharma's Denosumab Biosimilars

United States Healthcare

GP

Goodwin Procter LLP

Bicameral, Bipartisan Bill Would Strengthen U.S. Biopharmaceutical Manufacturing

United States Healthcare

BC

Bergeson & Campbell

FDA Accepts Sanofi And Regeneron's Dupixent SBLA For Priority Review

United States Healthcare

GP

Goodwin Procter LLP

Congress Joins The Biomanufacturing Onshoring Party

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Sandoz Launches Natalizumab Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

Sandoz And EirGenix Enter Licensing Agreement To Commercialize Proposed Pertuzumab Biosimilar

United States Healthcare

GP

Goodwin Procter LLP

GTCR/Surmodics Win On Divestiture, Share Analysis And Captive Capacity

United States Anti-trust

BB

Baker Botts LLP

From Great Idea To Market Success With Patricia W. Peiffer (Podcast)

United States Strategy

C

Crowley Law LLC

FDA's Move To Streamline Biosimilar Approval: What In-House Counsel Must Prepare For Now

United States IP

UT

Upadhye Tang

2025 Update On Plant Biostimulant Product Regulation Under FIFRA

United States Healthcare

BD

Beveridge & Diamond

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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

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

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