United States: Life Sciences, Biotechnology & Nanotechnology

Subscribe

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.

FDA In Flux - May 2026 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

Protecting Innovation In A Borderless Pharma Economy: The Reality Of Globalized Pharma Innovation

Today’s drug development programs routinely span continents: distributed research teams, multinational clinical trial networks, and complex webs of cross-border licensing, contract manufacturing...

United States IP

MG

Marshall, Gerstein & Borun LLP

Future-Proofing In-House Counsel: The Top Five Skills You Need Now

Partner Jason Schultz explores the evolving role of in-house counsel in healthcare organizations, identifying five critical capabilities that legal professionals must develop to remain effective strategic partners. The article examines how modern healthcare lawyers can enhance their value by mastering skills beyond traditional legal expertise, including project management, emotional intelligence, and business acumen.

United States Healthcare

BT

Barnes & Thornburg LLP

FDA’s AI In Early Phase Clinical Trials RFI: An Opportunity To Help Set The Rules Of The Road

The FDA has issued a Request for Information on a proposed AI-enabled optimization pilot program for early-phase clinical trials, signaling a shift toward "trustworthy AI" principles aligned with NIST frameworks.

United States Technology

CM

Crowell & Moring LLP

Rebuilding The Thymus: AI, Regenerative Medicine, And The Emerging Biotechnology Of Immune Longevity

United States Healthcare

FL

Foley & Lardner

USITC Will Hold Hearing On "China’s State Support And Pricing Practices In The Biotechnology Sector: Impact On U.S. Industry”

United States Healthcare

BC

Bergeson & Campbell

Third Circuit Affirms Denial Of Stelara Biosimilar Injunction

United States Healthcare

GP

Goodwin Procter LLP

FDA Considers Modernizing Dietary Supplements’ Regulatory Pathway

United States Healthcare

WR

Wiley Rein

Innovative Insights: Legal Updates In The Life Sciences

United States Healthcare

JD

Jones Day

AI In Health Care Is Scaling Quickly—As Regulation Lags, Internal Controls Need To Keep Pace

United States Healthcare

BS

Butler Snow LLP

Trump Administration Updates For The Life Sciences Industry Q1 2026

United States Healthcare

JD

Jones Day

Onshoring Pharmaceutical Manufacturing: Procedures To Apply For Onshoring Agreements To Reduce Section 232 Tariffs

Worldwide Healthcare

W

WilmerHale

Are Skinny Labels Getting Heavier For Generics? Key Takeaways From Hikma v. Amarin, The Supreme Court's First Patent Case Since 2023

United States IP

CM

Crowell & Moring LLP

Review Of Recent EPO Decisions On Polymorphs

United States IP

JA

J A Kemp LLP

The Cannabis Industry’s “Big Tobacco” Moment: What Insurers Need To Know About Murray v. Cresco

United States Cannabis

WE

Wilson Elser Moskowitz Edelman & Dicker LLP

Ankura CTIX FLASH Update – May 11, 2026

United States Technology

AC

Ankura Consulting Group LLC

What Every Multinational Should Know About…Managing The Aftermath Of The Supreme Court's IEEPA Tariff Decision (Part I)

United States International

FL

Foley & Lardner

Foreign Sovereign Immunity In International Construction

United States Litigation

J

JAMS

States Confront Oversight Of Medical Chatbots While FDA Stands Down: Implications From Pennsylvania’s Character.AI Lawsuit

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

FDA Approves Lannett, Lanexa Biologics, And Sunshine Lake Pharma’s Interchangeable Insulin Glargine Biosimilar

On May 4, 2026, the FDA approved Lannett Company, Inc. (“Lannett”), Lanexa Biologics LLC (“Lanexa”), and Sunshine Lake Pharma’s LANGLARA (insulin glargine-aldy)...

United States Healthcare

GP

Goodwin Procter LLP

HHS Office Of Civil Rights Issues Interim Final Rule Extending Section 504 Compliance Deadlines

On February 8, 2026,1 the Federal Department of Health and Human Services (the Department/HHS) issued the forthcoming publication of an Interim Final Rule (IFR) extending the dates that recipients of HHS funding...

United States Healthcare

BL

Butzel Long

Decentralized Clinical Trials: Key Sponsor Considerations Under FDA And EMA Guidance

The FDA and the European Medicines Agency (EMA) (jointly with the European Commission and Heads of Medicines Agencies) each have issued or updated their respective guidance addressing decentralized clinical trial...

United States Healthcare

CM

Crowell & Moring LLP

Discounts? For Spring? Groundbreaking

One does not need to be Miranda Priestly to observe that discounts are a trending topic for the US Department of Health and Human Services Office of Inspector General (OIG) advisory opinions (AOs).

United States Finance

SR

McDermott Will & Schulte

DOJ Civil Division Launches ‘FOCUS’ Initiative To Enhance Partnerships With 'Data-Miner' Whistleblowers

United States Government

AG

Akin Gump Strauss Hauer & Feld LLP

Critical Considerations For AI Model Licensing Agreements In Healthcare

United States Healthcare

FH

Foley Hoag LLP

AbbVie Regulatory Submission And Deal News

United States Healthcare

GP

Goodwin Procter LLP

Virtual & Digital Health Digest

United States Healthcare

AP

Arnold & Porter

FDA Makes Moves To Modernize Drug Development, Clinical Trial Paradigm

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

FDA Turns Up The Heat On GLP 1 Dupes Sold “For Research Use Only,” Finds Intended Use Suggests Otherwise (Podcast)

United States Healthcare

KD

Kelley Drye & Warren LLP

A Guide To Plaintiffs Litigation Playbook: Litigation Trends And Hot Topics Surrounding Medical Devices And Emerging Technologies

United States Healthcare

AP

Arnold & Porter

DOJ’s FCA Enforcement Priorities — Insights From The Deputy Assistant Attorney General

United States Healthcare

AP

Arnold & Porter

States Consider Options To Curtail Public Nuisance Suits

United States Litigation

D

Dechert

Episode 38: Let’s Talk Compliance: Not All WRVU’s Are Created Equal (Part 1) (Podcast)

United States Healthcare

FL

Foley & Lardner

A Guide To Plaintiffs Litigation Playbook: Litigation Trends And Hot Topics Surrounding Medical Devices And Emerging Technologies

The global medical device market is continuing to grow, especially with the use of AI-enabled devices for on real-time diagnostic imaging, clinical decision support, and patient monitoring via wearable devices

United States Healthcare

AP

Arnold & Porter

DOJ’s FCA Enforcement Priorities — Insights From The Deputy Assistant Attorney General

The U.S. Department of Justice has signaled its enforcement priorities for pharmaceutical manufacturers, focusing on conduct that raises drug prices and increases utilization. Deputy Assistant Attorney General Brenna Jenny outlined ...

United States Healthcare

AP

Arnold & Porter

States Consider Options To Curtail Public Nuisance Suits

New York considers legislation targeting AI chatbot operators for unauthorized practice of law, while Indiana pursues tort reform to limit public nuisance claims and the American Arbitration Association expands AI tools for dispute resolution. These developments signal a critical intersection of artificial intelligence regulation, professional liability standards, and evolving arbitration practices that will reshape how businesses navigate legal risk in an AI-driven landscape.

United States Litigation

D

Dechert

Episode 38: Let’s Talk Compliance: Not All WRVU’s Are Created Equal (Part 1) (Podcast)

In this episode, Jana Kolarik, a partner in Foley’s Health Care Practice Group and Angie Caldwell, Principal and CFO of PYA, discuss the importance of work relative value units (WRVUs) and fair...

United States Healthcare

FL

Foley & Lardner

Amneal Agrees To Acquire Kashiv BioSciences For Total Payment Up To $1.1 Billion

United States Healthcare

GP

Goodwin Procter LLP

Intellia Initiates Rolling BLA Submission For In Vivo CRISPR Therapy In Hereditary Angioedema

On April 27, 2026, Intellia Therapeutics (“Intellia”) announced that it has begun a rolling submission of a biologics license application (BLA) to the FDA for lonvoguran ziclumeran (lonvo-z), an investigational therapy for hereditary angioedema (HAE).

United States Healthcare

GP

Goodwin Procter LLP

A Changing Landscape: Bioengineered Trees For Improved Carbon Capture, Wood Processing, And Drought Resistance

Widespread deforestation poses a significant threat to the integrity of ecosystems around the world.

United States IP

JA

J A Kemp LLP

5 Costly IP Mistakes To Avoid

Patents serve as the fundamental currency of the medical technology industry, enabling companies to raise capital, form strategic alliances, and generate licensing revenue. Yet many medtech innovators fail to treat their intellectual property as a core business asset, risking the loss of competitive advantage and market exclusivity that could diminish the full value of their innovations.

United States IP

GT

Greenberg Traurig, LLP

US Department Of Justice Announces New Initiative For Data Miners Filing False Claims Act Lawsuits

On 30 April 2026, DOJ announced a new anti-fraud initiative: the Fraud Oversight through Careful Use of Statistics (FOCUS) initiative. The FOCUS initiative is intended to strengthen DOJ’s working relationship...

United States Criminal

KG

K&L Gates LLP

Trade Secret Litigation Trends In Life Sciences

United States IP

JD

Jones Day

Why Patent Portfolios Are Crucial For Life Science Innovators

United States IP

GT

Greenberg Traurig, LLP

U.S. Health And Human Services Tries Again To Improve Availability Of Innovative Devices In Medicare

United States Healthcare

AP

Arnold & Porter

Teva v. Lilly: Limiting Amgen’s Reach On Written Description And Enablement

United States IP

DS

Dinsmore & Shohl

Cosmetics Industry Update: What’s New With MoCRA?

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

1x1 With Dr. Jessica Gaulton At FamilyWell

United States Healthcare

GP

Goodwin Procter LLP

DOJ And DEA Order Immediately Reschedules FDA-Approved And State-Licensed Medical Cannabis To Schedule III: What Operators Need To Know

United States Cannabis

SH

Scarinci Hollenbeck LLC

The Critical First 30 Days: A Defense Perspective On Managing Traumatic Accident Claims

United States Litigation

BI

Buchanan Ingersoll & Rooney PC

Our Takeaways From The 2026 FDLI Annual Conference

Worldwide Healthcare

SM

Sheppard, Mullin, Richter & Hampton LLP

Patent Analysis Is Increasingly Shaping AI-driven Target And Drug Candidate Selection

United States Healthcare

FL

Foley & Lardner

Eli Lilly To Acquire Kelonia Therapeutics

United States Healthcare

GP

Goodwin Procter LLP

FDA Issues Draft Guidance On Safety Testing For Gene Editing Therapies

United States Healthcare

GP

Goodwin Procter LLP

OECD Blog Item Explores Why Biotech Start-Ups Lag In Europe

United States Healthcare

BC

Bergeson & Campbell

Trans-Atlantic Alignment? US Federal Circuit Moves Closer To The EPO/UPC Approach For Broad Antibody Claims To Medical Uses

United States IP

JA

J A Kemp LLP

Ambitious Priorities: Breaking Down FDA’s FY27 Budget

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

See more

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

A Guide To Plaintiffs Litigation Playbook: Litigation Trends And Hot Topics Surrounding Medical Devices And Emerging Technologies

AP

Arnold & Porter

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

W

WilmerHale

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

JL

Jackson Lewis P.C.

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

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More