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.

FDA In Flux — August 2025 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

Generative AI Can Be A Tool For Bioprocessing Quality Assurance

Colin Zick, Chair of the Healthcare Compliance Practice and Co-Chair of the Privacy and Data Security Practice, was featured in an article discussing AI applications in bioprocessing...

United States Healthcare

FH

Foley Hoag LLP

Reflections On The 12th Annual Summit For Women Leaders In Life Sciences Law

We closed out July 2025 in Boston alongside several of our Axinn colleagues attending the American Conference Institute's 12th Annual Summit for Women Leaders in Life Sciences Law.

United States Healthcare

AV

Axinn Veltrop & Harkrider

Final Judgment Of Non-Infringement Entered In Alnylam V. Pfizer Vaccine Patent Dispute

On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. ("Alnylam") and Pfizer, Inc.

United States IP

GP

Goodwin Procter LLP

EC Begins Public Consultation On Biotech Act

United States Healthcare

BC

Bergeson & Campbell

False Claims Act Settlements To Know From The First Half Of 2025

United States Healthcare

BB

Bass, Berry & Sims

Iowa Overhauls Business Tax Incentives: What Companies Need To Know

United States Tax

BW

BrownWinick Law

The Hidden Legal Risks In Healthcare AI Implementation: What Medical Practice CEOs Need To Know

United States Healthcare

MB

Michael Best

United States v. Schena: EKRA's Debut At The Ninth Circuit

United States Government

SJ

Steptoe LLP

Texas Struggles To Rein In 'Nuclear Verdicts' As Senate Bill 30 Fails

United States Litigation

PD

Phelps Dunbar LLP

The Healthcare Crossroads: Navigating The Impact Of Trump's 2025 Tax Bill

United States Healthcare

AC

Ankura Consulting Group LLC

FDA Okays Continued PFAS Use In Medical Devices: Says Unlikely To Cause Harm

United States Healthcare

AP

Arnold & Porter

White House Announces New Efforts On Most-Favored Nation Drug Pricing

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

FDA Launches PreCheck Program To Accelerate Onshoring Of Drug Manufacturing Facilities

United States Healthcare

FH

Foley Hoag LLP

Business Tax Law Provisions Of The OBBA

United States Commercial

OK

Offit Kurman

Protectionism Or Free Trade?

United States International

BG

Braumiller Law Group, PLLC

Trump Administration Passes The One Big Beautiful Bill Act

United States Tax

FL

Foley & Lardner

AMTL's AICP Files Second Case Against TSMC, Its Advanced Memory Amends Against SK Hynix

United States IP

RC

RPX Corporation

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

United States Employment

DP

Dilworth Paxson LLP

The European Commission Publishes An EU Life Sciences Strategy

On 2 July, 2025, the European Commission published its EU Life Sciences Strategy (the ‘Strategy'), setting out a roadmap to position the European Union (EU) as a global leader in life sciences by 2030.

United States Healthcare

AP

Arnold & Porter

FDA Moves Forward On Fluoropolymers

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary.

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

FDA Leads The Way On Fluoropolymers

On August 6, 2025, the U.S. Food and Drug Administration (FDA) became the latest governmental agency to confirm that fluoropolymers are both safe and necessary. After an independent safety review...

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Implications Of FDA's "Radical Transparency" Plan For Complete Response Letters

The U.S. Food and Drug Administration (FDA), as part of the push towards "radical transparency" led by U.S. Health and Human Services Secretary Robert F. Kennedy Jr., recently released 200 complete response letters...

United States Healthcare

AP

Arnold & Porter

PBM Audits: Assessment Of Escalating Trends And Strategies For Pharmacies

United States Accounting

BI

Buchanan Ingersoll & Rooney PC

USDA Seeks Public Comment On Reorganization Plan

United States Healthcare

BC

Bergeson & Campbell

Appeal Of Examiner's Final Rejection Of Claims 18-20 Reversed By PTAB

United States IP

OM

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

What To Watch: WHOOP Warning Letter

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Federal Court Preliminarily Enjoins Arkansas' Ban On PBM Ownership Of Pharmacies

United States Healthcare

DM

Duane Morris LLP

Big Surprises Unveiled In CMS's Proposed 2026 Medicare Physician Fee Schedule: Major Implications For FMV And Bona Fide Service Fee Assessments

United States Healthcare

AC

Ankura Consulting Group LLC

Move Fast: FDA Is Accepting Submissions For The Pilot Program Class For FDA Commissioner's National Priority Voucher Program

United States Healthcare

GP

Goodwin Procter LLP

Major Update On GLP-1 Litigation Involving Compounding Pharmacies

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Texas Senate Bill 1318: Reforms For Healthcare Practitioner Non-Compete Agreements

United States Healthcare

MB

Michael Best

Use Of The LLC Holding Company Structure By Life Sciences Companies

United States Healthcare

W

WilmerHale

Move Fast: FDA Is Accepting Submissions For The Pilot Program Class For FDA Commissioner's National Priority Voucher Program

FDA is now accepting submissions to the Commissioner's National Priority Voucher (CNPV) pilot program, and with only five vouchers to be awarded as part of the initial year of the program...

United States Healthcare

GP

Goodwin Procter LLP

Major Update On GLP-1 Litigation Involving Compounding Pharmacies

Pharmaceutical giants Novo Nordisk and Eli Lilly are intensifying their litigation strategies to safeguard their GLP-1 drugs, tirzepatide (Mounjaro®) and semaglutide (Ozempic®, Wegovy®).

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Texas Senate Bill 1318: Reforms For Healthcare Practitioner Non-Compete Agreements

Governor Abbott signed SB 1318 into law this June, after passage by the Legislature in late May 2025.

United States Healthcare

MB

Michael Best

Use Of The LLC Holding Company Structure By Life Sciences Companies

Life sciences companies (particularly early stage companies) may be attracted to an LLC holding company structure as an alternative to a typical C corporation structure to maximize both...

United States Healthcare

W

WilmerHale

Five Key Ways The Budget Reconciliation Bill Could Impact Life Sciences—and How To Prepare

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

States Challenge New Federal Restrictions On Benefits For Noncitizens, Suing HHS And Other Agencies

On July 21, a group of 21 state attorneys general sued four federal agencies challenging new interpretations of an immigration law restricting noncitizens' access to certain public benefits.

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Two's Company, Three's A Crowd: District Court Dismisses Complaint Because Of Group Pleading

In a recent decision, Silbersher et al. v. Valeant Pharmaceuticals Int'l, Inc., 2025 WL 2052307 (N.D. Cal. July 22, 2025), a federal district court in California ruled that a relator's second amended complaint (SAC) ...

United States Criminal

AP

Arnold & Porter

Pharma Company Challenges The U.S. False Claims Act: What's At Stake For Whistleblowers And Government Enforcement?

A pharmaceutical company is currently appealing a record USD1.6 billion judgment in the US, arguing that a key part of the U.S. False Claims Act (FCA) is unconstitutional.

United States Healthcare

AO

A&O Shearman

Legal Foundations Every Life Sciences Startup Needs To Scale Successfully

Many early-stage startup teams move fast, fueled by trust, optimism and a shared goal. But what happens when real money shows up? Or when a cofounder wants out?

United States Commercial

C

Crowley Law LLC

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

United States IP

C

Crowley Law LLC

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

United States Healthcare

GP

Goodwin Procter LLP

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

United States Healthcare

GP

Goodwin Procter LLP

DOJ False Claims "Working Group" Update

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

B

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

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

United States Healthcare

AP

Arnold & Porter

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

AM

Alvarez & Marsal

Life Science Dealmaking Trends 2025 (Video)

M

Mintz

Welcome: Judith Hasko (Video)

W

WilmerHale

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

AV

Axinn Veltrop & Harkrider

MoCRA Featured On The Class Action Weekly Wire Podcast With Guest Kelly Bonner (Video)

DM

Duane Morris LLP

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