United States: Food, Drugs, Healthcare, Life Sciences

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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.

Court Vacates HHS Regulation Allowing IRS To Certify Employer Shared Responsibility Penalty Under ACA

In Faulk Company, Inc. v. Becerra, 2025 WL1085080 (N.D. Tex. 2025), an employer sued the U.S. Department of Health and Human Services (HHS) for failure...

United States Healthcare

HB

Hall Benefits Law

Attorney Spotlight: Jekkie Kim (Video)

Meet Dr. Jekkie Kim, a nationally recognized life sciences transactional lawyer who joined WilmerHale as a partner in its Palo Alto office in 2024.

United States Healthcare

W

WilmerHale

First Few Details On MFN Pricing Emerge From HHS

Following up on Donald Trump's May 12 Executive Order on Most Favored Nation Prescription Drug Pricing (see our post here), The Department of Health...

United States Healthcare

HP

Hyman, Phelps, & McNamara

2025 Enforcement Trends: Risk Analysis Failures At The Center Of HHS's Multimillion-Dollar HIPAA Penalties

In the first five months of 2025, the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) announced it had entered into ten Health Insurance Portability...

United States Healthcare

OD

Ogletree, Deakins, Nash, Smoak & Stewart

Holland & Knight Health Dose: May 20, 2025

United States Healthcare

HK

Holland & Knight

DEA Gives Church Green Light On Ayahuasca

United States Healthcare

HS

Harris Sliwoski

Cybersecurity In Digital Health: Why HIPAA Compliance Alone Is Not Enough For M&A Success

United States Healthcare

FL

Foley & Lardner

New York Aims To Restore Choice In CDPAP With Expanded Fiscal Intermediary Licensure

United States Healthcare

HK

Holland & Knight

Noteworthy False Claims Act Settlement Demonstrates DOJ's Continued Scrutiny Of Arrangements Between Hospitals And Physician Practices

United States Healthcare

M

Mintz

Lifelines In Jeopardy: How Medicaid State Directed Payments Support Critical Health Care Providers

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Prescribing Red Flags: Pharmacists Be Wary Of What The Doctor Orders

United States Healthcare

HP

Hyman, Phelps, & McNamara

Everything Happens For A Riesling

United States Healthcare

Whiteman Osterman & Hanna LLP

MAHA's Vision For Healthier Diets: Awaiting Concrete Steps And Assessing Challenges

United States Healthcare

CM

Crowell & Moring LLP

Governor Cites Tariffs And Increased Medi-Cal Costs For $16 Billion Revenue Shortfall

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Security For New Bitcoin Strategic Reserve

United States Technology

BG

Braumiller Law Group, PLLC

I Attended Liberation Day And All I Got Was These Lousy Tariffs. Is This Liberation? Liberation Day Hangover

United States International

BG

Braumiller Law Group, PLLC

USMCA – We Have Some Good News And Some Terrible News

United States International

BG

Braumiller Law Group, PLLC

Discovery Special Masters And Referees: A View From Both Sides

United States Litigation

J

JAMS

2025 Trade Policy Agenda Provides Rationale For Trump Tariff Actions

United States International

BG

Braumiller Law Group, PLLC

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

The Silent Treatment: The EPO's Approach To Non-therapeutic Methods Encompassing Therapeutic Effects

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

Food and Drugs Law

First Few Details On MFN Pricing Emerge From HHS

Following up on Donald Trump's May 12 Executive Order on Most Favored Nation Prescription Drug Pricing (see our post here), The Department of Health...

United States Healthcare

HP

Hyman, Phelps, & McNamara

Holland & Knight Health Dose: May 20, 2025

The budget reconciliation package is expected to be considered by the full U.S. House of Representatives as soon as May 22, 2025. The House Committee on Rules is scheduled to meet on May 21...

United States Healthcare

HK

Holland & Knight

DEA Gives Church Green Light On Ayahuasca

The Church of Gaia announced on Friday that it has been "granted the first-ever approval for a Petition for Religious Exemption from the Controlled Substances Act pursuant to the Religious Freedom Restoration Act."

United States Healthcare

HS

Harris Sliwoski

GT Newsletter | Competition Currents | May 2025

Worldwide Anti-trust

GT

Greenberg Traurig, LLP

Prescribing Red Flags: Pharmacists Be Wary Of What The Doctor Orders

United States Healthcare

HP

Hyman, Phelps, & McNamara

Everything Happens For A Riesling

United States Healthcare

Whiteman Osterman & Hanna LLP

MAHA's Vision For Healthier Diets: Awaiting Concrete Steps And Assessing Challenges

United States Healthcare

CM

Crowell & Moring LLP

Teva And Alvotech Announce FDA Approval Of Interchangeability For SELARSDI (Ustekinumab-aekn) With STELARA (Ustekinumab)

United States Healthcare

GP

Goodwin Procter LLP

The Trump Administration Continues Focus On Drug Pricing With "Most-Favored-Nation Prescription Drug Pricing" Executive Order

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

See more

Life Sciences, Biotechnology & Nanotechnology

Attorney Spotlight: Jekkie Kim (Video)

Meet Dr. Jekkie Kim, a nationally recognized life sciences transactional lawyer who joined WilmerHale as a partner in its Palo Alto office in 2024.

United States Healthcare

W

WilmerHale

GT Newsletter | Competition Currents | May 2025

On April 2, 2025, the FTC announced it was seeking public comments through May 2, 2025, on a petition to reopen and modify its 2022 consent order relating to Verdun Oil Company II LLC's acquisition of EP Energy LLC.

Worldwide Anti-trust

GT

Greenberg Traurig, LLP

Enhancing Pharmacy Oversight And Auditing Practices

The following discussion highlights key compliance considerations for both existing pharmacies...

United States Healthcare

AC

Ankura Consulting Group LLC

The future of the robotics metaverse in the healthcare sector

United States Healthcare

AO

A&O Shearman

Former FDA Officials Howard Sklamberg And Eva Temkin Share Insights On AI's Role In Drug Development On FDA Watch Podcast

United States Healthcare

AP

Arnold & Porter

Reflections On The FDLI 2025 Annual Conference – Differing Tones, Shared Goals

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Speaker Programs: Two Recent Enforcement Actions Serve As A Reminder Of The Government's Longstanding Scrutiny

United States Healthcare

M

Mintz

Twenty States Sue The Trump Administration For HHS Program Eliminations And Staff Layoffs

United States Healthcare

M

Mintz

Mitigating Commercial Contracting Risk In Uncertain Times

United States Commercial

AP

Arnold & Porter

See more

Healthcare

Court Vacates HHS Regulation Allowing IRS To Certify Employer Shared Responsibility Penalty Under ACA

In Faulk Company, Inc. v. Becerra, 2025 WL1085080 (N.D. Tex. 2025), an employer sued the U.S. Department of Health and Human Services (HHS) for failure...

United States Healthcare

HB

Hall Benefits Law

First Few Details On MFN Pricing Emerge From HHS

Following up on Donald Trump's May 12 Executive Order on Most Favored Nation Prescription Drug Pricing (see our post here), The Department of Health...

United States Healthcare

HP

Hyman, Phelps, & McNamara

2025 Enforcement Trends: Risk Analysis Failures At The Center Of HHS's Multimillion-Dollar HIPAA Penalties

In the first five months of 2025, the U.S. Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) announced it had entered into ten Health Insurance Portability...

United States Healthcare

OD

Ogletree, Deakins, Nash, Smoak & Stewart

Holland & Knight Health Dose: May 20, 2025

United States Healthcare

HK

Holland & Knight

Cybersecurity In Digital Health: Why HIPAA Compliance Alone Is Not Enough For M&A Success

United States Healthcare

FL

Foley & Lardner

New York Aims To Restore Choice In CDPAP With Expanded Fiscal Intermediary Licensure

United States Healthcare

HK

Holland & Knight

Noteworthy False Claims Act Settlement Demonstrates DOJ's Continued Scrutiny Of Arrangements Between Hospitals And Physician Practices

United States Healthcare

M

Mintz

Lifelines In Jeopardy: How Medicaid State Directed Payments Support Critical Health Care Providers

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

GT Newsletter | Competition Currents | May 2025

Worldwide Anti-trust

GT

Greenberg Traurig, LLP

See more

Patents

The "Lead Compound" Approach To Obviousness And Obviousness-Type Double Patenting

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., the Federal Circuit upheld the district court’s determination that the claims at issue were neither obvious nor invalid under the doctrine of obviousness-type double patenting based on a "lead compound" approach to the obviousness determinations.

United States IP

FL

Foley & Lardner

With Ultramercial Remand, Is The Supreme Court Telegraphing View On Patent Eligibility To Federal Circuit?

After the Supreme Court decided that the personalized medicine method claims at issue in Mayo Collaborative Services v. Prometheus Laboratories, Inc. did not satisfy the patent eligibility requirements of 35 USC § 101.

United States IP

FL

Foley & Lardner

GSK And Genentech Settle Cabilly Patent Lawsuit

GlaxoSmithKline and Genentech have settled a U.S. lawsuit related to Genentech's Cabilly II (US 6,331,415) and Cabilly III (US 7,923,221) patents.

United States IP

BR

Beeser Ramamoorthy LLP

Supreme Court Holds That Generic Drug Manufacturers Can Challenge The Validity Of A Reference Drug’s "Use Code"

United States IP

BA

Bradley Arant Boult Cummings LLP

U.S. Supreme Court Allows Generic Drug Manufacturers To Challenge Brand’s FDA Use Codes

United States IP

VE

Vinson & Elkins LLP

Supreme Court Allows Generics To Challenge Orange Book Use Codes In Hatch-Waxman Litigation

United States Healthcare

PH

Paul Hastings LLP

Supreme Court Sides With Generic Drug Manufacturers, Closes Loophole In Hatch-Waxman Act

United States IP

PC

Perkins Coie LLP

U.S. Supreme Court Remands Myriad Case In Light Of Its Decision In Prometheus

United States IP

VE

Vinson & Elkins LLP

Federal Circuit Articulates Facts Establishing Jurisdiction In Declaratory Judgment Actions

United States IP

VE

Vinson & Elkins LLP

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Latest Videos

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Navigating FDA Compliance And Civil Litigation: Strategies For Food And Medical Product Companies (Video)

AP

Arnold & Porter

Artificial Intelligence In Healthcare (Video)

BI

Buchanan Ingersoll & Rooney PC

DSO Market Trends And 2025 Outlook ADSO Webinar Recording (Video)

B

Benesch Friedlander Coplan & Aronoff LLP

Preparing For Change: New CMS Survey Guidance Effective March 24, 2025 (Video)

SM

Sheppard Mullin Richter & Hampton

We Get Work®: An Exclusive Interview With Scipher Medicine CPO Kyla Pavlina (Podcast)

JL

Jackson Lewis P.C.

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