Worldwide: Healthcare

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 Requesting Comments On Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration ("FDA") issued draft guidance (the "510(k) Transfer Guidance") related to the transfer of a Premarket Notification (510(k)) Clearance.

United States Healthcare

KM

Katten Muchin Rosenman LLP

FDA Targets Gene Editing Clinical Trials In China And Other "Hostile Countries"

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and "immediate review" of new clinical trials where American patients' cells are sent to China or other "hostile countries" for genetic engineering with the expectation that the cells will be infused back into U.S. patients

United States Healthcare

CM

Crowell & Moring LLP

FDA Issues Final Guidance Addressing Remote Regulatory Assessments

On June 26, 2025, the U.S. Food and Drug Administration (FDA or the Agency) issued a final guidance that describes the Agency's conduct and use of remote regulatory assessments (RRAs).

United States Healthcare

AP

Arnold & Porter

Virtual And Digital Health Digest

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

Worldwide Healthcare

AP

Arnold & Porter

Ohio Board Of Pharmacy Prescribes New Rules For Ohio Pharmacies

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

BioNTech Announces Transaction To Acquire CureVac

United States Healthcare

GP

Goodwin Procter LLP

Supreme Court Narrows Medicaid Beneficiaries' Right To Sue: Key Takeaways From Medina v. Planned Parenthood South Atlantic

United States Healthcare

FH

Foley Hoag LLP

Health Canada Must Redetermine Exemption Requests For Psilocybin (Magic Mushroom)-Assisted Psychotherapy Training

Canada Healthcare

SB

Smart & Biggar

Understanding The Food Safety And Standards (Alcoholic Beverages) First Amendment Regulations, 2025

India Healthcare

IL

IndiaLaw LLP

HHS To Launch Campaign Promoting Wearable Devices

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

HIPAA Reproductive Health Privacy Rule Protections Struck Down

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Pharma, National Security And Tariffs: Where Do We Go From Here?

Canada Healthcare

BL

Borden Ladner Gervais LLP

Congressional Budget Proposal Includes Adjustments To Dual-Eligible Enrollment Pathways And Medicare Savings Program Rules

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

The Cali Fund And DSI: What Life Sciences And Biotech Companies Need To Know Now

Worldwide Healthcare

PC

Potter Clarkson

European Commission Proposes Further Prohibitions Of Territorial Restrictions On Branded Products

European Union Anti-trust

JD

Jones Day

UPCOMING WEBINAR: 2025 Global In-House Counsel Survey Report: Unique Insights Into The Global In-House Counsel Profession

Worldwide Law Practice

IC

In-House Counsel Worldwide

Looking Ahead: Irish Developments - Horizon Scanner: Finance, May 2025

Ireland Finance

AC

Arthur Cox

Hazine Ve Maliye Bakanlığının "Vergi Affı" Haberlerine İlişkin Açıklaması

B

BDO TURKIYE (DENET YEMINLI MALI MUSAVIRLIK A.S.)

GST Rates On Gold: 18, 22, 24 Carat & Making Charges

V

Vakilsearch

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

FDA Requesting Comments On Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration ("FDA") issued draft guidance (the "510(k) Transfer Guidance") related to the transfer of a Premarket Notification (510(k)) Clearance.

United States Healthcare

KM

Katten Muchin Rosenman LLP

Is A Ban On Alcohol Advertising Really On The Table?

According to the Times, the UK is considering a ban on alcohol advertising as part of the NHS's ten-year plan to shift focus from reactive to preventative care.

United Kingdom Media & IT

FK

Frankfurt Kurnit Klein & Selz

FDA Targets Gene Editing Clinical Trials In China And Other "Hostile Countries"

In a somewhat ambiguous press release on Wednesday, June 18, 2025, the Food and Drug Administration (FDA) announced a halt and "immediate review" of new clinical trials where American patients' cells are sent to China or other "hostile countries" for genetic engineering with the expectation that the cells will be infused back into U.S. patients

United States Healthcare

CM

Crowell & Moring LLP

FDA Issues Final Guidance Addressing Remote Regulatory Assessments

United States Healthcare

AP

Arnold & Porter

Ohio Board Of Pharmacy Prescribes New Rules For Ohio Pharmacies

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Health Canada Must Redetermine Exemption Requests For Psilocybin (Magic Mushroom)-Assisted Psychotherapy Training

Canada Healthcare

SB

Smart & Biggar

Understanding The Food Safety And Standards (Alcoholic Beverages) First Amendment Regulations, 2025

India Healthcare

IL

IndiaLaw LLP

HHS To Launch Campaign Promoting Wearable Devices

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

Pharma, National Security And Tariffs: Where Do We Go From Here?

Canada Healthcare

BL

Borden Ladner Gervais LLP

See more

Patents

Genentech And U Penn Settle HERCEPTIN Patent Suit

On June 8, 2012, Genentech’s lawsuit seeking a declaration that US Patent No. 6,733,752 was invalid and not-infringed by Genentech’s trastuzumab product (HERCEPTIN).

BR

Beeser Ramamoorthy LLP

Subsequent-Entry Biologic Patent Litigation Commences In Canada

Health Canada specifically contemplates certain proteins as SEBs in its Guidance, although Health Canada has not limited SEBs to only particular classes of drugs.

SB

Smart & Biggar

Pharma In Brief - Canada: Federal Court Reduces Claim For Section 8 Damages Based On Defence Of Ex Turpi Causa [MEVACOR® (lovastatin)]

On May 23, 2012, the Federal Court held that Merck Frosst Canada Ltd. ("Merck") is liable to Apotex Inc. ("Apotex") for damages under section 8 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations"), but exercised its discretion to reduce the amount of compensation payable based on a defence of ex turpi causa.

Canada Healthcare

NR

Norton Rose Fulbright Canada LLP

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

United States IP

FL

Foley & Lardner

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

United States IP

FL

Foley & Lardner

U.S. Appeals Court Overturns District Court's Finding Of Obviousness (AMRIX/Cyclobenzaprine Hydrochloride)

BR

Beeser Ramamoorthy LLP

GSK And Genentech Settle Cabilly Patent Lawsuit

United States IP

BR

Beeser Ramamoorthy LLP

Consultation On PMPRB Guidelines

Canada Healthcare

BL

Borden Ladner Gervais LLP

Drug Pricing & Reimbursement @ Gowlings: May 1, 2012 - Volume 6, Number 2

Canada Healthcare

GW

Gowling WLG

See more

Healthcare

Virtual And Digital Health Digest

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

Worldwide Healthcare

AP

Arnold & Porter

Ohio Board Of Pharmacy Prescribes New Rules For Ohio Pharmacies

As of May 1, 2025, new Rules and Regulations are in effect in Ohio related to Staffing. These new Rules come in response to concerns by the Ohio Board of Pharmacy...

United States Healthcare

BI

Buchanan Ingersoll & Rooney PC

Supreme Court Narrows Medicaid Beneficiaries' Right To Sue: Key Takeaways From Medina v. Planned Parenthood South Atlantic

As we wrote about in our Medicaid & the Law blog here, after South Carolina attempted to exclude Planned Parenthood clinics from the state's Medicaid program...

United States Healthcare

FH

Foley Hoag LLP

Health Canada Must Redetermine Exemption Requests For Psilocybin (Magic Mushroom)-Assisted Psychotherapy Training

Canada Healthcare

SB

Smart & Biggar

HHS To Launch Campaign Promoting Wearable Devices

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

HIPAA Reproductive Health Privacy Rule Protections Struck Down

United States Healthcare

MP

Manatt, Phelps & Phillips LLP

Pharma, National Security And Tariffs: Where Do We Go From Here?

Canada Healthcare

BL

Borden Ladner Gervais LLP

Congressional Budget Proposal Includes Adjustments To Dual-Eligible Enrollment Pathways And Medicare Savings Program Rules

United States Healthcare

SM

Sheppard Mullin Richter & Hampton

Texas SB 1318 Tightens Physician Non-Compete Rules, Extends Restrictions To Other Healthcare Practitioners

United States Healthcare

JL

Jackson Lewis P.C.

See more

Life Sciences, Biotechnology & Nanotechnology

BioNTech Announces Transaction To Acquire CureVac

On June 12, 2025, BioNTech SE ("BioNTech") announced its entry into a definitive purchase agreement to acquire all shares of CureVac N.V. ("CureVac"), with an implied aggregate equity value for CureVac of approximately $1.25 billion.

United States Healthcare

GP

Goodwin Procter LLP

Health Canada Must Redetermine Exemption Requests For Psilocybin (Magic Mushroom)-Assisted Psychotherapy Training

TheraPsil, a patient advocacy organization, and 73 healthcare practitioners (HCPs) have succeeded in the Federal Court of Appeal (FCA) to overturn the refusal of the Minister of Mental Health...

Canada Healthcare

SB

Smart & Biggar

HHS To Launch Campaign Promoting Wearable Devices

On June 24, 2025, in a hearing before the U.S. House of Representatives Committee on Energy and Commerce, the Secretary of Health and Human Services (HHS)...

United States Healthcare

AG

Akin Gump Strauss Hauer & Feld LLP

The Cali Fund And DSI: What Life Sciences And Biotech Companies Need To Know Now

Worldwide Healthcare

PC

Potter Clarkson

NASEM Will Hold Workshop On Synthetic Biology For Biomanufacturing And Predictable Engineering On July 1, 2025

United States Healthcare

BC

Bergeson & Campbell

The Pioneers: Financial Times Interview With Michelle Mitchell

United Kingdom Healthcare

WL

Withers LLP

Life Sciences Outlook 2025 - Oliver O'Connor, Irish Pharmaceutical Healthcare Association

Ireland Healthcare

AC

Arthur Cox

Supporting Growth – What Does The UK's Industrial Strategy Mean For Life Sciences?

United Kingdom Healthcare

GW

Gowling WLG

The New EU Product Liability Directive: Key Changes And Implications For The Life Sciences Sector

Ireland Healthcare

MF

McCann Fitzgerald

See more

Latest Videos

See more

FDA-Regulated Products Supply Chain Disruptions: Policy Shifts (Podcast)

B

BakerHostetler

Critical Medical Device Series: Part V Mitigating Litigation Risks For AI-Enabled Or Assisted Medical Devices (Video)

AP

Arnold & Porter

Navigating Healthcare Risks In A Rapidly Evolving Patient And Provider Centered AI Landscape (Video)

SM

Sheppard Mullin Richter & Hampton

Legal Consequences Of Abortion In The UAE: Jail Terms And Penalties

AM

Dr Hassan Elhais

CPD-Accredited: Rethinking Compassion Fatigue: Trauma-Informed Strategies For Professionals (Part 1) (Video)

GP

Gluckstein Lawyers

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