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HRSA issues 340B Program final rule modifying administrative dispute resolution process

On April 19, 2024, the Health Resources and Services Administration (HRSA) published a final rule (Final Rule) in the Federal Register adopting several changes to the current administrative ...

News

2024 Life Sciences & Health Care Horizons

While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent ...

News

Reduction of EU regulatory data protection, but not as short as the European Commission proposed

On 10 April 2024 the European Parliament adopted its position on the draft text on the revision of the European Union’s (EU) general pharmaceutical legislation, also referred to as...

News

FTC continues to highlight FDA Orange Book patent listings

With the recent filing of an amicus brief in a private pharmaceutical patent infringement case, the Federal Trade Commission (FTC) has continued its focus on allegedly “improperly...

News

Third Circuit: crime-fraud exception can apply to attorney-client privilege in sham-litigation case

In a ruling with significant implications for companies facing sham-litigation claims, such as those that can arise in the Hatch-Waxman context for pharmaceutical manufacturers, the Third...

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Spotlight on the U.S.: Panelists discuss navigating the IRA

Hogan Lovells is hosting a special webinar series for Life Sciences and Health Care companies based in, or with commercial interests in, the Asia-Pacific (APAC) region. The series shares...

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The European Commission report on competition enforcement in the pharmaceutical sector

On 26 January 2024, the European Commission published a report on competition enforcement in the pharmaceutical sector, highlighting the role of EU competition law in safeguarding market...

Insights and Analysis

Life Science Law Update – Key developments for pharma & device companies in EU and EU Big Five

In this Q4/23 issue of our Life Science and Health Care Law Update, our teams highlight key trends across life sciences regulatory, corporate, compliance, competition, and privacy...

News

Key considerations for responding to a CREATES Act request

Enacted in December 2019 as part of the Further Consolidated Appropriations Act of 2020, the Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act (21 USC 355-2) addresses ...

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