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News

CMS finalizes new standards and reporting obligations affecting Medicaid and CHIP managed care plans

On April 22, 2024, the Centers for Medicare & Medicaid Services (CMS) issued the Medicaid and Children's Health Insurance Program (CHIP) Managed Care Access, Finance, and Quality...

News

UK MHRA Publishes AI Regulatory Strategy

On 30 April 2024, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) published its strategic approach to AI and the steps it is taking to implement the UK Government's AI ...

Insights and Analysis

Hogan Lovells 2024 M&A Outlook

Our 10th annual M&A Year in Review features a 2024 M&A Outlook, which provides insights across the key topics that we expect will influence dealmaking in the months to come:...

News

The use of IVDs as CDx in pharmaceutical clinical trials

The current European legislation for in vitro diagnostic medical devices (IVD) (Regulation 2017/746 or the IVDR) has created challenges not only for IVD manufacturers but also for...

News

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

2024 outlook: Advancing AI innovations in patient care

Life sciences and health care companies are heavily regulated under the rigorous standards of the U.S. Food and Drug Administration to ensure high levels of quality and patient safety....

News

Podcast: Talking the cure

Our team is always thinking about how to foresee and conquer the most significant industry issues facing our clients. In 2020, we launched the podcast "Talking the Cure" where we cover...

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...

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