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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

FDA AI & Medical Products Paper advocates for a tailored risk-based regulatory framework

The Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER), Center for Drug Evaluation and Research (CDER), Center for Devices and...

Insights and Analysis

Unsung regulatory approval vital to deal closing in acquiring businesses using radioactive materials

Advancements in medical technology make healthcare and radiopharmaceutical companies attractive investment prospects. And we are seeing this interest in real time. However, acquiring...

News

Highlights of new SEC rules on climate-related disclosures

On March 6, 2024, the U.S. Securities and Exchange Commission adopted its highly anticipated rules requiring climate-related disclosures.

News

Key insights from the 2024 American Bar Association White Collar Crime Conference

The 2024 American Bar Association White Collar Crime conference delivered crucial insights from artificial intelligence’s tantalizing promise to its looming threats, a focus on...

News

Revealing the covert economics of licensing and collaborations: Technology transfers

Although upfront fees, milestones and royalties often take the spotlight in deal announcements in the life sciences sector, there exist numerous other cost allocation principles within...

News

Advances in Precision Medicine, the Future of Diagnostics, and FDA Priorities in an Election year

Speaking at the J.P. Morgan Healthcare Conference this year, Hogan Lovells life sciences regulatory partners Lowell Zeta and Blake Wilson, were joined by Greenleaf Health’s Kalah...

News

How to use a Data Monitoring Committee in clinical trials: FDA invites industry comment

Last week, the U.S. Food and Drug Administration (FDA) published a draft guidance on the use of data monitoring committees (DMCs) in clinical trials entitled “Use of Data Monitoring...

News

FDA updates 2016 guidance on the collection of race and ethnicity data

The U.S. Food and Drug Administration (FDA) continues its efforts to include diverse participants in clinical research with a newly-published revision to its draft guidance document...

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