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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

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

BIOSECURE Act aims to restrict funding and genetic data use by foreign adversary biotech companies

The BIOSECURE Act (the “Act”), introduced by members of the House Select Committee on the Strategic Competition between the United States and the Chinese Communist Party...

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

Florida still has a long way to go before it can begin importing certain Canadian drugs

On January 5, 2024, the U.S. Food and Drug Administration (FDA) authorized Florida’s proposal under the Section 804 Importation Program (SIP) to allow Florida to proceed to the next...

News

FDA warns animal drug companies over unapproved antimicrobials, identifying “public health concerns”

In December 2023, the U.S. Food and Drug Administration (FDA) issued nine Warning Letters for the manufacture and distribution of unapproved over-the-counter (OTC) antimicrobial animal...

News

Inside the FDA Advanced Manufacturing Technologies Designation Program

On Tuesday, the U.S. Food and Drug Administration (FDA) launched a new program for entities using or developing advanced manufacturing technologies that is intended to expedite development...

News

AI/ML: European Medicines Agency joins the fray

The European Medicines Agency (EMA) has finally joined the discussion on artificial intelligence (AI) and machine learning (ML), releasing a draft reflection paper on the use of these...

News

The “Borne Mission” Report analysis: Between hope and disappointment for the pharmaceutical industries

Borne's long-awaited Report on regulation of healthcare products has fallen well short of pharmaceutical industry expectations. Indeed, it contains very few concrete proposals.

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