News & Analysis as of

Acquisitions Regulatory Requirements Food and Drug Administration (FDA)

Sheppard Mullin Richter & Hampton LLP

Guarding Against the Unknown: M&A Due Diligence of AI Companies in Data-Sensitive Sectors

M&A in the AI sector is redefining deal risk, especially when sensitive data is involved. As AI companies power breakthroughs in biotech, healthcare, defense, and critical infrastructure, the stakes for companies acquiring...more

Paul Hastings LLP

Navigating Current Challenges in Biotech M&A

Paul Hastings LLP on

The biotech mergers and acquisitions market faces significant headwinds in the first half of 2025. These challenges include frozen capital markets, regulatory uncertainty at the Food and Drug Administration (FDA) and...more

Paul Hastings LLP

FDA Funding Changes Could Impact Biotech M&A

Paul Hastings LLP on

With companies constantly developing new therapies and technologies, the biotech industry is a hotbed of innovation. This dynamic environment often leads to mergers and acquisitions (M&A) as a vehicle for larger companies to...more

Morgan Lewis - As Prescribed

Navigating Key Challenges in M&A Deals in the Rare Disease Sector

In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed and Health Law Scan, focusing on issues impacting the rare disease community. The value of merger and...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Gardner Law

Beyond Paperwork: Assessing the Effectiveness of a Compliance Program

Gardner Law on

In the world of FDA-regulated companies, compliance with regulatory requirements is not just a matter of paperwork. It is a critical aspect that can significantly impact mergers and acquisitions (M&A) and the overall success...more

Jones Day

Vital Signs: Digital Health Law Update | Summer 2020

Jones Day on

Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more

McDermott Will & Schulte

[Event] Life Sciences Bootcamp For In-house Counsel - March 19th, Cambridge, MA

The life sciences industry faces a wide range of legal, regulatory and business challenges, along with constantly evolving trends that impact leadership priorities. McDermott’s cross-functional team of life sciences...more

Hogan Lovells

Regulatory Insights for Life Sciences and Health Care Investments: Medical Device and Technology

Hogan Lovells on

Investing in the life sciences industry without an understanding of the key regulatory factors that could determine a product’s success or failure could cost you millions of dollars....more

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