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Life sciences companies have long been outside the scope of US national security regulations and benefited from significant exemptions under US privacy laws. ...more
On January 8, 2025, the Department of Justice (“DOJ”) published its Final Rule to implement President Biden’s Executive Order 14117, “Preventing Access to Americans’ Bulk Sensitive Personal Data and United States...more
The BIOSECURE Act would prohibit federal agencies from contracting with, extending loans to, or awarding grants to, any company with existing or pending agreements with identified biotechnology companies. This limits funding...more
The year 2023 will be remembered as a challenging one for private equity (PE), with complexities to navigate on many fronts. Traditional debt financing was expensive and scarce, expectations on valuations were tricky to...more
With the consequences of the global pandemic still reverberating throughout the Asia-Pacific region, governments and businesses in the area continue to focus on the life sciences industry. From startups to global...more
The Report shows that CFIUS reviewed a record number of filings in 2022 and also required more mitigation as a condition of clearance. On July 31, 2023, the Committee on Foreign Investment in the United States (CFIUS)...more
In the midst of a significant increase in foreign direct investment (FDI) in the US life sciences industry, which includes medtech and biopharmaceutical companies, Chinese FDI has declined considerably since its peak year of...more
Dealmaking in the life sciences sector took a major hit in 2022: the year was one of the lowest recorded years by value since 2017, with only $105 billion in merger and acquisition (M&A) deals completed by November 2022. The...more
CFIUS reviewed a record number of transactions in 2021 according to its most recent annual report – and shows no signs of slowing down. High technology (including quantum computing), life sciences, and green energy...more
There has been a significant increase in cross-border investment (FDI) in the US life sciences industry, including both medtech and biopharmaceutical companies. Determining if life sciences companies, particularly those in...more
On October 5, 2021, the U.S. Commerce Department’s Bureau of Industry and Security (BIS) published a final rule amending the Export Administration Regulations (EAR) to include new controls on genetic editing software and...more
With the new administration poised to take office, public and private companies will need to consider how President Biden’s regulatory, enforcement, and legislative priorities will affect their businesses. During this...more
Transactions in the U.S. healthcare space rebounded in autumn, although with a greater proportion of smaller deals than in recent years. ...more
The COVID-19 pandemic has generated a renewed focus on biotechnology and life sciences companies. Non-U.S. investors need to be aware of the potential that the Committee on Foreign Investment in the United States (CFIUS) may...more
In this episode, Akin Gump international competition and trade partner Davina Garrod and corporate partner Gavin Weir discuss M&A in the U.K., EU, U.S., China and more, its state of health and where it might go in 2020....more
As the rest of the world backed away from the deal table, confident US corporates continued buying businesses—especially in the life sciences and TMT sectors, and particularly in the domestic market. US dealmakers had a...more
Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
A recent McDermott round table on European health private equity generated key insights into the future of medtech, digital health, and data analytics, and identified opportunities for companies and investors. Digital...more
Welcome to the Q3 2019 issue of our Life Sciences International Review. This issue covers new developments within Europe, Asia, and the United States in intellectual property, regulatory, pricing, and international trade,...more
The Situation: The Committee on Foreign Investment in the United States ("CFIUS," or the "Committee") recently published draft regulations implementing the Foreign Investment Risk Review Modernization Act ("FIRRMA"), which...more
Venture Fundraising and Investment in Healthcare - U.S. healthcare venture fundraising reached a record $9.6 billion in 2018, continuing a four-year upward trend. This was driven by excellent returns in the sector,...more
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
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
The Committee on Foreign Investment in the United States recently broadened its coverage of biotechnology transactions via new regulations that became effective on November 10, 2018. This article provides perspectives about...more