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SEC enforcement in the life sciences sector has not simply intensified—it has fundamentally changed in character. What regulators are...
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The U.S. biotech industry is at an inflection point. As U.S. pharma companies have increasingly turned to Chinese biotech firms to...
Introduction Companion diagnostics (“CDx”) are medical devices which provide information that is essential for the safe and effective use...
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The first quarter of 2026 has been anything but quiet in the life sciences sector. Here are the top issues and trends we’ve noticed in...
The past year has proven tumultuous for life sciences companies, whose pharmaceutical products, active ingredients, and medical devices...
Edwards Lifesciences Corp. (Edwards) abandoned its $945 million acquisition of JenaValve Technology, Inc. (JenaValve) after the U.S....
Life sciences is a high-stakes sector where antitrust enforcement is testing the boundaries of competition law. The focus differs sharply...
The MedTech industry is entering 2026 at a pivotal moment. Regulatory complexities, geopolitical tensions, and persistent supply chain...
The 44th Annual J.P. Morgan Healthcare Conference concluded last week in San Francisco. In general, we noted a cautiously optimistic...
Significant Chinese investment in its biotechnology industry has resulted in a shift in the biopharma licensing market over the last five...
The BIOSECURE Act, first introduced in Congress last year, has now been reintroduced for inclusion in Senate’s draft of the annual...
As big pharmas and other commercial-stage biopharma and biotech companies grapple with the reality of patent cliffs on the horizon, which...
We asked more than 200 Freshfields lawyers – across geographies and practice areas: what are the 1-2 issues top of mind for you and your...
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According to settled Supreme Court case law, the holder of a patent may not require a licensee to pay royalties after the patent...
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On June 18, 2024, the Federal Trade Commission (FTC) issued a comment (the FTC Comment) responding to the United States Patent and...
On May 22, 2024, the U.S. National Institutes of Health (NIH) announced it was soliciting feedback on a proposed policy (the Policy)1...