Biotech Insights
The Biotech Insights newsletter is your go-to resource for staying informed on the latest legal developments in biotechnology. Our Spring newsletter is featured below, as well as links to previous newsletters and information.
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Welcome to Haynes Boone’s Biotech Insights! This newsletter is your go-to resource for staying informed on the latest legal developments in biotechnology. Each edition will feature expert analysis of key topics impacting the biotechnology industry, a spotlight on one of our talented team members and details about where to connect with our team at upcoming industry events. We are committed to keeping you informed in this important and rapidly evolving field.
Read the Spring 2026 Biotech Insights here.
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The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently, the FDA approved Wegovy in tablet form, offering an alternative to the injection currently on the market. Whether relating to drug labeling, dosage form or containers, each change to an NDA must be reported to the FDA. But how? The exact reporting requirements can vary widely, depending on the severity of the change.
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U.S. Supreme Court opinions in Mayo Collaborative Services v. Prometheus Laboratories, Inc., Association for Molecular Pathology v. Myriad Genetics, Inc. and Alice Corporation Pty. Ltd. V. CLS Bank International et al., have left the Court of Appeals for the Federal Circuit grappling with the metes and bounds of patent subject matter eligibility, including the eligibility of nucleic acid sequences.
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This is the second article in our two-part series addressing a few key issues and considerations that life sciences business owners should consider when dealing with a merger or acquisition in California.
Part one covered approval mechanics, board composition, protections for minority and dissenting shareholders, California’s permit and fairness hearing process and the quasi-California corporation statute.
Part two addresses dispute resolution provisions, the enforceability of noncompetition and nonsolicitation covenants and tax considerations that commonly influence deal structure and negotiations.
