Pharmaceutical companies are increasingly outsourcing complex manufacturing activities to contract development and manufacturing organizations, or CDMOs. This enables pharmaceutical companies to streamline their operations and redeploy capital toward research and development activities. At the same time, the CDMO industry is booming, with many analysts predicting continued rapid growth. CDMOs need more capacity, and they need it quickly. As a result of these trends, many pharmaceutical companies are engaging in an increasing number of transactions in…
In brief On September 11, 2025, the U.S. Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) released a favorable advisory opinion (“AO 25-10”), addressing a financial arrangement between a healthcare services company (the “Company”) and a non-profit, tax-exempt, charitable foundation (the “Foundation”), pursuant to which the Company helped establish and makes donations to the Foundation and the Foundation provides financial assistance to families of children receiving a particular type of behavioral…
On May 12, 2025, the White House issued a wide-reaching Executive Order (“EO”) titled “Delivering Most Favored Nation Prescription Drug Pricing to American Patients” for the stated purpose of ensuring that American patients will have access to the most-favored-nation (“MFN”) price for prescription drugs and biologics.1 This EO came out about one month after the release of EO No. 14273 titled “Lowering Drug Prices by Once Again Putting Americans First” (April 15, 2025) which outlined…
In brief As we look back at 2023, we reflect on a year marked by significant developments in the legal framework governing the life sciences and healthcare industries in the US. These developments include the implementation of the Medicare Drug Price Negotiation Program under the Inflation Reduction Act; the rise of artificial intelligence in drug development and manufacturing; the evolving landscape of US Food and Drug Administration regulation and enforcement of laboratory-developed tests; and the…