The life sciences industry has long been at the forefront of innovation, and 2025 promises to continue this trajectory with exciting developments in intellectual property (IP), licensing, and mergers and acquisitions (M&A). As the sector navigates a dynamic landscape of scientific advancements, economic pressures, and regulatory changes, stakeholders are increasingly leveraging strategic transactions to gain a competitive edge.
As Prescribed
YOUR GO-TO SOURCE FOR ANALYSIS OF ISSUES AFFECTING THE PHARMA & BIOTECH SECTORS
The US Food and Drug Administration (FDA) has announced a final rule expanding the approval pathway for nonprescription drug products by allowing the approval of a nonprescription drug product with an “Additional Condition for Nonprescription Use” (ACNU). This rule aims to expand consumer access to certain nonprescription drugs—that would otherwise be available only via prescription—by permitting their retail sale with an additional condition beyond labeling, such as a digital questionnaire to help the consumer decide if the medication is right for them.
The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations under the Drug Supply Chain Security Act (DSCSA or the Act) that, when finalized, would require all US wholesale drug distributors (WDDs) and third-party logistic providers (3PLs) to be licensed according to a national standard.