Pharmaceutical Executive Daily: FDA's new Fast-Track Review

Welcome to Pharmaceutical Executive Daily, your quick briefing on the top news shaping the pharmaceutical and life sciences industry.

In today’s Pharmaceutical Executive Daily, we cover the FDA’s new fast-track review program for U.S.-made generics, Novartis’ FDA approval of Rhapsido for chronic spontaneous urticaria, and Halozyme’s $750 million acquisition of Elektrofi to strengthen drug delivery innovation.

The FDA has launched a fast-track review program for domestically manufactured generic drugs, a move designed to bolster U.S. pharmaceutical supply chain resilience. The program aims to incentivize companies to produce generics within the United States by offering accelerated review timelines, helping reduce reliance on overseas suppliers. Industry experts say the initiative could address concerns about drug shortages while supporting national policy goals of reshoring essential medicines. For generic manufacturers, the program provides both regulatory and commercial incentives to expand U.S. capacity.

In regulatory news, Novartis has secured FDA approval for Rhapsido, a treatment for chronic spontaneous urticaria, a condition marked by persistent hives and swelling without a known trigger. The approval provides a new option for patients who have not responded adequately to antihistamines, addressing a significant unmet need. For Novartis, Rhapsido strengthens its immunology portfolio and adds to its record of advancing therapies for dermatological and allergic conditions. Physicians welcomed the decision, noting that the therapy could meaningfully improve quality of life for patients managing this chronic and often debilitating disease.

And finally, Halozyme has signed a definitive agreement to acquire Elektrofi in a $750 million deal. Elektrofi specializes in ultra-concentrated, subcutaneous drug delivery technology that can improve patient convenience and expand treatment options. Halozyme said the acquisition aligns with its strategy to advance drug delivery platforms that reduce treatment burden and differentiate its partnerships with biopharma companies. Analysts suggest the deal highlights growing industry interest in drug delivery innovation as a competitive lever in crowded therapeutic categories.

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