News|Podcasts|October 21, 2026

Pharmaceutical Executive Daily: FDA Approves Hibsago

A new ICER and West Health report finds median drug launch prices climbed to $257,000, the FDA approves GSK’s Hibsago as the first functional-cure therapy for chronic hepatitis B, and CSL names Deborah Waterhouse as CEO and managing director.

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, a new ICER and West Health report finds median drug launch prices climbed 35% to $257,000 amid persistent access barriers, the FDA approves GSK’s Hibsago as a fixed-duration functional-cure option for chronic hepatitis B, and CSL names Deborah Waterhouse, departing ViiV Healthcare, as its next CEO and managing director.

The Institute for Clinical and Economic Review and West Health release a new Launch Price and Access Report finding that the median net launch price for new drugs rose 35%, from $190,000 in 2022 to $257,000 in 2025, with about one in four drugs launched in 2025 priced above $500,000 annually. The report also finds only one-third of outpatient prescriptions are filled within 30 days of an attempted fill, with Medicare recipients facing higher coverage-rejection rates than other payers. ICER president and CEO Sarah K. Emond calls it evidence of “a critical moment” for the US health care system.

The FDA approves GSK’s Hibsago (bepirovirsen), an antisense oligonucleotide, as an add-on therapy for adults with chronic hepatitis B already on nucleoside analogue treatment. In pooled data from the Phase III B-Well 1 and B-Well 2 trials, 19% of treated participants achieved functional cure after a six-month course, versus none on placebo, rising to 26% among those with lower baseline surface antigen levels. The approval extends the drug to a US patient population GSK estimates at about 1.7 million people.

Finally, CSL names Deborah Waterhouse as chief executive officer and managing director, drawing her from ViiV Healthcare, where she has served as CEO since 2017. Waterhouse’s move takes effect February 1, 2027, with Gordon Naylor continuing as CSL’s interim CEO until then, while Lynn Baxter is set to succeed her at ViiV effective November 1, 2026. CSL chair Brian McNamee says the board’s decision was unanimous.

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