Drug Pricing
Nektar surges again as alopecia drug shows new promise in extension study
Nektar Therapeutics announced on Monday that its experimental autoimmune drug rezpegaldesleukin helped patients who had previously responded to treatment grow more hair during the 52-week extension phase of a Phase II trial for alopecia areata. Although the drug did not achieve statistical significance at 36 weeks, the latest data supports its advancement into later-stage development. Boosted by the news, Nektar's shares rose nearly 25% in early trading, reaching their highest level since 2022.
Trump revives pharma tariffs with 100% charges, but leaves loopholes
The Trump administration, citing national security trade laws, imposed 100% tariffs on imported pharmaceuticals, but exempted countries with signed trade agreements, companies investing in U.S. manufacturing and participating in pricing agreements, as well as all generic drugs and biosimilars. Analysts believe the policy's impact on the industry is limited, but long-term uncertainty remains.
New FDA Guidelines Expected to Boost Biosimilar Market Development
Since the US FDA approved the first biosimilar 11 years ago, it has cleared over 80 products. The new draft guidance released this week aims to lower testing thresholds in some cases and permit the use of reference drug data from outside the US, potentially cutting development costs by about half. This move is expected to alleviate high prices for biologic drugs, especially in oncology, though patent barriers and thin profit margins remain challenges.