The commission seeks a preliminary injunction by 31 October to block the closing of the proposed Amgen-Horizon merger. Harvard Professor Aaron Kesselheim, FTC’s expert, says Amgen could circumvent a commitment not to bundle its and Horizon's products. The Pfizer-Seagen merger agreement also gets a second request for information.

Industry and patient groups take issue with draft guidance’s skeptical tone on utility and reliability of externally controlled studies, with some saying the guidance ignores special considerations inherent in studying rare diseases. Recommendations on access to patient-level data for external control arms also are problematic and likely infeasible, stakeholders say.

Public Company Edition: Follow-on offerings did not surge after ASCO, but Day One and Cogent raised $150m-plus. Also, IQVIA and Ionis sold $1.25bn and $500m in notes, while Krystal and Lexicon grossed $160m and $125m from post-approval offerings.

From ACIP to Part D to data transparency, GSK has several policy asks as it prepares to launch its new RSV vaccine for older adults. The Pink Sheet spoke with GSK’s vaccine policy lead about the firm’s new data platform and the worrisome US vaccination trends following the Covid pandemic.