Rare disease puts Phase III vax trial on hold

The FDA has placed a hold on a late-stage trial of an experimental hepatitis B vaccine after one of the patients in the test was diagnosed with a rare inflammatory condition. Researchers for Merck and Dynavax Technologies halted the study, but noted that none of the other 2,500 patients treated with Heplisav in 10 clinical trials reported the same condition, which causes blood vessels to become inflamed. Dynavax shares shed 43 percent of their value on the news.

- see this release
- read the AP report
- here's the AFX story

Suggested Articles

At ASH, Dana-Farber researchers presented promising preclinical data on AMG 701, Amgen's long-lasting BiTE for multiple myeloma, but rivals loom.

The takeover, the first of Paul Hudson’s time as CEO, will give Sanofi an IL-2 drug it thinks can become a foundation of future cancer combinations.

A phase 1/2b test showed Roche's antibody mosunetuzumab can trigger durable responses in a significant minority of hard-to-treat NHL patients.