FDA Pipeline preview, October 2008 (vernakalant, doripenem, custirsen, droxidopa, amrubicin, dronedarone, imatinib)

FDA has set an action date of March 31, 2024, for marnetegragene autotemcel to treat infants with a serious and often fatal immunodeficiency.

Biogen is still evaluating launch timeline for Tofidence, and information on pricing will be available closer to launch.

Aetna, Cigna, Humana, United Healthcare — some of the largest providers of Medicare Advantage plans — have released updates to prescription drug programs.

At issue are findings from the agency’s inspection of a third-party manufacturing company. The FDA indicated there were no concerns about the safety or labeling of lebrikizumab.

The two-component therapy of Pombiliti plus Opfolda to treat adults living with late-onset Pompe disease will have an annual list price of $650,000.

Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.