FDA Actions in Brief November 2012

Imkeldi is a new formulation of imatinib approved as a strawberry-flavored, shelf-stable liquid designed to be more appealing to a wider range of patients, pediatric patients included.

In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.

CVS Caremark has removed several diabetes drugs favor of newer products and generics, and is even favoring an insulin infusion system developed by a company that was cofounded by Alan Lotvin, a former executive at CVS Health.

Produced in Chinese hamster ovary cells, Ziihera (zanidatamab-hrii) is the first HER2-targeted bispecific antibody treatment for patients with previously treated, unresectable or metastatic biliary tract cancer.

After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.

The FDA has approved UCB's Bimzelx for moderate-to-severe hidradenitis suppurativa, offering a new treatment option for this painful autoimmune skin disease.