FDA Pipeline Preview, January 2012 (Alexza Pharmaceuticals, Pfizer, Celladon, Vertex, Avedro)

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.

Briana Contreras, editor of Managed Healthcare Executive, spoke with Nancy Lurker, CEO and president of EyePoint Pharmaceuticals. Nancy shared a bit about EyePoint and how the organization’s innovative therapies are addressing patient needs through eye care, and most importantly, she addressed C-Suite positions like the CEO role. Nancy shared advice for those seeking to reach the CEO level, especially toward women in healthcare and other roles, and what it takes to run a biopharma company.

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

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.

Relapsed or refractory acute leukemia with a KMT2A translocation currently has an overall survival rate of less than one year when treated with frontline therapies.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) date of April 2, 2025, for reproxalap for patients with dry eye disease. Reproxalap also is being tested in allergic conjunctivitis.