Operations and Quality Oversight of CMOs

Mirvetuximab soravtansine, brand name Elahere, is the first licensed treatment for women with platinum-resistant ovarian cancer in the UK in more than 10 years.

Hanns-Christian Mahler and Andrea Allmendinger from ten23 health will discuss some key aspects of biologic drug development and manufacturing.

Following an overhaul at ACIP, the HHS secretary took the advice of the committee’s new members, saying he was acting on guidance that dated back to 1999.

Manufacturing sites and a control site will work together in a hub-and-spoke model that has key differences from conventional manufacturing operations.

The agency has extended the review period for GSK’s biologics license application for belantamab mafodotin-blmf for the treatment of relapsed/refractory multiple myeloma.

Three deaths attributed to acute liver failure appear to have occurred following regular treatment or investigational therapy.