Monday, September 19, 2022 Daily Archives

Bluebird Skysona approval: ‘A resurgence for HSC gene therapy’

The US approval of bluebird bio’s Skysona (eli-cel) marks a resurgence for the wider hematopoietic stem cell (HSC) gene therapy sector, says AVROBIO. Following the endorsement by an Advisory Committee in June, the US Food and Drug Administration (FDA) granted approval of bluebird bio’s Skysona (elivaldogene autotemcel, or eli-cel) Friday for the treatment of active cerebral adrenoleukodystrophy (CALD). Skysona uses ex vivo transduction with a Lenti-D lentiviral vector (LVV) to add functional copies of the ABCD1 gene into a patient’s…

AbbVie: Manufacturing consistency will affect Humira biosimilar uptake

AbbVie says payors will look to consistent global supply as a key differentiator among the many Humira biosimilar makers poised to enter the US market. AbbVie’s autoimmune monoclonal antibody (mAb) Humira (adalimumab) is the bestselling drug of all time, clocking in over $193 billion for AbbVie (and previously Abbott) since its launch in 2003 to the end of 2021. Last year alone it pulled in $20.7 billion (though lost out to the industry’s top seller spot due to $36.9 billion…

Lonza ups ADC capabilities with Visp expansion

CDMO Lonza has added development and manufacturing capacity for antibody-drug conjugate (ADC) payloads at its Visp, Switzerland facility. Contract development manufacturing organization (CDMO) Lonza has completed the expansion of its Highly Potent API (HPAPI) multipurpose site in Visp, which will support the full development and production pipeline from studies to commercial supply of ADC payloads. “Lonza’s expanded multipurpose suite enables customers to meet the growing demand for targeted cancer treatments by developing and manufacturing ADC payloads with increased speed, capacity…