Friday, July 16, 2021 Daily Archives

Humira: AbbVie’s biosimilar erosion woes may be overstated

An analyst says general forecasts of biosimilar erosion for Humira (adalimumab) are too pessimistic as the size of the brand could still present upsides for AbbVie. AbbVie’s monoclonal antibody Humira continues to be the world’s top selling drug, despite biosimilar competition hitting sales outside of the US over the past few years. In 2020, global sales stood at $19.8 billion, $16.1 billion of which came from the US. As it stands, legal agreements between AbbVie and a host of biosimilar…

CDMO Ardena invests $35m to expand three European sites

Ardena says the investment is driven by business growth, capacity needs and its ambition to become a leading mid-sized CDMO. In partnership with GHO Capital, contract development manufacturing organization (CDMO) Ardena has invested $35 million to expand its European operations in Belgium, Sweden, and the Netherlands to ensure the firm can offer end-to-end solutions. “All expansion work is expected to be complete by Q1 in 2023,” Gerjan Kemperman COO at Ardena told BioProcess Insider. The firm will expand its drug product…

Forge Bio wins GentiBio AAV vector contract

Forge Bio will develop and manufacture adeno-associated viral (AAV) vectors for GentiBio’s engineered Tregs candidates from its site in Columbus, Ohio. The deal will see contract development and manufacturing organization (CDMO) Forge Bio use its Blaze Vector production platform and HEK 293 Suspension Ignition Cells to support GentiBio’s preclinical and clinical programs. The work will be undertaken at Forge Bio’s facilities at The Hearth, Columbus, which has grown through heavy investment over the past year. “Forge has rapidly expanded our…

Bluebird resumes Zynteglo sales after positive EMA committee review

Bluebird Bio has lifted the voluntary suspension on products containing its Zynteglo gene therapy after the EMA concluded the beta thalassemia therapy’s benefits outweigh its risks. The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) published its findings last week, concluding that there is “no evidence” Zynteglo causes a blood cancer known as acute myeloid leukaemia (AML). The EMA wrote “The PRAC reviewed two cases of AML in patients treated with an investigational medicine, bb1111 [also known as LentiGlobin] in a clinical trial for sickle…