European Commission authorises one of first ustekinumab biosimilars in Europe
This approval follows a development and commercialisation agreement made in September 2023 between Sandoz and Samsung Bioepis for the biosimilar ustekinumab.
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This approval follows a development and commercialisation agreement made in September 2023 between Sandoz and Samsung Bioepis for the biosimilar ustekinumab.
The driving factor for protein particle formation is surface mediated in protein only formulations in manufacturing, research asserts.
Preference for small molecule prefilled syringes and a greater demand for prefilled insulin syringes for diabetes is driving growth of the pharmaceutical parenteral packaging market, a report states.
EU approval for Roche’s subcutaneous OCREVUS is anticipated mid-2024, depending on acceptance of regulatory submission.
The agreement between Teva and mAbxience for the oncology biosimilar candidate will help to reduce costs within healthcare.
Cost effectivity of biosimilars is predicted to be a key contributor to growth of the global biosimilar market to 2032, research states.
While manufacturing capacity was a major challenge in early development of monoclonal antibody drugs (mAbs), outsourcing to CDMOs likely helped to remedy this, research reports.
In this Q&A, Jacqueline Barry, Chief Clinical Officer for Cell and Gene Therapy Catapult, elucidates on how the Advanced Therapy Treatment Centre (ATTC) Network can strengthen UK ATMP clinical trials.
A report has highlighted how the outsourcing of manufacturing activities to contract manufacturers is facilitating more streamlined and efficient pharmaceutical drug development.
The acquisition will give Genmab worldwide rights to three clinical candidates including a potential best-in-class folate receptor alpha (FRα)-targeted ADC for ovarian cancer.
The biologic therapy offers a novel therapeutic option that targets a new treatment pathway in pulmonary arterial hypertension (PAH).
A lack of standardised testing methods and subsequent delayed product approvals is limiting growth of the pyrogen testing market, according to a report.
At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder.
An alternative in vitro pyrogen detection test using transfected THP-1 cells detected endotoxin and nonendotoxin pyrogens with good sensitivity, stability and predictability, a study shows.
22 March 2024 | By Rapid Micro Biosystems
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