Finnish manufacturing facility to get €50m expansion
The planned €50 million investment at the Finland-based CDMO facility will enable advanced technologies to be used for development and manufacture of advanced therapy medicinal products (ATMPs).
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The planned €50 million investment at the Finland-based CDMO facility will enable advanced technologies to be used for development and manufacture of advanced therapy medicinal products (ATMPs).
The first SGLT2 inhibitor to demonstrate a statistically significant reduction in all-cause hospitalisations in chronic kidney disease (CKD) patients versus placebo has been approved in the EU.
Key data from a Phase II trial of a potentially first-in-class CSF-1R monoclonal antibody for chronic graft-versus-host disease (GVHD) has been released.
Key opportunities within the small molecule active pharmaceutical ingredient (API) market include adopting continuous manufacturing and delving into niche disease areas, research has indicated.
The European Medicines Agency (EMA) has updated its guidance on nitrosamine impurities in human medicinal products, amending Q&A 10 and adding three appendices.
An RNAi therapeutic that has best-in-disease potential for hypertension is set to be developed under a partnership between Roche and Alnylam Pharmaceuticals.
Research suggests that performing LAL gel clot tests and narrowing the dilution range can provide good estimation of endotoxin concentration in pharmaceuticals.
Public consultation is open for the European Medicines Agency (EMA)’s draft reflection paper on using artificial intelligence (AI) when developing and regulating medicines.
Data shared at the 2023 American Society of Retina Specialists (ASRS) Annual Meeting will reveal new clinical and real-world evidence for the first bispecific antibody (bsAb) approved for the eye.
Anticipating similar demand of antibiotic use in prior winter seasons, the European Medicines Agency (EMA) has proposed key actions to mitigate supply chain issues.
The only monoclonal antibody approved for passive immunisation to protect infants in their first RSV season has been approved by the US Food and Drug Administration (FDA).
Research predicts the pharma quality management systems (QMS) market will grow significantly in the next several years and is projected to value $3.97 billion by 2030.
Full results from the “first Phase III study of a disease-modifying therapy to replicate the positive clinical results observed in a previous study” have been published in JAMA.
Design of the world’s first continuous mRNA manufacturing platform, an $82 million, three-year, FDA-funded project aims to help accelerate development of mRNA technologies.
An agreement to obtain a global license for KSQ Therapeutics’ small molecule USP1 inhibitor, which has potential to treat a variety of cancers, has been signed by Roche.