Alex Cogut

Recent Form 483 indicates deficiencies at bimekizumab manufacturing site, PDUFA in Q2

Ahead of the upcoming PDUFA for bimekizumab for psoriasis in Q2, we came across a Form 483 issued by the FDA following an inspection in mid-April at a UCB facility in Belgium. The form points to deficiencies relating to inadequate i) document control, ii) environmental and personnel monitoring, and

UCB is a global biopharmaceutical company focused on severe diseases in two therapeutic areas, namely central nervous system disorders and immunology. In the area of central nervous system disorders, Co. is focused on advanced Parkinson's disease, epilepsy, restless legs syndrome and epilepsy. In the area of immunology disorders, Co. is focused on rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, systemic lupus erythematosus, juvenile idiopathic arthritis, post-menopausal osteoporosis, systemic lupus erythematosus and immunological diseases.

Bryan Garnier
Bryan Garnier

Since 1996, Bryan, Garnier & Co has been growing with an absolute conviction that the investment banking landscape would experience a major revolution: most of the large local generalist banking groups will disappear to the benefit of a handful of global powerhouses, and an emerging group of independent, highly specialised boutique investment banks.

Alex Cogut

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