Another FDA 'No' For Acacia Over Unresolved Facility Deficiencies
Confusion reigns at the UK firm as a second attempt to get approval for its nausea and vomiting treatment Barhemsys floundered following an insufficient resolution of manufacturing deficiencies at the supplier of the drug.
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Keeping Track: US FDA Approves Pfizer’s Vyndaqel, Jacobus’ Ruzurgi, But Nixes Acacia’s Barhemsys Again
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Having recently signed a gene therapy collaboration with Sarepta and received a positive opinion from the CHMP for its kidney transplant therapy, Sweden's Hansa has now raised a substantial sum in a "multiple times oversubscribed" placing.
Sanofi is paying €17.5m upfront to combine a preclinical NK cell product with its anti-CD38 antibody Sarclisa and develop a multiple myeloma drug that potentially may prove more effective than J&J's Darzalex, Kiadis's CEO tells Scrip.