The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee unanimously concluded that Amarin Corp. plc provided sufficient evidence of efficacy and safety to support approval of fish oil-based Vascepa (icosapent ethyl).
Regulatory decisions affecting biopharma products in development, including approvals, recommendations, rejections and the granting of regulatory pathways in October 2019.
It appears that the spirit of giving has come early, with leading biopharmaceutical companies providing investors with a surprise present of a significant jump in their share prices in October. The reversal in the sector's fortunes was catalyzed by an outpouring of positive news, including strong third-quarter financial results that has spilled over into early November.
BOSTON – At the AACR-NCI-EORTC Molecular Targets meeting in October, speakers in the second plenary session gave examples both of how far protein degradation has come as a pharmacological approach, and how far it could still go.
Arkuda Therapeutics, a new company targeting progranulin and lysosomal biology to treat neurodegenerative diseases, has completed a $44 million series A financing.
"Global approval doesn't mean Australia approval. Government needs a new way of valuing the benefit of therapies that are a one-off cure differently than other drugs."
RSS
