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."
President Donald Trump has officially nominated Stephen Hahn to the position of FDA commissioner, a position held on an interim basis by Ned Sharpless since April. Hahn has held the position of CEO of the MD Anderson Cancer Center in Houston since May 2018.
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