Protocols

FDA offers quick review for Shire’s prospective blockbuster lanadelumab; Big Pharma loves big buybacks

→  The FDA is helping Shire $SHPG hustle along its application for lanadelumab, which the big biotech believes can peak out at $2 billion in revenue if it can get approved for hereditary angioedema. The agency accepted their application and provided a priority review with a PDUFA date of August 26.

→ What’s biopharma doing with its big tax reform windfall? Well, stock buybacks is grabbing the lion’s share of it so far. Axios tallied up $50 billion in buybacks announced to date, which isn’t sitting well with everyone in the industry.

→ The FDA has handed orphan status to a brain cancer drug being developed by Australian oncology company Kazia Therapeutics Limited $KZIA. The investigational drug, called GFC-0084, was licensed from Genentech back in 2016. It’s a small molecule inhibitor of the PI3K/AKT/mTOR pathway that’s due to start Phase II trials in glioblastoma in March or April of this year. The data read-out is expected in early 2019. “We share FDA’s recognition of the need for new treatments in this very challenging disease, and we believe that GDC-0084 has great promise as a potential new therapy,” said Kazia’s CEO James Garner in a statement.


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