FDA Approves Lilly’s BTK Inhibitor for Rare Blood CancerJanuary 27th 2023
Jaypirca is the first BTK inhibitor specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor. It has a wholesale acquisition cost of $21,000 per 30 days of therapy.
FDA Accepts Jardiance sNDA for CKD IndicationJanuary 23rd 2023
A phase 3 trial showed that Jardiance reduced the risk of kidney disease progression or cardiovascular death in adults with chronic kidney disease by 28% compared with placebo. An FDA decision is expected in the second half of 2023.
FDA Accepts Application for NASH DrugJanuary 19th 2023
There are currently no medications approved for the treatment of NASH, which can lead to cirrhosis, eventual liver failure, cancer and death. The FDA has assigned a PDUFA target action of June 22, 2023, for the therapy, obeticholic acid.
Top 15 Potential Blockbuster Drugs to WatchJanuary 10th 2023
Clarivate analysts have identified the treatments they forecast could deliver annual sales of more than $1 billion within five years. These include therapies for rare diseases, as well as HIV, Parkinson’s disease, Crohn’s disease, alopecia, and cancer.