Update for January 25, 2022
New Drugs Added to Knowledgebase
Last week we added 10 new drugs to the knowledgebase:
The FDA rejected Levo Therapeutics’ intranasal carbetocin for the treatment of Prader-Willi syndrome and requested an additional Phase III trial.
Pfizer announced the FDA rejected somatrogon, but did not provide a reason for the rejection.
The FDA rejected Merck’s gefapixant for the treatment of chronic cough and requested additional information related to measurement of efficacy.
The FDA delayed the PDUFA date by three months for Bluebird Bio’s betibeglogene autotemcel, to treat transfusion-dependent beta-thalassemia, to allow more time to review additional clinical information
The FDA delayed the PDUFA date by three months for Bluebird Bio’s elivaldogene tavalentivec, to treat cerebral adrenoleukodystrophy, to allow more time to review additional clinical information
The FDA recommended that GenSight conduct an additional trial for lenadogene nolparvovec due to the unexpected bilateral vision improvement seen in unilaterally treated Leber Hereditary Optic Neuropathy patients in the RESCUE, REVERSE and REFLECT trials.
Announced Research Updates
Results from two Phase III bimekizumab trials; the axial spondyloarthritis BE MOBILE 1 trial and the psoriatic arthritis BE COMPLETE trial
Results from the HIMALAYA trial evaluating the addition of tremelimumab to a regimen to treat advanced hepatocellular carcinoma.
18-month data from the HELIOS-A trial evaluating vutrisiran to treat hATTR amyloidosis
Published Research Updates
Results from the Phase III, ECOSPOR III trial, evaluating SER-109 to prevent recurrent C. difficile infection.
Results from the Phase III, GEMSTONE-302 trial, evaluating sugemalimab in the treatment of metastatic squamous and non-squamous non-small cell lung cancer.
Results from a triple-negative breast cancer adavosertib trial.
Results from an ovarian cancer evaluating cediranib
Two Phase III daridorexant insomnia trials
Four Phase III faricimab trials. Two evaluating faricimab as a treatment for neovascular age-related macular degeneration and two for diabetic macular edema.
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