Update for March 1, 2022

Regulatory Update
 
Lexicon withdrew its NDA for sotagliflozin to correct a technical issue in the NDA. Lexicon plans to resubmit the NDA in 2Q22.

The FDA delayed approval of terlipressin as a treatment for hepatorenal syndrome until an inspection of the manufacturing facility can be completed.
 
The FDA rejected oleogel-S10 for the treatment of the cutaneous manifestations of Junctional and Dystrophic Epidermolysis Bullosa and requested additional efficacy data.
 
The FDA agreed with the Renal Drugs Advisory Committee and rejected bardoxolone methyl, due to a lack of efficacy data to support it is use in Alport syndrome. 
 
Published Research Updates
 
Effect of masitinib on the Expanded Disability Status Scale in patients with primary progressive multiple sclerosis. 
 
The composite clinical response in Japanese patients with non-small cell lung cancer or gastrointestinal cancer with cachexia of anamorelin.
 
Whether adding radiotherapy to durvalumab-tremelimumab affected the overall response rates in patients with non-small-cell lung cancer that is resistant to PD-1 and PD-L1 therapy.
 
How researchers used data from the CARTITUDE-1 trial to decrease movement and neurocognitive treatment-emergent adverse events (MNTs) with ciltacabtagene autoleucel.
 
Check out our new lower subscription rates and don't miss out on future clinical updates