Update for April 13, 2022

Regulatory Update
 
The FDA accepted the resubmitted BLA for eflapegrastim for the management of chemotherapy-induced neutropenia and set a PDUFA date for 9/9/2022. 
 
The FDA removed the hold on trials evaluating magrolimab and azacitidine, but left the hold on the magrolimab monotherapy trials in place.
 
Saniona paused two Phase IIb trials evaluating tesofensine and metoprolol in the treatment of hypothalamic obesity and Prader-Willi syndrome in order to reduce operating expenses.
 
Reata resubmitted an NDA for omaveloxolone for the treatment of Friedreich’s ataxia.
 
Announced Research Updates
 
Coherus BioSciences and Junshi Biosciences announced results from the JUPITER-02 trial, which evaluated the addition of toripalimab to gemcitabine plus cisplatin in the treatment of recurrent or metastatic nasopharyngeal carcinoma. 
 
Merck announced results from the cervical cancer cohort of the KEYVIBE trial, which was evaluating the combination of vibostolimab plus pembrolizumab.
 
Lilly announced ADhere trial results, which evaluated adding lebrikizumab to topical corticosteroids in the treatment moderate-to-severe atopic dermatitis. 
 
Published Research Updates
 
Two Phase III trials evaluating an investigational oral drug to an established parenteral drug were published.
 
The ASCEND-ID trial compared oral daprodustat to parenteral darbepoetin alfa on maintenance of hemoglobin levels in CKD patients receiving incident dialysis.
 
The ADAPT-PO trial compared oral tebipenem to intravenous ertapenem in the treatment of complicated urinary tract infection or acute pyelonephritis.