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Drug & Device Pipeline News
July 24, 2023
This week’s Pipeline includes phase 1 oncology trial authorizations, initiation of anxiety and depressive disorder trials, and FDA approvals for preventing RSV in infants and severe renal impairment from COVID-19.
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized |
|||
OncoBind extracorporeal blood filter procedure |
Removal of circulating tumor cells in patients with pancreatic cancer |
IDE for a phase 1 trial approved by the FDA |
|
ADRX-0706 |
Advanced solid tumors |
IND for a phase 1a/1b trial approved by the FDA |
|
Trials Initiated |
|||
CLD-101 |
Recurrent high-grade glioma |
Initiation of a phase 1 trial |
|
TLX250 plus peposertib |
Solid tumors expressing CAIX |
Initiation of a phase 1 trial |
|
BC3195 |
Locally advanced or metastatic solid tumors |
Initiation of a phase 1a/1b trial in China |
|
NBTXR3 plus anti-PD-1/L-1 immune checkpoint inhibitors |
Advanced solid tumors that have spread to the lungs and/or liver |
Initiation of a phase 1/2 trial |
|
HF1K16 |
Recurrent and refractory glioma |
Initiation of a phase 1b/2 trial |
|
ARM210 |
Catecholaminergic polymorphic ventricular tachycardia |
Initiation of a phase 2 trial |
|
Motixafortide plus cemiplimab and chemotherapy |
First-line metastatic pancreatic cancer |
Initiation of a phase 2 trial |
|
ENX-102 |
Generalized anxiety disorder |
Initiation of a phase 2 trial |
|
TNX-1900 (potentiated intranasal oxytocin) |
Social anxiety disorder |
Initiation of a phase 2 trial |
|
Imlifidase |
Pulmonary hemorrhage due to severe ANCA-associated vasculitis |
Initiation of a phase 2 trial in Germany |
|
CLS-AX (axitinib injectable suspension) |
Neovascular age-related macular degeneration |
Initiation of a phase 2b trial |
|
Navacaprant (NMRA-140) |
Major depressive disorder |
Initiation of a phase 3 trial |
|
Approvals |
|||
Beyfortus (nirsevimab-alip) |
Prevention of respiratory syncytial virus in infants |
Approved by the FDA |
|
Veklury (remdesivir) |
Treatment of COVID-19 patients with severe renal impairment, including those on dialysis |
Approved by the FDA for expanded indication |
|
Xpovio (selinexor) plus dexamethasone |
Relapsed/refractory multiple myeloma |
Approved in Hong Kong |
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