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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

March 14, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
Aravax PVX108 Peanut allergy IND approved by the FDA
Inventiva Lanifibranor plus empagliflozin Type 2 diabetes and noncirrhotic nonalcoholic steatohepatitis (NASH) IND approved by the FDA
Insightec Exablate Neuro ultrasound system Nonsmall-cell lung cancer and brain cancer IDE approved by the FDA
Akeso Cadonilimab plus docetaxel Nonsmall-cell lung cancer IND approved by China’s regulatory authority
Antengene ATG-101 Solid tumors and B-cell nonHodgkin’s lymphoma IND approved by China’s regulatory authority
CARsgen Therapeutics CLDN18.2 Gastric and pancreatic cancer Approval for a phase 2 trial granted by China’s regulatory authority
Biomind Labs N, N-dimethyltryptamine (DMT) Treatment-resistant depression Approval for a phase 2 trial granted by Brazil’s regulatory authority
Altamira Therapeutics Bentrio preventive nasal spray COVID-19 Approval for a clinical trial granted by Bulgaria’s regulatory authority
Trials Initiated
Pionyr Immunotherapeutics PY314 Solid tumors Initiation of phase 1b trial
Confo Therapeutics CFTX-1554 Neuropathic pain Initiation of phase 1 trial
Digestome Therapeutics DGX-001 Schizophrenia and Parkinson’s disease Initiation of phase 1 trial
MiNK Therapeutics AgenT-797 Solid tumors Initiation of phase 1 trial
Eucure Biopharma YH002 plus YH001 Solid tumors Initiation of phase 1 trial in Australia and China
Denali Therapeutics DNL593 Frontotemporal dementia-granulin Initiation of phase 1/2 trial
Freeline Therapeutics FLT180a Hemophilia B Initiation of phase 1/2 trial
Palleon Pharmaceuticals E-602 Advanced cancers Initiation of phase 1/2 trial
Aldeyra Therapeutics ADX-2191 Retinitis pigmentosa Initiation of phase 2 trial
Pfizer Paxlovid COVID-19 Initiation of phase 2/3 pediatric trial
Equillium Itolizumab Acute graft-versus-host disease Initiation of phase 3 trial
KalVista Pharmaceuticals KVD900 Hereditary angioedema Initiation of phase 3 trial
Approvals
Bristol Myers Squibb Opdivo (nivolumab) Nonsmall-cell lung cancer in the neoadjuvant setting Approved by the FDA for expanded indication
Antengene Xpovio (selinexor) Relapsed and/or refractory multiple myeloma and triple-class refractory multiple myeloma Approved in Australia

 

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