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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

January 23, 2023
Company Drug/Device Medical Condition Status
Trials Authorized
Exegenesis Bio EXG102-031 Neovascular age-related macular degeneration IND for a phase 1 trial approved by the FDA
Cyrano Therapeutics CYR-064 Post-viral smell loss IND for a phase 2 trial approved by the FDA
Orthogen Orthogen device Knee osteoarthritis stages II through IV IDE for a phase 3 trial approved by the FDA
Trials Initiated
Ceruvia Lifesciences NYPRG-101 (BOL-148) Neurological and psychiatric disorders, including cluster headaches Initiation of a phase 1 trial
Trefoil Therapeutics TTHX1114 Corneal epithelial defects Initiation of a phase 1 trial
Asher Biotherapeutics AB248 and AB248 plus Keytruda Locally advanced/metastatic solid tumors, including melanoma, renal cell carcinoma, non-small cell lung cancer and squamous cell carcinoma of the head and neck Initiation of a phase 1a/1b trial
Biomea Fusion BMF-219 KRAS-mutated unresectable, locally advanced or metastatic non-small cell lung cancer, colorectal cancer and pancreatic ductal adenocarcinoma Initiation of a phase 1/1b trial
Cardiol Therapeutics CardiolRx Recurrent pericarditis Initiation of a phase 2 trial
ORYZON Therapeutics Iadademstat Relapsed/refractory high-grade neuroendocrine carcinomas Initiation of a phase 2 trial
Apex Labs APEX-52 (synthetic psilocybin) Post-traumatic stress disorder Initiation of a phase 2b trial
Palatin Technologies Bremelanotide Type 2 diabetic kidney disease Initiation of a phase 2b trial
Plus Therapeutics Rhenium (186Re) obisbemeda Recurrent glioblastoma Initiation of a phase 2b trial
Theriva Biologics VCN-01 plus chemotherapy Newly diagnosed metastatic pancreatic ductal adenocarcinoma Initiation of a phase 2b trial
Versanis Bio Bimagrumab and bimagrumab plus Rybelsus (semaglutide) Obesity Initiation of a phase 2b trial
Stemedica Cell Technologies Allogeneic mesenchymal stem cells Ischemic stroke Initiation of a phase 2b/3 trial
Life Molecular Imaging PI-2620 imaging agent Alzheimer’s disease Initiation of a phase 3 trial
Approvals
Luye Pharma Rykindo (risperidone) for extended-release injectable suspension Schizophrenia and bipolar 1 disorder in adults Approved by the FDA for new formulation
Novo Nordisk Rybelsus (semaglutide) First-line treatment for type 2 diabetes in adults Approved by the FDA for expanded indication
Abbott Navitor transcatheter aortic valve implantation system Severe aortic stenosis in patients at high or extreme risk for open heart surgery Approved by the FDA
Shanghai Henlius Biotech Hansizhuang (serplulimab) injection in combination with carboplatin and etoposide Extensive-stage small cell lung cancer Approved in China

 

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