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Home » Drug & Device Pipeline News

Drug & Device Pipeline News

April 18, 2022
Company Drug/Device Medical Condition Status
Trials Authorized
Aprinoia Therapeutics APNmAb005 Tau-related diseases Study May Proceed letter issued by the FDA
Blue Earth Therapeutics 177Lu-rhPSMA-10.1 Metastatic castration-resistant prostate cancer IND approved by the FDA
MediLink Therapeutics YL201 Multiple tumor types IND approved by the FDA
Triastek T20 Cardiovascular and clotting disorders IND approved by the FDA
Ilias Biologics ILB-202 Cardiac surgery-associated acute kidney injury Approval for a phase 1 trial granted by Australia’s regulatory authority
Jiangsu Recbio Technology ReCOV COVID-19 vaccine COVID-19 Phase 2/3 trial approved by the United Arab Emirates regulatory authority
Trials Initiated
Asana Biosciences ASN004 5T4-expressing advanced solid tumors Initiation of phase 1 trial
Chinook Therapeutics CHK-336 Hyperoxalurias Initiation of phase 1 trial
Exelixis XL114 Non-Hodgkin’s lymphoma Initiation of phase 1 trial
Immune-Onc Therapeutics IO-202 Advanced solid tumors Initiation of phase 1 trial
Nabriva Therapeutics Xenleta (lefamulin) Cystic fibrosis in adults Initiation of phase 1 trial
Sonnet BioTherapeutics SON-1010 Advanced solid tumors Initiation of phase 1 trial
Sciwind Biosciences XW004 Metabolic disease Initiation of phase 1 trial in Australia
Caladrius Biosciences CLBS201 Diabetic kidney disease Initiation of phase 1b trial
Daré Bioscience DARE-HRT1 Symptoms of menopause Initiation of phase 1/2 trial
Imcyse Imotope IMCY-0141 Relapsing-remitting multiple sclerosis Initiation of phase 1/2 trial
Inozyme Pharma INZ-701 ABCC6 deficiency Initiation of phase 1/2 trial
Moderna Therapeutics mRNA-1020 and mRNA-1030 seasonal influenza vaccines Seasonal influenza Initiation of phase 1/2 trial
MaaT Pharma MaaT013 in combination with immune checkpoint inhibitors Metastatic melanoma Initiation of phase 2a trial in France
Gannex Pharma ASC42 Primary biliary cholangitis Initiation of phase 2 trial
IO Biotech IO102-IO103 plus Keytruda Nonsmall-cell lung cancer, squamous-cell carcinoma of the head and neck, and urothelial bladder cancer Initiation of phase 2 trial
Phosplatin Therapeutics PT-112 Recurrent thymic epithelial tumors Initiation of phase 2 trial
Surface Oncology SRF388 plus atezolizumab and bevacizumab Hepatocellular carcinoma Initiation of phase 2 trial
Surface Oncology SRF388 Nonsmall-cell lung cancer Initiation of phase 2 trial
Akston Biosciences AKS-452 COVID-19 vaccine COVID-19 Initiation of phase 2/3 trial in India
Approvals
Transit Scientific XO Cross support catheter platform Coronary and peripheral vasculature procedures Approved by the FDA for expanded use
Astellas

Seagen
Padcev (enfortumab vedotin) Locally advanced or metastatic urothelial cancer Approved by the European Union
AffaMed Therapeutics Dextenza Ocular inflammation and pain following ophthalmic surgery Approved in China
Novavax Nuvaxovid COVID-19 vaccine COVID-19 Conditional marketing authorization in Switzerland

 

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