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Home » Pipeline

Pipeline

August 9, 2021
Company Drug/Device Medical Condition Status
Angion Biomedica ANG-3070 primary proteinuric kidney diseases IND approved by the FDA for a phase 2 trial
Avidity Bioscience AOC 1001 adults with myotonic dystrophy type 1 IND approved by the FDA
Excel Diagnostics 225Ac-PSMA I&T targeted alpha therapy metastatic castrate-resistant prostate cancer IND approved by the FDA
I-Mab Protollin Alzheimer's disease IND approved by the FDA
Monopar Therapeutics camsirubicin plus growth-factor support (pegfilgrastim) advanced soft tissue sarcoma IND approved by the FDA
Sorrento Therapeutics allogeneic anti-CD38 dimeric antigen receptor (DAR) T-cell therapy relapsed or refractory multiple myeloma IND approved by the FDA
Vaxart S-only oral tablet SARS-CoV-2 vaccine IND approved by the FDA
ABL Bio ABL501 solid tumors IND approved by South Korea's Ministry of Food and Drug Safety
Arcturus Therapeutics ARCT-810 ornithine transcarbamylase (OTC) deficiency approval received from the UK Health Research Authority for a phase 2 trial
Arcturus Therapeutics ARCT-154 and ARCT-165 STARR mRNA vaccines SARS-CoV-2 alpha, beta, gamma and delta variants approval received from the Singapore Health Sciences Authority for a phase 1/2 trial
Cytodyn leronlimab (PRO 140) patients with severe COVID-19 requiring supplemental oxygen clinical trial authorized by Brazil’s ANVISA (Agência Nacional de Vigilância Sanitária)
Eledon Pharmaceuticals AT-1501 replacement for tacrolimus as an immunosuppressive regimen component in patients undergoing kidney transplantation clinical trial authorized by Health Canada
Everest Medicines Xerava (eravacycline) community-acquired bacterial pneumonia phase 3 clinical trial authorized by China’s National Medical Products Administration
Hummingbird Bioscience HMBD-001 advanced cancers clinical trial authorized by the UK Medicines and Healthcare Products Regulatory Agency (MHRA)
PanTher Therapeutics PTM-101 pancreatic cancer approval from the Human Research Ethics Committee of Australia for a phase 1 trial
Revolo Biotherapeutics ‘1104 moderate-to-severe grass pollen allergy clinical trial authorized by the UK MHRA
Shenzhen Kangtai Biological Products inactivated COVID-19 vaccine (Vero cells) COVID-19 vaccine approval granted by the Philippine Food and Drug Administration for a phase 3 trial
Noema Pharma NOE-105 Tourette syndrome initiation of phase 2a trial
Prometheus Biosciences PRA023 moderate-to-severe Crohn’s disease initiation of phase 2a trial
Stemedica Cell Technologies intravenous allogeneic mesenchymal stem cells patients with moderate-to-severe acute respiratory distress syndrome due to COVID-19 initiation of phase 2 trial
Cytokinetics reldesemtiv amyotrophic lateral sclerosis initiation of phase 3 trial
Eli Lilly baricitinib with or without remdesivir treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen Emergency Use Authorization expanded by the FDA
Allergan Botox (onabotulinumtoxinA) upper-limb spasticity in adults approved by the FDA for expanded indication
AstraZeneca Saphnelo (anifrolumab-fnia) moderate-to-severe systemic lupus erythematosus approved by the FDA
GlaxoSmithKline Nucala (mepolizumab) chronic rhinosinusitis with nasal polyps approved by the FDA for new indication
Janssen Uptravi (selexipag) intravenous injection pulmonary arterial hypertension new formulation approved by the FDA
Pillar Bioscience OncoReveal Dx lung and colon cancer assay qualitative detection of somatic mutations in DNA derived from nonsmall-cell lung cancer and colorectal cancer tumors approved by the FDA
Amicus Therapeutics Galafold (migalastat) Fabry disease in children age 12 years and older approved by the European Commission for expanded indication
Bristol Myers Squibb Opdivo (nivolumab) adjuvant treatment of adults with esophageal or gastroesophageal junction with residual pathologic disease following chemoradiotherapy approved by the European Commission

 

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