Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Perfuse Therapeutics | PER-001 Intravitreal Implant | Glaucoma | IND for a phase 1/2a trial approved by the FDA |
| Trials Initiated | |||
| Avacta Group | AVA6000 | Soft tissue sarcoma | Initiation of a phase 1 trial |
| Deka Biosciences | DK210 (EGFR) | EGFR- expressing advanced solid tumors | Initiation of a phase 1 trial |
| Kodiak Sciences | KSI-501 | Diabetic macular edema | Initiation of a phase 1 trial |
| Mythic Therapeutics | MYTX-011 | Non-small cell lung cancer | Initiation of a phase 1 trial |
| Y-mAbs Therapeutics | GD2-SADA | GD2-positive solid tumors, including small cell lung cancer, sarcoma and malignant melanoma | Initiation of a phase 1 trial |
| Alzamend Neuro | ALZN002 immunotherapy vaccine | Mild-to-moderate Alzheimer’s dementia | Initiation of a phase 1/2a trial |
| Contrafect | Exebacase | Chronic prosthetic joint infections of the knee due to Staphylococcus aureus or coagulase-negative staphylococci | Initiation of a phase 1b/2 trial |
| Invivyd | VYD222 | COVID-19 | Initiation of a phase 1 trial in Australia |
| Vico Therapeutics | VO659 | Huntington's disease and spinocerebellar ataxia types 1 and 3 | Initiation of a phase 1/2a trial in the Netherlands |
| Astrocyte Pharmaceuticals | AST-004 | Stroke and traumatic brain injuries | Initiation of a phase 1b trial in the Netherlands |
| Vaxcyte | VAX-24 (24-valent pneumococcal conjugate vaccine) | Invasive pneumococcal disease in infants | Initiation of a phase 2 trial |
| Sustained Therapeutics | ST-01 | Chronic scrotal pain | Initiation of a phase 2 trial in Canada |
| Abcuro | ABC008 | Inclusion body myositis | Initiation of a phase 2/3 trial |
| Arrowhead Pharmaceuticals | Fazirsiran (TAK-999/ARO-AAT) | Alpha-1 antitrypsin deficiency associated liver disease | Initiation of a phase 3 trial |
| Approvals | |||
| InflaRx | Gohibic (vilobelimab) | Hospitalized adults with COVID-19 | Emergency Use Authorization granted by the FDA |
|
Astellas Seagen |
Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) | Locally advanced or metastatic urothelial cancer | Accelerated approval granted by the FDA |
| Synapse Biomedical | NeuRx Diaphragm Pacing System | Patients with spinal cord injuries who rely on mechanical ventilation | Approved by the FDA |
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