Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Gamida Cell | GDA-201 | B-cell lymphomas | IND approved by the FDA |
| Moleculin Biotech | WP1066 | Recurrent malignant glioma | IND approved by the FDA |
| Quoin Pharmaceuticals | QRX003 | Netherton syndrome | IND approved by the FDA |
| Sorrento Therapeutics | STI-9167 (Intravenous COVISHIELD) | COVID-19 | IND approved by the FDA |
| Renovion | ARINA-1 | Noncystic fibrosis bronchiectasis | Study may proceed letter issued by the FDA for phase 2 trial |
| Direct Biologics | ExoFlo | Acute respiratory distress syndrome due to COVID-19 | Phase 3 trial approved by the FDA |
| Alterity Therapeutics | ATH434 | Multiple system atrophy | Phase 2 trial authorized by the UK regulatory authority |
| Lemonex | LEM-S401 | Hypertrophic scars | IND approved by South Korea’s regulatory authority |
| Trials Initiated | |||
| Starton Therapeutics | 24-hour continuous subcutaneous infusion of lenalidomide | Multiple myeloma | Initiation of phase 1 trial in the Netherlands |
| Phio Pharmaceuticals | PH-762 | Advanced melanoma | Initiation of phase 1b trial |
| Biomind Labs | BMND01 (inhaled formulation of N,N-dimethyltryptamine) | Treatment-resistant depression | Initiation of phase 1/2a trial |
| SOTIO Biotech | SOT102 | Gastric and pancreatic cancer | Initiation of phase 1/2 trial |
| VITRAC Therapeutics | VIC-1911 | Graft-vs.-host disease prophylaxis | Initiation of phase 1/2 trial |
| Arrowhead Pharmaceuticals | ARO-ANG3 | Homozygous familial hypercholesterolemia | Initiation of phase 2 trial |
| Fervent Pharmaceuticals | FP-101 | Symptoms of menopause | Initiation of phase 2 trial |
| HiberCell | Odetiglucan plus Keytruda (pembrolizumab) | Metastatic, hormone-refractory breast cancer | Initiation of phase 2 trial |
| Lyra Therapeutics | LYR-220 | Postsurgical chronic rhinosinusitis | Initiation of phase 2 trial |
| Tryp Therapeutics | TRP-8802 in combination with psychotherapy | Binge eating disorder | Initiation of phase 2 trial |
| HighTide Therapeutics | HTD1801 | Type 2 diabetes | Initiation of phase 2 trial in China |
| Citius Pharmaceuticals | Halo-Lido | Hemorrhoids | Initiation of phase 2b trial |
| Harmony Biosciences | Pitolisant | Idiopathic hypersomnia | Initiation of phase 3 trial |
| Novavax | NVX-CoV2373, COVID-19 vaccine | COVID-19 | Initiation of phase 3 booster expansion trial in adolescents |
| Sedana Medical | Inhaled isoflurane | Sedation of adult mechanically ventilated ICU patients | Initiation of two phase 3 trials |
| Approvals | |||
| Gilead | Veklury (remdesivir) | COVID-19 in pediatric patients older than 28 days | Approved by the FDA for expanded indication |
| Mycovia Pharmaceuticals | Vivjoa (oteseconazole capsules) | Recurrent vulvovaginal candidiasis (chronic yeast infection) | Approved by the FDA |
| Biohaven Pharmaceuticals Pfizer |
Vydura (rimegepant) | Acute treatment of migraine and prophylaxis of episodic migraine | Approved by the European Commission |
| Vifor Fresenius Medical Care Renal Pharma Cara Therapeutics |
Kapruvia (difelikefalin) | Moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients | Approved by the European Commission |
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