Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| SCG Cell Therapy | SCG101 | Hepatitis B virus-related liver cancer | IND approved by the FDA for phase 1/2 trials |
| Annovis Bio | Buntanetap | Early Parkinson’s disease | Study May Proceed letter issued by the FDA for phase 3 trial |
| Nyxoah | Genio system | Moderate-to-severe obstructive sleep apnea and complete concentric collapse of the soft palate | IDE approved by the FDA |
| Dyne Therapeutics | DYNE-101 | Myotonic dystrophy type 1 | Phase 1/2 trial approved by New Zealand’s regulatory authority |
| Rznomics | RZ001 | Liver cancer | IND approved by South Korea’s regulatory authority for phase 1/2a trial |
| Trials Initiated | |||
| Biomica | BMC128 plus Opdivo | Non-small cell lung cancer, melanoma or renal cell carcinoma | Initiation of phase 1 trial |
| Bio-Thera Solutions | BAT8006 | Advanced solid tumors | Initiation of phase 1 trial |
| Endevica Bio | TCMCB07 | Cachexia | Initiation of phase 1 trial |
| Moderna Therapeutics | mRNA-1215 Nipah virus vaccine | Nipah virus | Initiation of phase 1 trial |
| Propanc Biopharma | PRP (trypsinogen and chymotrypsinogen) | Advanced cancer | Initiation of phase 1 trial |
| Pulmatrix | PUR3100 | Acute migraine | Initiation of phase 1 trial |
| Verve Therapeutics | VERVE-101 | Heterozygous familial hypercholesterolemia | Initiation of phase 1 trial |
| Clinilabs Drug Development | CYB003 | Major depressive disorder | Initiation of phase 1/2a trial |
| SunHo BioPharmaceutical | IAP0971 | Locally advanced or metastatic malignant tumors | Initiation of phase 1/2 trial |
| SunHo BioPharmaceutical | IAE0972 | Locally advanced or metastatic malignant tumors | Initiation of phase 1/2 trial |
| Edgewise Therapeutics | EDG-5506 | Becker muscular dystrophy | Initiation of phase 2 trial |
| Tetra Therapeutics | BPN14770 (zatolmilast) | Fragile X syndrome | Initiation of phase 2b/3 trial |
| Overland ADCT BioPharma | Zynlonta plus rituximab | Diffuse large B-cell lymphoma | Initiation of phase 3 trial in China |
| Biohaven Pharmaceuticals | Taldefgrobep alfa | Spinal muscle atrophy | Initiation of phase 3 trial |
| Radius Health | RAD011 | Prader-Willi syndrome | Initiation of phase 2/3 trial |
| Approvals | |||
| Horizon Therapeutics | Krystexxa (pegloticase) injection co-administered with methotrexate | Uncontrolled gout | Approved by the FDA for expanded indication |
| Novavax | COVID-19 Vaccine | COVID-19 | Emergency Use Authorization granted by the FDA |
| Aurora Spine | ZIP MIS implants | Lumbar spinal stenosis | Approved by the FDA for new indication |
| Renovia | Leva Pelvic Health System | Chronic fecal incontinence in women | Approved by the FDA |
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