Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| InnoCare Pharma | ICP-189 | Advanced solid tumors | IND approved by the FDA |
| MyMD Pharmaceuticals | MYMD-1 | Aging | IND approved by the FDA for a phase 2 trial |
| Paradigm Biopharmaceuticals | Zilosul (pentosan polysulphate sodium) | Knee osteoarthritis pain | IND approved by the FDA for a phase 3 trial |
| Vitro Biopharma | AlloRx stem cells | Pitt Hopkins syndrome | IND approved by the FDA |
| Cardialen | MultiPulse therapy | Paroxysmal and persistent atrial fibrillation | IDE approved by the FDA |
| Paracrine | Celution system to deliver adipose derived regenerative cells | Diabetic foot ulcers | IDE approved by the FDA |
| MimiVax | SurVaxM | Newly diagnosed glioblastoma | Approval for a phase 2b trial granted by the FDA |
| Emergex Vaccines | COVID-19 vaccine | COVID-19 | Approval for a phase 1 trial granted by Switzerland’s regulatory authority |
| Gannex Pharma | ASC42 | Primary biliary cholangitis | Approval for phase 2 and 3 trials granted by China’s regulatory authority |
| HebaBiz Biotech | Clevudine (L-FMAU) | Chronic hepatitis B virus | Approval for phase 3 trial granted by China’s regulatory authority |
| Trials Initiated | |||
| Revelation Biosciences | REVTx-99 | Allergic rhinitis and chronic nasal congestion without polyps | Initiation of phase 1b trial in Australia |
| Eureka Therapeutics | ET140203 ARTEMIS T-cell therapy | Pediatric cases of relapsed or refractory hepatoblastoma, hepatocellular neoplasm not otherwise specified or hepatocellular carcinoma | Initiation of phase 1/2 trial |
| Graphite Bio | GPH101 | Sickle cell disease | Initiation of phase 1/2 trial |
| Inozyme Pharma | INZ-701 | ENPP1 deficiency in adults | Initiation of phase 1/2 trial |
| NiKang Therapeutics | NKT2152 | Clear-cell renal-cell carcinoma | Initiation of phase 1/2 trial |
| Rafael Pharmaceuticals | CPI-613 (devimistat) | Clear-cell sarcoma | Initiation of phase 1/2 trial |
| Biosight | Aspacytarabine (BST-236) | Relapsed or refractory myelodysplastic syndrome or acute myeloid leukemia | Initiation of phase 2 trial |
| Dermata Therapeutics | DMT310 | Moderate-to-severe rosacea | Initiation of phase 2 trial |
| Oryzon | Vafidemstat | Schizophrenia | Initiation of phase 2b trial in Spain |
| Saniona | Tesomet | Hypothalamic obesity | Initiation of phase 2b trial |
| Merck | Verquvo (vericiguat) | Chronic heart failure and reduced ejection fraction in patients who have not had a recent worsening heart-failure event | Initiation of phase 3 trial |
| Approvals | |||
| Merck | Keytruda | Adjuvant treatment of patients with renal-cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions | Approved by the FDA for expanded indication |
| PharmaEssentia | Besremi (ropeginterferon alfa-2b-njft) | Polycythemia vera | Approved by the FDA |
| AbbVie | Skyrizi (risankizumab) | Active psoriatic arthritis in adults | Approved by the European Commission |
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