Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Precigen | PRGN-3007 | ROR1+ hematological and solid tumors | IND approved by the FDA |
| Bio-Path | Prexigebersen-A | Solid tumors | IND approved by the FDA for a phase 1/1b trial |
| Angel Pharmaceuticals | CPI-818 | Relapsed/refractory T-cell lymphoma | IND for a phase 1/1b trial approved by China’s regulatory authority |
| Medicenna | MDNA11 | Advanced, relapsed or refractory solid tumors | IND for expansion of a phase 1/2 trial approved by the FDA |
| TFF Pharmaceuticals | Inhaled formulation of Niclosamide | COVID-19 | Phase 1 trial approved by Canada’s regulatory authority |
| HCW Biologics | HCW9218 | Advanced pancreatic cancer | Phase 1b trial approved by the FDA |
| Huyabio International | HBI-2376 | KRAS and EGFR mutated tumors | IND for a phase 1 trial approved by the FDA |
| BioVie | NE3107 | Parkinson’s disease | Phase 2 trial approved by the FDA |
| Vitti Labs | Umbilical cord mesenchymal stem cells in combination with umbilical cord mesenchymal stem cell exosomes | Acute respiratory distress syndrome associated with the COVID-19 | IND for a phase 2 trial approved by the FDA |
| Axial Therapeutics | AB-2004 | Irritability associated with autism spectrum disorder | IND for a phase 2b trial approved by the FDA |
| Trials Initiated | |||
| Cleveland Clinic Anixa Biosciences |
Breast cancer vaccine | Early-stage triple-negative breast cancer | Initiation of a phase 1 trial |
| Akeso | AK127 + Cadonilimab | Advanced or metastatic solid tumors | Initiation of phase 1 trial in Australia |
| Dice Therapeutics | S011806 | Psoriasis | Initiation of phase 1 trial |
| Matinas Biopharma | MAT2501 | Nontuberculous mycobacterial infection | Initiation of phase 1 trial |
| Sumitomo Dainippon Pharma | DSP-0390 | Recurrent high-grade glioma | Initiation of phase 1 trial |
| EsoCap | ESO-101 | Active eosinophilic esophagitis | Initiation of phase 2 trial |
| Gilead Merck |
islatravir and lenacapavir | HIV treatment for patients who are virologically suppressed and on antiretroviral therapy | Initiation of phase 2 trial |
| Revolo Biotherapeutics | ‘1104 | Allergy | Initiation of phase 2 trial in the UK |
| Alkermes | nemvaleukin alfa with pembrolizumab | Platinum-resistant ovarian cancer | Initiation of a phase 3 trial |
| HutchMed | HMPL-523 | Primary immune thrombocytopenia | Initiation of a phase 3 trial in China |
| Approvals | |||
| Bausch + Lomb Clearside Biomedical |
XIPERE (triamcinolone acetonide injectable suspension) | Macular edema associated with uveitis | Approved by the FDA |
| Genentech | Susvimo (ranibizumab injection) | Patients with wet, or neovascular, age-related macular degeneration who have previously responded to at least two anti- VEGF injections | Approved by the FDA |
| Moderna Janssen |
COVID-19 vaccines | Immunization against COVID-19 | Booster dose following primary immunization approved by the FDA |
| Merck | Keytruda in combination with chemotherapy | First-line treatment of locally recurrent unresectable or metastatic PD-L1-expressing triple-negative breast cancer in adults who have not received prior chemotherapy for metastatic disease | Approved by the European Commission |
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