Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Adagene | ADG126 plus pembrolizumab | Solid tumors | Approval for a phase 1b/2 trial granted by the FDA |
| Amolyt Pharma | AZP-3601 | Hypoparathyroidism | IND approved by the FDA |
| Kairos Pharma | KROS 201 | Glioblastoma | IND approved by the FDA |
| Ossium Health | OSSM-001 | Perianal fistulizing Crohn’s disease | IND approved by the FDA |
| Pharmazz | Centhaquine | COVID-19 patients with acute respiratory distress syndrome | IND approved by the FDA |
| Sonnet BioTherapeutics | SON-1010 | Advanced solid tumors | IND approved by the FDA |
| Maia Biotechnology | THIO | Nonsmall-cell lung cancer | Approval for a phase 2 trial granted by Australia’s regulatory authority |
| PepGen | PGN-EDO51 | Duchenne muscular dystrophy | Clinical trial authorization granted by Canada’s regulatory authority |
| Trials Initiated | |||
| Cocrystal Pharma | CC-42344 | Pandemic and seasonal influenza A | Initiation of phase 1 trial in Australia |
| Emergent BioSolutions | Stabilized isoamyl nitrite | Acute cyanide poisoning | Initiation of phase 1 trial |
| Entheon Biomedical | N, N-dimethyltryptamine | Addiction disorders | Initiation of phase 1 trial |
| Gan & Lee Pharmaceuticals | GZR18 | Type 2 diabetes | Initiation of phase 1 trial |
| Immunomic Therapeutics | ITI-3000 DNA vaccine | Merkel cell carcinoma | Initiation of phase 1 trial |
| Moderna | mRNA-1574 vaccine | HIV | Initiation of phase 1 trial |
| Inversago Pharma | INV-202 | Metabolic syndrome | Initiation of phase 1b trial |
| Wugen | WU-CART-007 | Relapsed or refractory T-cell acute lymphoblastic leukemia / lymphoma | Initiation of phase 1/2 trial |
| ENA Respiratory | INNA-051 | Viral respiratory infections | Initiation of phase 2a trial |
| Ascentage Pharma | Lisaftoclax (APG-2575) | Relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma | Initiation of phase 2 trial |
| Glaukos | iLink therapy | Keratoconus | Initiation of phase 2 trial |
| Shanghai Junshi Biosciences | VV116 | Moderate-to-severe COVID-19 | Initiation of phase 3 trial in China |
| Approvals | |||
| AbbVie | Rinvoq (upadacitinib) | Moderately-to-severely active ulcerative colitis | Approved by the FDA for new indication |
| AstraZeneca Merck |
Lynparza (olaparib) | BRCA-mutated, HER2-negative high-risk early breast cancer | Approved by the FDA for expanded indication |
| Corium | Adlarity (donepezil transdermal system) | Alzheimer’s dementia | Approved by the FDA |
| Shoulder Innovations | InSet stemless humeral system | Shoulder surgery | Approved by the FDA |
| BeiGene Medison Pharma |
Brukinsa (zanubrutinib) | Waldenström’s macroglobulinemia | Approved in Israel |
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