Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Altimmune | Pemvidutide | Obesity | IND approved by the FDA |
| Denovo Biopharma | DB104 (liafensine) | Treatment-resistant depression | IND approved by the FDA |
| Immune-Onc Therapeutics | IO-202 | Solid tumors | IND approved by the FDA |
| Akeso | Ligufalimab and ivonescimab | Triple-negative breast cancer | Approval for a phase 2 trial granted by China’s regulatory authority |
| Sellas Life Science 3D Medicines |
3D189 (galinpepimut-S) | Hematological malignancies | IND approved by China’s regulatory authority |
| Trials Initiated | |||
| CRISPR Therapeutics ViaCyte |
VCTX210 | Type 1 diabetes | Initiation of phase 1 trial |
| Kintor Pharma | GT20029 gel | Androgenetic alopecia and acne | Initiation of phase 1 trial |
| NorthSea Therapeutics | SEFA-6179 | Intestinal failure-associated liver disease | Initiation of phase 1 trial |
| Synthekine | STK-012 | Solid tumors | Initiation of phase 1 trial |
| Lava Therapeutics | LAVA-1207 | Metastatic castration-resistant prostate cancer | Initiation of phase 1/2 trial |
| Minerva Biotechnologies | huMNC2-CAR44 T cells | Metastatic breast cancer in patients with MUC1-reactive tumors. | Initiation of phase 1/2 trial |
| Oncorena | Orellanine | Advanced kidney cancer in patients on dialysis | Initiation of phase 1/2 trial in Sweden |
| Viracta Therapeutics | Nana-val (nanatinostat and valganciclovir) | Epstein-Barr virus-positive solid tumors | Initiation of phase 1/2 trial |
| Aardvark Therapeutics | ARD-101 | Obesity | Initiation of phase 2 trial |
| Aardvark Therapeutics | ARD-101 | Refractory weight gain after bariatric surgery | Initiation of phase 2 trial |
| Aardvark Therapeutics | ARD-101 | Prader-Willi syndrome | Initiation of phase 2 trial |
| TRACON Pharmaceuticals | TRC102 | Stage III nonsquamous, nonsmall-cell lung cancer | Initiation of phase 2 trial |
| Can-Fite BioPharma | Namodenoson | NASH | Initiation of phase 2b trial |
| Akeso | Ivonescimab | EGFR-TKI-resistant EGFR mutation advanced nonsquamous, nonsmall-cell lung cancer | Initiation of phase 3 trial |
| Reviva Pharmaceuticals | Brilaroxazine | Acute exacerbation of schizophrenia | Initiation of phase 3 trial |
| Valneva | VLA1553 vaccine | Chikungunya | Initiation of phase 3 trial |
| Approvals | |||
| Genenetech | Vabysmo (faricimab-svoa) | Neovascular, age-related macular degeneration and diabetic macular edema | Approved by the FDA |
| Moderna | Spikevax (COVID-19 Vaccine, mRNA) | COVID-19 | Full approval granted by the FDA |
| Takeda | Vonvendi | Routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 Von Willebrand disease receiving on-demand therapy | Approved by the FDA for expanded indication |
| ViiV Healthcare | Cabenuva (cabotegravir, rilpivirine) | HIV | Approved by the FDA for a new dosing regimen |
Upcoming Events
-
21Oct
