Home » Drug & Device Pipeline News
Drug & Device Pipeline News
June 5, 2023
Company | Drug/Device | Medical Condition | Status |
---|---|---|---|
Trials Authorized | |||
Cocrystal Pharma | CDI-988 | COVID-19 treatment | Approval for a phase 1 trial granted by Australia’s regulatory authority |
IGM Biosciences | Imvotamab | Severe systemic lupus erythematosus | IND for a phase 1b trial approved by the FDA |
IGM Biosciences | Imvotamab | Severe rheumatoid arthritis | IND for a phase 1b trial approved by the FDA |
Precigen | PRGN-2009 plus pembrolizumab | Recurrent or metastatic cervical cancer | IND for a phase 2 trial approved by the FDA |
YS Biopharma | PIKA rabies vaccine | Rabies | Approval for a phase 3 trial granted by the Philippines regulatory authority |
Trials Initiated | |||
A2 Biotherapeutics | A2B530 | Colorectal, pancreatic and non-small cell lung cancers | Initiation of a phase 1 trial |
Celldex Therapeutics | CDX-585 | Advanced solid tumors | Initiation of a phase 1 trial |
Debiopharm | Debio 0123 plus carboplatin and etoposide | Recurrent or progressive small cell lung cancer | Initiation of a phase 1 trial |
Immorna | JCXH-105 shingles vaccine | Shingles | Initiation of a phase 1 trial |
Pyxis Oncology | PYX-106 | Advanced solid tumors | Initiation of a phase 1 trial |
Brii Biosciences | BRII-297 | Anxiety and depression | Initiation of a phase 1 trial in Australia |
Lynk Pharmaceuticals | LNK01004 | Mild-to-moderate plaque psoriasis | Initiation of a phase 1b trial in China |
Sensei Biotherapeutics | SNS-101 | Advanced solid tumors | Initiation of a phase 1/2 trial |
Structure Therapeutics | GSBR-1290 | Type 2 diabetes and obesity | Initiation of a phase 2a trial |
Alterity Therapeutics | ATH434 | Multiple system atrophy | Initiation of a phase 2 trial |
Aviceda Therapeutics | AVD-104 | Geographic atrophy secondary to age-related macular degeneration | Initiation of a phase 2 trial |
BIAL | BIA 28-6156 | Parkinson's disease in patients with a GBA1 gene mutation | Initiation of a phase 2 trial |
AUM Biosciences | AUM001 | Metastatic colorectal cancer | Initiation of a phase 2 trial in Australia |
Caliway Biopharmaceuticals | CBL-0204 | Abdominal subcutaneous fat reduction | Initiation of a phase 2b trial |
Immutep | Eftilagimod alpha plus paclitaxel | Metastatic breast cancer | Initiation of a phase 2/3 trial |
Hansa Biopharma | Imlifidase | Anti-glomerular basement membrane disease | Initiation of a phase 3 trial |
Pathalys Pharma Launch Therapeutics |
Upacicalcet | Secondary hyperparathyroidism in end-stage kidney disease patients on hemodialysis | Initiation of two phase 3 trials |
RayzeBio | RYZ101 | SSTR+ gastroenteropancreatic neuroendocrine tumors | Initiation of a phase 3 trial |
Stallergenes Greer | Staloral Birch | Birch pollen-induced allergic rhinoconjunctivitis with or without asthma | Initiation of a phase 3 trial in Europe |
Approvals | |||
AstraZeneca Merck |
Lynparza plus abiraterone and prednisone or prednisolone | BRCA-mutated metastatic castration-resistant prostate cancer | Approved by the FDA for expanded indication |
Lexicon Pharmaceuticals | Inpefa (sotagliflozin) | Heart failure | Approved by the FDA |
Pfizer | Paxlovid (nirmatrelvir tablets and ritonavir tablets) | Treatment of adult patients at high risk of progression to severe COVID-19 | Approved by the FDA |
Pfizer | Abrysvo respiratory syncytial virus vaccine | Respiratory syncytial virus in patients age 60 years and older | Approved by the FDA |
Upcoming Events
-
21Oct