Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| YS Biopharma | PIKA COVID-19 vaccine | COVID-19 | IND approved by the FDA |
| Gmax Biopharm | GMA131 | Diabetic kidney disease | IND approved by the FDA |
| Ascletis Pharma | ASC10 | Monkeypox | IND approved by the FDA for phase 1b trial |
| Asieris Pharmaceuticals | APL-1401 | Moderately-to-severely active ulcerative colitis | IND approved by the FDA for phase 1b trial |
| J INTS BIO | JIN-A02 | Advanced non-small cell lung cancer | IND approved by the FDA for phase 1/2 trial |
| NeuroSense Therapeutics | PrimeC | Amyotrophic lateral sclerosis | IND approved by the FDA for phase 2b trial |
| AUM Biosciences | AUM001 | Metastatic colorectal cancer | Approval for a phase 2 trial granted by Australia’s regulatory authority |
| Trials Initiated | |||
| Virogin Biotech | VG201 | Advanced solid tumors | Initiation of phase 1 trial |
| Beam Therapeutics | BEAM-101 | Severe sickle cell disease in adults | Initiation of phase 1/2 trial |
| Equillium | EQ101 | Alopecia areata | Initiation of phase 2 trial |
| EpiEndo Pharmaceuticals | EP395 | Chronic obstructive pulmonary disease | Initiation of phase 2a trial in Germany and the UK |
| Ayala Pharmaceuticals | AL102 | Desmoid tumors | Initiation of phase 3 trial |
| Innovent Biologics | Mazdutide (IBI362) | Obesity | Initiation of phase 3 trial in China |
| Approvals | |||
| Sobi North America | Kineret (anakinra) | COVID-19-related pneumonia in hospitalized adults requiring supplemental oxygen | Emergency Use Authorization granted by the FDA |
| AstraZeneca | Imfinzi (durvalumab) plus Imjudo (tremelimumab) plus platinum-based chemotherapy | Non-small cell lung cancer | Approved by the FDA |
| ImmunoGen | Elahere (mirvetuximab soravtansine-gynx) | Treatment of previously treated adults with folate receptor alpha-positive, platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer | Accelerated approval granted by the FDA |
| Medicines360 | Liletta (levonorgestrel-releasing intrauterine system) | Pregnancy prevention for up to eight years | Approved by the FDA for extended treatment duration |
| Seagen | Adcetris (brentuximab vedotin) | Previously untreated high-risk classical Hodgkin lymphoma in children age two years and older | Approved by the FDA for expanded age indication |
| Agios Pharmaceuticals | Pyrukynd (mitapivat) | Pyruvate kinase deficiency in adults | Approved in the EU |
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