Drug & Device Pipeline News
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Trials Authorized | |||
| Shanghai Junshi Biosciences | TAB009/JS009 | Advanced solid tumors | IND approved by the FDA |
| Starton Therapeutics | STAR-OLZ | Chemotherapy-induced nausea and vomiting | IND approved by the FDA |
| Tonix Pharmaceuticals | TNX-102 SL | Long COVID | IND approved by the FDA |
| ValenzaBio | VB421 | Thyroid eye disease | IND approved by the FDA |
| Sorrento Therapeutics | Abivertinib | Severe pneumonia in hospitalized patients due to COVID-19 | Approval for a phase 2/3 trial granted by the FDA |
| Fractyl Health | Revita DMR system | Type 2 diabetes patients who are not yet on insulin | IDE approved by the FDA |
| Accutar Biotechnology | AC0682 | ER+ breast cancer | IND approved by China’s regulatory authority |
| Ascletis Pharma | ASC60 | Advanced solid tumors | IND approved by China’s regulatory authority |
| Claritas Pharmaceuticals | R-107 | Pulmonary arterial hypertension | Approval for a phase 1 trial granted by Australia’s regulatory authority |
| Trials Initiated | |||
| Athira Pharma | ATH-1020 | Neuropsychiatric conditions | Initiation of phase 1 trial |
| Bond Biosciences | BBI-001 | Hemochromatosis | Initiation of phase 1 trial |
| NGM Bio | NGM831 | Advanced solid tumors | Initiation of phase 1 trial |
| Nurix Therapeutics | DeTIL-0255 | Advanced gynecological malignancies | Initiation of phase 1 trial |
| Sirnaomics | STP707 | Liver fibrosis in primary sclerosing cholangitis | Initiation of phase 1 trial |
| Zhimeng Biopharma | CB06 | Chronic hepatitis B virus infection | Initiation of phase 1 trial |
| PepGen | PGN-EDO51 | Duchenne muscular dystrophy | Initiation of phase 1 trial in Canada |
| 4D Molecular Therapeutics | 4D-710 | Cystic fibrosis | Initiation of phase 1/2 trial |
| Genprex | Reqorsa plus Keytruda | Nonsmall-cell lung cancer | Initiation of phase 1/2 trial |
| Ocugen | OCU400 | Retinitis pigmentosa | Initiation of phase 1/2 trial |
| Processa Pharmaceuticals | PCS12852 | Gastroparesis | Initiation of phase 2a trial |
| Altimmune | Pemvidutide | Obesity | Initiation of phase 2 trial |
| Lakewood-Amedex | Bisphosphocin Nu-3 | Chronic diabetic foot ulcers | Initiation of phase 2 trial |
| Meiji Seika Pharma | ME3183 | Plaque psoriasis | Initiation of phase 2 trial |
| NewAmsterdam Pharma | Obicetrapib in combination with ezetimibe | High levels of low-density lipoprotein cholesterol | Initiation of phase 2 trial |
| Verrica Pharmaceuticals | LTX-315 | Basal cell carcinoma | Initiation of phase 2 trial |
| Respira Therapeutics | RT234 | Pulmonary arterial hypertension | Initiation of phase 2b trial |
| Tonix Pharmaceuticals | TNX-102 SL | Fibromyalgia | Initiation of phase 3 trial |
| Approvals | |||
| BioXcel Therapeutics | Igalmi (dexmedetomidine) sublingual film | Agitation associated with schizophrenia or bipolar disorder in adults | Approved by the FDA |
| Kite Therapeutics | Yescarta (axicabtagene ciloleucel) | Relapsed or refractory large B-cell lymphoma | Approved by the FDA for expanded indication |
| Nobelpharma America | Hyftor (sirolimus topical gel) | Facial angiofibroma associated with tuberous sclerosis complex | Approved by the FDA |
| Novartis | Vijoice (alpelisib) | PIK3CA-related overgrowth spectrum | Approved by the FDA |
| Bristol Myers Squibb | Breyanzi (lisocabtagene maraleucel) | Certain forms of relapsed or refractory large B-cell lymphoma | Approved by the European Commission |
| Bristol Myers Squibb | Opdivo (nivolumab) | Adjuvant treatment of muscle-invasive urothelial carcinoma patients at high risk of recurrence after undergoing radical resection | Approved by the European Commission for expanded indication |
| Bristol Myers Squibb | Opdivo (nivolumab) plus Yervoy (ipilimumab) | Esophageal squamous cell carcinoma | Approved by the European Commission for expanded indication |
| Immunocore | Kimmtrak (tebentafusp) | Unresectable or metastatic uveal melanoma | Approved by the European Commission |
| Sanofi | Dupixent (dupilumab) | Severe asthma with type 2 inflammation in children age 6 to 11 years | Approved by the European Commission for expanded indication |
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