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Pipeline
January 21, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| ADC Therapeutics | ADCT-601 | advanced or metastatic solid tumors | Phase I trial initiated enrolling 75 subjects |
| Mirati Therapeutics, Inc. | MRTX849 | advanced solid tumors that harbor KRAS G12C mutations | Phase I/II trial initiated |
| Promentis Pharmaceuticals, Inc. | SXC-2023 | moderate to severe trichotillomania in adults | Phase II trial initiated enrolling 100 subjects in the U.S. |
| Innovent Biologics, Inc. | Tyvyt (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) in combination with capecitabine and oxaliplatin | advanced, recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma (GC or GEJ) | Phase III trial initiated enrolling 650 subjects in China |
| TransEnterix | Senhance Ultrasonic System | minimally invasive surgery | 510(k) clearance granted by the FDA |
| OSSIO | OSSIOfiber Bone Pin | stability and secure bone fixation during the orthopedic healing process | 510(k) clearance granted by the FDA |
| Mundipharma International | Flutiform pMDI | asthma treatment in children five years of age or older | Approval granted by the EMA |
| Bristol-Myers Squibb Company | Opdivo (nivolumab) 3 mg/kg plus Yervoy (ipilimumab) 1 mg/kg | first-line treatment of patients with intermediate- and poor-risk advanced renal cell carcinoma (RCC) | Approval granted by the EMA |
| iSchemaView | RAPID neuroimaging platform | stroke patients who are likely to benefit from endovascular thrombectomy (clot removal) | 510(k) clearance granted by the FDA |
| Novartis | crizanlizumab (SEG101) | prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD) | Breakthrough Therapy Designation granted by the FDA |
| Exelixis, Inc. | CABOMETYX (cabozantinib) tablets | hepatocellular carcinoma (HCC) | NDA approval granted by the FDA |
| AIVITA Biomedical | anti-PD1 monoclonal antibodies in combination with AV-MEL-1 | metastatic melanoma | IND approval granted by the FDA |
| NeoImmuneTech, Inc. and Genexine | Hyleukin-7 (IL-7-hyFc) and atezolizumab (Tecentriq) | high-risk skin cancers | IND approval granted by the FDA |
| Zydus Cadila | Amlodipine in combination with Atorvastatin | high blood pressure and lowering cholesterol | ANDA approval granted by the FDA |
| Amneal Pharmaceuticals, Inc. | generic version of Exelon Patch (Rivastigmine Transdermal System), 4.6 mg/24 hours, 9.5 mg/24 hours and 13.3 mg/24 hours | mild to moderate dementia caused by Alzheimer's or Parkinson's disease | ANDA approval granted by the FDA |
| Abbott | Amplatzer Piccolo Occluder | patent ductus arteriosus (PDA) in premature babies and newborns | Approval granted by the FDA |
| Sanofi | Adacel (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine Adsorbed) | repeat vaccination to help protect against tetanus, diphtheria and pertussis | Approval granted by the FDA |
