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Pipeline
February 4, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Dicerna Pharmaceuticals, Inc. | DCR-HBVS | chronic hepatitis B virus (HBV) | Phase I trial initiated enrolling healthy volunteers and subjects with non-cirrhotic chronic HBV |
| Navitor Pharmaceuticals, Inc. | NV-5138 | Treatment-Resistant Depression (TRD) | Phase Ib trial initiated enrolling up to 88 subjects, including healthy volunteers and those diagnosed with TRD |
| Theravance Biopharma, Inc. | ampreloxetine (TD-9855) | symptomatic neurogenic orthostatic hypotension (nOH) | Phase III trial initiated enrolling 188 subjects with symptomatic nOH caused by primary autonomic failure associated with multiple system atrophy (MSA), Parkinson's disease (PD) and pure autonomic failure (PAF) |
| Qualigen, Inc. | FastPack IP Sex Hormone Binding Globulin (SHBG) Immunoassay | diagnosis and treatment of men's health | 510(k) clearance granted by the FDA |
| Merck | V114 | prevention of invasive pneumococcal disease (IPD) caused by the vaccine serotypes in pediatric patients 6 weeks to 18 years of age | Breakthrough Therapy Designation granted by the FDA |
| C2N Diagnostics | brain amyloidosis blood test | screening for brain amyloid pathology in individuals being assessed for an Alzheimer’s Disease diagnosis | Breakthrough Device Designation granted by the FDA |
| BioInvent International AB | BI-1206 | mantle cell lymphoma (MCL) | Orphan Drug Designation granted by the FDA |
| Eureka Therapeutics, Inc. | ET140202 ARTEMIS T-cell therapy | AFP-positive patients with advanced hepatocellular carcinoma (HCC) | IND approval granted by the FDA |
| MGB Biopharma | MGB-BP-3 | Clostridium difficile-associated diarrhea (CDAD) | IND approval granted by the FDA |
| CorMatrix Cardiovascular, Inc. | Cor TRICUSPID ECM cardiac valve | adults with endocarditis and for pediatric patients with congenital heart valve disease | IDE approval granted by the FDA |
| Amerigen Pharmaceuticals, Limited | generic version of Shire's Adderall XR (dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate, extended-release capsules) | attention deficit hyperactivity disorder (ADHD) | ANDA approval granted by the FDA |
| AbbVie and Promius Pharma, LLC | TOSYMRA (previously known as DFN-02) | acute treatment of migraine with or without aura in adults | NDA approval granted by the FDA |
| Dr. Reddy’s Laboratories Ltd. and Janssen Pharmaceutical Companies of Johnson & Johnson | IMBRUVICA (ibrutinib) in combination with Roche’s obinutuzumab (GAZYVA) | adult patients with previously untreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) | NDA approval granted by the FDA |
