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Pipeline
May 13, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Xencor, Inc. | XmAb23104 | advanced solid tumors | Phase I trial initiated |
| Shattuck Labs, Inc. | SL-279252 (PD1/OX40L) | advanced solid tumors and lymphomas | Phase I trial initiated |
| Alector, Inc. | AL002 | Alzheimer’s disease | Phase Ib trial initiated |
| VivaQuant | RX-1 Rhythm Express | cardiac arrhythmias | 510(k) clearance granted by the FDA |
| Imperative Care, Inc. | ZOOM Aspiration System | ischemic stroke | 510(k) clearance granted by the FDA |
| LENSAR, Inc. | LENSAR Laser System with Streamline IV | micro radial incisions to optimize outcomes of refractive cataract procedures | 510(k) clearance granted by the FDA |
| BioLineRx Ltd. | AGI-134 | solid tumors | IND approval granted by the FDA |
| Phoenix Tissue Repair, Inc. | PTR-01 | recessive dystrophic epidermolysis bullosa (RDEB) | Fast Track designation granted by the FDA |
| Savara, Inc. | Molgradex | autoimmune pulmonary alveolar proteinosis (aPAP) | Fast Track designation granted by the FDA |
| Concept Medical, Inc. | MagicTouch Sirolimus drug-coated balloon (DCB) catheter | coronary in-stent restenosis (ISR) | Breakthrough Device designation granted by the FDA |
| Vertex Pharmaceuticals, Inc. | KALYDECO (ivacaftor) | cystic fibrosis (CF) in children ages six months to less than 12 months | Approval granted by the FDA |
| AbbVie, Inc. | Mavyret (glecaprevir and pibrentasvir) tablets | six genotypes of hepatitis C virus (HCV) in children ages 12 to 17 | Approval granted by the FDA |
| Medtronic plc | Attain Stability Quad MRI SureScan left heart lead | CRT treatment for heart failure | Approval granted by the FDA |
| Genentech | Kadcyla (ado-trastuzumab emtansine) | adjuvant treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant taxane and Herceptin (trastuzumab)-based treatment | Approval granted by the FDA |
| Dr. Reddy’s Laboratories Ltd. | Testosterone Gel 1.62% (20.25 mg/1.25 g pump actuation) | testosterone deficiency | Approval granted by the FDA |
| Boston Scientific | VICI VENOUS STENT System | iliofemoral venous obstructive disease | Approval granted by the FDA |
