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Pipeline

New Pipeline Updates from Savara, AbbVie and Genentech

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