Pipeline

April 1, 2019
Company Drug/Device Medical Condition Status
International AIDS Vaccine Initiative (IAVI) BG505 SOSIP.664 gp140 HIV Phase I trial initiated enrolling 60 healthy adult subjects in Seattle, Boston and Nairobi
Aerie Pharmaceuticals, Inc. netarsudil ophthalmic solution open-angle glaucoma or ocular hypertension Phase II trial initiated enrolling 208 subjects in Japan
DURECT Corporation DUR-928 (topical) mild to moderate plaque psoriasis Phase IIa trial initiated enrolling 20 subjects at multiple sites across the U.S.
Modra Pharmaceuticals B.V. ModraDoc006/r recurrent or metastatic HER-2 negative breast cancer Phase IIa trial initiated enrolling 24 subjects
Urovant Sciences vibegron overactive bladder (OAB) in men who are receiving pharmacological treatment for benign prostatic hyperplasia (BPH) Phase III trial initiated enrolling 1,000 male subjects with BPH who are also taking BPH medications but continue experiencing OAB symptoms
Breath Therapeutics L CsA i Bronchiolitis Obliterans Syndrome (BOS) Phase III trial initiated enrolling 110 subjects with BOS following single lung (BOSTON-1) or double lung (BOSTON-2) transplantation at leading lung transplant specialty centers in eight countries
Novocure Tumor Treating Fields combined with paclitaxel recurrent, platinum-resistant ovarian cancer Phase III trial initiated enrolling 540 subjects
Eisai Co., Ltd. BAN2401 Alzheimer's disease Phase III trial initiated enrolling 1,566 subjects with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild Alzheimer's disease dementia (collectively known as early AD) with confirmed amyloid pathology in the brain
Zimmer Biomet, Inc. ROSA ONE Spine System minimally invasive and complex spine surgeries 510(k) clearance granted by the FDA
Genetesis, Inc. CardioFlux cardiac imaging 510(k) clearance granted by the FDA
Beckman Coulter DxH 520 hematology analyzer neonate, pediatric and critical care 510(k) clearance granted by the FDA
Enzyvant RVT-801 Farber disease Rare Pediatric Disease designation granted by the FDA
Promedior, Inc. PRM-151 Idiopathic Pulmonary Fibrosis (IPF) Breakthrough Therapy designation granted by the FDA
Impulse Dynamics Optimizer Smart System for delivering CCM therapy heart failure Breakthrough Device designation granted by the FDA
Lipella Pharmaceuticals, Inc. LP-10 cancer survivors with hemorrhagic cystitis resulting from pelvic radiation therapy and/or systemic chemotherapy IND approval granted by the FDA
Slayback Pharma LLC Hydroxyprogesterone Ca-proate Injection, USP 250 mg/ 1 ml preterm birth prevention ANDA approval granted by the FDA
Enzyvant RVT-801 Farber disease Fast Track approval granted by the FDA
Novartis Mayzent (siponimod) multiple sclerosis (MS) Fast Track approval granted by the FDA
BrightWater Medical, Inc. ConvertX Biliary Stent System biliary obstructions Approval granted by the FDA
Jazz Pharmaceuticals Sunosi narcolepsy Approval granted by the FDA

 

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