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Home » Pipeline

Pipeline

August 26, 2019
Company Drug/Device Medical Condition Status
MyoKardia, Inc. MYK-224 hypertrophic cardiomyopathy (HCM) Phase 1 trial initiated enrolling healthy adults
Bio-Thera Solutions, Ltd. single subcutaneous dose of either BAT2506 or EU-sourced Simponi (golimumab) ulcerative colitis Phase 1 trial initiated enrolling 182 subjects
Kite Pharma, a Gilead company KITE-439 HPV-associated cancers with HPV type 16, a strain which causes about 70% of all cervical cancers worldwide, as well as oropharyngeal, anal, penile and vaginal cancers Phase 1 trial initiated enrolling subjects who must be HLA-A*02:01 positive, relapsed or refractory after at least one line of therapy at City of Hope in Duarte, CA
NKMax America SNK plaque psoriasis Phase 1 trial initiated enrolling nine subjects with mild to severe plaque psoriasis in Tijuana, Mexico
Forendo Pharma HSD17B1 inhibitor FOR-6219 endometriosis Phase 1b trial initiated enrolling healthy premenopausal women
BioInvent International AB BI-1206 in combination with pembrolizumab (Keytruda) solid tumors Phase 1/2a trial initiated enrolling subjects with advanced solid tumors, who have been previously treated with anti-PD1 or anti-PD-L1 antibodies
Rocket Pharmaceuticals, Inc. RP-L102 Fanconi anemia Phase 2 trial initiated enrolling up to five pediatric patients who have not developed severe bone marrow failure in Europe
Landos Biopharma BT-11 mild to moderate ulcerative colitis (UC) Phase 2 trial initiated enrolling 195 UC subjects with mild to moderate disease in 11 countries with 60 sites throughout the U.S., Europe and Eastern Europe.
Inovio Pharmaceuticals, Inc. VGX-3100 immunotherapy human papillomavirus (HPV) Phase 2 trial initiated enrolling 24 subjects with precancerous lesions of the anus, i.e. anal high-grade squamous intraepithelial lesions (anal HSIL, aka anal intraepithelial neoplasia)
Knopp Biosciences LLC oral dexpramipexole eosinophilic asthma Phase 2 trial initiated enrolling 100 subjects with moderate-to-severe eosinophilic asthma
Emalex Biosciences, Inc. ecopipam HCl tablets Tourette Syndrome (TS) Phase 2b trial initiated enrolling 150 children and adolescent subjects (aged >6 to <18 years) at multiple centers in the United States, Canada, and the European Union
Satsuma Pharmaceuticals, Inc. STS101 (dihydroergotamine (DHE) nasal powder) acute treatment of migraine Phase 3 trial initiated enrolling 1,140 subjects at sites across U.S.
ActoBio Theraputics, Inc. AG017 celiac disease IND approval granted by the FDA
Vyaire Medical, Inc. Vyntus ONE Pulmonary Function Testing (PFT) 510(k) clearance granted by the FDA
Vyaire Medical, Inc. Vyntus BODY with SentrySuite Software Pulmonary Function Testing (PFT) 510(k) clearance granted by the FDA
Moderna, Inc. mRNA-1893 Zika virus infection Fast Track designation granted by the FDA
Genentech Rozlytrek (entrectinib) ROS1-positive, metastatic non-small cell lung cancer (NSCLC) Accelerated approval granted by the FDA
CVRx, Inc. BAROSTIM NEO device for heart failure Chronic heart failure Premarket approval granted by the FDA
Nabriva Therapeutics Xenleta (lefamulin) community-acquired bacterial pneumonia Approval granted by the FDA
AbbVie Rinvoq (upadacitinib) moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX-IR) Approval granted by the FDA
Boston Scientific Corporation ImageReady MRI labeling for the Vercise Gevia Deep Brain Stimulation (DBS) System Parkinson's Disease Approval granted by the FDA
Zimmer Biomet The Tether anterior vertebral body tethering (AVBT) solution scoliosis, providing a fusion-less alternative for young patients requiring surgery Approval granted by the FDA
Celgene Inrebic (fedratinib) capsules Myelofibrosis Approval granted by the FDA
TB Alliance Pretomanid tablets in combination with bedaquiline and linezolid Extensively Drug-Resistant Tuberculosis (XDR-TB) and treatment intolerant/non-responsive Multidrug-Resistant (MDR) TB Approval granted by the FDA
Harmony Biosciences LLC WAKIX (pitolisant) excessive daytime sleepiness (EDS) in adult patients with narcolepsy Approval granted by the FDA

 

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