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Pipeline
September 10, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Janssen | Esketamine nasal spray | Treatment-resistant depression in adults | Submitted a new drug application to the FDA |
| EpicGenetics | BCG (an inexpensive generic vaccine to prevent tuberculosis) | Fibromyalgia | Massachusetts General Hospital granted FDA approval for human trial |
| ARMGO Pharma, Inc. | ARM210 (also known as S48168) | Ryanodine Receptor Type 1 Related Myopathies (RYR1-RM) | Granted Orphan Drug Designation by the FDA |
| Lysogene | LYS-SAF302 | Mucopolysaccharidosis Type IIIA (MPS IIIA) | Granted Investigational New Drug (IND) clearance by FDA for Phase II-III (AAVance) trial in U.S. |
| Pfizer | Oral Janus kinase 3 (JAK3) inhibitor PF-06651600 | Alopecia areata, a chronic autoimmune skin disease that causes hair loss | Granted Breakthrough Therapy designation by the FDA |
| ITF Pharma | TIGLUTIK™ (riluzole) oral suspension | Amyotrophic lateral sclerosis (ALS) | Granted approval by the FDA |
| Baxter International, Inc. | Actifuse Flow Bone Graft Substitute | Orthopedic surgical procedures | Granted clearance by the FDA |
| AstraZeneca/MedImmune | Anifrolumab | Moderate to severe lupus erythematosus (SLE) | Flunked Phase III clinical trial |
| Horizon Pharma plc | Teprotumumab | Moderate-to-severe active thyroid eye disease (TED) | Early completion of enrollment for confirmatory Phase III trial |
| SillaJen/Lee’s Pharmaceutical Holdings | Oncolytic immunotherapy Pexa-Vec (formerly JX-594) | Advanced liver cancer | First patient enrolled in China in the Phase III PHOCUS clinical trial |
| Eli Lilly and Company | Flortaucipir F 18, a Positron Emission Tomography (PET) imaging agent | Predicting brain tau pathology and Alzheimer's disease diagnosis | Phase III trial successfully met two primary endpoints |
| Advicenne | ADV7103 | Distal Renal Tubular Acidosis (dRTA) | Granted Investigational New Drug (IND) clearance by FDA for ARENA-2 Phase III clinical trial |
| Gilead Sciences and Galapagos NV | Filgotinib, a selective JAK1 inhibitor | Active ankylosing spondylitis (AS) in adults | Phase II TORTUGA clinical trial met endpoint of greater improvements in AS Disease Activity Score (ASDAS) |
| Neumentum | Non-opioid NTM-001 (pre-mixed bag ketorolac for continuous infusion) | Moderately severe acute pain | Completed dosing the first cohort of patients in its Phase I trial |
| PvP Biologics, Inc. | Kuma062 | Celiac disease | Two first-in-human clinical trials initiated |
