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Pipeline
April 30, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| AOBiome Therapeutics | Ammonia Oxidizing Bacteria (AOB) intranasal spray | episodic migraine | Phase II trial initiated enrolling 303 subjects |
| Mithra | Donesta | Vasomotor Symptoms (VMS) in post-menopausal women | Phase II top-line results announced evaluating 257 subjects |
| Concert Pharmaceuticals | CTP-543 | moderate-to-severe alopecia areata | Phase IIa trial initiated evaluating 90 subjects |
| Aldeyra Therapeutics, Inc. | topical ocular reproxalap | allergic conjunctivitis | Phase III trial initiated enrolling 300 subjects |
| Catalyst Pharmaceuticals, Inc. | Firdapse (amifampridine phosphate) | MuSK antibody positive Myasthenia Gravis (MuSK-MG) | Phase III trial initiated enrolling 60 subjects in the U.S. and Italy |
| Pfizer Inc. | TRUMENBA (Meningococcal Group B Vaccine) | Active immunization to prevent invasive disease caused by Neisseria meningitides group B (MenB) in children ages 1 through 9 years | Breakthrough Therapy Designation granted by the FDA |
| Lumendi, LLC | DiLumen C2 | second-generation endoscopic accessory indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment | 510(k) clearance granted by the FDA |
| Varian | Calypso Anchored Beacon transponder | tumor detection | 510(k) clearance granted by the FDA |
| Amerigen Pharmaceuticals Limited and Dipharma S.A. | Miglustat 100 mg capsules | Adult patients with mild to moderate type 1 Gaucher disease for whom enzyme replacement therapy is not a therapeutic option | aNDA filed with the FDA |
| Sage Therapeutics | intravenous formulation of brexanolone (SAGE-547) | postpartum depression (PPD) | NDA filed with the FDA |
| Veloxis Pharmaceuticals A/S | de novo indication of ENVARSUS XR (tacrolimus extended-release tablets) | Prophylaxis of organ rejection in kidney transplant patients | sNDA filed with the FDA |
| Abeona Therapeutics Inc. | ABO-102 | AAV-mediated gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA) | RMAT Designation granted by the FDA |
| MeiraGTx Limited | AAV-RPGR | X-linked retinitis pigmentosa (SLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene | Fast Track Designation granted by the FDA |
| Polyphor | balixafortide (POL6326) in combination with eribulin | patients with HER2-negative metastatic breast cancer who previously received at least two chemotherapeutic regiments in the metastatic setting | Fast Track Designation granted by the FDA |
| QIAGEN | PartoSure | preterm birth | FDA approved |
