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Pipeline
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Stallergenes Greer | Oralair®, an allergy immunotherapy sublingual tablet | Grass pollen-induced allergic rhinitis | Received FDA approval for the extension of the indication to treat patients ages five to nine |
| REGENXBIO | RGX-181, a one-time treatment candidate | Late-infantile neuronal ceroid lipofuscinosis type 2 (CLN2) disease, one of the most common forms of Batten disease | Granted Orphan Drug Designation by the FDA |
| Eli Lilly and Company | Lasmiditan | Migraine with or without aura in adults | Submitted a New Drug Application (NDA) to the FDA |
| Eli Lilly and Company | Emgality | Episodic cluster headache | Granted Breakthrough Therapy Designation by the FDA |
| Lumendi | DiLumen™ EIP | Easier dissection and resection of polyps without the need for surgical intervention | Received 510(k) clearance from the FDA |
| Theravance Biopharma, Inc. and Mylan N.V. | YUPELRITM (revefenacin), once-daily, nebulized bronchodilator | COPD | Granted approval by the FDA |
| Biohaven Pharmaceutical Holding Company Ltd | Rimegepant, oral calcitonin gene-related peptide (CGRP) receptor antagonist | Migraine | Enrolled first patient in Phase III clinical trial |
| AbbVie | Mavyret (glecaprevir/pibrentasvir) | Hepatitis C (HCV) | Results from Phase IIIb EXPEDITION-8 trial: patients receiving the drug for 8 weeks with genotype 1, 2, 4, 5 and 6 had a 100-percent sustained virologic response 12 weeks after treatment |
| Merck | KEYTRUDA® (PEMBROLIZUMAB) | Advanced or metastatic esophageal or esophagogastric junction carcinoma in patients whose tumors expressed PD-L1 | Significantly improved Overall Survival (OS) compared to chemotherapy in Phase III KEYNOTE-181 clinical trial |
| AbbVie | Elagolix, in combination with add-back therapy | Heavy menstrual bleeding associated with uterine fibroids | Achieved statistically significant reduction in two replicate pivotal Phase III clinical trials |
| Calliditas Therapeutics | NEFIGARD | IgA nephropathy (IgAN) | First patient enrolled in pivotal Phase III clinical trial |
| Palvella Therapeutics, Inc. | PTX-022 (novel, high-strength rapamycin topical formulation | Pachyonychia congenita (PC) | Granted Fast Track Designation by the FDA |
| TWi Biotechnology, Inc. | AC-201CR | Hemophilic arthropathy | Completed patient enrollment in Phase II clinical trial |
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