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Pipeline
August 13, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| OncoPep, Inc. | PVX-410, investigational multi-peptide cancer vaccine | Smoldering multiple myeloma (SMM) | Phase Ib trial initiated |
| SW Safety Solutions, Inc. | Nitrile Exam Gloves with Low Dermatitis Potential Claim | Skin irritation or sensitization | Initial – Looking for Principal Investigator to head clinical study |
| Kyowa Kirin, Inc. | Poteligo (mogamulizumabkpkc) injection | Relapsed or refractory mycosis fungoides (MF) or Sezary syndrome after at least one prior systemic therapy | Approval granted by FDA |
| Celltrion, Inc. | Bevacizumab biosimilar ‘CT-P16’ | Metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, and glioblastoma | Phase III trial initiated |
| Apotex Inc. | New generic potassium chloride oral solution | Hypokalemia (low potassium blood levels) in patients who are on diuretics | Approval granted by the FDA under a novel term called the Competitive Generic Therapy designation |
| Alector, LLC | AL001, a human recombinant monoclonal antibody | Frontotemporal dementia (FTD) | Granted Orphan Drug Designation by the FDA |
| Pliant Therapeutics, Inc. | PLN-74809 | Idiopathic pulmonary fibrosis (IPF) | Granted Orphan Drug designation by the FDA |
| Castle Creek Pharmaceuticals, LLC | Diacerein 1% ointment (CCP-020) | Epidermolysis bullosa simplex (EBS) | Fast Track Designation granted by the FDA |
| Elite Pharmaceuticals, Inc. | Generic methadone hydrochloride 5 mg and 10 mg tablets | Severe pain, maintenance treatment of opioid addiction (heroin or other morphine-like drugs) | Approval granted by the FDA |
| Alteogen Inc. | ALT-P7, an antibody-drug conjugate (ADC) using a Trastuzumab variant form of antibody | Gastric cancer | Granted Orphan Drug Designation by the FDA |
| Vertex Pharmaceuticals Inc. | Orkambi (lumacaftor/ ivacaftor) | Underlying cause of cystic fibrosis in children ages 2 to 5 with the most common form of the disease | Approval granted by the FDA |
| BioCryst Pharmaceuticals, Inc. | BCX7353 | Prevention of angioedema attacks in patients with hereditary angioedema | Fast Track Designation granted by the FDA |
| PharmaMar | Lurbinectedin | Small cell lung cancer | Granted Orphan Drug Designation by the FDA |
| Sensus Healthcare, Inc. | SRT-100+, the next-generation Superficial Radiation Therapy solution | Non-melanoma skin cancers (NMSC) and keloids | Granted 501(k) clearance by the FDA |
| Armagen Inc. | GT-184, an investigational enzyme replacement therapy (ERT) | Mucopolysaccharidosis type IIIA (also known as Sanfilippo Syndrome A or MPS IIIA) | Granted Orphan Drug Designation by the FDA |
| Shionogi & Co., Ltd | Mulpleta®(lusutrom-bopag) | Thrombocytopenia in adult patients with chronic liver disease (CLD) who are scheduled to undergo a procedure | Approval granted by the FDA |
