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Pipeline
September 4, 2018
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Cycle Pharmaceuticals Ltd | Ketorolac Tromethamine Tablets 10mg (as continuation treatment post IV/IM dosing of ketorolac tromethamine) | Moderately severe acute pain | Granted FDA approval of Abbreviated New Drug Application (“ANDA”) |
| Compass Pathways | Psilocybin, the active ingredient in “magic mushrooms” | Treatment-resistant depression | Received FDA approval for Phase IIb Clinical Trial |
| Akcea Therapeutics | Waylivra (volanesorsen) | Familial chylomicronemia syndrome (FCS) | Received Complete Response Letter from FDA |
| Poxel SA | Imeglimin | Type 2 diabetes | Patient enrollment completed in TIMES 3 trial of the Phase III registration program |
| Ceterix Orthopaedics, Inc. | NovoStitch® Pro Meniscal Repair System – size 0 suture cartridge | Meniscal tears | 501 (k) clearance granted by the FDA |
| Reflection Biotechnologies Limited | RBIO-101 program (AAV.CYP4V2), an AAV-based gene therapy product | Bietti's Crystalline Dystrophy (BCD) | Granted Orphan Drug Designation by the FDA |
| Berlin Cures | BC 007, a DNA-based aptamer compound that binds to and eliminates functional pathogenic autoantibodies | Cardiomyopathy | Announced successful completion Phase I trial |
| Novaremed AG | Lead compound NRD.E1, a novel, first-in-class, small molecule | Diabetic neuropathy pain | Announced funding goal reached to begin global Phase IIb trial |
| Promore Pharma AB | LL-37 | Venous leg ulcers | Approval to start Phase IIb clinical trial in Sweden and Poland |
| Pfizer | Tafamidis | Transthyretin Cardiomyopathy | Announced Phase III findings that therapy cut death risk by 30 percent in patients with distinct disease type |
| Ortho Dermatologics | New Drug Application for ALTRENO™ (tretinoin 0.05%) lotion | Acne vulgaris in patients 9 years of age and older | Granted approval by the FDA |
| Kala Pharmaceuticals, Inc. | INVELTYS™ (loteprednol etabonate ophthalmic suspension) 1% | Post-operative inflammation and pain following ocular surgery | Granted approval by the FDA |
| Biocodex | DIACOMIT (stiripentol) | Seizures associated with Dravet syndrome (DS) in patients 2 years of age and older taking clobazam | Granted approval by the FDA |
| Dompé | Oervate™ (cenegermin-bkbj ophthalmic solution) | neurotrophic keratitis (NK) | Granted approval by the FDA |
| Seqirus | Next-generation cell-based vaccine manufacturing process at Holly Springs, N.C. | Influenza | Granted approval by the FDA |
| Shire | Takhzyro (lanadelumab-flyo) injection | Hereditary angioedema (HAE) in people 12 years of age and older | Granted approval by the FDA |
