New Pipeline Updates from Pfizer, Shire, Poxel and Compass Pathways

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