New Pipeline Updates from Amgen, Eli Lilly, Applied BioCode and Ocugen

October 8, 2018

Company Drug/Device Medical Condition Status
Paratek Pharmaceuticals, Inc. SEYSARA™ (sarecycline) Inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older Granted approval by the FDA
Clovis Oncology, Inc. Rubraca® (rucaparib) BRCA1/2-mutated mCRPC after androgen receptor (AR)-directed therapy and taxane-based chemotherapy Granted Breakthrough Therapy designation by the FDA
PharmAbcine, Inc. Bevacizumab (Avastin®) Recurrent glioblastoma Received “Study May Proceed Letter “ for IND application from the FDA; can initiate Phase II trials
Amgen KYPROLIS® (carfilzomib) Relapsed or refractory multiple myeloma FDA approved supplemental New Drug Application to expand prescribing information
Applied BioCode BioCode® Gastrointestinal Pathogen Panel on BioCode® MDx-3000 molecular system Tests for 17 most common bacteria, viruses and parasites that cause infectious diarrhea Granted 510 (k) clearance by the FDA
Eisai Co., Ltd. Fycompa (perampanel) Partial-onset seizures in pediatric patients with epilepsy 4 years of age and older Granted approval by the FDA for an indication expansion
Eli Lilly and Company Ultra Rapid Lispro (URLi) Type 1 and Type 2 diabetes Phase III clinical trials show met primary efficacy endpoint
Seattle Genetics, Inc. and Takeda Pharmaceutical Company Limited ADCETRIS (brentuximab vedotin) in combination with CHP (cyclophosphamide, doxorubicin, prednisone) CD30-expressing peripheral T-cell lymphoma (PTCL), also known as mature T-cell lymphoma (MTCL) Phase III ECHELON-2 clinical trial met its primary endpoint
Acorda Therapeutics, Inc. INBRIJA, investigational inhaled levodopa OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen Releasing efficacy analysis from SPAN-PD, Phase III clinical trial
Five Prime Therapeutics, Inc. Bemarituzumab (FPA144), an isoform-selective FGF receptor 2b (FGFR2b) antibody, with chemotherapy Advanced gastric cancer (GC) or gastroesophageal junction (GEJ) cancer First patient dosed in Phase III FIGHT pivotal trial
Ocugen, Inc. OCU310 Dry eye Initiated Phase III clinical trial
PTC Therapeutics Risdiplam (RG7916) Type 1, 2 and 3 spinal muscular atrophy (SMA) Interim data from open-label clinical trials show increases in developmental motor milestones
Veloce BioPharma, LLC VBP-926 (Povidone-Iodine) topical treatment Chemo-associated paronychia, or painful, inflamed nails, a chemo side effect Positive results of Phase IIb trial