Industry News

• Ultragenyx Announces FDA Accepts New Drug Application for UX007 (triheptanoin) for LC-FAOD  Ultragenyx announced the FDA has accepted for review the company’s NDA for UX007 (triheptanoin) for treatment of long-chain fatty acid oxidation disorders. The FDA has assigned a standard review designation with a Prescription Drug User Fee Act target date of July 31, 2020.
  October 14, 2019  
• Xenikos receives FDA Fast Track designation for T-Guard(R) for treating SR-aGVHD  Xenikos announced the FDA has granted Fast Track designation to T-Guard, Xenikos' flagship product designed to treat steroid-refractory acute graft-versus-host disease in patients following allogeneic stem cell transplantation.
  October 14, 2019  
• Cara Therapeutics announces completion of interim statistical assessment   Cara Therapeutics announced completion of an interim statistical assessment of its pivotal KALM-2 Phase 3 global clinical trial of KORSUVA™ (CR845/difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus.
  October 14, 2019  
• Flexion Therapeutics announces extended FDA review of sNDA for ZILRETTA®  Flexion Therapeutics announced the FDA has informed the company it needs additional time to complete the review of the supplemental New Drug Application for ZILRETTA (triamcinolone acetonide extended-release injectable suspension). The anticipated PDUFA action date was today, Oct. 14, 2019.
  October 14, 2019  
• Matinas BioPharma initiates EnACT study of MAT2203 (oral amphotericin B)  Matinas announced it has initiated its Phase 2 EnACT clinical study, which will explore the use of MAT2203 for both induction and maintenance therapy in HIV-patients with cryptococcal meningitis, a life-threatening fungal infection most commonly observed in immunocompromised individuals.
  October 14, 2019  
• Exact Sciences and Mayo Clinic initiate 150,000 patient, 7-year Cologuard® study  Exact Sciences announced it has initiated a collaboration with Mayo Clinic to generate evidence of the real-world impact of Cologuard on colorectal cancer screening, incidence, and mortality rates. Voyage is a prospective, observational study designed to enroll more than 150,000 people.
  October 14, 2019  
• Phase III PEMPHIX study shows Roche’s MabThera/Rituxan (rituximab) superior to MMF  Roche announced data from the Phase III PEMPHIX study evaluating efficacy and safety of MabThera®/Rituxan® (rituximab) compared to mycophenolate mofetil in adults with moderate to severe pemphigus vulgaris. The study met the primary endpoint at Week 52.
  October 14, 2019  
• Incyte announces positive 52-week results from randomized phase 2 study of ruxolitinib  Incyte announces positive 52-week results from its randomized, double-blind, dose-ranging, Phase 2 study evaluating ruxolitinib cream, a nonsteroidal, anti-inflammatory, JAK inhibitor therapy, in adult patients with vitiligo.
  October 12, 2019  
• REGENXBIO announces additional positive interim phase I/IIa trial update for RGX-314  REGENXBIO announced interim data from the ongoing Phase I/IIa trial of RGX-314 for treatment of wet age-related macular degeneration. As of October 9, 2019, RGX-314 continues to be well-tolerated across all cohorts, with no drug-related serious adverse events reported.
  October 11, 2019  
• New data from teprotumumab phase 3 OPTIC study shows significantly reduced double vision  Horizon Therapeutics announced new data from the Phase 3 OPTIC confirmatory clinical trial showing that teprotumumab provided significant benefit on several devastating effects of active thyroid eye disease compared with placebo, including diplopia, QoL and CAS.
  October 11, 2019  

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