Human Trials

Celltrion showcases positive one-year results for subcutaneous formulation of infliximab in patients with active Crohn’s disease and ulcerative colitis

Celltrion Healthcare announced new 1-year data from a randomised controlled trial to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 subcutaneous (SC) formulation compared to the CT-P13 intravenous (IV) formulation in patients with active Crohn’s disease (CD) and ulcerative colitis (UC).

New phase 3b interim data from STARDUST study show majority patients with moderately to severely active Crohn’s Disease achieved clinical remission after two doses of STELARA

The Janssen Pharmaceutical Companies of Johnson & Johnson announced interim data from the Phase 3b STARDUST study. At week 16, 79 percent of patients with moderately to severely active Crohn’s disease (CD) achieved clinical responsea and 67 percent were in clinical remissionb after receiving one ~6 mg/kg intravenous (IV) dose followed by one 90 mg subcutaneous (SC) dose of STELARA® (ustekinumab), open label.

Merck’s Keytruda plus chemotherapy meets primary endpoint in mTNBC trial

Merck’s Keytruda in combination with chemotherapy has achieved the primary endpoint of progression-free survival (PFS) as first-line treatment for metastatic triple-negative breast cancer (mTNBC) in the phase 3 KEYNOTE-355 trial.

Pfizer, Astellas’ Xtandi significantly improves OS in phase 3 prostate cancer study

Pfizer and Astellas Pharma announced that Xtandi (enzalutamide) has shown significant improvement in overall survival (OS) in phase 3 PROSPER trial.

Lilly’s solanezumab fails to meet objective in phase 2/3 DIAN-TU Study

Eli Lilly and Company (Lilly) said that its anti-amyloid monoclonal antibody solanezumab failed to meet the primary endpoint in the phase 2/3 Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) Study.

Moderna announces progress in prophylactic vaccines modality with CMV Vaccine phase 2 study data now expected in third quarter 2020

Moderna, a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, announced that the Phase 2 dose-confirmation study of its mRNA vaccine against cytomegalovirus (CMV) is enrolling ahead of plan with data now expected in the third quarter of 2020.

Biohaven’s troriluzole study for generalised anxiety disorder misses primary endpoint

Biohaven Pharmaceutical Holding reported negative topline results from its Phase 3 clinical trial evaluating troriluzole compared to placebo for the treatment of patients with Generalized Anxiety Disorder (GAD).

Regeneron’s Eylea delivers positive two-year results in PANORAMA trial

Regeneron Pharmaceuticals said that a phase 3 trial assessing Eylea (aflibercept) Injection 2 mg (0.05 mL) in moderately severe to severe non-proliferative diabetic retinopathy (NPDR) has yielded positive two-year results.

Elios Therapeutics presents new Phase IIb data for personalized cancer vaccine in high-risk melanoma patients

Elios Therapeutics presented a subgroup analysis of the prospective, randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating its personalized tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine, in patients with Stage III and IV resected melanoma.