Month: January 2019

Roche Discontinues P-III CREAD-1 and 2 Trials of Crenezumab in

Shots: The P-III CREAD-1 and 2 study involves assessing of Crenezumab vs PBO in 1500 patients with early AD with confirmed evidence of cerebral beta-amyloid pathology (CSF or amyloid PET) for a duration of two years The discontinuation process of trial is based on its unmet 1EPs results from baseline Clinical Dementia Rating-Sum of Boxes […]Read More

Sumitomo Dainippon’s Latuda (lurasidone HCl) Receives NMPA’s (CFDA) Approval for

 Shots: The approval is based on P-III clinical studies results assessing Latuda (n=245) vs Placebo (n=233) in 483 patients with schizophrenia The study results: PANSS @6weeks (-19.3 vs -12.7); AEs (47.0% vs 51.1%); discontinued patients (5.7% vs 6.4%); improvement in CGI-S @6 weeks; well tolerated in patients Lurasidone (40/80 mg/day; flexible dose) is an antipsychotic […]Read More

Takeda Reports Results of TAK-003 in P-III TIDES (DEN-301) Trial

Shots: The P-III TIDES study contains three parts assessing TAK-003 (0.5ml, SC) vs PBO in patients for the prevention of dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents, evaluating the efficacy, safety and immunogenicity The P-III study demonstrated well-tolerated, safe and efficacious results in […]Read More

Pfizer and Eli Lilly Report Results of Tanezumab in P-III

Shots: The P-III OA study involves assessing of tanezumab (2.5mg/5mg, SC) vs PBO in 849 patients in the ratio (1:1:1) with moderate-to-severe OA pain of the knee or hip across EU and Japan for 24 wks. The study showed a meeting in all 1EPs improvement in pain, physical function with well-tolerated results and has shown […]Read More