Tags : Initiate

Meiji and Dong-A Socio Initiate P-I Trial for DMB-3115 (biosimilar,

Shots: The P-I trial involves assessing of DMB-3115 vs reference products (US- and EU-marketed products under the name of Stelara) in healthy volunteers to evaluate its safety, PK and tolerability in Europe In 2011, Meiji and Dong-A signed a joint venture agreement on biosimilars to build DM Bio Limited in Incheon Free Economic Zone and […]Read More

Exact Sciences and Mayo Clinic Initiate Voyage Study Evaluating the

Shots: Exact & Mayo has initiated the Voyage study to generate evidence of the real-world impact of Cologuard on colorectal cancer screening, incidence, and mortality rates. The Voyage study will provide additional, real-world evidence demonstrating the clinical impact of Cologuard & position it as SoC in colorectal cancer screening The Voyage study is a prospective, […]Read More

Medtronic to Initiate Clinical Study Evaluating Infuse Bone Graft in

Shots: Medtronic has initiated site recruitment for the Transforaminal Lumbar Interbody Fusion (TLIF) clinical study to enroll up to 50 sites with over 1,000 patients. The expanded indication to use Infuse posterior spine procedures provide patients a powerful option in a spine surgeon’s armamentarium Additionally, in 2017, Medtronic got approval to evaluate Infuse Bone Graft […]Read More

BioInvent to Initiate P-I/IIa Study with BI-1206 in Combination with

Shots: In July’2019, Bioinvent reports the FDA’s acceptance of its IND application of BI-1206 + Keytruda combination therapy based on the preclinical data demonstrating that BI-1206 enhances anti-tumor immune responses in patients with solid tumors BioInvent will evaluate the combination therapy in P-I/IIa study in patients with an advanced solid tumor, prior treated with anti-PD1 […]Read More

Celltrion to Initiate P-I trial for CT-P39 (biosimilar, omalizumab)

Shots: Celltrion plans for the onset of P-I trial for CT-P39 referencing Xolair, and further plans to enter P-III trial in H1’20 with its expected commercialization by 2020 The P-I trial will involve assessing of CT-P39,EU-licensed Xolair and US-licensed Xolair evaluating PK and safety in 171 patients in with its expected completion in Aug’20. In […]Read More