Month: <span>March 2018</span>

Mylan and Biocon’s Semglee Receives EU Approval for Patients with

Shots: The approval is based on CHMP (EMA) recommendation, reviewed by EU for diabetic patients In 2009, Mylan and Biocon globally collaborated to jointly develop multiple generic biologic compounds Semglee is a prefilled 100unit/ml 3ml disposable pen, approved in Australia by TGA and in EU including Norway, Iceland and Liechtenstein for patients with diabetes with […]Read More

Amgen and Allergan’s ABP 980 (biosimilar, Herceptin) Receives CHMP Recommendation

Shots: The CHMP recommendation is based on P-III study results assessing ABP 980 in adult female patients with HER2-positive early breast cancer The P-III study resulted in analytical, PK, pharmacology, toxicology data with efficacy, safety and immunogenicity in patients ABP 980 (trastuzumab) is a recombinant DNA-derived mIgG1 kappa Ab indicated for HER2-overexpressing early BC, adjuvant […]Read More

Rigel Pharmaceuticals’ Tavalisse (fostamatinib disodium hexahydrate) Receives FDA Approval for

Shots: The approval is based on three FIT studies results assessing Tavalisse (100/150mg, bid) vs Placebo in 150 patients with chronic ITP in ratio 2:1 The FIT studies result: FIT-1 (NCT02076399) stable platelets response (SPR) (18% vs 0%); FIT-2 (NCT02076412) SPR (16% vs 4%); FIT-3 (23%) Tavalisse (fostamatinib disodium hexahydrate, PO) is a spleen tyrosine […]Read More