Month: <span>December 2019</span>

MorphoSys Reports Submission of Tafasitamab’s BLA to the US FDA

Shots: The BLA submission is based on L-MIND P-II trial data results assessing Tafasitamab + lenalidomide in patients with r/r DLBCL and retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received Tafasitamab + lenalidomide vs lenalidomide monothx Re-MIND has met its 1EPs and has shown improved ORR of the […]Read More

Clover Reports First Patient Dosing in P-III Trial with SCB-808

Shots: The P-III study involves assessing of SCB-808 (SC) vs Enbrel (SC) in patients with ankylosing spondylitis (radiographic axial spondyloarthritis) to evaluate its safety, efficacy and PK The company utilizes its Trimer-Tag technology platform to develop novel therapies targeting trimerization-dependent pathways and is also leveraging its cGMP biomanufacturing capabilities to develop biosimilars SCB-808 is mAb […]Read More

GenScript Signs an Agreement with Selecxine to Develop Therapies for

Shots: GenScript will be responsible for all pre-clinical pharmacy research and IND filling in Selecxine’s project which is based on cytokine-antibody complexes The company provided development solutions in different hosts tailored to customers and provided the preparation and purification solutions for the final complex,; further the project will test and enhance the process development capability […]Read More

Acceleron Signs a License Agreement with Fulcrum for the Identification

Shots: Fulcrum to receive $10M upfront, reimbursement for R&D costs, research, development and commercial milestone of up to $295M for first product commercialized and additional payments $143.5M for all subsequent products commercialized plus royalties on sales of product Acceleron to get rights to access Fulcrum’s product engine and target identification platform for identifying small molecule […]Read More

Eli Lilly Opens its P-III LIBRETTO-531 Clinical Trial for LOXO-292

Shots: The second P-III LIBRETTO-531 involves assessing of selpercatinib vs physician’s choice of cabozantinib or vandetanib in 400 patients in ratio (2:1) with advanced or metastatic RET-mutant MTC who have received no prior systemic therapy for metastatic disease The study will have efficacy endpoints as progression-free survival (PFS), treatment failure-free survival (TFFS), overall survival (OS), […]Read More

AstraZeneca and Merck & Co’s Lynparza Receive the US FDA’s

Shots: The approval follows the US FDA Oncologic drugs Advisory Committee (ODAC) on 17 Dec based on P-III POLO trial, which involves assessing of Lynparza tablets (300 mg bid) as maintenance monothx vs. PBO in 154 patients in ratio (3:2) with gBRCAm metastatic pancreatic cancer whose disease had not progressed on at least 16 weeks […]Read More

Zai Lab’s Zejula (niraparib) Receives NMPA’s Approval as Maintenance Therapy

Shots: Zejula (niraparib) is an oral once-daily poly (ADP-ribose) polymerase (PARP) inhibitor used as a maintenance therapy for adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy The NMPA approval of Zejula is novel product approved in Mainland China, has shown 73% […]Read More

Clover Reports Dosing of SCB-808 (biosimilar, etanercept) in P-III Trial

Shots: The P-III study involves assessing of SCB-808 vs Enbrel in patients with AS (axSpA) via SC administration SCB-808 is being developed in the prefilled syringe formulation which is ready for injection and can be self-administered by the patients, thus overwhelming the current Enbrel biosimilar which are available in lyophilized powder formulation in China Clover […]Read More