BioSpace News Archive

Drug Development

Nordic Nanovector: Single Administration Betalutin® is Effective and Well-tolerated in R/R iNHL Patients: 6 Month Follow-up Data Presented at ASH

Overall response rate (ORR) of 61% and complete response (CR) rate of 28% in 74 patients with indolent non-Hodgkin’s lymphoma (iNHL)

December 2, 2018
·
8 min read
Drug Development

Celgene Corporation Announces Initial Phase 1/2 Liso-cel Data in Patients with Relapsed/Refractory CLL, Including Those with High-Risk Disease, Previously Treated with Ibrutinib, at ASH 2018

Eighty one percent overall response rate and 43% complete response rate observed in heavily pre-treated patients

December 2, 2018
·
4 min read
Drug Development

Harpoon Therapeutics Presents Preclinical Data Supporting Development of HPN217, a New BCMA-Targeting TriTAC, at the 2018 American Society of Hematology (ASH) Annual Meeting

Harpoon’s Third Product Candidate is Slated for Clinical Development in 2019

December 2, 2018
·
3 min read
Drug Development

Blueprint Medicines Announces Updated Results from Ongoing EXPLORER Clinical Trial of Avapritinib Demonstrating Broad Clinical Activity and Significant Symptom Reductions in Patients with Systemic Mastocytosis

83% overall response rate, with evidence of deepening of response over time

December 2, 2018
·
15 min read
Drug Development

NewLink Genetics Presents Encouraging Updated Phase 1 Data with Indoximod Plus Chemotherapy in Frontline AML in an Oral Session at 2018 ASH Annual Meeting

Updated Phase 1 data for indoximod plus standard-of-care chemotherapy in newly diagnosed AML show post-induction minimal residual disease (MRD) negativity rate of 86% and post-consolidation MRD negativity of 100%

December 2, 2018
·
6 min read
Drug Development

Celgene Corporation and Acceleron Pharma Announce Results of the Phase 3 MEDALIST Trial Evaluating Luspatercept in Patients with Myelodysplastic Syndromes at the ASH 2018 Plenary Session

Pivotal phase 3 data demonstrated treatment with investigational luspatercept resulted in statistically significant increased red blood cell transfusion independence compared to placebo

December 2, 2018
·
9 min read
Drug Development

bluebird bio and Celgene Corporation Present Initial Data from Ongoing Phase 1 Clinical Study of Next-Generation Anti-BCMA CAR T Cell Therapy bb21217 in Patients with Relapsed/Refractory Multiple Myeloma at ASH Annual Meeting

bb21217 early safety profile consistent with CAR T platform therapies

December 2, 2018
·
10 min read
Drug Development

Magenta Therapeutics Presents New Data from Phase 2 Study of MGTA-456 Cell Therapy in Patients with Inherited Metabolic Disorders

All five patients with inherited metabolic disorders (IMDs) treated with MGTA-456 in ongoing Phase 2 study met the primary endpoint of successful engraftment

December 2, 2018
·
9 min read
Policy

European Medicines Agency Accepts Extension Marketing Authorisation Application for Review of Celltrion’s Remsima SC, the Subcutaneous Version of Remsima®

European Medicines Agency started to officially review ‘Remsima SC’; expecting European approval in the second half of next year

December 2, 2018
·
2 min read