MorphoSys AG: MorphoSys to Present Data on Tafasitamab (Monjuvi) at the 2021 ASCO Annual Meeting
PLANEGG/MUNICH, GERMANY / ACCESSWIRE / May 19, 2021 / MorphoSys AG (FSE:MOR)(NASDAQ:MOR) today announced that new data from the tafasitamab (Monjuvi
(R)) development program will be presented at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting from June 4-8, 2021.
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, which was approved as Monjuvi
(R) (tafasitamab-cxix) in July 2020 by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be
Incyte and MorphoSys Announce First Patient Dosed in Phase 3 frontMIND Study Evaluating Tafasitamab Combination as a First-Line Treatment for Diffuse Large B-Cell Lymphoma
finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.
MorphoSys AG: MorphoSys and Incyte Announce First Patient Dosed in Phase 3 frontMIND Study Evaluating Tafasitamab Combination as a First-line Treatment for Diffuse Large B-Cell Lymphoma
The
frontMIND (NCT04824092) trial is a randomized, double-blind, placebo-controlled, global Phase 3 clinical study in previously untreated high-intermediate and high-risk DLBCL patients that is conducted in partnership with the German Lymphoma Association (GLA), the Italian Lymphoma study group and the US Oncology Network.
The study aims to enroll approximately 880 DLBCL patients to receive either tafasitamab plus lenalidomide in addition to rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) or R-CHOP alone. The primary endpoint is investigator-assessed progression-free survival, according to Lugano 2014 criteria, and key secondary endpoints include event-free survival by investigator, overall survival, metabolic complete response rate by a Blinded Independent Review Com
MorphoSys AG Reports First Quarter 2021 Results
Tremfya royalties of € 11.6 million
Reaffirming group revenue guidance of € 150 to € 200 million
Conference call and webcast (in English) tomorrow, May 6, 2021 at 2:00pm CEST
(1:00pm BST/8:00am EDT)
PLANEGG/MUNICH, GERMANY / ACCESSWIRE / May 5, 2021 / MorphoSys AG (FSE:MOR; NASDAQ:MOR) reports financial results for the first quarter of 2021. For 2021, our focus is on three key areas: executing on the Monjuvi launch; rapidly advancing the tafasitamab backbone strategy through additional clinical studies; and expanding our pipeline, said Jean-Paul Kress, M.D., Chief Executive Officer of MorphoSys. While we experienced headwinds from the pandemic in the first quarter, we are cautiously optimistic that the COVID-19 impact in the U.S. will start to diminish in the second half of 2021. We are confident in the potential of Monjuvi given its broad second-line label and overall profile in the r/r DLBCL setting. We are also making
Hikma announces US FDA approval of KLOXXADOTM (naloxone hydrochloride) nasal spray 8mg
Important new option for reversing opioid overdoses
News provided by
Share this article
Share this article
LONDON, April 30, 2021 /PRNewswire/ Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the approval of KLOXXADO
TM (naloxone hydrochloride) nasal spray 8mg, by the US Food and Drug Administration (FDA) for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.
KLOXXADO
TM contains twice as much naloxone per spray as Narcan
® Nasal Spray 4mg in a ready-to-use nasal spray to reverse the effects of opioid overdose, providing an important new treatment option in addressing the opioid epidemic.
vimarsana © 2020. All Rights Reserved.