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Janssen Reports New Data for BCMA CAR-T, Cilta-Cel, Showing Deep and Durable Responses in Patients with Relapsed or Refractory Multiple Myeloma

Eighteen-month follow-up data from pivotal CARTITUDE-1 study, including progression-free-survival data, to be presented at ASCO and EHA Annual Meetings Findings from the Phase 2 CARTITUDE-2 study

United statesCiltacabtagene autoleucelNoah reymondJennifer mcintyreSaadz usmaniChristopher deloreficeSen zhuangEdmond chanHematology am soc hematol educ programNational cancer instituteJanssen biotech incAmerican society of clinical oncologyAmerican society of hematology annual meetingEuropean hematology associationJanssen research developmentCongress abstract

Halozyme Announces Janssen Receives Two Positive CHMP Opinions for DARZALEX® (daratumumab) Subcutaneous Formulation Utilizing ENHANZE®

Halozyme Announces Janssen Receives Two Positive CHMP Opinions for DARZALEX® (daratumumab) Subcutaneous Formulation Utilizing ENHANZE® - For Use of Subcutaneous Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (D-VCd) in Newly Diagnosed Adult Patients with Systemic Light Chain (AL) Amyloidosis - - For Use of Subcutaneous Daratumumab in Combination with Pomalidomide and Dexamethasone (D-Pd) in Adult Patients with Relapsed or Refractory Multiple Myeloma - News provided by Share this article Share this article SAN DIEGO, May 21, 2021 /PRNewswire/ Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Pharmaceutica N.V. (Janssen) received two positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending to broaden the existing marketing authorization for the DARZALEX

San diegoUnited statesAl kildaniHelen torleyBristol myers squibbJanssen pharmaceuticaAmerican society of hematology annual meetingEuropean commissionHalozyme therapeutics incExchange commissionCorporate communicationsEuropean medicines agencyCommittee for medicinal products human useEuropean myeloma networkHalozyme therapeuticsMedicinal products

Halozyme Announces Janssen Receives Two Positive CHMP Opinions for DARZALEX® (daratumumab) Subcutaneous Formulation Utilizing ENHANZE®

Halozyme Announces Janssen Receives Two Positive CHMP Opinions for DARZALEX® (daratumumab) Subcutaneous Formulation Utilizing ENHANZE®
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San diegoUnited statesAl kildaniHelen torleyBristol myers squibbJanssen pharmaceuticaAmerican society of hematology annual meetingEuropean commissionHalozyme therapeutics incExchange commissionCorporate communicationsEuropean medicines agencyCommittee for medicinal products human useEuropean myeloma networkHalozyme therapeuticsMedicinal products

Janssen Receives Two Positive CHMP Opinions Recommending Expanded Use of DARZALEX? (daratumumab) Subcutaneous (SC) Formulation for New Indications in Europe

Janssen Receives Two Positive CHMP Opinions Recommending Expanded Use of DARZALEX? (daratumumab) Subcutaneous (SC) Formulation for New Indications in Europe
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United statesUnited kingdomCraig tendlerDaratumumab pomalidomideChristopher deloreficeVelcade melphalanBortezomib melphalanJennifer mcintyreNoah reymondVelcade bortezomib melphalanGlobal medical affairsJanssen biotech incAmerican society of hematology annual meetingAmerican society of clinical oncologyJanssen research developmentJanssen pharmaceutical companies

Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of BCMA CAR-T Therapy Ciltacabtagene Autoleucel (cilta-cel) for the Treatment of Relapsed and/or Refractory Multiple Myeloma

(1) Application based on positive Phase 1b/2 data from the CARTITUDE-1 study and follows confirmation of accelerated assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency The Janssen Pharmaceutical Companies of Johnson Johnson announced today that they have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel, an investigational B cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy, for the treatment of patients with relapsed and/or refractory multiple myeloma. The application is supported by positive results from the ongoing Phase 1b/2 CARTITUDE-1 study, investigating the safety and efficacy of cilta-cel.

United statesUnited kingdomCiltacabtagene autoleucelNoah reymondJennifer mcintyreCiltacabtagene autoleucel cilta celChristopher deloreficePeter lebowitzMathai mammenHematology am soc hematol educ programAmerican society of clinical oncologyNational cancer instituteInternational myeloma working groupJanssen biotech incAmerican society of hematology annual meetingJanssen pharmaceutical companies