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FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

FDA accepts Mundipharma EDO's Investigational New Drug Application for EDO-S101

Mundipharma EDO GmbH (Early Development in Oncology) is pleased to announce that the United States Food and Drug Administration has accepted the company's Investigational New Drug Application ("IND") for EDO-S101, a fusion molecule to treat relapsed/refractory haematologic malignancies and solid tumours. [More]
Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Amgen announces submission of supplemental New Drug Application to FDA for Kyprolis (carfilzomib)

Amgen today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Kyprolis (carfilzomib) for Injection to seek an expanded indication for the treatment of patients with a form of blood cancer, relapsed multiple myeloma, who have received at least one prior therapy. [More]
PharmaMar, TTY Biopharm sign agreement to market and distribute APLIDIN (plitidepsin) in Taiwan

PharmaMar, TTY Biopharm sign agreement to market and distribute APLIDIN (plitidepsin) in Taiwan

PharmaMar has entered into an exclusive license and commercialization agreement with the pharmaceutical company TTY Biopharm to market and distribute the drug candidate APLIDIN (plitidepsin) in Taiwan. Under the terms of the agreement, PharmaMar will receive an upfront payment, royalties and additional remunerations for regulatory milestones achieved by APLIDIN (plitidepsin). [More]
Genetic variation influences survival in patients with multiple myeloma

Genetic variation influences survival in patients with multiple myeloma

As part of a multi-institutional effort, researchers with Huntsman Cancer Institute at the University of Utah have found that multiple myeloma patients with a genetic variation in the gene FOPNL die on average 1-3 years sooner than patients without it. [More]
New TCR therapy demonstrates encouraging clinical responses in patients with multiple myeloma

New TCR therapy demonstrates encouraging clinical responses in patients with multiple myeloma

Results from a clinical trial investigating a new T cell receptor (TCR) therapy that uses a person's own immune system to recognize and destroy cancer cells demonstrated a clinical response in 80 percent of multiple myeloma patients with advanced disease after undergoing autologous stem cell transplants (ASCT). [More]
Adaptimmune’s NY-ESO-1 TCR-engineered T-cell therapy mediates sustained antitumor effects in multiple myeloma patients

Adaptimmune’s NY-ESO-1 TCR-engineered T-cell therapy mediates sustained antitumor effects in multiple myeloma patients

Adaptimmune Therapeutics plc, a clinical stage biopharmaceutical company focused on the use of T-cell therapy to treat cancer, today announced that data from its Phase I/II study of its affinity enhanced T-cell receptor therapeutic targeting the NY-ESO-1 cancer antigen in patients with multiple myeloma has been published in Nature Medicine. [More]
Patients' own genetically engineered immune cells show significant success against multiple myeloma

Patients' own genetically engineered immune cells show significant success against multiple myeloma

In recent years, immunotherapy has emerged as a promising treatment for certain cancers. Now this strategy, which uses patients' own immune cells, genetically engineered to target tumors, has shown significant success against multiple myeloma, a cancer of the plasma cells that is largely incurable. [More]
Abingdon Health seeks distributors for newly launched Seralite - FLC diagnostic device

Abingdon Health seeks distributors for newly launched Seralite - FLC diagnostic device

Following the commercial launch of Seralite - FLC Abingdon Health is looking to appoint distributors in order to enable as many people as possible affected by multiple myeloma (a cancer arising from plasma cells) to have access to, and benefit from its rapid diagnostic capabilities. [More]
New research identifies potential treatment for primary effusion lymphoma

New research identifies potential treatment for primary effusion lymphoma

New research from the University of Southern California Norris Comprehensive Cancer Center has identified a potential treatment for a rare but previously incurable form of lymphoma that is observed primarily in patients with HIV/AIDS infection. [More]
SkylineDx’s MMprofiler test helps predict prognosis of patients with multiple myeloma

SkylineDx’s MMprofiler test helps predict prognosis of patients with multiple myeloma

SkylineDx, an innovative biotechnology company specialising in the development and commercialization of genetic tests, is today launching its MMprofiler assay. This test enables clinicians to more accurately predict the prognosis of patients with multiple myeloma (bone marrow cancer) than traditional methods. [More]
BioLight receives CE Mark approval for CellDetect bladder cancer test

BioLight receives CE Mark approval for CellDetect bladder cancer test

BioLight Life Sciences Investments Ltd., a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, announced today that its CellDetect non-invasive test for detecting bladder cancer in urine has obtained CE Marking, enabling the product to be marketed and sold in Europe and other territories. [More]
Solstice CEO honored with LLS's John Engdahl Award

Solstice CEO honored with LLS's John Engdahl Award

Solstice's Chief Executive Officer Dr. Leonard Weiss has been honored by the Leukemia & Lymphoma Society with its John Engdahl Award. The award was established in recognition of John's dreams and his accomplishments of running and raising much needed funds for the Society. [More]
Current treatments for blood cancer priced too high to be considered cost-effective, new analysis finds

Current treatments for blood cancer priced too high to be considered cost-effective, new analysis finds

The costs associated with cancer drug prices have risen dramatically over the past 15 years, which is of concern to many top oncologists. In a new analysis, researchers at The University of Texas MD Anderson Cancer Center concluded the majority of existing treatments for hematologic, or blood, cancers are currently priced too high to be considered cost-effective in the United States. [More]
Vaxil's ImMucin receives FDA orphan drug designation for treatment of multiple myeloma

Vaxil's ImMucin receives FDA orphan drug designation for treatment of multiple myeloma

Vaxil Bio, a company specializing in the development of immunotherapy-based drugs, reports today that its lead product, ImMucin, has been granted an "orphan drug" designation by the US Food and Drug Administration, for the treatment of multiple myeloma (MM). [More]
Novartis presents positive Phase III results of Farydak therapy at EHA

Novartis presents positive Phase III results of Farydak therapy at EHA

Novartis today presented results from a pivotal Phase III clinical trial exploratory subgroup analysis showing a 7.8-month improvement in median progression-free survival when using Farydak in combination with bortezomib and dexamethasone in patients with relapsed or relapsed and refractory multiple myeloma who had received two or more prior regimens, including bortezomib and an immunomodulatory agent. [More]
BioLight expands relationship with Ora to develop TeaRx multi-parameter diagnostic test for DES

BioLight expands relationship with Ora to develop TeaRx multi-parameter diagnostic test for DES

BioLight Life Sciences Investments, a firm that invests in, manages and commercializes biomedical innovations in ophthalmology and cancer diagnostics, today announced that it has expanded its relationship with Ora, Inc., a world-leading independent, full-service ophthalmic contract research organization and product development firm, via the signing of a Collaboration Agreement (the "Agreement") pursuant to which the companies will work together to advance the clinical, regulatory and commercial development of BioLight's TeaRx multi-parameter diagnostic test for dry eye syndrome ("DES"). [More]
US cancer physicians explore new approach to help older patients undergoing hematopoietic stem cell transplant

US cancer physicians explore new approach to help older patients undergoing hematopoietic stem cell transplant

When stem cell transplant first became part of standard treatment for certain cancers and blood diseases twenty years ago, individuals older than 60 were rarely considered for the procedure. [More]
Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

Janssen Research & Development, LLC has initiated the rolling submission of its Biologic License Application (BLA) for daratumumab to the U.S. Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and an IMiD. [More]
Elotuzumab boosts response in relapsed, refractory multiple myeloma

Elotuzumab boosts response in relapsed, refractory multiple myeloma

Addition of the immunostimulatory antibody elotuzumab to the combination of lenalidomide and dexamethasone improves progression-free survival and the overall response rate in patients with relapsed or refractory multiple myeloma, research suggests. [More]
CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

CASI files application with CFDA to conduct ENMD-2076 Phase 2 trial in fibrolamellar carcinoma patients

CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a commercial focus on China, announced today that it has filed an application with China's Food and Drug Administration to conduct a Phase 2 clinical trial in fibrolamellar carcinoma (FLC) patients in China for its proprietary drug candidate, ENMD-2076. [More]
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