Bio Pharma Dive
DECEMBER 5, 2020
Results from 10 patients with beta thalassemia or sickle cell disease show CRISPR Therapeutics and Vertex's pioneering treatment to be effective, building on earlier study data.
Scienmag
DECEMBER 5, 2020
Credit: Dana-Farber Cancer Institute Clonal hematopoiesis (CH) is a recently identified condition in which mutations associated with blood cancers are detected in the blood of some healthy, usually older, individuals who don’t have cancer. People with CH, while asymptomatic, have an elevated risk of developing blood cancers and other negative health outcomes, including heart attacks […].
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Bio Pharma Dive
DECEMBER 5, 2020
The company plans to submit an approval application to the FDA in the next few weeks, chasing a rival Bristol Myers therapy that's now under review.
Scienmag
DECEMBER 5, 2020
Credit: Photo credit: The CityCollege of New York First came their pioneering research a few years ago linking burnout and depression. Now City College of New York psychologist Irvin Sam Schonfeld and his University of Neuchâtel collaborator Renzo Bianchi present the Occupational Depression Inventory [ODI], a measure designed to quantify the severity of work-attributed depressive […].
The Pharma Data
DECEMBER 5, 2020
SATURDAY, Dec. 5, 2020 — A pair of new gene therapies promise a potentially lasting cure for sickle cell disease by subtly altering the genetic information in patients’ bone marrow cells, researchers report. Both therapies work by switching on a gene that promotes production of fetal hemoglobin, said Dr. Lewis Hsu, chief medical officer of the Sickle Cell Disease Association of America.
Scienmag
DECEMBER 5, 2020
Credit: Dana-Farber Cancer Institute A CAR T-cell therapy known as axicabtagene ciloleucel (axi-cel) drove cancer cells to undetectable levels in nearly 80% of patients with advanced non-Hodgkin lymphoma (NHL) in a phase 2 clinical trial, Dana-Farber Cancer Institute investigators report at the virtual 62nd American Society of Hematology (ASH) Annual Meeting.
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Scienmag
DECEMBER 5, 2020
Gazelle from Hemex Health combines trusted diagnostic technologies with software upgrades to address a growing list of diseases Researchers from Case Western Reserve University presented research today in which Hemex Health’s Gazelle platform diagnostic technology successfully tested 46 patients with 100% sensitivity and over 92.3% specificity for anemia and with 100% accuracy for hemoglobin variants. […].
The Pharma Data
DECEMBER 5, 2020
TARRYTOWN, N.Y. , Dec. 5, 2020 /PRNewswire/ — 63% response rate in patients treated with the highest reported dose. Among all patients responding to treatment, 95% experienced a very good partial response or better; among responding patients with ?6 months of follow-up, 83% have ongoing responses for up to 13 months at the time of analysis. Potentially registrational Phase 2 portion of the trial has been initiated and is enrolling patients.
Scienmag
DECEMBER 5, 2020
Teclistamab injection found to be safe and elicit responses in 74% of patients with relapsed/refractory multiple myeloma PHILADELPHIA– A subcutaneous injection of the immune-boosting drug teclistamab was found to be safe and elicit responses in a majority of patients with relapsed or refractory multiple myeloma, according to findings from a multi-institutional phase I study being […].
BioTech 365
DECEMBER 5, 2020
Updated Results from the Phase 1 Study of the BCMAxCD3 Bispecific Teclistamab Show Preliminary Efficacy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma Updated Results from the Phase 1 Study of the BCMAxCD3 Bispecific Teclistamab Show Preliminary Efficacy … Continue reading →
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Drug Discovery Today
DECEMBER 5, 2020
OVO Biomanufacturing, a spin-out from the University of Warwick and Coventry University, is developing digital solutions to improve the efficiency of viral vaccine and gene therapy manufacture. OVO’s technology allows manufacturers of both established and novel viral vaccines and gene therapies to maximise the production of the target virus used to produce each therapy.
BioTech 365
DECEMBER 5, 2020
GlycoMimetics’ Uproleselan in Combination With Venetoclax/HMA Shown to Break Chemoresistance, Reduce Tumor Burden and Increase Survival in AML Model GlycoMimetics’ Uproleselan in Combination With Venetoclax/HMA Shown to Break Chemoresistance, Reduce Tumor Burden and Increase Survival in AML Model GlycoMimetics exploring … Continue reading →
Drug Patent Watch
DECEMBER 5, 2020
This chart shows the pharmaceutical companies with the most cream dosed drugs. For a different perspective, see the most popular dosage types. The companies with the most cream dosed drugs…. The post Which pharmaceutical companies have the most cream dosed drugs? appeared first on DrugPatentWatch - Make Better Decisions.
BioTech 365
DECEMBER 5, 2020
Yescarta® Is First CAR T-cell Therapy to Demonstrate High Response Rates and Durable Clinical Benefit in a Pivotal Indolent Non-Hodgkin Lymphoma Study Yescarta® Is First CAR T-cell Therapy to Demonstrate High Response Rates and Durable Clinical Benefit in a Pivotal … Continue reading →
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Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud
The Pharma Data
DECEMBER 5, 2020
CAMBRIDGE, Mass.–(BUSINESS WIRE) December 5, 2020 — Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, today announced new clinical data from its Phase 2 trial evaluating SY-1425, its first-in-class selective retinoic acid receptor alpha (RAR?) agonist, in combination with azacitidine in two acute myeloid leukemia (AML) patient populations.
BioTech 365
DECEMBER 5, 2020
Bristol Myers Squibb and bluebird bio Present Data Highlighting Anti-BCMA CAR T Cell Therapy, Ide-cel, in Relapsed and Refractory Multiple Myeloma at ASH 2020 Bristol Myers Squibb and bluebird bio Present Data Highlighting Anti-BCMA CAR T Cell Therapy, Ide-cel, in … Continue reading →
BioTech 365
DECEMBER 5, 2020
Syros Presents New Data From Phase 2 Clinical Trial of SY-1425 and Announces Plans to Initiate Registration-Enabling Trial in MDS and Randomized Phase 2 Trial in AML Syros Presents New Data From Phase 2 Clinical Trial of SY-1425 and Announces … Continue reading →
BioTech 365
DECEMBER 5, 2020
Syros Acquires Clinical-Stage Drug Candidate for Acute Promyelocytic Leukemia, Expanding Its Pipeline of Targeted Therapies for Hematologic Malignancies Syros Acquires Clinical-Stage Drug Candidate for Acute Promyelocytic Leukemia, Expanding Its Pipeline of Targeted Therapies for Hematologic Malignancies Oral Arsenic Trioxide has … Continue reading →
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This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.
BioTech 365
DECEMBER 5, 2020
Genentech Announces New Data Reinforcing the Long-Term Benefit of Venclexta-Based Combination for People With Relapsed or Refractory Chronic Lymphocytic Leukemia Genentech Announces New Data Reinforcing the Long-Term Benefit of Venclexta-Based Combination for People With Relapsed or Refractory Chronic Lymphocytic Leukemia … Continue reading →
BioTech 365
DECEMBER 5, 2020
Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment for Patients with Chronic Lymphocytic Leukaemia Disease-Free Survival Data from CAPTIVATE Study Demonstrate Benefit of IMBRUVICA® (ibrutinib)-Based Regimen as Fixed Duration, First-Line Treatment … Continue reading →
BioTech 365
DECEMBER 5, 2020
Legend Biotech Announces Phase 1b/2 Study Data of Cilta-cel, an Investigational BCMA CAR-T, Showing Early, Deep, and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma Legend Biotech Announces Phase 1b/2 Study Data of Cilta-cel, an Investigational BCMA CAR-T, Showing … Continue reading →
BioTech 365
DECEMBER 5, 2020
ImmunoGen Presents Updated Findings from Phase 1/2 Study of IMGN632 in Blastic Plasmacytoid Dendritic Cell Neoplasm at ASH Annual Meeting ImmunoGen Presents Updated Findings from Phase 1/2 Study of IMGN632 in Blastic Plasmacytoid Dendritic Cell Neoplasm at ASH Annual Meeting … Continue reading →
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When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.
BioTech 365
DECEMBER 5, 2020
Early, Deep, Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) Observed in Phase 1b/2 CARTITUDE-1 Study Show Potential of BCMA CAR-T in Treatment of Heavily Pretreated Patients with Multiple Myeloma Early, Deep, Durable Responses of Ciltacabtagene Autoleucel (cilta-cel) Observed in Phase 1b/2 … Continue reading →
BioTech 365
DECEMBER 5, 2020
Allogene Therapeutics Reports Positive Initial Results from Phase 1 UNIVERSAL Study of ALLO-715 AlloCAR T™ Cell Therapy in Relapsed/Refractory Multiple Myeloma at the 62nd American Society of Hematology Annual Meeting Allogene Therapeutics Reports Positive Initial Results from Phase 1 UNIVERSAL … Continue reading →
BioTech 365
DECEMBER 5, 2020
Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia Roche announces new data reinforcing the long-term benefit of Venclexta/Venclyxto-based combination for people with relapsed or refractory chronic lymphocytic leukaemia … Continue reading →
BioTech 365
DECEMBER 5, 2020
GeneTx and Ultragenyx Announce Presentation of Phase 1/2 Data on Investigational GTX-102 in Patients with Angelman Syndrome GeneTx and Ultragenyx Announce Presentation of Phase 1/2 Data on Investigational GTX-102 in Patients with Angelman Syndrome Results presented at Foundation for Angelman … Continue reading →
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
BioTech 365
DECEMBER 5, 2020
IGM Biosciences Presents First Clinical Data from IGM-2323 in Non-Hodgkin’s Lymphoma at 2020 ASH Annual Meeting IGM Biosciences Presents First Clinical Data from IGM-2323 in Non-Hodgkin’s Lymphoma at 2020 ASH Annual Meeting – 9 of 14 Patients Showed Reduction in … Continue reading →
BioTech 365
DECEMBER 5, 2020
Autolus Therapeutics presents compelling AUTO1 data from ALLCAR Phase 1 study in Adult Acute Lymphoblastic Leukemia (ALL) during the 62nd ASH Annual Meeting Autolus Therapeutics presents compelling AUTO1 data from ALLCAR Phase 1 study in Adult Acute Lymphoblastic Leukemia (ALL) … Continue reading →
BioTech 365
DECEMBER 5, 2020
New Data for TecartusTM Demonstrate Durable Responses at One Year Follow-Up in Relapsed or Refractory Mantle Cell Lymphoma New Data for TecartusTM Demonstrate Durable Responses at One Year Follow-Up in Relapsed or Refractory Mantle Cell Lymphoma — Median Overall Survival … Continue reading →
BioTech 365
DECEMBER 5, 2020
New Four-Year Data Show Long-Term Survival in Patients With Large B-Cell Lymphoma Treated With Yescarta® in ZUMA-1 Trial New Four-Year Data Show Long-Term Survival in Patients With Large B-Cell Lymphoma Treated With Yescarta® in ZUMA-1 Trial — Unparalleled 44 Percent … Continue reading →
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As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.
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