Dacarbazine

Junshi Biosciences Announces 2023 Full Year Financial Results and Provides Corporate Updates

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金曜日, 3月 29, 2024
CPS, Patient, Lung cancer, IND, Infection, Cancer, Investment, Cisplatin, Paclitaxel, Melanoma, Marketing, RNA, New chemical entity, Gentlemen's agreement, NRDL, Food, Therapeutic Goods Administration, Biologics license application, Insurance, Research, Junshi, National Medical Products Administration, TGA, FDA, NMPA, Tablet, COVID-19, NPC, Spacecraft, DSM-IV codes, Dacarbazine, Axitinib, Total, Pharmaceutical industry

SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.

Key Points: 
  • SHANGHAI, China, March 29, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (“Junshi Biosciences,” HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced its financial results for the full year of 2023 and provided corporate updates.
  • Total research and development (“R&D”) expenses were approximately RMB1,937 million in 2023, representing a decrease of approximately 19% compared to 2022.
  • Loss attributable to owners was RMB2,282 million in 2023, representing a decrease of RMB104 million compared to the previous year.
  • This application was later approved for marketing in December 2023, marking the first and only approved perioperative therapy for lung cancer domestically.

Withdrawn application: Adcetris, 23/02/2024

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水曜日, 4月 3, 2024
PTCL-NOS, Lymphoma, B-cell lymphoma, CHOP, Patient, PTCL, Doxorubicin, Vincristine, CHP, Cancer, Vinblastine, European Medicines Agency, CTCL, Prednisone, Lymphocyte, Agency, Clinical trial, Skin, Dacarbazine, CD30, Cyclophosphamide, Medicine

Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.

Key Points: 
  • Adcetris was designated an ‘orphan medicine’ (a medicine used in rare diseases) for peripheral T cell lymphoma 21 August 2019.
  • The cytotoxic molecule then enters the cancer cells and prevents them from dividing, causing the cancer cells to die.
  • The application was withdrawn after the European Medicines Agency had evaluated the initial information from the company and had prepared questions for the company.
  • If you are in a clinical trial and need more information about your treatment, speak with your clinical trial doctor.

ADCETRIS® (brentuximab vedotin) Plus Novel Immunotherapy Combination Delivers 100% Progression Free Survival at 12 months in Phase 2 Trial of Patients with Early Stage Classical Hodgkin Lymphoma

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月曜日, 12月 11, 2023
Research, Genetics, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Science, Oncology, Doxorubicin, Safety, Toxicity, Rollcage Stage II, AVD, Progression-free survival, Progressive multifocal leukoencephalopathy, ADC, Febrile neutropenia, Brentuximab vedotin, Patient, Research and development, PFS, Bleomycin, DOR, PML, Hodgkin lymphoma, PD-1, CHL, Lymphoma, Vinblastine, Dacarbazine, Development, Nivolumab, Survival, Massachusetts General Hospital, ADCETRIS, Immunotherapy, Society, Inc., Hospital, Ima Hogg, Pharmaceutical industry, Vaccine, Medical device, Birth control, Seagen

This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL.

Key Points: 
  • This is the first time 12-month PFS results were presented for the treatment combination, which avoids use of vinblastine and bleomycin in patients with early stage cHL.
  • The PFS rate was 100% (95% CI: 100, 100) at 12 months and 97% (95% CI: 90.3, 99.1) at 18 months.
  • Among 56 efficacy-evaluable patients, 95% had an OR (95% CI: 85.1, 98.9) and 89% had a CR (95% CI: 78.1, 96.0).
  • The estimated PFS rate at 24 months was 88% (95% CI: 75.7, 94.6), with a median follow-up of 24.2 months (95% CI: 23.4, 26.9).

Sarah Cannon Research Institute to Present Latest Research Insights at the 2023 ASH Annual Meeting & Exposition

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木曜日, 12月 7, 2023
Health, Science, Research, Clinical Trials, Oncology, HCA Healthcare, Methodist Hospital, Annual general meeting, PST, St. Elizabeth Healthcare (Kentucky), Sickle cell disease, Bone marrow, ASH, BMT, BSN, Malignancy, Exposition, Sarah Cannon Research Institute, SCRI, Abstract, Nursing care plan, Nivolumab, Society, Physician, Monomethyl auristatin E, Safety, McKesson Corporation, Pharmaceutical industry, Nursing, Vaccine, Dacarbazine, MD, Doxorubicin, Texas Oncology, Patient

Sarah Cannon Research Institute ( SCRI ) announced today that more than 80 abstracts and presentations have been selected for inclusion at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition .

Key Points: 
  • Sarah Cannon Research Institute ( SCRI ) announced today that more than 80 abstracts and presentations have been selected for inclusion at the 65th American Society of Hematology (ASH) Annual Meeting & Exposition .
  • Hosted in San Diego and online from Dec. 9-12, the meeting is the year’s most comprehensive global hematology event.
  • At this year’s ASH Annual Meeting & Exposition, SCRI investigators, including physicians from The US Oncology Network , will discuss groundbreaking research in malignant and non-malignant blood cancer, CAR T-Cell therapy, real-world outcomes, and targeted immunotherapies.
  • Investigators highlighting research at this year’s ASH Annual Meeting & Exposition represent studies being conducted across SCRI, Sarah Cannon Transplant & Cellular Therapy Network, and partners from The US Oncology Network and Ontada.

Takeda to Present Data at 65th American Society of Hematology (ASH) Annual Meeting, Demonstrating Continued Commitment to Patients with Hematologic Diseases

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月曜日, 11月 27, 2023
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Dexamethasone, Doxorubicin, Multiple myeloma, Food and Drug Administration, Genetics, Safety, Toll, Food, Haemophilia, Sickle cell disease, ASH, Bone marrow, ADAMTS13, Prednisone, Meta-analysis, Leukemia, Patient, Brentuximab vedotin, Bleomycin, FDA, Etoposide, Pharmacokinetics, Vincristine, Dacarbazine, 65th Infantry Regiment, Cyclophosphamide, Society, Procarbazine, Environment, Lymphoma, Pharmaceutical industry, Medical imaging, Takeda, Hematology

Takeda (TSE:4502/NYSE:TAK) today announced that it will present 17 company-sponsored abstracts at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego.

Key Points: 
  • Takeda (TSE:4502/NYSE:TAK) today announced that it will present 17 company-sponsored abstracts at the 65th American Society of Hematology (ASH) Annual Meeting being held December 9-12, 2023 in San Diego.
  • Takeda’s latest research focuses on improving treatment options for those living with hematologic diseases.
  • “Our aspiration is to deliver life-transforming medicines for difficult-to-diagnose, rare hematologic diseases with high unmet patient need,” said Björn Mellgård, M.D., Ph.D., vice president and global program lead of Rare Genetics and Hematology at Takeda.
  • “Our continued research aims to improve long-term outcomes for patients suffering from these conditions.

Florida Cancer Specialists & Research Institute Contributing to Cutting-Edge Advancements in Hematology Science

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水曜日, 12月 13, 2023
Annual Reviews (publisher), ASH, BTK, Research, Bortezomib, Omicron, Conference, Bangladesh Technical Education Board, Poster, Mantle cell lymphoma, SLL, Risk, Science, Abstract, Drug development, Tyrosine kinase, Society, B-cell lymphoma, FACP, Rituximab, Reversibility, Delta, Phase, Nivolumab, Hospital, Safety, DRD, MCL, FCS, FDA, Lymphocytosis, Pivotal trial, Chronic lymphocytic leukemia, Meta-analysis, Artery, Bias, Coronary thrombosis, NHL, CLL, Pharmaceutical industry, Dietary supplement, Vaccine, Birth control, Incidence, Patient, Dexamethasone, Lenalidomide, Hematology, Relapse, Dacarbazine, MD, Doxorubicin

FORT MYERS, Fla., Dec. 13, 2023 /PRNewswire/ -- Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) was presented in the cutting-edge advancements being shared at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition in San Diego on Dec. 9 - 12, 2023. Scientific abstracts submitted by FCS hematologists and medical oncologists were among the 7,000 accepted submissions selected through an extensive peer review process.

Key Points: 
  • FORT MYERS, Fla., Dec. 13, 2023 /PRNewswire/ -- Research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) was presented in the cutting-edge advancements being shared at the American Society of Hematology (ASH) 65th Annual Meeting and Exposition in San Diego on Dec. 9 - 12, 2023.
  • Scientific abstracts submitted by FCS hematologists and medical oncologists were among the 7,000 accepted submissions selected through an extensive peer review process.
  • Pirtobrutinib has also been approved for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
  • Once again, FCS is proud to have a strong presence, sharing the latest and most promising research and science that is moving the field forward."

European Commission Approves ADCETRIS® (brentuximab vedotin) for the Treatment of Adult Patients with Previously Untreated CD30+ Stage III Hodgkin Lymphoma in Combination with AVD

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水曜日, 10月 18, 2023
Oncology, Health, Research, Pharmaceutical, Science, Biotechnology, Survival, Brentuximab vedotin, Christie, TAK, Progression-free survival, CHMP, European Commission, IRF, Committee, Bleomycin, Vinblastine, European Directive on Traditional Herbal Medicinal Products, AVD, Doxorubicin, PFS, EC, University of Manchester, Civil service commission, Hodgkin lymphoma, ADC, CD30, ABVD, Risk, Dacarbazine, University, The Christie NHS Foundation Trust, Committee for Medicinal Products for Human Use, Hatim al-Awni, Overalls, Safety, ADCETRIS, Patient, OS, Lymphoma, Medical device, Medical imaging, Pharmaceutical industry, Takeda, Fellow of the Academy of Medical Sciences

Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) approved ADCETRIS® (brentuximab vedotin) in combination with doxorubicin, vinblastine and dacarbazine (AVD) to treat adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma.
  • ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma, and has been previously approved as a therapy for adult patients in Europe in six distinct indications, including those with previously untreated CD30+ Stage IV Hodgkin lymphoma.
  • The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on September 14, 2023.
  • “We are thrilled with the decision of the European Commission to approve ADCETRIS in combination with chemotherapy as a treatment for adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma, particularly as up to one third of patients with Stage III & IV disease are at risk of experiencing treatment failure with current regimens,” said Awny Farajallah, M.D., head of global medical affairs oncology, Takeda.

Phase 3 Trial of ADCETRIS® (brentuximab vedotin) with Modified Chemo Regimen Shows Non-Inferiority with Unprecedented 3-Year Progression Free Survival of 94.9% vs Less Tolerable International Standard of Care in Advanced Classical Hodgkin Lymphoma

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火曜日, 6月 20, 2023
Science, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Other Health, Hodgkin lymphoma, Doxorubicin, Inc., Vincristine, Brentuximab vedotin, Vinblastine, PML, Takeda, Progression-free survival, Hematology, ABVD, ICML, Procarbazine, Survival, Lymphoma, PET, Cyclophosphamide, Bleomycin, ADCETRIS, CHL, PFS, Teaching hospital, Dexamethasone, FSH, Research and development, Dacarbazine, Prednisone, Development, Etoposide, International Conference on Nuclear Disarmament, Oslo, 2008, Patient, Risk, Progressive multifocal leukoencephalopathy, Fertility, BEACOPP, Peripheral neuropathy, Death, Society, Conference, Pharmaceutical industry, Birth control, Seagen

The data results of the HD21 study were presented in a late-breaking session at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17.

Key Points: 
  • The data results of the HD21 study were presented in a late-breaking session at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on June 17.
  • 12-month post-treatment safety data were consistent with previously presented HD21 data results at the American Society of Hematology 2022 Annual Meeting.
  • Preservation of fertility potential was indicated by measurement of follicle-stimulating hormone (FSH) and was available for 597 patients.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Six-Year Overall Survival Results Added to U.S. Prescribing Information for ADCETRIS® (brentuximab vedotin) as First-Line Treatment for Advanced Hodgkin Lymphoma

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木曜日, 6月 15, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hodgkin lymphoma, Doxorubicin, Inc., Brentuximab vedotin, Vinblastine, European Hematology Association, Progression-free survival, ABVD, Survival, American Society of Clinical Oncology, Bleomycin, ADCETRIS, AVD, Patient, Peripheral neuropathy, Death, Society, Disease, Dacarbazine, Pharmaceutical industry

The statistically significant data were presented last year at the annual meetings of the American Society of Clinical Oncology and the European Hematology Association.

Key Points: 
  • The statistically significant data were presented last year at the annual meetings of the American Society of Clinical Oncology and the European Hematology Association.
  • ADCETRIS was approved for advanced Hodgkin lymphoma in 2018 based on an improvement in progression-free survival in combination with chemotherapy agents AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) in the ECHELON-1 trial.
  • Patients with advanced classical Hodgkin lymphoma are often young adults with their whole lives ahead of them,” said David Epstein, Chief Executive Officer, Seagen.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.

Seagen Announces ADCETRIS® (brentuximab vedotin) Plus Novel Immunotherapy Combination Delivers 98% Overall Response Rate and 93% Complete Response Rate in Patients with Early-Stage Classical Hodgkin Lymphoma (cHL)

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火曜日, 6月 13, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Hodgkin lymphoma, Doxorubicin, Inc., Febrile neutropenia, Brentuximab vedotin, Vinblastine, PML, Takeda, Progression-free survival, European Hematology Association, ICML, Lymphoma, Survival, Aes, Trae tha Truth, EOT, Bleomycin, Toxicity, ADCETRIS, CHL, PFS, Diabetic neuropathy, Research and development, Dacarbazine, Congress, Development, Hair, International Conference on Population and Development, MD, Patient, Risk, Progressive multifocal leukoencephalopathy, BEACOPP, CR, Nausea, Hospital, PD-1, Massachusetts General Hospital, Death, Conference, ORR, Safety, Fatigue, Nivolumab, Pharmaceutical industry, Vaccine, Birth control, Part, Seagen

Data results will be presented at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland June 13-17.

Key Points: 
  • Data results will be presented at the 17th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland June 13-17.
  • The study will be presented on June 17, 2023.
  • Immune-mediated AEs observed to date are consistent with the individual safety profile of nivolumab.
  • Please see Important Safety Information, including a BOXED WARNING for progressive multifocal leukoencephalopathy (PML), for ADCETRIS below.