Daratumumab

Genmab Announces Financial Results for the First Quarter of 2024

Retrieved on: 
Giovedì, Maggio 2, 2024
USD, FDA, Pfizer, EDT, Priority review, AbbVie, Food, Risk, Annual report, Johnson & Johnson, DKK, Janssen, U.S. FDA, Risk management, Environment, Rituximab, Follicular lymphoma, Novartis, PDUFA, ADC, Patient, Acquisition, Interim, Lenalidomide, Daratumumab, Priority, BST, Pharmaceutical industry

Genmab is maintaining its 2024 financial guidance published on February 14, 2024.

Key Points: 
  • Genmab is maintaining its 2024 financial guidance published on February 14, 2024.
  • We expect to update our guidance no later than in connection with our second quarter 2024 earnings.
  • Genmab will hold a conference call to discuss the results for the first quarter of 2024 today, Thursday, May 2, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT.
  • Actual results or performance may differ materially from any future results or performance expressed or implied by such statements.

Johnson & Johnson Reports Q1 2024 Results

Retrieved on: 
Martedì, Aprile 16, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Medtech, Patient, News, Pulmonary hypertension, Johnson & Johnson, Security (finance), Relapse, Press release, Esketamine, General surgery, Daratumumab, COVID-19, Pharmaceutical industry

First Quarter 2024 Segment Commentary:

Key Points: 
  • First Quarter 2024 Segment Commentary:
    Operational sales* reflected below excludes the impact of translational currency.
  • Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.
  • Notable New Announcements in the Quarter:
    The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K.
  • Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson.

HUTCHMED Highlights Data to be Presented at AACR Congress 2024

Retrieved on: 
Venerdì, Aprile 5, 2024
IOV, Tao, Medicine, Savolitinib, VEGFR, Immunotherapy, Patient, MMAE, ERK, Relapse, Neoplasm, University, Huachung University, Cisplatin, Lymphoid leukemia, Lymphoma, Chongqing Medical University, Cholangiocarcinoma, Tyrosine-protein kinase SYK, Classification, Efficacy, MET, ADC, Cardiotoxicity, Nanjing Medical University, Non-receptor tyrosine kinase, Safety, Ferroptosis, Macrophage, Pancreatic cancer, Dual role, National Taiwan University Hospital, GPR34, Oncology, Guangzhou Medical University, MD Anderson Cancer Center, Daratumumab, HCM, NPM1, MLL, 301 Hospital, Acute leukemia, Pharmaceutical industry

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.

Key Points: 
  • HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., April 05, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the upcoming American Association of Cancer Research (“AACR”) Annual Meeting 2024, taking place on April 5-10, 2024 in San Diego, California.
  • Initial preclinical data will be presented for HMPL-506, a novel, highly potent and differentiated menin-MLL inhibitor for the treatment of certain types of acute leukemia.
  • Compared with five other menin inhibitors in clinical development, HMPL-506 showed the stronger inhibitory potency in MLL-rearranged and NPM1 mutant leukemia cell line models.
  • Furthermore, HMPL-506 in combination with azacytidine, venetoclax or gilteritinib synergistically improved the anti-tumor effect against MLL-rearranged leukemias both in vitro and in vivo.

CARVYKTI® is the First and Only BCMA-Targeted Treatment Approved by the U.S. FDA for Patients with Relapsed or Refractory Multiple Myeloma Who Have Received at Least One Prior Line of Therapy

Retrieved on: 
Sabato, Aprile 6, 2024
Guillain–Barré syndrome, Bone marrow, Medical College of Wisconsin, Encephalopathy, Survival, Immunotherapy, BCMA, Patient, Hypotension, Mortality, B-cell maturation antigen, Edema, Periodic breathing, Associate professor, Dexamethasone, Certification, Neutropenia, Dizziness, Risk, Headache, Chills, Myelodysplastic syndrome, Coagulopathy, DPD, Johnson & Johnson, Immune system, Effect, Fatigue, Thrombocytopenia, Food, Disease, Drive, Appetite, Lymphocytopenia, JNJ, Constipation, Multiple myeloma, Acute myeloid leukemia, CRS, Death, Hypersensitivity, Cytopenia, Cytokine release syndrome, ASCO, Use, Hematology, FDA, PVD, Annual general meeting, T cell, DSM-IV codes, Incidence, Tachycardia, Bortezomib, Diarrhea, Viral, Hope, United, Cough, Daratumumab, Nausea, Society, Division, Physician, Pharmaceutical industry

HORSHAM, Pa., April 5, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.1 With this approval, CARVYKTI® becomes the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for the treatment of patients with multiple myeloma as early as first relapse.

Key Points: 
  • "This milestone underscores our commitment to improve outcomes for patients and transform the treatment of multiple myeloma with CARVYKTI," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • CARVYKTI® is a cell therapy that works by harnessing a patient's immune system, or T cells, to fight the disease.
  • Treatment requires extensive training, preparation, and certification to ensure a positive experience for patients.
  • Since initial approval in February 2022, Johnson & Johnson has made significant advances in manufacturing to rapidly scale CARVYKTI® production.

Kelonia Therapeutics Appoints Kristen Hege, M.D., and Mathai Mammen, M.D., Ph.D., to Board of Directors

Retrieved on: 
Giovedì, Marzo 28, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Oncology, Harvard Medical School, Flexner Report, Organization, Bone marrow, Internal medicine, UCSF, Hematology, Science, HST, Massachusetts Institute of Technology, BCMA, Patient, HIV, Dartmouth College, BMS, Cancer, Bristol Myers Squibb, Doctor of Philosophy, Daratumumab, Biochemistry, Chemistry, Therapy, Harvard University, Hospital, Johnson & Johnson, Drug development, FDA, Pharmaceutical industry

Kelonia Therapeutics , a biotech company revolutionizing in vivo gene delivery, today announced the appointments of global leaders in cell therapy and drug development, Kristen Hege, M.D., and Mathai Mammen, M.D., Ph.D., to its board of directors.

Key Points: 
  • Kelonia Therapeutics , a biotech company revolutionizing in vivo gene delivery, today announced the appointments of global leaders in cell therapy and drug development, Kristen Hege, M.D., and Mathai Mammen, M.D., Ph.D., to its board of directors.
  • Furthermore, some patients never receive their autologous CAR-T products due to disease progression or clinical deterioration during the manufacturing window.
  • In addition, the field of cell and gene therapy has gained tremendous expertise and insight into the manufacturing of lentiviral vectors at commercial scale.
  • from the Harvard Medical School and Massachusetts Institute of Technology (HST) and a Ph.D. in chemistry from Harvard University.

Onco360 Selected as the Preferred National Specialty Pharmacy Partner for XPOVIO® (selinexor)

Retrieved on: 
Mercoledì, Marzo 13, 2024
Oncology, Health, Clinical Trials, Research, Pharmaceutical, Science, Diagnosis, B-cell lymphoma, Dexamethasone, Selinexor, Partnership, Bortezomib, Patient, Carfilzomib, National Cancer Institute, Multiple myeloma, B cell, Lenalidomide, Daratumumab, Therapy, Bone marrow, Food, FDA, DLBCL, Follicular lymphoma, Pharmaceutical industry

Onco360®, the nation’s largest independent Oncology Pharmacy, is now the national specialty pharmacy network partner for Karyopharm’s product XPOVIO® (selinexor), a first-in-class, XPO-1 inhibitor.

Key Points: 
  • Onco360®, the nation’s largest independent Oncology Pharmacy, is now the national specialty pharmacy network partner for Karyopharm’s product XPOVIO® (selinexor), a first-in-class, XPO-1 inhibitor.
  • “Onco360 is excited to expand our partnership with the team at Karyopharm and become the preferred national specialty pharmacy partner for XPOVIO,” said Benito Fernandez, Chief Commercial Officer.
  • Multiple myeloma is an incurable hematological malignancy involving plasma cells.
  • Only 50 percent of patients diagnosed with multiple myeloma survive past five years following initial diagnosis.

U.S. FDA Oncologic Drugs Advisory Committee recommends CARVYKTI® (ciltacabtagene autoleucel) for the earlier treatment of patients with relapsed or refractory multiple myeloma

Retrieved on: 
Venerdì, Marzo 15, 2024
Dexamethasone, Type, Health, Survival, Multiple myeloma, Disease, Bortezomib, Oncology, Patient, Committee, EMA, Lenalidomide, European Medicines Agency, Daratumumab, DPD, Society, Johnson & Johnson, ODAC, Safety, ASCO, Food, Hematology, FDA, CHMP, Immunomodulatory imide drug, PVD, Annual general meeting, PDUFA, Pharmaceutical industry

RARITAN, N.J., March 15, 2024  /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI® (ciltacabtagene autoleucel, cilta-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. The committee reviewed survival and safety data from the Phase 3 CARTITUDE-4 study and voted unanimously in favor of CARVYKTI® (11 to 0) finding the risk-benefit assessment of CARVYKTI® for the proposed indication as favorable. A supplemental Biologics License Application (sBLA) supported by the CARTITUDE-4 study is currently under review by the FDA with a Prescription Drug User Fee Act (PDUFA) date of April 5, 2024. 

Key Points: 
  • "We are pleased with the advisory committee's support for CARVYKTI in earlier lines of treatment based on the CARTITUDE-4 data," said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine.
  • "As a physician and researcher committed to advancing patient care, the potential of CARVYKTI in earlier lines of therapy represents an important therapeutic option for patients with multiple myeloma."
  • The ODAC is convened upon request of the FDA to review and evaluate safety and efficacy data of human drug products for use in the treatment of oncologic diseases.
  • The committee provides non-binding recommendations based on its evaluation; however, final decisions on approval of the drug are made by the FDA.

Genmab Publishes 2023 Annual Report

Retrieved on: 
Mercoledì, Febbraio 14, 2024
Pfizer, DKK, USD, BioNTech, Annual report, EST, AbbVie, PDF, Daratumumab, Accelerator, Medicine, Janssen, Novartis, GRDC, IND, Follicular lymphoma, Pharmaceutical industry

COPENHAGEN, Denmark; February 14, 2024 – Genmab A/S (Nasdaq: GMAB) announced today the publication of its Annual Report for 2023.

Key Points: 
  • COPENHAGEN, Denmark; February 14, 2024 – Genmab A/S (Nasdaq: GMAB) announced today the publication of its Annual Report for 2023.
  • Below is a summary of business progress in 2023, financial performance for the year and the financial outlook for 2024.
  • Genmab will hold a conference call in English to discuss the full year results for 2023 today, February 14, 2024 at 6:00 pm CET, 5:00 pm GMT, 12:00 pm EST.
  • Net sales of DARZALEX by Janssen were USD 9,744 million in 2023 compared to USD 7,977 million in 2022.

Johnson & Johnson Reports Q4 and Full-Year 2023 Results

Retrieved on: 
Martedì, Gennaio 23, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Growth, Contact, Ustekinumab, Esketamine, General surgery, Infliximab, Abiraterone acetate, Press release, Acquisition, COVID-19, Medtech, Johnson & Johnson, Abiomed, Daratumumab, Security (finance), News, Pharmaceutical industry

Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.

Key Points: 
  • Adjusted operational sales* reflected below excludes the net impact of acquisitions and divestitures and translational currency.
  • Innovative Medicine worldwide operational sales, excluding the COVID-19 Vaccine, grew 7.2%*.
  • Notable New Announcements in the Quarter:
    The information contained in this section should be read together with Johnson & Johnson’s other disclosures filed with the Securities and Exchange Commission, including its Current Reports on Form 8-K, Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K.
  • Copies of these filings are available online at www.sec.gov , www.jnj.com or on request from Johnson & Johnson.

Indapta Therapeutics Announces First Patients Treated with IDP-023 Allogeneic Natural Killer (NK) Cell Therapy for Cancer

Retrieved on: 
Giovedì, Gennaio 11, 2024
Oncology, Health, Hospitals, General Health, Clinical Trials, Pharmaceutical, Biotechnology, NK, Patient, Therapy, CMV, Cytokine, University, Cancer, Interleukin, GMP, Lymphoma, Multiple myeloma, Safety, Cytomegalovirus, Daratumumab, MD Anderson Cancer Center, Cell, Vaccine

Indapta Therapeutics, Inc., a privately held biotechnology company developing IDP-023, a natural killer (NK) cell therapy for the treatment of cancer, today announced that the company has initiated treatment of the first patients in its Phase 1 trial in multiple myeloma and Non-Hodgkin’s lymphoma.

Key Points: 
  • Indapta Therapeutics, Inc., a privately held biotechnology company developing IDP-023, a natural killer (NK) cell therapy for the treatment of cancer, today announced that the company has initiated treatment of the first patients in its Phase 1 trial in multiple myeloma and Non-Hodgkin’s lymphoma.
  • The patients were treated at the University of Texas MD Anderson Cancer Center and NEXT Oncology, Virginia.
  • To generate IDP-023, Indapta preferentially expands g-NK cells from healthy donors with increased numbers of g-NK cells.
  • Indapta’s off-the-shelf g-NK cell therapy is further differentiated from other NK cell therapies in that it is a cryopreserved product with low variability.