CR

Day One’s OJEMDA™ (tovorafenib) Receives US FDA Accelerated Approval for Relapsed or Refractory BRAF-altered Pediatric Low-Grade Glioma (pLGG), the Most Common Form of Childhood Brain Tumor

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화요일, 4월 23, 2024
Neuro-Oncology (journal), First grade, FDA, Society, University, BRAF V600, Day One, Hospital, Acne, Safety, Food, Biopharmaceutical, Conference call, Nausea, Insurance, Conference, Research, Webcast, Viral, Speech, Fatigue, Human, Disease, BRAF, Vomiting, Patient, Medicine, Headache, Event, Rash, Constipation, Diagnosis, Head, Neoplasm, Upper respiratory tract infection, PRS, Xeroderma, Fever, Caregiver, Ageing, Pharmaceutical industry

BRISBANE, Calif., April 23, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a commercial-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved OJEMDA (tovorafenib), a type II RAF inhibitor, for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. This indication is approved under accelerated approval based on response rate and duration of response. With the approval, Day One received a rare pediatric disease priority review voucher from the FDA.

Key Points: 
  • With the approval, Day One received a rare pediatric disease priority review voucher from the FDA.
  • “We are very proud that our first approved medicine addresses this serious and life-threatening disease of childhood and adolescence.
  • BRAF is the most commonly altered gene in pLGG, with up to 75 percent of children having a BRAF alteration.
  • “This is a tremendous moment not only for Day One, but also for the broader pediatric brain tumor community.

ImmunityBio Announces FDA Approval of ANKTIVA®, First-in-Class IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

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화요일, 4월 23, 2024
Oncology, Health, Hospitals, General Health, Pharmaceutical, Biotechnology, UCLA, FDA, Cystoscopy, Safety, Food, Immunotherapy, Recurrence, Carcinoma in situ, Cystectomy, BCG, CIS, Patient, Medicine, NMIBC, Bacillus, Multimedia, Memory, Biology, Associate, Quality of life, Breakthrough therapy, NK, Pharmaceutical industry

View the full release here: https://www.businesswire.com/news/home/20240422820209/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240422820209/en/
    ImmunityBio’s ANKTIVA is approved for non-muscle invasive bladder cancer (Photo: Business Wire)
    “The FDA’s approval of ANKTIVA marks our launch of a next-generation immunotherapy beyond checkpoint inhibitors,” said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio.
  • This novel mechanism of action, which mimics the biology of the dendritic cell, begins the evolution of immunotherapy beyond T cells alone.
  • The combination of the proliferation of key cancer-killing immune cells, together with the activation of T cells with memory, results in durable complete responses.
  • The 77 evaluable patients in this single-arm, multicenter trial received ANKTIVA with BCG maintenance therapy for up to 37 months.

ESCMID Global 2024: Shionogi presents real-world data demonstrating efficacy of Fetcroja® / Fetroja® (cefiderocol) in critically ill patients with certain difficult-to-treat bacterial infections

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목요일, 4월 18, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Stenotrophomonas maltophilia, Mortality, Genetically modified bacteria, Cefiderocol, Safety, Kidney disease, Infection, Survival, Immunosuppression, Diabetes, Pseudomonas aeruginosa, ECCMID, Head, Urinary tract infection, CHAI, Patient, Hospice and palliative medicine, Gram-negative bacteria, Klebsiella pneumoniae, Chronic obstructive pulmonary disease, Pharmaceutical industry

Please see below under About Cefiderocol for full indications of Fetroja in the U.S.

Key Points: 
  • Please see below under About Cefiderocol for full indications of Fetroja in the U.S.
  • Additionally,19.5% of patients had polymicrobial infections.1
    The study included 261 critically ill adult patients with limited treatment options who received cefiderocol for less than 28 days as part of Shionogi’s Early Access Program in Spain.
  • Real-world evidence is particularly important when reviewing antibiotic use for multidrug-resistant pathogens because of the challenges of conducting randomized clinical trials.
  • We also know how important it is to ensure equitable, global, access to essential medicines like cefiderocol.

MaaT Pharma Presents Positive 18-month Data for MaaT013 Showing a Clear Overall Survival Advantage in aGvHD from the Early Access Program at the 2024 EBMT Event

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월요일, 4월 15, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, FDA, EAP, Cancer, MET, Hospital, Hematology, Food, Sorbonne University, Survival, Orphan, OS, DSMB, Disease, Rated R, Patient, ARES, D28, EMA, Symantec Endpoint Protection, Hematopoietic stem cell transplantation, EBMT, Toxicity, European Medicines Agency, Data monitoring committee, Pharmaceutical industry

Prof. Malard commented: “MaaT013 shows remarkable efficacy at 18 months, yielding more complete responses in aGvHD patients who have shown resistance to current treatments, as compared to other available therapies.

Key Points: 
  • Prof. Malard commented: “MaaT013 shows remarkable efficacy at 18 months, yielding more complete responses in aGvHD patients who have shown resistance to current treatments, as compared to other available therapies.
  • Notably, these results are achieved with just 3 doses in less than 2 weeks of treatment initiation.
  • The data presented highlights the strong safety profile of MaaT013 (full details here ) and translates into increased OS.
  • MaaT Pharma also presented its ongoing Phase 2b trial design for MaaT033 developed as an adjunctive therapy to enhance OS in allogeneic hematopoietic stem cell transplantation.

Ionis Publishes 2023 Corporate Responsibility Report

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목요일, 4월 25, 2024
DEI, Corporation, LEED, Education, IONS, Amyloidosis, Materiality, Certification, AFL, Ionis Pharmaceuticals, Vitamin A, STEM, Culture, Engineering, Environment, Science, Patient, Corporate social responsibility, DSM-IV codes, Caregiver, Serum, Gold, Polyneuropathy, Vitamin A deficiency, Corporate responsibility, Pharmaceutical industry

Received approval for two Ionis-discovered medicines in 2023, and continued to advance a broad pipeline poised to bring a steady cadence of important new medicines to people with serious diseases

Key Points: 
  • Received approval for two Ionis-discovered medicines in 2023, and continued to advance a broad pipeline poised to bring a steady cadence of important new medicines to people with serious diseases
    CARLSBAD, Calif., April 25, 2024 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS), today published its 2023 Corporate Responsibility Report: Action for a Healthier Future .
  • The report details Ionis' relentless passion to create better futures for people touched by serious disease as well as other stakeholders.
  • In 2023, Ionis extended its commitment to corporate responsibility (CR) through the establishment of three strategic pillars with actionable goals.
  • For more information on the 2023 Corporate Responsibility program, please visit: https://www.ionispharma.com/about/corporate-responsibility/
    For more information about QALSODY, visit https://www.qalsody.com/ .

"A Decade and Beyond": Creality Celebrates 10 Years of Innovation and Community Engagement

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월요일, 4월 15, 2024
Cloud, LCD, Pictor, Ecosystem, Safety, RFID, Dragon Flame, Versatile, K series, Empowerment, Calibration, K2, 3D, Emotion, HALOT, Amazon, PETG, Video, Laser, Printing, Creativity, CFS, 3D printing

The anniversary event marked a significant moment for Creality, showcasing a new logo - a creative green "A" symbolizing sustainability, proficiency, and community.

Key Points: 
  • The anniversary event marked a significant moment for Creality, showcasing a new logo - a creative green "A" symbolizing sustainability, proficiency, and community.
  • Over the past decade, Creality has led the 3D printing industry evolution, democratizing access with Creality Devices, Creality Cloud , and Creality Ecosystem.
  • Reflecting on its journey, Creality transitions into "Creality Life," dedicating itself to technology-driven creativity and empowerment.
  • To engage and reward the users and 3DP community, Creality also launched anniversary promotions on Creality Store and Creality's Amazon shop.

"A Decade and Beyond": Creality Celebrates 10 Years of Innovation and Community Engagement

Retrieved on: 
월요일, 4월 15, 2024
Cloud, LCD, Pictor, Ecosystem, Safety, RFID, Dragon Flame, Versatile, K series, Empowerment, Calibration, K2, 3D, Emotion, HALOT, Amazon, PETG, Video, Laser, Printing, Creativity, CFS, 3D printing

The anniversary event marked a significant moment for Creality, showcasing a new logo - a creative green "A" symbolizing sustainability, proficiency, and community.

Key Points: 
  • The anniversary event marked a significant moment for Creality, showcasing a new logo - a creative green "A" symbolizing sustainability, proficiency, and community.
  • Over the past decade, Creality has led the 3D printing industry evolution, democratizing access with Creality Devices, Creality Cloud , and Creality Ecosystem.
  • Reflecting on its journey, Creality transitions into "Creality Life," dedicating itself to technology-driven creativity and empowerment.
  • To engage and reward the users and 3DP community, Creality also launched anniversary promotions on Creality Store and Creality's Amazon shop.

Building Momentum: A Year of Impact With the Cybersecurity Coalition for Education

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수요일, 4월 10, 2024
Advisory Council, Education, School, Polk County School District, NIST Cybersecurity Framework, Coalition, CDWG, Information, NIST, Organization, CCRE, Information system, Nursing

CLIFTON, N.J., April 10, 2024 /PRNewswire/ -- In April 2023, the Cybersecurity Coalition for Education was formed with a mission of helping schools become more cyber-secure.

Key Points: 
  • CLIFTON, N.J., April 10, 2024 /PRNewswire/ -- In April 2023, the Cybersecurity Coalition for Education was formed with a mission of helping schools become more cyber-secure.
  • During this past year, two new organizations became contributing members of the Coalition.
  • Caetra.io, a premier cybersecurity consulting firm specializing in serving schools and CDWG, a top-tier solution provider to schools everywhere.
  • The Coalition offers an on-demand training and certification exam for technology professionals to become Certified Cybersecurity Rubric Evaluators (CCREs).

Imugene's oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx featured at the AACR Annual Meeting 2024

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화요일, 4월 9, 2024
HER2, CD8, Phosphorylation, Survival, Cholangiocarcinoma, Immunotherapy, RECIST, Oncology, MAST, Patient, City, Degranulation, ASX, ADCC, Cancer, Hope, Overalls, Pembrolizumab, PRS, AACR, SPECT, Vaccination, Melanoma, Recurrence, PD-L1, IMU, Medical imaging

Oncolytic virus CF33-hNIS (VAXINIA) alone or in combination with KEYTRUDA is a safe treatment option for advanced cancer patients.

Key Points: 
  • Oncolytic virus CF33-hNIS (VAXINIA) alone or in combination with KEYTRUDA is a safe treatment option for advanced cancer patients.
  • SYDNEY, Australia, April 09, 2024 (GLOBE NEWSWIRE) -- Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, is pleased to announce poster presentations featuring its CF33 oncolytic virotherapy VAXINIA and B cell immunotherapy HER-Vaxx at the American Association for Cancer Research (AACR) Annual Meeting 5-10 April 2024, in San Diego, CA.
  • HER-Vaxx induced HER2-specific antibodies able to mediate antibody-dependent cell cytotoxicity (ADCC) and inhibit intracellular HER2 phosphorylation and correlated with tumour reduction.
  • The HER-Vaxx induced HER2-specific antibodies demonstrate a similar mechanism of action to HERCEPTINâ validating B cell immunotherapy as an alternative anti-cancer agent to monoclonal antibodies.

Nurix Therapeutics Reports First Clinical Evidence of CNS Activity of NX-5948, a Brain-Penetrant, Orally Available, BTK Degrader in Development for B Cell Malignancies

Retrieved on: 
화요일, 4월 9, 2024
Histology, Brain, Rituximab, Chronic lymphocytic leukemia, CLL, Lymphoma, Disease, CSF, Central nervous system, SAN, CNS, Patient, PCNSL, BCL2, Cancer, Leukemia, Inflammation, Cerebrospinal fluid, NHL, Lymph, AACR, Proteolysis targeting chimera, Neoplasm, Therapy, MYC, BTK, Myenteric plexus, Lymphoid leukemia, Spleen, Medical imaging

SAN FRANCISCO, April 09, 2024 (GLOBE NEWSWIRE) -- Nurix Therapeutics, Inc. (Nasdaq: NRIX), a clinical stage biopharmaceutical company developing targeted protein modulation drugs designed to treat patients with cancer and inflammatory diseases, today announced the presentation of the first findings of clinical responses in the brain for NX-5948, an orally available, selective degrader of Bruton’s tyrosine kinase (BTK). The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses. The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement. These data were presented by Gwenn M. Hansen, Ph.D., chief scientific officer of Nurix, as part of the Major Symposium session Molecular Glues, PROTACs, and Next-Gen Degraders: Discovery and Early Preclinical Advances at the AACR 2024 Annual Meeting, which is being held from April 5-10, 2024, in San Diego, CA.

Key Points: 
  • The presentation included case studies for two patients, one with CLL with CNS involvement and the other with PCNSL, each demonstrating clinically meaningful responses.
  • The presentation also provided evidence of measurable drug levels in the CNS of multiple patients in the ongoing Phase 1 trial who had CNS tumor involvement.
  • “These data are the first demonstration of clinical activity in the brain of a targeted protein degrader, opening the door for new therapeutic strategies to treat leukemias and lymphomas with CNS involvement,” said Dr. Hansen.
  • “The CLL patient with CNS involvement showed an impressive durable response with NX-5948 as single agent therapy in this setting.