Immunodeficiency

FDA Clears the Individualized Nomogram for Rika Plasma Donation System

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木曜日, 5月 9, 2024
FDA, Ecosystem, Cell, Safety, Food, BCT, Plasma, Collection, Blood, Hematocrit, Patient, Clinical trial, Food and Drug Administration, Immunodeficiency, Medical device

LAKEWOOD, Colo., May 9, 2024 /PRNewswire/ -- Terumo Blood and Cell Technologies (Terumo BCT), a medical technology company, recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Rika Plasma Donation System™ with the iNomi™ Nomogram. This innovation means that plasma collection volume can be determined by an individual donor's height, weight and hematocrit level on the day they donate plasma.

Key Points: 
  • Rika's individualized nomogram, iNomi, can enable plasma donors to donate the right amount of plasma on any given day based on height, weight and hematocrit.
  • The Rika Plasma Donation System (Rika) is designed for donor comfort and safety.
  • Rika is the next-generation plasma collection system designed and developed for use in plasma collection centers.
  • "CSL Plasma looks forward to the rollout of the individualized nomogram as we continue to introduce the Rika Plasma Donation System to our close to 330 centers in the United States.

EQS-News: Biotest increased sales by 83.6% to Euro 215.2 million in first quarter 2024

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金曜日, 5月 10, 2024
Birth, FDA, Phase, Pneumonia, Grifols, Technology transfer, Dreieich, Management, Fibrinogen, Immunodeficiency, Collection, Research, Community-acquired pneumonia, Factor, Biologics license application, ROCE, SCAP, Tax, Patient, Next Level, Health, Plasma, Disclosure, Video game

The Biotest Group recorded revenue of € 215.2 million in the first quarter of the 2024 financial year.

Key Points: 
  • The Biotest Group recorded revenue of € 215.2 million in the first quarter of the 2024 financial year.
  • EBIT for the first quarter of 2024 amounted to € 52.8 million, a significant improvement on the first quarter of the previous year (prior year period: € - 9.1 million).
  • The financial result for the first quarter of the current year deteriorated by € -1.4 million to € -10.7 million (prior-year period: € -9.3 million).
  • The Biotest Group's earnings after taxes improved to € 29.5 million in the first quarter of 2024 after € -20.4 million in the same quarter of the previous year due to the influencing factors described above.

Invivyd Reports First Quarter 2024 Financial Results and Recent Business Highlights

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木曜日, 5月 9, 2024
FDA, CMS, Risk, SARS-CoV-2, Food, Webcast, U.S. FDA, Administration, Research and development, Pre-exposure prophylaxis, COVID-19, Patient, Immunodeficiency, Medicine, Medicare, Clinical trial, HCPCS, Vaccine

“The recent months have been incredibly productive for Invivyd.

Key Points: 
  • “The recent months have been incredibly productive for Invivyd.
  • At the beginning of April, Invivyd announced that PEMGARDA is available for purchase in the U.S. through a network of authorized specialty distributors.
  • The company will begin reporting PEMGARDA net product revenue with its second quarter 2024 financial results.
  • First Quarter 2024 Financial Results:
    Cash Position: Cash and cash equivalents were $189.4 million as of March 31, 2024.

Invivyd to Pursue Rapid Immunobridging Pathway to Potential EUA for Treatment of COVID-19 in Moderately to Severely Immunocompromised People, Based on U.S. FDA Feedback

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火曜日, 5月 7, 2024
FDA, Immunoglobulin G, COVID-19, Risk, SARS-CoV-2, Pharmacokinetics, RBD, Food, Virology, Chronic lymphocytic leukemia, SVP, CLL, MDCM, Pre-exposure prophylaxis, Patient, Immunodeficiency, Medicine, Infection, Vaccine

This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA.

Key Points: 
  • This immunobridging pathway leverages a similar approach Invivyd used to achieve its current EUA for PEMGARDA™ (pemivibart) for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised people and was aligned in principle with the FDA.
  • The potential COVID-19 treatment EUA request would focus on the critical treatment needs of people in the U.S. who have moderate-to-severe immune compromise and for whom alternative COVID-19 treatment options are not clinically appropriate or accessible.
  • Subsequent to the anticipated submission of an EUA request, Invivyd plans to initiate a compact clinical trial focused on confirmatory safety, pharmacokinetics (PK), and clinical virology.
  • “We are glad to once again align with the FDA on a rapid pathway towards addressing a critical unmet medical need among immunocompromised people who may benefit from alternative approaches to treating their symptomatic COVID-19.

Karius Raises $100M Co-Led by Khosla Ventures, 5AM Ventures and Gilde Healthcare, to Expand Access to Advanced Genomic Diagnostics in Infectious Disease, Addressing Antimicrobial Resistance Crisis

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木曜日, 5月 2, 2024
Technology, Medical Devices, Medical Supplies, Infectious Diseases, Genetics, Clinical Trials, Biotechnology, Health, Artificial Intelligence, AbCellera, CFO, University, Cancer, SoftBank Vision Fund, Antimicrobial resistance, Bone marrow, HBM, Pneumonia, Head, Risk, Hospital, Metagenomics, Infection, Survival, AMR, Public, Eli Lilly, Khosla Ventures, Partnership, University of California, Research, Artificial intelligence, DNA, Partner (business rank), Transplant, Patient, Immunodeficiency, Eric Schmidt, General partnership, MD Anderson Cancer Center, Death, Growth, Pharmaceutical industry

Karius® , Inc., a world leader in genomic diagnostics for infectious disease, today announced it has secured $100 million in Series C funding.

Key Points: 
  • Karius® , Inc., a world leader in genomic diagnostics for infectious disease, today announced it has secured $100 million in Series C funding.
  • The round was co-led by Khosla Ventures and new investors 5AM Ventures and Gilde Healthcare.
  • The funding enables Karius to address increasing demand from healthcare providers to expand access to the Karius Test beyond the hospital setting.
  • Additionally, it will support research into the broader health implications of Karius’ microbial cell-free DNA technology beyond infectious diseases.

ADLM releases guidance to help healthcare professionals navigate respiratory virus testing in a post-COVID world

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木曜日, 5月 2, 2024
Education, Laboratory, Virology, Medical laboratory, Research, AACC, DRS, Diagnosis, Patient, Pan American Society, Immunodeficiency, Respiratory tract infection, Infection, Lower respiratory tract infection, COVID-19, Vaccine

As respiratory virus testing continues to evolve rapidly in the wake of the COVID-19 pandemic, this guidance aims to ensure that patients benefit fully from emerging technologies in this field.

Key Points: 
  • As respiratory virus testing continues to evolve rapidly in the wake of the COVID-19 pandemic, this guidance aims to ensure that patients benefit fully from emerging technologies in this field.
  • Furthermore, the guidance document discusses the role of diagnostic stewardship in respiratory virus testing, which can help generate accurate and clinically relevant results while conserving laboratory resources.
  • Additionally, the authors of the guidance document propose an algorithm that can help laboratories efficiently decide on the most appropriate tests for a given case of respiratory virus infection.
  • "Laboratorians should remain alert and involved to provide guidance on managing testing and the information obtained from a wider range of testing settings."

Genomenon Partners with Pharming to Advance APDS Diagnosis

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木曜日, 5月 2, 2024
Mortality, American College, Probability, Laboratory, ANN, Survival, APDS, Disorder, Partnership, Genetic testing, PIK3R1, Molecular diagnostics, Disease, ACMG, Lymphoma, Patient, Bronchiectasis, AMP, Primary immunodeficiency, Caregiver, Genome, Immunodeficiency, Diagnosis, Infection, PIK3CD, Medicine, Activated, Medical genetics, Gene, Medical device

ANN ARBOR, Mich., May 2, 2024 /PRNewswire-PRWeb/ -- Genomenon, a genomic intelligence company, has partnered with Pharming Group in an effort to make variant data on the PIK3CD and PIK3R1 genes available to genetic testing labs, as well as clinicians and researchers, worldwide. This data enables accurate molecular diagnoses and supports the precise medical management of the disease. The partnership also improves the ability of diagnostic laboratories and clinicians to resolve variants of uncertain significance (VUSs) and advances Genomenon's mission to curate the human genome.

Key Points: 
  • APDS, or Activated PI3K delta syndrome, is a rare primary immunodeficiency affecting approximately 1 to 2 people per million worldwide.
  • As the symptoms of APDS can be associated with a variety of conditions, patients typically experience a median 7-year diagnostic delay.
  • "Through our AI-driven technology and genomic expertise, Genomenon has produced the world's most comprehensive variant landscape on PIK3CD and PIK3R1.
  • This curated genetic dataset is being made available to the community through Genomenon's Mastermind Genomic Intelligence Platform to help inform and accelerate the diagnosis for patients with APDS," said Mike Klein, Genomenon CEO.

23andMe to Present Preliminary Efficacy and Biomarker Data for 23ME-00610 at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

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水曜日, 4月 24, 2024
Safety, Cancer, Genetics, Abstract, 23andMe, Research, Immune tolerance, CD200, Immunodeficiency, Patient, DOK2, Therapy, Ovarian cancer, SAN, Vaccine

23andMe will present clinical data, including preliminary efficacy and exploratory biomarker analyses, for the neuroendocrine and ovarian cancer patient cohorts in the Phase 2a portion of its ongoing Phase 1/2a clinical trial.

Key Points: 
  • 23andMe will present clinical data, including preliminary efficacy and exploratory biomarker analyses, for the neuroendocrine and ovarian cancer patient cohorts in the Phase 2a portion of its ongoing Phase 1/2a clinical trial.
  • 23andMe scientists discovered the target for 23ME-00610 through the Company’s proprietary database of human genetic and health information.
  • 23andMe has more than 15 million genotyped customers, roughly 80 percent of whom consent to participate in research.
  • Title: Safety, efficacy, and PKPD of 23ME-00610, a first-in-class anti-CD200R1 antibody, in patients with advanced neuroendocrine cancers: Results from a multi-center multi-country phase 1/2a expansion cohort.

Journal of Craniofacial Surgery Study Proves Planatome Blades Reduce Tissue Damage and Improve Diabetic Wound Healing from Surgical Incisions

Retrieved on: 
木曜日, 4月 18, 2024
Microsurgery, University, Rat, MMM, Inflammation, Hope, Risk, Craniofacial surgery, Diabetes, Ulsan College, Craniofacial, Surgeon, Doctor of Philosophy, Tearing, Research, Foot, Asan Medical Center, Patient, Immunodeficiency, Nano, MBA, Wound healing, Journal, Plastic, Dentistry

The study highlights the superior performance of Planatome blades in surgical procedures, particularly noting their ability to reduce incisional tissue damage, which reduced inflammation in diabetic rats.

Key Points: 
  • The study highlights the superior performance of Planatome blades in surgical procedures, particularly noting their ability to reduce incisional tissue damage, which reduced inflammation in diabetic rats.
  • The study found that using ultra-smooth blade technology significantly mitigated tissue injury, which, in turn, lessened inflammation and hasten wound healing.
  • Scar measurements proved a statistically significant reduction in scar width and scar tissue formation along the incisions made with Planatome blades.
  • The analysis demonstrated that incisions made using nano-polished Planatome blades resulted in more even, cleaner margins and less damage to surrounding tissue.

Novel cell therapy treatments offer promise to immune-compromised children

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木曜日, 4月 18, 2024
Sickle cell disease, University, Cancer, Disorder, Nature Communications, Immunodeficiency, Pediatric Transplantation, Hope, Hospital, CCIR, Food, Blood, Regenerative medicine, Intermountain, Cytomegalovirus, Huntsman Cancer Institute, Cell, Research, Infant, Bollard, VST, DRS, Epstein–Barr virus, Patient, Anemia, Haematopoietic system, Virus, Faculty, Malignancy, Infection, Good, Immune system, GMP, Clinical trial, Viral, Vaccine

Without this therapy, estimates suggest that less than 30% of patients would recover, using standard protocols.

Key Points: 
  • Without this therapy, estimates suggest that less than 30% of patients would recover, using standard protocols.
  • , the paper’s first author and the Translational Research Laboratory director at the Children’s National Cell Enhancement and Technologies for Immunotherapy (CETI) program.
  • They combined the expertise at Children’s National in producing and banking cell therapy products with the community built around the PTCTC.
  • In the decade ahead, Dr. Bollard sees promise in cell therapies for patients with cancer, immune deficiencies after transplant and dozens of other disorders, including genetic and autoimmune diseases.