End organ damage

Phase 2 Study of Upadacitinib (RINVOQ®) Alone or as a Combination Therapy Meets Primary and Key Secondary Endpoints in Patients with Systemic Lupus Erythematosus

Retrieved on: 
Wednesday, May 31, 2023
NORTH, Sleek, SFI, Safety, ABBV, End organ damage, SLE, European Congress of Radiology, NYSE, Prednisone, Patient, AbbVie, Physician, EULAR, Pharmaceutical industry, Sewage treatment, Rheumatology, Estrogen

NORTH CHICAGO, Ill., May 31, 2023 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the results of the Phase 2 SLEek study evaluating upadacitinib (RINVOQ® 30 mg) alone and in combination [ABBV-599 high dose (elsubrutinib 60 mg and upadacitinib 30 mg)] in adults with moderately to severely active systemic lupus erythematosus (SLE) who continued to receive standard lupus therapies. The study results are being presented as an oral presentation during the European Congress of Rheumatology, EULAR 2023.

Key Points: 
  • - Upadacitinib maintained greater improvements in SLE disease activity at week 48 as measured by the British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA), SRI-4, Lupus Low Disease Activity State (LLDAS) and lupus flares compared with placebo2
    - No new safety signals were observed beyond the known safety profile for upadacitinib.
  • The study results are being presented as an oral presentation during the European Congress of Rheumatology, EULAR 2023.
  • "As a leader in immunology, AbbVie is committed to advancing care in areas of unmet need, such as SLE.
  • We are encouraged by these positive Phase 2 data and look forward to continuing to study upadacitinib for systemic lupus erythematosus in two Phase 3 trials as part of our ongoing clinical program."

Record-breaking Donor Heart Transplant Utilizing the Paragonix SherpaPak®

Retrieved on: 
Tuesday, May 23, 2023
FDA, Surgery, Medical Devices, Health, Cardiology, Heart, Maintenance, MGH, Policy, End organ damage, Record, Temperature, MD, Freezing, Patient, Risk, Physician, Hospital, Transport, Massachusetts General Hospital, Medical device

Paragonix Technologies, Inc. , a leading organ transplant company, announces a milestone achievement with Massachusetts General Hospital (Boston, MA) successfully accessing a donor heart over a total of 2,506 nautical miles away using the Paragonix SherpaPak® Cardiac Transport System .

Key Points: 
  • Paragonix Technologies, Inc. , a leading organ transplant company, announces a milestone achievement with Massachusetts General Hospital (Boston, MA) successfully accessing a donor heart over a total of 2,506 nautical miles away using the Paragonix SherpaPak® Cardiac Transport System .
  • Beginning in Juneau, Alaska, and ending in Boston, Massachusetts, the procurement distance beats previous records in distance to safely deliver a donor heart to a recipient.
  • Advanced Organ Preservation with the FDA-cleared Paragonix SherpPak® Cardiac Transport System is designed to protect organs during transport.
  • The Paragonix SherpaPak® has protected close to 3,000 donor hearts and has been adopted by over 80 transplant centers worldwide.

Leading Patient Advocacy Groups Launch Honor the Gift Campaign to Oppose Medicare Restrictions to Post-Transplant Diagnostic Testing

Retrieved on: 
Monday, May 15, 2023
Health Resources and Services Administration, Life, Survival, Dialysis, Journal, Patient, Transplant, Sussel-Washington Artist, Mended Hearts, Heart, Gift, Registry, Journal of Thoracic Disease, TRIO, GEP, Ann Harrison (lung transplant recipient), Russell Westbrook, Gene expression profiling, Organization, Lung transplantation, The Journal of Heart and Lung Transplantation, Kidney, Heart transplantation, Legislation, American Society of Transplantation, Multimedia, George Washington University Hospital, International Organization (journal), Organ transplantation, Transplant surgeon, End organ damage, Health, Alport syndrome, Society, International Society, Pharmaceutical industry, Dentistry, Health insurance, Medicare

WASHINGTON, May 15, 2023 /PRNewswire/ -- Leading transplant advocacy groups announced today the re-activation of the Honor the Gift campaign, a coalition dedicated to advocating for greater access and coverage to ensure the long-term health of transplant patients. The reinvigorated campaign, which originally contributed to the successful passage of the Immuno Bill, will take on the latest challenge following Medicare's recent restriction of non-invasive diagnostic tests for solid organ allograft injury. Additionally, the coalition will focus on state and federal policies to protect and expand access to innovative tests that are vital to post-transplant patient's health.

Key Points: 
  • The Honor the Gift campaign will focus first and foremost on restoring Medicare coverage following the March 2023 release of a billing article that restricts coverage of non-invasive post-transplant diagnostic tests like dd-cfDNA and GEP.
  • A recent survey of transplant patients found that 95% believe reduced coverage for non-invasive tests would negatively impact their post-transplant care.
  • "I am proud to be part of the Honor the Gift campaign to advocate for continued coverage.
  • American journal of transplantation: official journal of the American Society of Transplantation and the American Society of Transplant Surgeons vol.

Gracell Biotechnologies Initiates Investigational Study Evaluating GC012F for Treatment of Refractory Systemic Lupus Erythematosus (SLE)

Retrieved on: 
Monday, May 15, 2023
Tissue, IIT, CD19, CRS, Bone marrow, Cancer, End organ damage, Quality of life, SLE, Cytokine release syndrome, Patient, Graceling, SAN, B cell, Immune system, Autoimmune disease, Disease, RRMM, Death, IND, ORR, BCMA, Autoantibody, Pharmaceutical industry, Vaccine

SAN DIEGO, Calif., SUZHOU and SHANGHAI, China, May 15, 2023 /PRNewswire/ -- Gracell Biotechnologies Inc. ("Gracell" or the "Company", NASDAQ: GRCL), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer and autoimmune diseases, today announced the initiation of an investigator-initiated trial (IIT) in China of GC012F, the Company's autologous FasTCAR therapeutic candidate dual-targeting B cell maturation antigen (BCMA) and CD19, for the treatment of refractory SLE.

Key Points: 
  • "Our lead candidate GC012F leverages several next-generation CAR-T technologies including CD19/BCMA dual-targeting and the FasTCAR next-day manufacturing.
  • "Patients with refractory SLE have limited options to treat their wide-ranging and often debilitating symptoms.
  • As such, there is urgent, high unmet medical need for more effective – and even curative – therapies, particularly to help manage refractory SLE.
  • [3]
    Gracell's GC012F represents a novel approach entering human study for refractory SLE and pioneers the use of CD19/BCMA dual-targeting CAR-T in autoimmune disease.

First Comprehensive Care Plan to Prevent Preeclampsia Published in the American Journal of Obstetrics and Gynecology

Retrieved on: 
Friday, April 28, 2023
Research, Women, Publishing, Baby, Maternity, Communications, Other Health, Biotechnology, Consumer, Health, Science, Blood pressure, Exercise, Survivor, Medical Affairs Bureau, Pregnancy, Diet, Obstetrics, Education, Care, Parent, Sleep, End organ damage, Risk assessment, Woman, Nursing care plan, AJOG, Risk, Aspirin, Pre-eclampsia, American Journal, Patient, EHR, Preterm birth, Medicine, Biology, Mortality, UPMC, Principal, American Journal of Obstetrics and Gynecology, Disease, Dietary supplement, Birth control, Philip H. Mirvis, Gynaecology

These recommendations are a significant shift from the current care approach, which has historically lacked a comprehensive, integrated strategy.

Key Points: 
  • These recommendations are a significant shift from the current care approach, which has historically lacked a comprehensive, integrated strategy.
  • While technology to reliably predict preeclampsia is imminent, until now there has not been clear direction on optimal strategies for its prevention.
  • Today, most pregnant individuals at increased risk do not receive even one of the interventions to prevent preeclampsia.
  • “An unprecedented collaboration between medical experts and preeclampsia advocates created this novel patient-centered Care Plan.

4DMT Acquires Complement Pathway Inhibitor Payload for 4D-175 Product Candidate for Geographic Atrophy

Retrieved on: 
Monday, April 24, 2023
Retina, Injection, Perelman School of Medicine at the University of Pennsylvania, CFH, University, Chelsea Handler, Doctor of Philosophy, Attention deficit hyperactivity disorder predominantly inattentive, AMD, Cubic foot, Inflammation, CMC, Survival, Complement, End organ damage, Factor, University of Pennsylvania, Atypical hemolytic uremic syndrome, GA, AAV, Geographic atrophy, IVT, Patient, Ophthalmology, Therapy, Autoimmunity, Disease, Vaccine, Pharmaceutical industry, R100, Pharmacology

Geographic atrophy is a highly prevalent disease with a significant unmet medical need.

Key Points: 
  • Geographic atrophy is a highly prevalent disease with a significant unmet medical need.
  • According to published estimates, there are over one million individuals with GA in the U.S. alone as of 2022.
  • The first treatment for GA, complement inhibitor pegcetacoplan injection, was approved in the U.S. in February 2023 and is administered by intravitreal (IVT) injection once every 25 to 60 days.
  • Complement Factor H (CFH) is a master regulator of the complement system, functioning as a natural inhibitor of the alternative complement pathway.

What is sepsis? How to spot, manage and prevent it

Retrieved on: 
Sunday, April 23, 2023
Blood pressure, Infection, CT, Conversation, Central nervous system, Diabetes, Sepsis, HIV, Gallbladder, Hypotension, Public, Respiratory rate, Marie Cassidy, Osteomyelitis, Non-communicable disease, Pancreas, End organ damage, Respiratory system, National Institute, Organ dysfunction, Temperature, Risk, Diarrhea, History, Septic shock, Chronic obstructive pulmonary disease, Pyelonephritis, MRI, Magnetic resonance imaging, Vital signs, Patient, Sanitation, Blood, Water, Abscess, Viral, Hypovolemia, Abdomen, National Institute for Communicable Diseases, Conditional sentence, Confusion, Personality, Septic, Liver, Burns, Heart rate, Acute respiratory distress syndrome, Mortality, Society, ICU, System, Computerize, Meningitis, Pneumonia, Skin, Kidney disease, Disease, Pharmaceutical industry, Vaccine, Sewage treatment, Nursing, Medical device, Tachypnea

Sepsis, a life threatening condition, happens when the body has an excessive immune response to an infection in the blood stream.

Key Points: 
  • Sepsis, a life threatening condition, happens when the body has an excessive immune response to an infection in the blood stream.
  • The Conversation Africa’s Ina Skosana spoke to pathologists from the National Institute of Communicable Diseases about the illness and its impact.

What causes sepsis?

    • There are common causes of sepsis.
    • Infections of the central nervous system (meningitis) as well as skin and soft tissue (surgical site, wounds or burns) are also common causes of sepsis.

Who is at risk of sepsis?

    • But babies up to one month old and people older than 65 years have a higher risk of developing the condition.
    • Prolonged hospital stays or admission to an intensive care unit (ICU) can also increase the risk of sepsis.

What are the symptoms of sepsis and septic shock?


    Symptoms of sepsis are not specific. These may include one or more of these:
    Septic shock is a progression of sepsis. It’s characterised by hypotension (low blood pressure), hypovolaemia (loss of bodily fluids such as water and blood) and organ dysfunction. Patients typically present with extreme confusion or loss of consciousness.

How is sepsis and septic shock diagnosed?

    • There are various tests available to diagnose sepsis and septic shock.
    • Sepsis and septic shock are clinical syndromes defined by a combination of signs, symptoms, laboratory and physiological abnormalities.
    • A variety of clinical variables and tools such as vital signs (heart rate, respiratory rate, temperature and blood pressure), laboratory blood tests (confirmation of infection) and clinical examinations have to be reviewed for sepsis screening.

How is sepsis managed?

    • Patients with sepsis need close monitoring and treatment in a hospital ICU.
    • Intravenous fluids should be started as soon as possible, preferably within the first three hours of sepsis being identified.

How is sepsis prevented?

    • In healthcare facilities prevention of the sepsis include practising appropriate infection prevention and control measures which can reduce infections by 50%.
    • Recognising sepsis early and introducing antibiotics treatment early can reduce the likelihood of sepsis progressing to mortality.
    • Anyone who has signs and symptoms of sepsis, even when the underlying infection is not apparent, should seek medical care immediately.

Cabaletta Bio Receives FDA Clearance of IND Application for CABA-201 for Treatment of Systemic Lupus Erythematosus

Retrieved on: 
Friday, March 31, 2023
Kidney disease, Lupus, Partnership, Nature Medicine, Clinical trial, Pathology, Autoimmunity, Woman, Cyclophosphamide, SLE, Patient, End organ damage, Risk, Autoimmune disease, Immune system, Seventh Avenue station (IND lines), Diagnosis, FDA, Death, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, IND, Food, Pharmaceutical industry, Cabaletta

PHILADELPHIA, March 31, 2023 (GLOBE NEWSWIRE) -- Cabaletta Bio, Inc. (Nasdaq: CABA), a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies for patients with autoimmune diseases, today announced that the Company’s Investigational New Drug (IND) application for CABA-201, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy, has been cleared by the U.S. Food and Drug Administration (FDA). The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 for the treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis (LN) or active SLE without renal involvement.

Key Points: 
  • The Company plans to initiate a Phase 1/2 clinical trial of CABA-201 for the treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis (LN) or active SLE without renal involvement.
  • “We believe the clearance of this IND application within 6 months of licensing the binder for CABA-201 is an important milestone for patients with autoimmune disease.
  • “The Phase 1/2 clinical trial will begin in patients with either active LN or SLE without renal involvement.
  • This represents the first trial that employs Cabaletta’s CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy.

Sickle Cell Disease Association of America to promote clinical trials

Retrieved on: 
Friday, March 17, 2023
Sickle Cell Disease Association of America, Education, Perception, Sickle cell disease, Stroke, Clinical trial, End organ damage, Quality of life, Editas Medicine, Beam Therapeutics, Organization, Jaundice, Forma, Gallstone, Death, Patient, Blood, Anemia, Sanofi, Vertex Pharmaceuticals, Research, Therapy, Chronic pain, Safety, Caregiver, Sickle, Pharmaceutical industry, Science, Pfizer

HANOVER, Md., March 17, 2023 /PRNewswire-PRWeb/ -- The Sickle Cell Disease Association of America, a national nonprofit membership organization that advocates for people affected by sickle cell, formed the Sickle Cell Disease C.A.R.E.S. Consortium, an initiative of pharmaceutical companies united to promote clinical trial participation and education.

Key Points: 
  • The Sickle Cell Disease Association of America, a national nonprofit membership organization that advocates for people affected by sickle cell, formed the Sickle Cell Disease C.A.R.E.S.
  • HANOVER, Md., March 17, 2023 /PRNewswire-PRWeb/ -- The Sickle Cell Disease Association of America, a national nonprofit membership organization that advocates for people affected by sickle cell, formed the Sickle Cell Disease C.A.R.E.S.
  • "We have an opportunity and a responsibility to change the perception of clinical trials and increase the participation of sickle cell patients in clinical trials," said Regina Hartfield, president and CEO of the Sickle Cell Disease Association of America.
  • Sickle Cell Disease Association of America advocates for people affected by sickle cell conditions and empowers community-based organizations to maximize quality of life and raise public consciousness while advancing the search for a universal cure.

Extra pounds put kids at higher risk for hypertension

Retrieved on: 
Tuesday, March 14, 2023
BMI, End organ damage, Health information management, University, JAMA Network Open, Hypertension, Doctor of Philosophy, Blood pressure, Parent, Habit, Human, Risk, Obesity, Child, Body mass index, Kaiser Permanente, Overweight, Pharmaceutical industry, Dietary supplement, Birth control, MD

PASADENA, Calif., March 14, 2023 /PRNewswire/ -- A Kaiser Permanente study of more than 800,000 young people between the ages of 3 and 17 showed that youth at the upper range of average weight had a 26% higher risk of developing hypertension than those closer to what is considered average weight. The study was published March 8, 2023, in JAMA Network Open.

Key Points: 
  • "Hypertension during youth tracks into adulthood and is associated with cardiac and vascular organ damage.
  • "The findings of this study of hypertension among a diverse population of children in Southern California show us the detrimental effects of even a few extra pounds on our young people."
  • Compared to youths in the medium range of average weight, the risk of developing hypertension within 5 years was 26% higher for youths at the high end of the average weight range.
  • The rate of hypertension was higher among boys than girls, and among youth on state-subsidized health plans in comparison to those not on state-subsidized health plans.