Periodic breathing

Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate Treatment of mucopolysaccharidosis type I, 22/09/2016 Positive

Retrieved on: 
Thursday, April 18, 2024
Eurostat, Diagnosis, Civil service commission, Death, Glycosaminoglycan, B cell, Enzyme, Mutation, Medicine, Cell, Mental disability, Disease, Patient, Committee, Knowledge, Scheie syndrome, Regulation, EMA, IRIS, Periodic breathing, Mucopolysaccharidosis, European, COMP, Enzyme replacement therapy, European Commission, Safety, DSM-IV codes, IQVIA, Marketing, Haematopoiesis, Liver, RDS, FGK, Hurler syndrome, MPS, Pharmaceutical industry

Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate Treatment of mucopolysaccharidosis type I, 22/09/2016 Positive

Key Points: 


Orphan designation: 6'-(R)-methyl-5-O-(5-amino-5,6-dideoxy-α-L-talofuranosyl)-paromamine sulfate Treatment of mucopolysaccharidosis type I, 22/09/2016 Positive

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: 
Saturday, April 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.

Arch Biopartners Clinical Team Publishes Data from Phase II Trial for LSALT Peptide Targeting Organ Inflammation in Hospitalized Patients Infected with SARS-CoV-2

Retrieved on: 
Monday, March 18, 2024
CCL7, COVID, Major, BMJ Open, IL-6, AKI, Inflammation, Lung, Biomarker, Hospital, Acute respiratory distress syndrome, TMX Group, CXCL10, Acute kidney injury, SARS-CoV-2, Human, TSX, Chemokine, Arch, Cytokine, Periodic breathing, Phase, OTCQB, CXCL8, Liver, Somayaji, BMJ, Randomness, Pharmaceutical industry

New biomarker data from the pandemic Phase II trial, provides further scientific rationale for Arch to bring LSALT peptide into larger trials to inhibit DPEP-1 mediated organ inflammation.

Key Points: 
  • New biomarker data from the pandemic Phase II trial, provides further scientific rationale for Arch to bring LSALT peptide into larger trials to inhibit DPEP-1 mediated organ inflammation.
  • Arch is currently performing a Phase II human trial to support LSALT peptide as a first ever treatment for preventing cardiac surgery-associated acute kidney injury.
  • The results of the Phase II trial provided first-ever evidence validating DPEP-1 as a mediator of organ inflammation and therapeutic target in humans.
  • The new data provides more scientific rationale for Arch to advance LSALT peptide to prevent leukocyte recruitment and organ inflammation for other indications, including a larger Phase II trial targeting cardiac surgery-associated AKI, which recently began recruiting patients.

ResMed's 2024 Global Sleep Survey Uncovers a World in Sleep Crisis

Retrieved on: 
Friday, March 15, 2024
Health, Sleep apnea, Conditional sentence, Obesity, Exercise, RMD, ResMed, Somnolence, SAN, Insomnia, Social media, Sleep, ASX, News, Female, Irritation, Woman, Periodic breathing, COPD, Nursing

More than one-third of respondents are now actively tracking their sleep patterns, and many are adjusting bedtime routines in an effort to improve sleep quality.

Key Points: 
  • More than one-third of respondents are now actively tracking their sleep patterns, and many are adjusting bedtime routines in an effort to improve sleep quality.
  • SAN DIEGO, March 15, 2024 (GLOBE NEWSWIRE) -- ResMed (NYSE: RMD, ASX: RMD), the global leader in digital health and cloud-connected medical devices that transform care for people with sleep apnea, COPD, and other chronic diseases, today announced the results of its 2024 Global Sleep Survey in conjunction with World Sleep Day (March 15), shedding light on the critical sleep challenges faced by people around the world.
  • To learn more about ResMed’s 2024 Global Sleep Survey or for help identifying if you have symptoms that could indicate poor sleep health, visit https://www.resmed.com/sleepassessment .
  • The 2024 ResMed Global Sleep Survey included a total of 36,000 respondents across 17 markets including Australia, Brazil, China, France, Germany, Hong Kong, India, Ireland, Japan, Korea, Mexico, New Zealand, Singapore, Taiwan, Thailand, UK and USA, between December 2023 and January 2024.

ADC Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates

Retrieved on: 
Wednesday, March 13, 2024
AXL, PIN, Neutropenia, Growth, Rituximab, Sarcoma, ALT, NSCLC, ASH, FY, Progression-free survival, Skin infection, Patient, Follicular lymphoma, S&M, Research, EDT, Aes, Periodic breathing, G&A, University, Lung cancer, Insurance, AACR, DLT, Pancreatic cancer, Hyperglycemia, Society, Therapy, Clinical trial, Diffuse large B-cell lymphoma, PFS, CD22, ADC, Data, Fatigue, MD Anderson Cancer Center, FDA, DLBCL, Marketing, PSMA, IDMC, Pharmaceutical industry

LAUSANNE, Switzerland, March 13, 2024 (GLOBE NEWSWIRE) -- ADC Therapeutics SA (NYSE: ADCT) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided business updates.

Key Points: 
  • “In the fourth quarter we saw results of our strategy in action across a number of key areas.
  • A return to sequential quarter-over-quarter growth in the fourth quarter of 2023 followed the restructuring of the commercial model, with sales volume increasing in both community and academic settings.
  • R&D expenses were $30.3 million for the fourth quarter and $127.1 million for full year 2023, compared to $48.1 million and $186.5 million, respectively, for the fourth quarter and full year 2022.
  • ADC Therapeutics management will host a conference call and live audio webcast to discuss fourth quarter and full year 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time.

ENHERTU® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors

Retrieved on: 
Saturday, April 6, 2024
Research, Women, FDA, Clinical Trials, Biotechnology, Pharmaceutical, Consumer, Health, Science, Oncology, Orbis, Urinary tract infection, Cardiac arrest, Stomatitis, Patient, Stroke, Lung cancer, University, Acute kidney injury, Neoplasm, Therapy, Anemia, Vomiting, Pleural effusion, Cellulitis, Shock (mechanics), Periodic breathing, Colorectal cancer, Abdominal pain, Safety, Immunohistochemistry, Fatigue, ADC, Daiichi Sankyo, Food, IHC, Sepsis, NSCLC, Appetite, Biliary tract, Constipation, NCCN, MD, Priority review, Fatality, Pneumonitis, HER2, ILD, Medication, Pneumonia, AstraZeneca, COVID-19, Biomarker, Diarrhea, Bleeding, MD Anderson Cancer Center, Nausea, Upper respiratory tract infection, Pharmaceutical industry

The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .

Key Points: 
  • The first tumor agnostic approval of a HER2 directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including DESTINY-PanTumor02 , DESTINY-Lung01 or DESTINY-CRC02 .
  • In DESTINY-PanTumor02, efficacy was assessed in a subgroup of previously treated patients (n=111) with centrally or locally assessed HER2 positive (IHC 3+) solid tumors including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic or other tumors.
  • In DESTINY-Lung01, efficacy was assessed in a subgroup of patients (n=17) with centrally confirmed HER2 positive (IHC 3+) non-small cell lung cancer (NSCLC).
  • In DESTINY-CRC02, efficacy was assessed in the subgroup of patients (n=64) with centrally confirmed HER2 positive (IHC 3+) colorectal cancer.

FDA Approves New Antibiotic for Three Different Uses

Retrieved on: 
Wednesday, April 3, 2024
Daptomycin, Research, Hypersensitivity, Hypokalemia, Fungal infection, Aztreonam, Dizziness, Pneumonia, Survival, Dysgeusia, Potassium, Seizure, Abdominal pain, Dietary supplement, CABP, Headache, Patient, Public, Insomnia, Bacterial pneumonia, Food and Drug Administration, Animal, Bilirubin, Diarrhea, History, Mortality, Vancomycin, Leukopenia, Clostridioides, Human services, Injection site reaction, Nausea, Rash, Priority review, Bronchopneumonia, Skin, Fever, Heated tobacco product, Ceftriaxone, Safety, SAB, Anemia, Division, Phlebitis, Cosmetics, Vaccine, Infection, Food, Vomiting, Blood, Multimedia, FDA, Periodic breathing, ABSSSI, Pharmaceutical industry

"The FDA will continue our important work in this area as part of our efforts to protect the public health."

Key Points: 
  • "The FDA will continue our important work in this area as part of our efforts to protect the public health."
  • Zevtera's efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial .
  • In the trial, researchers randomly assigned 390 subjects to receive Zevtera (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects).
  • A total of 69.8% of subjects who received Zevtera achieved overall success compared to 68.7% of subjects who received the comparator.

Weston A. Price Foundation Proposes Deeper Look Into the Cause of TB

Retrieved on: 
Friday, March 22, 2024
Chelation, Crimean War, Industrial Age, Periodic breathing, Health, Meat, Siderosis, Cough, Natural gas, TIME, Lactoferrin, Coal, Mycobacterium tuberculosis, Disease, Tuberculosis, Incidence, Anglo-French Wars, Iron, Research, Mystery, Weston A. Price Foundation, Stainless steel, Death, Human, Bacillus, IRON, Atmosphere, Vaccination, Industrialisation, Contagious disease, TB, Power, Aluminium, Multimedia, Blood

DALLAS, March 22, 2024 /PRNewswire/ -- World TB Day, March 24, commemorates the date in 1882 when Dr. Robert Koch announced his discovery of Mycobacterium tuberculosis, the bacillus believed to cause tuberculosis (TB). Koch argued that TB is a contagious disease, spreading from one person to the next through the air. Based on the notion that TB is caused by a contagious bacterium, conventional treatment for TB involves vaccination and administration of multiple antibiotics over a long period. New information requires the scientific community to reexamine the reigning theories about tuberculosis.

Key Points: 
  • DALLAS, March 22, 2024 /PRNewswire/ -- World TB Day, March 24, commemorates the date in 1882 when Dr. Robert Koch announced his discovery of Mycobacterium tuberculosis , the bacillus believed to cause tuberculosis (TB).
  • Koch argued that TB is a contagious disease, spreading from one person to the next through the air.
  • "We propose looking elsewhere for the cause of TB," says Sally Fallon Morel of the Weston A.
  • "We propose looking elsewhere for the cause of this terrible illness," says Sally Fallon Morell, president of the Weston A.

Onymos and Vapotherm Announce Partnership to Create an End-to-End Internet of Medical Things Solution (IoMT)

Retrieved on: 
Wednesday, March 20, 2024
Temperature, Logic, Organization, Partnership, Internet of things, Fraction of inspired oxygen, VAPO, Patient, SAN, Gateway, Internet, Hospital, HVT, IoMT, HIPAA, OTCQX, Data, Periodic breathing, SOC 2

SAN FRANCISCO, March 20, 2024 /PRNewswire/ -- Onymos, developer of the world's first Features-as-a-Service platform, and Vapotherm, Inc. (OTCQX: VAPO), ("Vapotherm"), a global medical technology company whose proprietary high-velocity therapy® products treat patients of all ages suffering from respiratory distress, today announced the formation of a development and commercialization partnership. This partnership will help Vapotherm create a unique respiratory digital platform to meet its data visualization and device management goals for the Vapotherm HVT® 2.0 system in the acute care space as well as for future products in the home.

Key Points: 
  • Through the Onymos Features-as-a-Service platform , Vapotherm accesses Onymos' suite of Internet of Things (IoT) features — including Onymos Edge, Onymos Access, and Onymos DataStore — to build a secure end-to-end solution to connect the HVT 2.0 fleet with the cloud.
  • It consists of a GoLang-based "Gateway" application, an Angular web dashboard for remote device management, and cloud storage for patient data.
  • The Onymos platform also supports many of the other most popular frameworks for web and mobile application development.
  • For more information on Onymos, its Features-as-a-Service platform, or how it can help your company realize its IoT or IoMT goals, visit Onymos.com .

Ferinject® approved by Health Canada for the treatment of iron deficiency anemia in adult and pediatric patients and iron deficiency in adult patients with heart failure

Retrieved on: 
Tuesday, March 19, 2024
CSL Vifor, University, Research, Exercise, Classification, Health professional, Risk, Patient, Public, Palpitations, Health care, NYHA, News, Periodic breathing, Cardiovascular Research, Quality of life, Health Canada, Woman, Heart failure, Anemia, Fatigue, Hospital, Dietary supplement

Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4.

Key Points: 
  • Research shows that rates of iron deficiency are even higher than previously reported in Canada, with the condition particularly prevalent in women of reproductive age3 and children4.
  • "The news of a new treatment option tested in clinical trials is welcomed, given that oral irons may not be able to adequately deliver the desired outcomes for Canadian patients with heart failure impacted by iron deficiency."
  • Iron deficiency affects one in every two hospitalized patients with heart failure5.
  • * The New York Heart Association Functional Classification is used by Healthcare Professionals to classify patients' heart failure based on the severity of their symptoms.