Hypoxia

Movano Health Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, April 4, 2024
Blood pressure, COVID, Institutional review board, SOC, Obesity, Growth, Remote patient monitoring, Evie, D2C, Patient, Conditional sentence, Heart rate, Sleep, Workplace, Trial of the century, Woman, TAM, Oxygen saturation (medicine), Skin temperature, Hypoxia, FDA, Hand, RPM, Food, IRB, Pharmaceutical industry

PLEASANTON, Calif., April 4, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, reported fourth quarter and year end 2023 results and provided a business update.

Key Points: 
  • PLEASANTON, Calif., April 4, 2024 /PRNewswire/ -- Movano Health (Nasdaq: MOVE), a pioneer in health technology, reported fourth quarter and year end 2023 results and provided a business update.
  • Movano Health achieved significant development milestones on its path to obtaining the FDA clearances necessary to launch the medical device version of the ring, Evie Med.
  • In October 2023, announced the results of its Institutional Review Board (IRB)-approved blood pressure clinical study.
  • Management will host a conference call and live audio webcast to discuss these results and provide a business update today at 2:00 pm PT/5:00 pm ET.

Data-Science-Powered Research by Seattle Children's and Microsoft Shows Promise of Predicting SIDS and Other Causes of Sudden Death

Retrieved on: 
Thursday, March 28, 2024
Gene, Sudden death, Herbal cigarette, SIDS, Learning, Medical genetics, Child, Infant, Electronic cigarette, Oxygen, Rutgers University, Research institute, Microsoft, Partnership, Risk, International, Pediatrics, Death, Fatality, Seattle Children's, Preterm birth, Database, American Journal, Research, AI, University, Pregnancy, DRS, Cardiac arrest, Hypoxia, Genetic testing, Developing Story, Mortality, SUID, Doctor of Philosophy, Life, Smoking, Summit, Pacific Northwest, Medical device

The event was sponsored by The Center for Integrative Brain Research at Seattle Children's and Microsoft AI for Good Lab.

Key Points: 
  • The event was sponsored by The Center for Integrative Brain Research at Seattle Children's and Microsoft AI for Good Lab.
  • Among the many topics attendees discussed was groundbreaking new research that suggests genetic testing at birth may hold the promise of detecting SIDS risk — and potentially other causes of sudden death later in life.
  • The Aaron Matthew SIDS Research Foundation funds the database, which is maintained and managed at Seattle Children's Research Institute.
  • "Scientific research sometimes leads to surprises," said Jan-Marino Ramirez , PhD, Director of the Center for Integrative Brain Research at Seattle Children's.

Akebia Receives FDA Approval of Vafseo® (vadadustat) Tablets for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients on Dialysis

Retrieved on: 
Thursday, March 28, 2024
CSL Vifor, Thrombosis, Myocardial infarction, Conference, Organization, Tablet, Caregiver, Anemia, Physician, CKD, Webcast, Patient, Coronary thrombosis, Stroke, AKBA, Death, Renal Support Network, Kidney disease, Nephrology, Kidney, Chronic kidney disease, Dialysis, Division, Safety, Stanford University, Food, Hypoxia, FDA, Erythropoietin, Pharmaceutical industry

CAMBRIDGE, Mass., March 27, 2024 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has approved Vafseo® (vadadustat) Tablets for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Vafseo is a once-daily oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin to manage anemia. Vafseo is now approved in 37 countries.

Key Points: 
  • "At Akebia we are committed to kidney patients, a dedication that has driven our team to achieve this milestone.
  • We believe this commitment uniquely positions the company to execute a successful launch designed to drive toward a potential new oral standard of care for dialysis patients."
  • Approximately 500,000 adult patients in the U.S. on dialysis suffer from anemia due to CKD1, which may be associated with many adverse clinical outcomes.
  • Today, most CKD patients are treated for anemia with injectable erythropoiesis-stimulating agents mostly administered at dialysis centers.

Arcus Biosciences Reports Fourth-Quarter and Full-Year 2023 Financial Results and Provides a Pipeline Update

Retrieved on: 
Wednesday, February 21, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, General Health, Health, Clinical Trials, Cancer, PFS, PD, KIT, Toxicity, Anemia, Roche, Research and development, Security (finance), Part, Hypoxia, PD-1, Belzutifan, Safety, Income tax, Death, Access code, Administration, Exelixis, Webcast, Patient, Acceleration, TIGIT, Plasma, G&A, Pancreatic cancer, AXL, CD73, Pharmaceutical industry

Enrollment was discontinued for the Phase 3 study ARC-10 evaluating domvanalimab plus zimberelimab compared to pembrolizumab in first-line PD-L1-high NSCLC.

Key Points: 
  • Enrollment was discontinued for the Phase 3 study ARC-10 evaluating domvanalimab plus zimberelimab compared to pembrolizumab in first-line PD-L1-high NSCLC.
  • The companies also plan to initiate a Phase 2 trial to evaluate domvanalimab plus zimberelimab in a new disease setting.
  • Arcus will host a conference call and webcast today, February 21, at 2:00 PM PT / 5:00 PM ET to discuss its fourth-quarter and full-year 2023 financial results and pipeline updates.
  • To access the live webcast and accompanying slide presentation, please visit the “Investors & Media” section of the Arcus Biosciences website at www.arcusbio.com .

Fauna Bio Announces Dr. Lara Do Amaral-Silva as Recipient of the CEPS FaunaBio Translational Research Award

Retrieved on: 
Monday, March 4, 2024
Oxygen, Wake Forest University, Breakfast, Animal, Physiology, Hypoxia, Myenteric plexus, Health, DSM-IV codes, APS, NMDA, Mammal, American Physiological Society, Genomics, Biology, Hibernation, Research, Human, Brain, Medical device

EMERYVILLE, Calif., March 4, 2024 /PRNewswire/ -- Fauna Bio, biotechnology company improving human health by leveraging animal genomics, announced today Dr. Lara Do Amaral-Silva, assistant professor of biology at Wake Forest University, as the recipient of the FaunaBio Translational Research Award through the American Physiological Society (APS).

Key Points: 
  • Her research focuses on the physiology of animals that can overcome metabolic challenges in the brain to gain overarching insights into brain diseases.
  • "While Fauna Bio is focused on data and discovery from mammals, we recognize there is important translational work being done in a broader range of species.
  • This important research highlights the resilience of brain function in animals under challenging conditions that would be fatal to humans," said Ashley Zehnder, Ph.D., CEO & Co-Founder, Fauna Bio.
  • The research also identified specific NMDA receptor subunits, GluN2B and GluN2C, as key players in mediating the NMDA receptor current.

FDA Approves First Cellular Therapy to Treat Patients with Unresectable or Metastatic Melanoma

Retrieved on: 
Friday, February 16, 2024
Human services, BRAF, Skin cancer, Neoplasm, Fever, Immune system, Melanoma, Cosmetics, Multimedia, Febrile neutropenia, Immunotherapy, Diarrhea, Hair loss, Dietary supplement, FDA, Food, Infection, Growth, Swelling, Tachycardia, PD-1, Edema, Cell, Hypoxia, Vaccine, Risk, Antibody, Animal, Metastasis, Safety, Heated tobacco product, Fatigue, Accelerated approval (FDA), Death, Rash, Public, BRAF V600, Patient, Protein, Chills, Sunlight, Hypotension, MEK, Cancer, Pharmaceutical industry

"Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).

Key Points: 
  • "Unresectable or metastatic melanoma is an aggressive form of cancer that can be fatal," said Peter Marks, M.D., Ph.D., director of the FDA's Center for Biologics Evaluation and Research (CBER).
  • Melanoma can spread to other parts of the body if not detected and treated early, resulting in metastatic disease.
  • Treatment for unresectable or metastatic melanoma may include immunotherapy using PD-1 inhibitors, which are antibodies targeting certain proteins in the body to help the immune system fight off cancer cells.
  • Those patients whose melanoma has progressed with these therapies have a high unmet medical need.

RAPT Therapeutics Bolsters Leadership Team with the Appointment of Nipun Davar, Ph.D., as Senior Vice President of Technical Operations

Retrieved on: 
Tuesday, February 13, 2024
SAN, Pharmacy, RAPT, Drug development, MBA, Hypoxia, Inflammation, Doctor of Philosophy, University, Therapy, Business, Patient, Astex Pharmaceuticals, CMC, Pharmaceutical industry

“I am delighted to announce the addition of Nipun to the RAPT leadership team and welcome his wealth of experience in small molecule product development and commercial manufacturing,” said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics.

Key Points: 
  • “I am delighted to announce the addition of Nipun to the RAPT leadership team and welcome his wealth of experience in small molecule product development and commercial manufacturing,” said Brian Wong, M.D., Ph.D., President and Chief Executive Officer of RAPT Therapeutics.
  • Nipun brings over 27 years of extensive biopharmaceutical and drug development experience specializing in successful product development and commercial manufacturing.
  • Nipun holds a Ph.D. in Pharmaceutical Sciences from the University of Maryland and an MBA from the Wharton School of Business.
  • Nipun added, "I am pleased to join the RAPT leadership team during this exciting period.

Orphan designation: Autologous blood-derived tumour and hypoxia educated macrophages Treatment of spinal cord injury, 22/05/2023 Positive

Retrieved on: 
Sunday, February 4, 2024
COMP, Hypoxia, IRIS, European Commission, Committee, Macrophage, EMA, Pharmaceutical industry

EU/3/23/2777 - orphan designation for treatment of spinal cord injury

Key Points: 
  • EU/3/23/2777 - orphan designation for treatment of spinal cord injury
    Autologous blood-derived tumour and hypoxia educated macrophages
    OrphanHuman
    Hemera S.r.l.
  • For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

Mallinckrodt Presents New Data on TERLIVAZ® (terlipressin) for Injection at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress

Retrieved on: 
Monday, January 22, 2024
Hypoxia, Patient, Alcoholic hepatitis, Cirrhosis, ACLF, Respiratory failure, Society, Risk, Critical care, Mallinckrodt, Oxygen saturation (medicine), Congress, Boxed warning, Critical Care Medicine (journal), Clinical trial, Volume overload, HRS, SCCM, Use, SCR, Dietary supplement

DUBLIN, Jan. 22, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced the presentation of findings from a post hoc analysis of the Phase 3 CONFIRM clinical trial. In this analysis, treatment with TERLIVAZ® (terlipressin) for injection was associated with improvements in verified hepatorenal syndrome (HRS) reversal and HRS reversal vs. placebo in adult cirrhosis patients with alcoholic hepatitis (AH) and HRS with rapid reduction in kidney function.1,2 The results will be shared in an oral presentation at the Society of Critical Care Medicine (SCCM) 2024 Critical Care Congress, taking place January 21-23, 2024, in Phoenix, AZ.

Key Points: 
  • Patients with volume overload or with acute-on-chronic liver failure (ACLF) Grade 3 are at increased risk.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.
  • Ineligibility for Liver Transplant: TERLIVAZ-related adverse reactions (respiratory failure, ischemia) may make a patient ineligible for liver transplantation, if listed.
  • For patients with high prioritization for liver transplantation (e.g., MELD ≥35), the benefits of TERLIVAZ may not outweigh its risks.

Eisai Furthers Oncology Research Across Multiple Cancers at ASCO GI and ASCO GU 2024

Retrieved on: 
Tuesday, January 16, 2024
MSD, PRISM, Renal cell carcinoma, Hypoxia, Patient, HCC, Research, Neoplasm, Meta-analysis, Oxidative stress, Rescue coordination centre, RCC, Merck & Co., ASCO, Cell lineage, Everolimus, Society, Pembrolizumab, Headquarters, FGFR2, Deep, Cholangiocarcinoma, Drug discovery, Hepatocellular carcinoma, Cancer, Food, Proteostasis, CBP, Safety, Abstract, Food and Drug Administration, FDA, Inflammation, CREB-binding protein, Biomarker, LEAP, TKI, Merck, Differentiable function, Pharmaceutical industry

TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.

Key Points: 
  • TOKYO, Jan 16, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today the presentation of oncology research at two upcoming medical meetings taking place in-person in San Francisco, California and virtually.
  • First, the company will share findings in hepatocellular carcinoma (HCC) and cholangiocarcinoma during the 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium (#GI24), which is taking place from January 18-20.
  • Tasurgratinib, for which a marketing authorization application was submitted in Japan in December 2023, is an orally available selective tyrosine kinase inhibitor of FGFR1-3.
  • Eisai aspires to discover innovative new drugs with new targets and mechanisms of action from these domains, with the aim of contributing to the cure of cancers.