Hypotension

Synthekine Presents Positive Initial Results from Phase 1a/1b Clinical Trial of α/β Biased IL-2, STK-012, for Treatment of Advanced Solid Tumors

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Tuesday, April 9, 2024
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, Arthralgia, Toxicity, Cell, NSCLC, RECIST, HNSCC, Patient, Diarrhea, Maculopapular rash, Lung cancer, Renal cell carcinoma, Injection site reaction, AACR, Nausea, Lymphocyte, Hypotension, RCC, Transaminase, Poster, Itch, CLS, Capillary leak syndrome, Fatigue, Vomiting, NK, Inc., Pharmaceutical industry

Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.

Key Points: 
  • Synthekine Inc ., an engineered cytokine therapeutics company, today announced positive initial results from a Phase 1a/1b clinical trial of its α/β biased IL-2 partial agonist, STK-012, for the treatment of advanced solid tumors.
  • The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego.
  • In the results presented, which included 47 patients treated in Phase 1a dose escalation, STK-012 monotherapy demonstrated a favorable safety, efficacy, pharmacokinetic and pharmacodynamic profile.
  • The poster, titled “Initial results from a Phase 1a/1b study of STK-012, a first-in-class α/β IL-2 receptor biased partial agonist in advanced solid tumors (NCT05098132),” will be presented today at AACR from 9 am to 12:30 pm PT.

FDA Accepts Filing of New Drug Application for Nalmefene Auto-injector for the Treatment of Known or Suspected Opioid Overdose

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Monday, April 8, 2024
General Health, FDA, Health, Pharmaceutical, Medical Supplies, Hypoventilation, Hypersensitivity, Nalmefene, Pulmonary edema, Caregiver, Safety, Tachycardia, Risk, New Drug Application, Patient, Ventricular tachycardia, Naloxone, Health care, Buprenorphine, Mortality, NDA, MD, Methadone, Ventricular fibrillation, Hypotension, Oxygen, LAAM, Recurrence, Allergy, Purdue University, Hypertension, Fentanyl, Pharmaceutical industry

Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.

Key Points: 
  • Purdue Pharma L.P. (“Purdue”) announced today that FDA has accepted for filing the company’s New Drug Application (NDA) for the auto-injector delivery form of nalmefene hydrochloride injection*.
  • "Through this auto-injector FDA submission, our goal is to help expand the availability of nalmefene to the community alongside existing available options for healthcare professionals.
  • Priority review status means that FDA will expedite the review process to evaluate a drug that would significantly improve treatment of a serious condition.
  • Nalmefene Hydrochloride Injection is indicated in the management of known or suspected opioid overdose.

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

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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.

Purdue Pharma L.P. Awards Grant for Investigator-initiated Research to Examine Opioid Overdose Reversal Using Nalmefene HCl Injection

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Wednesday, March 27, 2024
Other Health, Research, General Health, Pharmaceutical, University, Education, Clinical Trials, Science, Biotechnology, FDA, Other Science, Health, Hypoventilation, Hypersensitivity, Nalmefene, IIR, Pulmonary edema, Doctor of Pharmacy, University of New Mexico, Safety, Tachycardia, Risk, Patient, Hydrogen chloride, Purdue Pharma, Naloxone, UNM, Emergency medicine, Ventricular tachycardia, Mortality, Buprenorphine, MD, Methadone, Emergency department, Ventricular fibrillation, Hypotension, Oxygen, HCI, ED, Hypertension, Recurrence, LAAM, Opioid overdose, Purdue University, Pharmaceutical industry

“We are enthusiastic about supporting research that can contribute to addressing the opioid overdose crisis.”

Key Points: 
  • “We are enthusiastic about supporting research that can contribute to addressing the opioid overdose crisis.”
    The prospective, randomized study, “Evaluation of Nalmefene HCl Injection for Recurrent Respiratory Depression After Suspected Acute Opioid Overdose in an Emergency Department,” will compare the efficacy and safety of nalmefene HCl injection to naloxone injection in the treatment of recurrent respiratory depression due to opioid overdose.
  • Nalmefene HCl injection is an opioid antagonist indicated for the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids and in the management of known or suspected opioid overdose.
  • Nalmefene Hydrochloride injection is contraindicated in patients with a known hypersensitivity to the product.1 The Company distributes nalmefene HCl injection for no profit.
  • The study will be independently developed and carried out by UNM’s research team with Purdue Pharma providing only funding and nalmefene HCI injection.

Vivacelle Bio and University of Missouri-Kansas City School of Medicine Announce Groundbreaking Results from Phase 2a Clinical Trial of VBI-S for Refractory Hypotension in Severe Septic Shock Patients

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Thursday, February 29, 2024
Real-time, Prothrombin time, Sepsis, MD, Inflammation, FDA, Infection, University, Nitric oxide, Hope, Pelvic floor dysfunction, Safety, Lancet, Disease, Patient, Optimism, Septic shock, Clinical trial, Survival, Mortality, Hypotension, Research, Pharmaceutical industry

This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients.

Key Points: 
  • This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients.
  • Patients, after failing standard fluids, received intravenous VBI-S, a revolutionary composition of phospholipid nanoparticles that reversibly absorb nitric oxide.
  • These results fuel our optimism that at last we may have an effective and safe intervention for these very sick patients."
  • This groundbreaking research opens new possibilities for the treatment of septic shock, offering hope and potential survival for millions of patients worldwide.

Vivacelle Bio Integrates Sub-Saharan Africa Strategy into Series B Financing Round

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Thursday, February 22, 2024
Blood pressure, Blood, School, Sepsis, Woman, IIA, Bleeding, Doctor of Philosophy, Resuscitation, The, Shock, MD, Diarrhea, Temperature, Septic, University, Nitric oxide, Shock (mechanics), Senior advisor, Finger, Life, Urinary tract infection, Risk, Internal bleeding, Pelvic floor dysfunction, Malaria, Hypovolemia, Nanoparticle, Gangrene, Neonatal sepsis, JD, Patient, Septic shock, Clinical trial, UMKC, Child, Reperfusion injury, Hypotension, Partnership

Targeted $20M Series B Round to include Sub-Saharan Africa in product development.

Key Points: 
  • Targeted $20M Series B Round to include Sub-Saharan Africa in product development.
  • Vivacelle Bio is partnering with Propelevate to drive the Sub-Saharan Africa strategy, which is fully integrated into its Series B financing round.
  • Through partnership with Propelevate, Vivacelle Bio will engage global health funders and stakeholders during final stages of product development, and Propelevate will drive Vivacelle Bio's go-to-market strategy for African markets upon regulatory approval.
  • "We are excited to partner with Vivacelle Bio because of their commitment to Sub-Saharan Africa.

Mallinckrodt Presents Data on Real-World Outcomes with THERAKOS™ CELLEX™ Photopheresis System Treatment at the 2024 Tandem Meetings

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Wednesday, February 21, 2024
Thermal, Bangladesh Technical Education Board, Pulmonary embolism, Hypotension, Mallinckrodt, Anemia, Month, NIH, PUVA, Meta-analysis, Erythroderma, Excipient, Safety, PUVA therapy, Pain, Infection, Quality of life (healthcare), Deep vein thrombosis, Photopheresis, Artifact, FFS, ECP, Risk, OS, Graft-versus-host disease, Society, Extracorporeal, Methoxsalen, Patient, Systematic review, Burns, Transplant, Massachusetts General Hospital, Sunlight, Literature, Clutch (eggs), Environment, Pharmaceutical industry

DUBLIN, Feb. 21, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical company, today announced a poster presentation of findings from a systematic literature review and meta-analysis of the safety, efficacy, and real-world outcomes of extracorporeal photopheresis (ECP) treatment for patients with steroid-refractory chronic graft-versus-host disease (SR-cGvHD).1 An analysis of 47 studies reporting on the THERAKOS™ CELLEX™ Photopheresis System showed that treatment of SR-cGvHD with ECP was associated with improvements in patients' overall survival (OS), failure-free survival (FFS), and overall response rate (ORR).1 The results will be shared in a poster presentation at the 2024 Tandem Meetings, the combined Transplantation & Cellular Therapy Meetings of the American Society of Transplantation and Cellular Therapy (ASTCT) and the Center for International Blood and Marrow Transplant Research (CIBMTR) taking place February 21-24, 2024 in San Antonio, TX.

Key Points: 
  • Skin-specific response at Months 2-3 and at Months 4-6 were 34.86% (95% CI: 13.26-65.21) and 54.22% (95% CI: 35.67-71.67), respectively.
  • Outcomes may be influenced by therapies not evaluated in the study and the clinical/health economics outcomes may not be solely attributable to THERAKOS ECP.
  • THERAKOS™ Photopheresis is contraindicated in:
    THERAKOS™ Photopheresis treatments should always be performed in locations where standard medical emergency equipment is available.
  • Please refer to the THERAKOS™ CELLEX™ Photopheresis System Operator Manual for a complete list of warnings and precautions and adverse events.

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.

FDA Approves First Medication to Treat Severe Frostbite

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Wednesday, February 14, 2024
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SILVER SPRING, Md., Feb. 14, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.

Key Points: 
  • SILVER SPRING, Md., Feb. 14, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation.
  • Frostbite can occur in several stages, ranging from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite when both the skin and underlying tissue are frozen and blood flow is stopped, sometimes requiring amputation.
  • Iloprost's efficacy in treating severe frostbite was primarily established in an open-label, controlled trial that randomized 47 adults with severe frostbite, who all received aspirin by vein and standard of care, into one of three treatment groups.
  • The two other groups received other medications that are unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3).

JCR Pharmaceuticals’ Research Presentations at WORLDSymposium™ 2024 Showcase JR-141 (Pabinafusp Alfa) and Other Investigational Treatments for Lysosomal Storage Disorders

Retrieved on: 
Wednesday, February 14, 2024
Science, Other Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Clinical Trials, Enzyme replacement therapy, BBB, JCR, MPS II, Traffic barrier, Glycogen storage disease, Ministry, MHLW, ERT, Hunter syndrome, Syndrome, Scheie syndrome, MPS, Safety, Developmental psychology, Hurler syndrome, Child, Patient, Hurler–Scheie syndrome, Trial of the century, Consciousness, DSM-IV codes, Hypotension, Mouse, Pharmaceutical industry

JCR Pharmaceuticals Co., Ltd. (TSE 4552; Chairman and President: Shin Ashida; “JCR”) today announced the presentation of several datasets demonstrating the potential benefits of its investigational therapies for lysosomal storage disorders (LSDs).

Key Points: 
  • JCR Pharmaceuticals Co., Ltd. (TSE 4552; Chairman and President: Shin Ashida; “JCR”) today announced the presentation of several datasets demonstrating the potential benefits of its investigational therapies for lysosomal storage disorders (LSDs).
  • JCR is dedicated to address the unmet medical needs for this community,” said Shin Ashida, President and CEO of JCR Pharmaceuticals.
  • Finally, the third JR-141 presentation is pre-clinical and highlights the recovery of retinal function in mice with MPS II.
  • “We are pleased to be able to offer IZCARGO® to patients with MPS II in Japan,” said Yoshikatsu Eto, M.D., Ph.D., Institute of Neurological Disorders, Advanced Clinical Research Center, Kanagawa, Japan.