Hypersensitivity

Celldex Reports First Quarter 2024 Financial Results and Provides Corporate Update

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måndag, maj 6, 2024
AAAAI, Angioedema, Cell, Research, Enrollment, Itch, Atopic dermatitis, Injection, Congress, American Academy, Skin, PN, ILT4, Allergy, KIT, Cold urticaria, Therapy, Omalizumab, Neuropeptide, Patient, UAS7, Survival, PD-1, Rockefeller University, EAACI, Hypersensitivity, Clinical trial, Xeroderma, CSU, G&A, B cell, Prurigo nodularis, Myelocyte, Disease, Inflammation, Eosinophilic esophagitis, Pharmaceutical industry

HAMPTON, N.J., May 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2024 and provided a corporate update.

Key Points: 
  • Celldex is currently planning two Phase 3 studies of barzolvolimab in CSU, which are expected to initiate this summer.
  • Revenues: Total revenue was $0.2 million in the first quarter of 2024, compared to $1.0 million for the comparable period in 2023.
  • G&A Expenses: General and administrative (G&A) expenses were $9.1 million in the first quarter of 2024, compared to $6.6 million for the comparable period in 2023.
  • Financial Guidance: Celldex believes that the cash, cash equivalents and marketable securities at March 31, 2024 are sufficient to meet estimated working capital requirements and fund current planned operations through 2027.

scPharmaceuticals Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of FUROSCIX Auto-Injector (furosemide 80mg/mL) Injection

Retrieved on: 
onsdag, april 24, 2024
Urine, Kidney, FDA, Shanda, Embolism, Huber loss, Hepatic encephalopathy, Uric acid, Oliguria, Congestion, Blood volume, Furosemide, Organic acid, Deafness, Erythema, Cerebral edema, Ascites, Tinnitus, History, Thrombosis, Creatinine, NYHA, Dehydration, BUN, Patient, Hypersensitivity, Ototoxicity, Anuria, Glucose, Azotemia, Hypoproteinemia, CO2, Diuresis, Cirrhosis, Chronic kidney disease, Edema, Urinary retention, Bruise, Growth, Benign prostatic hyperplasia, Coma, Heart failure, Pharmaceutical industry

BURLINGTON, Mass., April 24, 2024 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (Nasdaq: SCPH) (the “Company”), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector.

Key Points: 
  • The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility.
  • If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs.
  • FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema.
  • The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain.

Lumicell’s Cutting-Edge Imaging Platform Receives Historic FDA Approval to Illuminate Residual Breast Cancer

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torsdag, april 18, 2024
Medical Devices, Surgery, FDA, Clinical Trials, Health Technology, Other Health, Biotechnology, Pharmaceutical, Health, Oncology, Urine, Society, Cancer, Hospital, Safety, Woman, NDA, New Drug Application, Surgeon, Breast, MD, Doctor of Philosophy, Patient, DVS, Anaphylaxis, Hypersensitivity, NEJM, Harvard Medical School, Multimedia, MD Anderson Cancer Center, Surgical oncology, Neoplasm, Massachusetts General Hospital, PMA, Breast cancer, Medical imaging

The most common side effects with LUMISIGHT are hypersensitivity and an abnormal color in urine.

Key Points: 
  • The most common side effects with LUMISIGHT are hypersensitivity and an abnormal color in urine.
  • Results of the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial, used to support the efficacy of the system, were published in NEJM Evidence .
  • “We want to thank our clinical investigators and the hundreds of women who participated in our breast program for LUMISIGHT and Lumicell DVS,” said Jorge Ferrer, Chief Scientific Officer, Lumicell.
  • “Due to your important contributions, LUMISIGHT and Lumicell DVS are now approved and will be available in the United States shortly.”
    Please visit www.LumiSystem.com to learn more about LUMISIGHT and Lumicell DVS.

FDA Approves New Treatment for Uncomplicated Urinary Tract Infections

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onsdag, april 24, 2024
Urine, UTI, FDA, Public, Patient, Staphylococcus, Urinary tract infection, Pivmecillinam, Priority review, Safety, Woman, Cosmetics, Food, Dietary supplement, Heated tobacco product, Infection, Research, Human services, Bacteria, Nausea, Staphylococcus saprophyticus, Escherichia coli, Porphyria, Vaccine, History, Female, Therapy, System, Tablet, Diarrhea, Hypersensitivity, Multimedia, Animal, Proteus mirabilis, Clinical trial, Metabolic disorder, Division, Ibuprofen

SILVER SPRING, Md., April 24, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.

Key Points: 
  • SILVER SPRING, Md., April 24, 2024 /PRNewswire/ -- Today, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus.
  • "The FDA is committed to fostering new antibiotic availability when they prove to be safe and effective, and Pivya will provide an additional treatment option for uncomplicated UTIs."
  • Uncomplicated UTIs are bacterial infections of the bladder in females with no structural abnormalities of their urinary tract.
  • Approximately one-half of all women experience at least one UTI in their lifetime.

AMGEN TO PRESENT TEZSPIRE® PHASE 2A COPD DATA AT ATS 2024

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tisdag, april 16, 2024
Fetus, AMGN, American Thoracic Society, Congress, Arthralgia, ATS, Chronic obstructive pulmonary disease, Emphysema, Pregnancy, Infection, Tezepelumab, PDT, Allergic conjunctivitis, Amgen, Research and development, Back pain, Conference, Placentalia, Vaccine, Miscarriage, Development, Ageing, Helminthiasis, Incidence, Patient, Anaphylaxis, Hypersensitivity, Rash, Pharyngitis, Birth, Asthma, Bronchitis, AstraZeneca, Excipient, Pharmaceutical industry

THOUSAND OAKS, Calif., April 16, 2024 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today provided an update regarding the results of the Phase 2a COURSE trial for TEZSPIRE® (tezepelumab-ekko) in chronic obstructive pulmonary disease (COPD), which were accepted for presentation in the Clinical Trials Symposium at The American Thoracic Society (ATS) 2024 International Conference on Monday, May 20, from 9:15-11:15 a.m. PDT. 

Key Points: 
  • Overall, tezepelumab numerically reduced the annualized rate of moderate or severe COPD exacerbations versus placebo by 17% (90% CI: −6, 36; p=0.1042).
  • Of note, more reductions were observed in a prespecified subgroup of patients with BEC ≥150 cells/μL (37% [95% CI: 7, 57]).
  • The trend in reduction was greater in a small number of subjects with BEC ≥300 cells/µL.
  • We look forward to presenting the full data set at the congress and based on these findings, we are actively planning for the Phase 3 development of tezepelumab in COPD.

EISAI TO PRESENT DATA ON ROBUST NEUROLOGY PORTFOLIO AT THE 76th AMERICAN ACADEMY OF NEUROLOGY® (AAN) ANNUAL MEETING

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fredag, april 12, 2024
Amyloid, Angioedema, Brain, Anticoagulant, Neuroimaging, Patient, Vascular malformation, Lecanemab, Siderosis, Dementia, Cell, Seizure, ARIA, Risk, Aspirin, Focal neurologic signs, Nausea, Cerebral edema, Dizziness, Paracetamol, Arthralgia, Cerebral amyloid angiopathy, Effectiveness, Genetic testing, Intraparenchymal hemorrhage, Observation, Confusion, Alzheimer's disease, Intracerebral hemorrhage, Status epilepticus, Vomiting, Incidence, Aneurysm, Anaphylaxis, Headache, Hypersensitivity, Hypertension, MRI, Magnetic resonance imaging, Chills, Neuron, Bronchospasm, Fatal, Hypotension, Tissue plasminogen activator, Edema, Fever, Excipient, Pharmaceutical industry

Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.

Key Points: 
  • Testing for ApoE ε4 status should be performed prior to initiation of treatment to inform the risk of developing ARIA.
  • Depending on ARIA severity, use clinical judgment in considering whether to continue dosing, temporarily discontinue treatment, or permanently discontinue LEQEMBI.
  • There is no experience in patients who continued dosing through symptomatic ARIA-E or through asymptomatic, but radiographically severe, ARIA-E.
  • There is limited experience in patients who continued dosing through asymptomatic but radiographically mild to moderate ARIA-E.

Esperion Presents Important New Data from CLEAR Outcomes at ACC.24 Highlighting Value of NEXLETOL® (bempedoic acid) Tablets in Diverse Populations Including Women, Hispanics/Latinx and Patients with Obesity

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söndag, april 7, 2024
Uric acid, Urinary tract infection, Anaphylaxis, Myocardial infarction, Common, Bronchitis, Patient, Atherosclerosis, FAHA, Cleveland Clinic, Bempedoic acid, Ezetimibe, Therapy, Anemia, Pain, MACE, Sinusitis, ACC, FOMA, FNLA, FACC, Obesity, Cardiovascular disease, Esperion Therapeutics, Abdominal pain, Risk, Gout, Spasm, Woman, American College, Body mass index, ESPR, Back pain, Outcome, ATP, Safety, Fatigue, Arthralgia, ANN, Angioedema, Kidney, Journal, Constipation, University, Adverse event, Pregnancy, CLEAR, Rash, MPH, Rupture, FDA, Molina Healthcare, JACC, Hypersensitivity, Health, Circulatory system, Tablet, CVD, Incidence, Diarrhea, Fetus, Gallstone, Diet, Excipient, Upper respiratory tract infection, Dietary supplement

ANN ARBOR, Mich., April 07, 2024 (GLOBE NEWSWIRE) -- Esperion (Nasdaq: ESPR) today announced the presentation of results from three pre-specified subgroups from CLEAR Outcomes at the 2024 American College of Cardiology’s Annual Scientific Sessions (ACC.24): women, Hispanic/Latinx, and patients with obesity. These results align with the American College of Cardiology’s robust diversity, equity and inclusion programs to drive cultural change across the profession and ensure that the cardiovascular care team is as diverse as the patients they care for and that all patients are represented in cardiovascular research. The data also reinforce the mission of the ACC: transforming cardiovascular care for all.

Key Points: 
  • “Bempedoic acid is the only FDA approved non-statin LDL lowering therapy to demonstrate reductions in MACE in both primary prevention and secondary prevention patient populations.
  • The Hispanic population is the largest ethnic minority in the U.S., yet is a population historically underrepresented in clinical trials.
  • At Esperion, we discover, develop, and commercialize innovative medicines to help improve outcomes for patients with or at risk for cardiovascular and cardiometabolic diseases.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Lundbeck to Present Data on Migraine Impact Reduction and Sustained Response with VYEPTI® (eptinezumab-jjmr) at 76th Annual Meeting of the American Academy of Neurology

Retrieved on: 
tisdag, april 9, 2024
Health, Other Science, General Health, Clinical Trials, Research, Science, Pharmaceutical, Hypersensitivity, Anaphylaxis, Angioedema, Brain, Eptinezumab, Virtual Private LAN Service, Headache, Patient, American Academy, Interview, MD, Neurology, Migraine, Lundbeck, Quality of life, AAN, Abstract, Pharmaceutical industry

These data will be presented during an oral session at the 76th Annual Meeting of the American Academy of Neurology (AAN) taking place in Denver, Colo., and virtually from April 13-18, 2024.

Key Points: 
  • These data will be presented during an oral session at the 76th Annual Meeting of the American Academy of Neurology (AAN) taking place in Denver, Colo., and virtually from April 13-18, 2024.
  • “Our real-world data helps us better understand how individuals are uniquely impacted by migraine beyond monthly headache days.
  • We’re excited to continually partner with the migraine community to raise the bar on preventive treatment expectations.”
    VYEPTI is indicated for the preventive treatment of migraine in adults.
  • The safety and efficacy of VYEPTI has not been evaluated for use in any psychiatric conditions.

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

Retrieved on: 
måndag, 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.

Calliditas Therapeutics to Present Nefecon Data at the ISN World Congress of Nephrology April 13 - 16 in Buenos Aires

Retrieved on: 
måndag, april 8, 2024
Diabetes, Anaphylaxis, IgA nephropathy, Glaucoma, CYP3A4, Dermatitis, Patient, Parasitism, Indinavir, Budesonide, Ritonavir, Quality of life, Peripheral edema, UPCR, Drug interaction, Vaccine, Saquinavir, Erythromycin, Congress, White, Risk, Headache, Spasm, Ketoconazole, Immunoglobulin A, Liver, Adrenal insufficiency, Immune system, Prediabetes, Proteinuria, Hypertension, Contraindication, Arthralgia, Ciclosporin, International Society, Immunosuppression, KOL, Acne, Infection, EGFR, Measles, Miscarriage, ISN, Hypersensitivity, Pregnancy, HPA, Chickenpox, Fetus, Birth, Itraconazole, CALT, Upper respiratory tract infection, Osteoporosis, Kidney, Cataract, Tropical ulcer, Pharmaceutical industry

The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.

Key Points: 
  • The ISN World Congress of Nephrology will be held in Buenos Aires, Argentina April 13-16, 2024.
  • Presentations will highlight the eGFR results found in patients on Nefecon as well as the data on quality of life during the trial.
  • There will also be a presentation on the subanalysis evaluating benefits of Nefecon for patients with lower levels of UPCR.
  • The congress will include a symposium, Evolving Landscape of eFGR and Proteinuria Surrogate Markers in IgA Nephropathy, moderated by KOL Richard Lafayette, M.D., F.A.C.P.