Urinary tract infection

Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections

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пятница, мая 31, 2024
New Drug Application, Patient, Food, NDA, Clinical trial, FDA, Therapy, PDUFA, ITRM, Infection, Woman, Urinary tract infection, Physician, Pharmaceutical industry

Under the Prescription Drug User Fee Act (“PDUFA”), the FDA has deemed the Company’s NDA resubmission to be a Class II complete response which has a six-month review period from the date of resubmission.

Key Points: 
  • Under the Prescription Drug User Fee Act (“PDUFA”), the FDA has deemed the Company’s NDA resubmission to be a Class II complete response which has a six-month review period from the date of resubmission.
  • As a result, the FDA has assigned a PDUFA action date of October 25, 2024.
  • “We are very pleased that the FDA has accepted the resubmission of the NDA for oral sulopenem,” said Corey Fishman, Chief Executive Officer.
  • “This significant milestone brings us one step closer to the potential approval of oral sulopenem for uUTIs providing patients and physicians with a much-needed treatment option for this underserved market.

Xeris Biopharma Announces Positive Topline Phase 2 Clinical Data of Its Investigational XeriSol™-Formulated Once-Weekly Subcutaneous (SC) Levothyroxine (XP-8121)

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четверг, мая 30, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Patient, Headache, Patient satisfaction, Urinary tract infection, Endocrine Society, Erythema, TSH, Prevalence, FDA, Doctor of Pharmacy, Safety, Edema, Medication, Absorption, Hypothyroidism, Injection, Șaeș, Journal, Fatigue, Pharmaceutical industry

XP-8121 employs the Company’s XeriSol™ formulation technology to enable a novel once-weekly SC injection of levothyroxine.

Key Points: 
  • XP-8121 employs the Company’s XeriSol™ formulation technology to enable a novel once-weekly SC injection of levothyroxine.
  • The Phase 2 study included the following periods: Screening, Titration Period (2 to 8 weeks), and Maintenance Period (4 weeks).
  • Participants entered the study on a stable oral dose (≥ 3 months) with normal TSH and free T4 laboratory values.
  • Participants were receiving a daily oral levothyroxine dose of 83.7 ± 31.14 mcg (mean ± SD) at study entry.

IN8bio Announces INB-200 Phase 1 Study Data in Newly Diagnosed Glioblastoma to be Presented at the 2024 ASCO Annual Meeting

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четверг, мая 23, 2024
Weakness, GBM, Patient, Progression-free survival, Headache, Drug, Urinary tract infection, Thrombosis, NK, PFS, EDT, TMZ, DRI, Balance disorder, Platelet, Cytokine release syndrome, KPS, Glioblastoma, NKG2D, Appetite, Neurotoxicity, Hydrocephalus, ASCO, Performance status, Fatigue, OS, Society, Annual general meeting, Medical imaging

INB-200 is evaluating autologous Drug Resistant Immunotherapy (DeltEx DRI) or chemotherapy resistant gamma-delta T cells as a potential first-line treatment for patients with newly diagnosed glioblastoma multiforme (GBM).

Key Points: 
  • INB-200 is evaluating autologous Drug Resistant Immunotherapy (DeltEx DRI) or chemotherapy resistant gamma-delta T cells as a potential first-line treatment for patients with newly diagnosed glioblastoma multiforme (GBM).
  • “The current standard-of-care for newly diagnosed GBM has not advanced progression-free survival (PFS) beyond 4-7 months or overall survival beyond 14-16 months for over two decades,” said William Ho, CEO and co-founder, IN8bio.
  • “We’re excited to update the status of patients who received INB-200 for front-line GBM in addition to standard-of-care at the upcoming ASCO Annual Meeting.
  • Autologous DeltEx DRI is a gene-modified autologous gamma-delta T cell therapy designed for the treatment of newly diagnosed GBM patients receiving maintenance TMZ therapy.

First-In-Class Cholesterol-Lowering Treatment NILEMDO® (NEXLETOL® in the U.S.) and Its Combination with Ezetimibe, NUSTENDI® (NEXLIZET® in the U.S.), Approved In Europe To Treat Hypercholesterolemia and Significantly Reduce Cardiovascular Risk

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среда, мая 22, 2024
ATP, ACL, Risk, Molina Healthcare, Ageing, Agent handling, Adverse event, CVD, Esperion Therapeutics, Back pain, Angioedema, Cholesterol, Gout, Kidney, Constipation, Treatment, Civil service commission, European Commission, Fetus, Anaphylaxis, Hypersensitivity, Moyamoya disease, Bempedoic acid, Urinary tract infection, Anemia, Hypercholesterolemia, Upper respiratory tract infection, Safety, Ezetimibe, CLEAR, Incidence, Bronchitis, Excipient, Diet, Gallstone, Rash, Patient, Cardiovascular disease, Diarrhea, Abdominal pain, Uric acid, Spasm, University, University of Milan, Therapy, Arthralgia, Sinusitis, Pregnancy, European, Stroke, Health, Common, Death, FDC, Fatigue, Myocardial infarction, Tablet, Rupture, Pain, CHMP, Dietary supplement

ANN ARBOR, Mich. and MUNICH, Germany, May 22, 2024 (GLOBE NEWSWIRE) -- Daiichi Sankyo Europe GmbH (hereafter, ‘Daiichi Sankyo’) and Esperion Therapeutics, Inc. jointly announced today that the European Commission (EC) has approved the label update of both NILEMDO® (bempedoic acid) and NUSTENDI® (bempedoic acid / ezetimibe fixed-dose combination (FDC)), as treatments for hypercholesterolemia (high levels of cholesterol) and to reduce the risk of adverse cardiovascular events. The EC’s decisions to update the labels of bempedoic acid and bempedoic acid / ezetimibe FDC are based on the positive CLEAR Outcomes trial results and makes them the first and only LDL-C lowering treatments indicated for primary and secondary prevention of cardiovascular events.

Key Points: 
  • Bempedoic acid is a first-in-class oral treatment which lowers cholesterol, and which can be combined with other treatments to help lower cholesterol even further.
  • Bempedoic acid provided additional cholesterol lowering of up to 28% on top of statin therapy, compared to placebo.
  • “Today's announcement marks a pivotal moment in our ongoing efforts to reduce cardiovascular risk.
  • CLEAR Outcomes is part of the CLEAR clinical research program for NEXLETOL® (bempedoic acid) Tablet and NEXLIZET® (bempedoic acid and ezetimibe) Tablet.

Traws Pharma Reports First Quarter 2024 Financial Results and Provides Business Update

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четверг, мая 16, 2024
ARK, Insurance, Patient, LP, Risk, Urinary tract infection, Neutropenia, COVID19, Sale, Ritonavir, CDK, Cancer, Acquisition, OrbiMed, Omicron, COVID, COVID 19, Research, G&A, Infection, Delta, SARS-CoV-2, Pharmaceutical industry

NEWTOWN, Pa., May 16, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (“Traws” or “Traws Pharma”), a clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, today announced financial results for the first quarter of 2024, and provided a business update.

Key Points: 
  • Excellent pipeline progress, led by candidates for COVID 19, influenza, and oncology programs
    NEWTOWN, Pa., May 16, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (“Traws” or “Traws Pharma”), a clinical stage biopharmaceutical company developing oral small molecules for respiratory viral diseases and cancer, today announced financial results for the first quarter of 2024, and provided a business update.
  • “2024 has already been a transformative year for Traws Pharma to advance our portfolio of novel treatments for serious respiratory infections and oncology programs.
  • Furthermore, we completed the last dose escalation cohort for our CDK4+ inhibitor, narazaciclib,” stated Werner Cautreels, Ph.D., Chief Executive Officer of Traws Pharma.
  • The Company believes that its cash and cash equivalents will be sufficient to fund ongoing clinical trials and business operations into the fourth quarter of 2024.

Spero Therapeutics Announces First Quarter 2024 Operating Results and Provides a Business Update

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среда, мая 15, 2024
FDA, GSK, Fast Track, NTM, Unitary state, Research, G&A, Bangladesh Technical Education Board, NIAID, Infection, AP, Pseudomonas aeruginosa, Acinetobacter baumannii, Army, Human services, Urinary tract infection, Clinical trial, National Institutes of Health, Safety, MDR, Pyelonephritis, Administration, Department of Defence, Policy, Mycobacterium avium complex, Patient, Pharmacokinetics, Therapy, Assistant, HBR, Tebipenem, Federal, Government, Quality of life, Pharmaceutical industry

Supported by a strong balance sheet, Spero remains well capitalized with expected cash runway into late 2025.”

Key Points: 
  • Supported by a strong balance sheet, Spero remains well capitalized with expected cash runway into late 2025.”
    Top-line data from the Phase 2a proof-of-concept clinical trial are expected in 2H 2024.
  • Total revenue for the first quarter of 2024 was $9.3 million, compared with total revenue of $2.1 million for the first quarter of 2023.
  • General and administrative expenses for the first quarter of 2024 were $5.9 million, compared to $7.3 million for the same period in 2023.
  • As of March 31, 2024, Spero had cash and cash equivalents of $82.3 million, compared to $76.3 million at December 31, 2023.

iCell Gene Therapeutics Announces Positive Clinical Data from Investigator Initiated Phase 1 Trial Evaluating BCMA-CD19 Compound CAR in Patients with Systemic Lupus Erythematosus/Lupus Nephritis Published in Annals of the Rheumatic Diseases

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четверг, мая 23, 2024
Biotechnology, Health, Genetics, Pharmaceutical, Clinical Trials, European Alliance, Patient, Survival, Lupus, CCAR, Data, Infection, IIT, COVID-19, Class, Patent, T cell, SLE, Clinical trial, CD19, Immunoglobulin M, IND, Safety, Urinary tract infection, Autoantibody, MFR, Cancer, Autoimmunity, Cyclophosphamide, Hospital, EULAR, B cell, BCMA, Glucocorticoid, Canadian Aviation Regulations, LN, Lupus nephritis, CRS, Pharmaceutical industry

The clinical trial evaluated the safety and efficacy of a complete humoral reset of both long-lived plasma cells and B cells in 13 systemic lupus erythematosus (SLE) patients treated with iCell’s cCAR, including 11 patients with SLE and lupus nephritis (LN).

Key Points: 
  • The clinical trial evaluated the safety and efficacy of a complete humoral reset of both long-lived plasma cells and B cells in 13 systemic lupus erythematosus (SLE) patients treated with iCell’s cCAR, including 11 patients with SLE and lupus nephritis (LN).
  • These patients achieved symptom-free and medication-free remission (MFR), with post-cCAR follow-up to 46 months.
  • There are currently no approved therapies that deliver MFR in SLE/LN patients who are at high risk of long-term organ damage and kidney transplant.
  • The data suggest that cCAR therapy was safe and effective in inducing MFR and depleting disease-causing autoantibodies in SLE and LN patients.

NanoVibronix Announces Commencement of UroShield Clinical Study at the University of Michigan

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среда, мая 22, 2024
Research, Medical Devices, Clinical Trials, Health Technology, Biotechnology, Health, University, Science, Education, Patient, SAW, Clinical trial, FDA, Urinary tract infection, Clinical study design, Quality of life, Pharmaceutical industry

NanoVibronix, Inc. (Nasdaq: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that the University of Michigan will begin the pilot phase of its clinical trial of UroShield this week.

Key Points: 
  • NanoVibronix, Inc. (Nasdaq: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that the University of Michigan will begin the pilot phase of its clinical trial of UroShield this week.
  • The “pilot” phase of the study is the first component of the broader study.
  • As previously announced on November 28, 2023, the company signed a Research Agreement with the Regents of the University of Michigan for a Randomized Control Trial (“RCT”) study of UroShield to further advance clinical evidence of the efficacy of UroShield.
  • Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., said, “Entering into the pilot phase of the UroShield study at the University of Michigan is an important step towards our goal of applying for permanent FDA clearance or approval for the UroShield product.

Venatorx Pharmaceuticals Announces Changes to Executive Leadership

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четверг, мая 16, 2024
Infectious Diseases, Pharmaceutical, Health, Clinical Trials, Patient, Doctor of Philosophy, Pfizer, HIV, Food, FDA, Medication, Entasis, Therapy, Safety, Pyelonephritis, Research, Meropenem, Global health, Acquisition, Acinetobacter baumannii, Urinary tract infection, Pneumonia, Cutis, Food and Drug Administration, Tropical disease, Development, Pharmaceutical industry

Venatorx Pharmaceuticals, a private, pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, announced today several changes to its executive leadership team.

Key Points: 
  • Venatorx Pharmaceuticals, a private, pre-commercial pharmaceutical company focused on improving health outcomes for patients with multidrug-resistant bacterial infections and hard-to-treat viral infections, announced today several changes to its executive leadership team.
  • Manos Perros, PhD, has been appointed to the Board of Directors as Executive Chairman.
  • Dr. Perros is a distinguished pharmaceutical and biotech executive with an impressive track record that includes more than 25 years in life sciences research and development.
  • Dr. Perros’ appointment follows the resignation of Christopher J. Burns, Ph.D., who has stepped down as Chief Executive Officer and Director of Venatorx Pharmaceuticals.

NanoVibronix Issues Letter to Stockholders

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четверг, мая 16, 2024
FDA, Public Relations, Investor Relations, Medical Devices, Health, Communications, Insurance, Partnership, Gold, Patient, SAW, COVID-19, University, GSA, Food, Veterans' affairs, Growth, Research, General Services Administration, National Health Service, Urinary tract infection, University of Michigan, Pain, NHS, Quality of life, Pharmaceutical industry

We are focused on several areas that we believe will have a substantial impact on our growth and product adoption.

Key Points: 
  • We are focused on several areas that we believe will have a substantial impact on our growth and product adoption.
  • Many of these areas of focus have begun showing positive results, as reflected in our most recent quarterly financial results.
  • Our balance sheet remains strong with approximately $2.7 million of cash and inventory of approximately $2.6 million.
  • Our penetration into the Veterans Affairs (“VA”) continues to improve both in facilities served as well as adoption within those facilities.