Pyelonephritis

NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) Announces FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation of NRX-101 in Complicated Urinary Tract Infection and Pyelonephritis

Retrieved on: 
Tuesday, January 16, 2024
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Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.

Key Points: 
  • Receipt of QIDP designation confers Priority Review, and critically, five additional years of data-exclusivity to NRX-101's already strong Intellectual Property position.
  • The FDA also granted NRX-101 Fast Track designation for cUTI, which additionally allows for rolling submission of the Company's New Drug Application.
  • On the basis of this advance, NRx is seeking partners with active involvement in urology, infectious disease and/or women's health for commercialization of NRX-101.
  • NRx thanks the US FDA for its rapid award of QIDP designation for cUTI and pyelonephritis.

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) Plus Chemoradiotherapy as Treatment for Patients With FIGO 2014 Stage III-IVA Cervical Cancer

Retrieved on: 
Friday, January 12, 2024
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Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.

Key Points: 
  • Important immune-mediated adverse reactions listed here may not include all possible severe and fatal immune-mediated adverse reactions.
  • “Building on the established role of KEYTRUDA in advanced cervical cancer, KEYTRUDA plus chemoradiotherapy is now the first anti-PD-1-based regimen approved in the U.S. for the treatment of patients with FIGO 2014 Stage III-IVA cervical cancer regardless of PD-L1 expression,” said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories.
  • The trial enrolled 1,060 patients with cervical cancer who had not previously received any definitive surgery, radiation, or systemic therapy for cervical cancer.
  • In the exploratory subgroup analysis of 596 patients with FIGO 2014 Stage III-IVA disease, 61 patients (21%) in the KEYTRUDA plus CRT arm (n=293) experienced a PFS event versus 94 patients (31%) in the placebo plus CRT arm (n=303).

Lexicon Pharmaceuticals Provides Business and Pipeline Update at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024
Lithium, UGT, Risk, Digoxin, Shanda, Hypotension, FDA, SGLT1, Type 2 diabetes, Acute kidney injury, Congress, Pyelonephritis, Conference, Fever, Ketoacidosis, Pregabalin, Pregnancy, Pain, Assessment, Gabapentin, Tenderness, New Drug Application, Amber Grid, HCM, Common, SGLT2, PROGRESS, Hypertrophic cardiomyopathy, Diabetes, Kidney, Heart failure, Dialysis, History, Patient, Prescription, Type, Neuropathic pain, Webcast, Insulin, T2DM, EGFR, Erythema, T1DM, Hypoglycemia, Partnership, Contraindication, Diarrhea, NDA, Incidence, Swelling, Urinary tract infection, Hospital, Chronic kidney disease, Internationalized domain name, Metabolic acidosis, Creatinine, Growth, Lactation, Pharmaceutical industry

THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.

Key Points: 
  • THE WOODLANDS, Texas, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives, today announced a business and pipeline update at the 42nd Annual J.P. Morgan Healthcare Conference taking place January 8-12, 2024.
  • “Lexicon achieved major advancements in 2023 in its business and pipeline of pharmaceutical innovations,” said Lonnel Coats, chief executive officer and director of Lexicon.
  • The company will also focus on ensuring a strong ongoing awareness of INPEFA in the medical community through medical publications and congress presence.
  • Company to Present at J.P. Morgan Healthcare Conference Thursday, January 11, 2024 at 10:30am PST (1:30pm ET)
    Lonnel Coats, Lexicon’s chief executive officer, will make a company presentation.

Spero Therapeutics Provides Corporate Update and 2024 Outlook

Retrieved on: 
Friday, January 5, 2024
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CAMBRIDGE, Mass., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset, clinical-stage, biopharmaceutical company, focused on identifying and developing novel therapies for rare diseases and multi-drug resistant (MDR) bacterial infections with high unmet need, today provided a corporate update highlighting its recent accomplishments and anticipated milestones for 2024.

Key Points: 
  • Entitled to receive $95 million in development milestones, payable over two years, as part of the GSK license agreement
    CAMBRIDGE, Mass., Jan. 05, 2024 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), a multi-asset, clinical-stage, biopharmaceutical company, focused on identifying and developing novel therapies for rare diseases and multi-drug resistant (MDR) bacterial infections with high unmet need, today provided a corporate update highlighting its recent accomplishments and anticipated milestones for 2024.
  • “We look forward to another productive year for Spero in 2024, having achieved important clinical and regulatory milestones over the past twelve months,” said Sath Shukla, President, and CEO of Spero Therapeutics.
  • Our Phase 2a trial of SPR720 in nontuberculous mycobacterial pulmonary disease is on track, and we look forward to reporting topline data, which is expected in the second half of 2024.
  • The trial is expected to enroll up to 35 treatment-naïve or treatment-experienced non-refractory participants with NTM-PD, due to Mycobacterium avium complex.

Spero Therapeutics Announces First Patient, First Visit for Phase 3 PIVOT-PO Trial Evaluating Tebipenem HBr in Complicated Urinary Tract Infections

Retrieved on: 
Tuesday, January 2, 2024
Patient, MDR, Sale, Physician, FDA, Tebipenem, Infection, Pyelonephritis, Therapy, HBR, GSK, Spero, Urinary tract infection, AP, Pharmaceutical industry

Spero is entitled to receive $95 million in development milestone payments from GSK, which is payable in four equal installments over two years.

Key Points: 
  • Spero is entitled to receive $95 million in development milestone payments from GSK, which is payable in four equal installments over two years.
  • “First patient visit, in the PIVOT-PO Phase 3 clinical trial, is an important milestone in our tebipenem HBr program,” said Sath Shukla, President and CEO of Spero Therapeutics.
  • "We are developing Tebipenem HBr to potentially be the first oral broad-spectrum carbapenem in the U.S. for use in patients with cUTI.
  • The primary efficacy endpoint will be overall response (composite of clinical cure plus microbiological eradication) at the test-of-cure visit.

Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024
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Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Nulojix, belatacept, Date of authorisation: 17/06/2011, Revision: 21, Status: Authorised

Melinta Therapeutics and Venatorx Pharmaceuticals Announce Licensing Agreement to Commercialize Cefepime-Taniborbactam in the U.S.

Retrieved on: 
Thursday, November 9, 2023
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The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.

Key Points: 
  • The partnership follows Venatorx’s submission of a New Drug Application (NDA) for cefepime-taniborbactam for the treatment of cUTI including pyelonephritis, in adults.
  • Venatorx has been assigned a Prescription Drug User Fee Act (PDUFA) target action date for February 22, 2024.
  • The U.S. Food and Drug Administration (FDA) granted cefepime-taniborbactam Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the cUTI and HABP/VABP indications.
  • Venatorx has granted GARDP exclusive rights to distribute and sub-distribute cefepime-taniborbactam, once it is approved for clinical use, in low- and lower middle-income countries.

SPERO ALERT: Bragar Eagel & Squire, P.C. is Investigating Spero Therapeutics, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the Firm

Retrieved on: 
Friday, November 3, 2023
Class Action Lawsuit, Professional Services, Legal, FDA, Food, Rare, Treatment, Tebipenem, Telephone, Workforce, News, Infection, HBR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Urinary tract infection, P.C, Complicated, Jeanne Eagels, New Drug Application, NDA, Patient, Cryptocurrency, Pharmaceutical industry, Spero, Pyelonephritis

Our investigation concerns whether the board of directors of Spero have breached their fiduciary duties to the company.

Key Points: 
  • Our investigation concerns whether the board of directors of Spero have breached their fiduciary duties to the company.
  • Spero, a clinical-stage biopharmaceutical company, focuses on identifying, developing, and commercializing treatments for multi-drug resistant bacterial infections and rare diseases in the United States.
  • The Company's product candidates include Tebipenem Pivoxil Hydrobromide (HBr), an oral carbapenem-class antibiotic to treat complicated urinary tract infections, including pyelonephritis for adults.
  • On March 31, 2022, Spero issued a press release announcing the Company’s fourth quarter and full year 2021 financial results.

Recce Pharmaceuticals Announces Safety Committee Approves Faster Infusion Rate in Phase I/II Trial of RECCE® 327 for Urinary Tract Infections and Urosepsis

Retrieved on: 
Wednesday, October 25, 2023
ASX, Pyelonephritis, Urinary tract infection, IV, Mortality, SCC, Pharmacokinetics, Phase, ID, Clinical trial, Genetically modified bacteria, FSE, Safety, Sepsis, Patient, RCE, Pharmaceutical industry

The next cohort of subjects has been recruited, with dosing to begin imminently.

Key Points: 
  • The next cohort of subjects has been recruited, with dosing to begin imminently.
  • “We are pleased to receive approval from the Independent Safety Committee to commence dosing of R327 at 15 minutes, a faster infusion rate than what has been administered in previous doses at 1-hour and 30-minute infusion rates,” said James Graham, Chief Executive Officer of Recce Pharmaceuticals.
  • Antibiotics administered as an IV infusion, usually over 30 minutes, have benefits such as savings in nursing time, reduced costs, and improved safety.
  • More information on this trial can be found at the Australia New Zealand Clinical Trial Registry (ANZCTR) under the trial ID ACTRN12623000448640 .

Venatorx Pharmaceuticals Awarded a Third Antibiotic BARDA Contract

Retrieved on: 
Tuesday, October 10, 2023
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Venatorx has recently completed multiple Phase 1 clinical studies with ceftibuten-ledaborbactam etzadroxil and will advance directly to global Phase 3 clinical trial testing under this contract.

Key Points: 
  • Venatorx has recently completed multiple Phase 1 clinical studies with ceftibuten-ledaborbactam etzadroxil and will advance directly to global Phase 3 clinical trial testing under this contract.
  • “We thank BARDA, ASPR, and HHS for their dedication to scientific innovation and commitment to this private-public partnership.
  • BARDA and Venatorx will share the costs of all studies needed to bring the drug to market, including a planned pivotal global Phase 3 clinical trial to treat cUTI.
  • Venatorx will lead all regulatory activities necessary to seek FDA approval of ceftibuten-ledaborbactam etzadroxil under the contract.