Urinary tract infection

Clarametyx Announces FDA Acceptance of Investigational New Drug (IND) Application for Phase 1 Study of Immune-Enabling Antibody Therapy CMTX-101

Retrieved on: 
Wednesday, October 5, 2022

(Clarametyx), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that the U.S. Food and Drug Administration (FDA) has accepted the companys Investigational New Drug (IND) application to initiate a first-in-human Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a novel immune-enabling antibody therapy.

Key Points: 
  • (Clarametyx), a biotechnology company developing targeted, immune-enabling biologic therapies to counter serious infections associated with biofilms, today announced that the U.S. Food and Drug Administration (FDA) has accepted the companys Investigational New Drug (IND) application to initiate a first-in-human Phase 1 safety study followed by a Phase 1b trial of CMTX-101, a novel immune-enabling antibody therapy.
  • Weve made tremendous progress with the early development of this potentially game-changing technology to specifically address bacterial biofilms, which is a major driver of resistance in bacterial infections, said David Richards, Chief Executive Officer, Clarametyx.
  • Collectively, these infections contribute substantial costs to the healthcare system due to significantly increased hospitalization rates and lengths of stay, as well as increased morbidity and mortality.
  • CMTX-101 is intended to be administered concomitantly with a wide range of standard-of-care antibiotics that target both Gram-negative and Gram-positive bacteria.

Beyond Cancer™ to Present Pre-Clinical Data for Ultra-High Concentration Nitric Oxide Therapy at the 2022 SITC Annual Meeting

Retrieved on: 
Wednesday, October 5, 2022

Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide (UNO) via a proprietary delivery platform to treat primary tumors and prevent metastatic disease.

Key Points: 
  • Beyond Cancer, Ltd., an affiliate of Beyond Air, Inc., is a development-stage biopharmaceutical and medical device company utilizing ultra-high concentration nitric oxide (UNO) via a proprietary delivery platform to treat primary tumors and prevent metastatic disease.
  • Nitric oxide at ultra-high concentrations has been reported to show anticancer properties and to potentially serve as a chemosensitizer and radiotherapy enhancer.
  • Ultra-high concentration Nitric Oxide (UNO) therapy is a completely new approach to preventing relapse or metastatic disease.
  • In vitro murine data show that local tumor ablation with UNO stimulates an anti-tumor immune response in solid tumor cancer models.

Allecra Therapeutics Publishes Final Phase 3 ALLIUM Data in JAMA: Cefepime/Enmetazobactam Met Criteria for Superiority

Retrieved on: 
Wednesday, October 5, 2022

The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.

Key Points: 
  • The publication represents the first full analysis of the completed Phase 3 program, which showed that cefepime/enmetazobactam met criteria for non-inferiority and superiority compared to piperacillin/tazobactam in the primary outcome of clinical cure and microbiological eradication.
  • Cefepime/enmetazobactam is a novel -lactam/-lactamase inhibitor combination for the treatment of resistant gram-negative infections mediated by Extended Spectrum Beta-Lactamases (ESBLs).
  • Based on the positive data readout, Allecra expects to submit for marketing approval in the U.S. and EU.
  • Allecra Therapeutics, founded in 2013, is a private, clinical-stage biopharmaceutical company developing novel therapies to combat antibiotic resistance by overcoming emergent resistance mechanisms.

Cue Health Applies with FDA for Emergency Use Authorization of its Cue Flu + COVID-19 Molecular Test

Retrieved on: 
Tuesday, October 4, 2022

SAN DIEGO, Oct. 4, 2022 /PRNewswire/ -- Cue Health ("Cue") (Nasdaq: HLTH), a healthcare technology company that puts diagnostic information at the center of care, today announced that on September 30, 2022, it submitted an application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) for its Cue® Flu + COVID-19 Molecular Test for at-home and point-of-care (POC) use.

Key Points: 
  • The new Cue Flu + COVID-19 Molecular Test can simultaneously detect and differentiate between influenza and COVID-19 in approximately 25 minutes, with results delivered digitally to the Cue Health App on the user's mobile device.
  • The Cue Flu + COVID-19 Molecular Test Cartridge uses a lower nasal swab sample and runs on the Cue Reader, which communicates test results digitally to the Cue Health App on a mobile device.
  • Currently, Cue's standalone molecular tests for both flu and COVID-19 are under de novo review with the FDA for full clearance.
  • Cue Health's first-of-its-kind COVID-19 test was the first FDA-authorized molecular diagnostic test for at-home and over-the-counter use without a prescription and physician supervision.

GoodRx Offers Free Telehealth Appointments to Florida Residents Affected by Hurricane Ian

Retrieved on: 
Tuesday, October 4, 2022

GoodRx (Nasdaq: GDRX), a leading consumer-focused digital healthcare platform, today announced it is offering free online healthcare provider visits to Florida residents impacted by Hurricane Ian.

Key Points: 
  • GoodRx (Nasdaq: GDRX), a leading consumer-focused digital healthcare platform, today announced it is offering free online healthcare provider visits to Florida residents impacted by Hurricane Ian.
  • GoodRx Care can also be used to get quick access to medication that may have been damaged in the storm or left behind during evacuation.
  • Residents in need can also find quality health information from physicians on relevant topics or questions at GoodRx Health .
  • In the wake of Hurricane Ians destruction, we want to ensure that Florida residents are able to take care of themselves and prioritize their health, said Doug Hirsch, co-founder and co-CEO of GoodRx.

Synairgen announces positive data from the US NIH-led ACTIV-2 Phase 2 trial for SNG001 in home-based participants with COVID-19

Retrieved on: 
Tuesday, October 4, 2022

There were no statistically significant differences between SNG001 and placebo with respect to the primary outcomes of safety (SNG001 was well-tolerated), symptom resolution, or virology.

Key Points: 
  • There were no statistically significant differences between SNG001 and placebo with respect to the primary outcomes of safety (SNG001 was well-tolerated), symptom resolution, or virology.
  • Based on the study results, the Independent Data Safety Monitoring Board for ACTIV-2 recommended SNG001 advance from Phase 2 into Phase 3 in the ACTIV-2 trial in October 2021.
  • We will now begin to evaluate the full data set and factor these findings into our development plans.
  • 2 Synairgen conducted a trial of SNG001 in high-risk, home-based COVID-19 patients (SG016) in which fewer patients treated with SNG001 were hospitalised (0/56) compared to placebo (2/58).

Breathe Easy: Improve Your Home's Air Quality

Retrieved on: 
Monday, October 3, 2022

According to the Environmental Protection Agency, indoor air quality can be up to five times worse than outdoor air quality.

Key Points: 
  • According to the Environmental Protection Agency, indoor air quality can be up to five times worse than outdoor air quality.
  • With the average person taking about 22,000 breaths per day, installing smarter indoor air quality technology is key to healthier living year-round.
  • Improving your home's air quality begins with recognizing what contributes to poor indoor air quality, the potentially harmful effects and how to address these problems.
  • Understanding and controlling some of the common pollutants found in homes, schools and offices may help improve your indoor air and reduce your family's risk of health concerns related to indoor air quality.

Beyond Air® Announces that Annals of the American Thoracic Society Published a Review of the Third Pilot Study of High Dose Nitric Oxide for Bronchiolitis

Retrieved on: 
Monday, October 3, 2022

The manuscript in the Annals of the American Thoracic Society is available at (https://doi.org/10.1513/AnnalsATS.202103-348OC).

Key Points: 
  • The manuscript in the Annals of the American Thoracic Society is available at (https://doi.org/10.1513/AnnalsATS.202103-348OC).
  • This multicenter, double-blind, randomized-controlled study enrolled 89 patients under the age of 12 months who were hospitalized with moderate-severe bronchiolitis.
  • The patients were randomized equally across three arms: standard supportive therapy (SST); 85 ppm NO + SST and 150 ppm NO + SST.
  • The primary endpoint was time to fit-to-discharge (FTD), a composite of the modified TAL score and sustained oxygen saturation on room air.

Recce Pharmaceuticals Announces Expansion and Acceleration of Clinical Programs

Retrieved on: 
Monday, October 3, 2022

SYDNEY Australia, Oct. 03, 2022 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX:RCE, FSE:R9Q) (the Company), the Company developing new classes of synthetic anti-infectives, is pleased to provide an updated timeline on its clinical programs with several significant data read-outs in 2022 and 2023.

Key Points: 
  • We have therefore established an ambitious development plan, aiming to get new anti-infective therapies into market as expediently possible.
  • Recces anti-infective pipeline is unique and comprised of broad-spectrum synthetic polymer antibiotics RECCE 327, RECCE 435, and RECCE 529 for viral infections with unique mechanisms of action against hyper-mutation on bacteria and viruses, respectively.
  • Recce wholly owns its automated manufacturing, ready to support first-in-human clinical trials.
  • Recces anti-infective pipeline seeks to exploit the unique capabilities of RECCE technologies targeting synergistic, unmet medical needs.

Olive Diagnostics Receives European CE Mark for its Cutting Edge AI-based Urine Analysis

Retrieved on: 
Monday, October 3, 2022

Olive KG performs high quality analysis of important parameters in the patients' urine in each urination without user intervention.

Key Points: 
  • Olive KG performs high quality analysis of important parameters in the patients' urine in each urination without user intervention.
  • The user does nothing more than urinate in the toilet the same way they have been their whole lives.
  • Among other parameters, the device measures red blood cells, proteins, Nitrites, pH levels, alongside features such as volume, pressure, color, and frequency of urination.
  • "The milestone of receiving the CE Marking provides validation for our vision and technology and paves the way for us to enter the European market," said Guy Goldman, CEO of Olive Diagnostics.