Particle-size distribution

Aridis Reports Top-Line Results of the Phase 3 Double-Blinded, Superiority Trial of AR-301 For the Treatment of Staphylococcus aureus Ventilator Associated Pneumonia (VAP)

Retrieved on: 
Wednesday, January 25, 2023
Standard of care, Particle-size distribution, Safety, MD, COVID-19, Pneumonia, Data monitoring committee, Teaching hospital, European Medicines Agency, Hospital, Șaeș, DSMB, S. aureus, MSSA, MRSA, Patient, VAP, Gram-positive bacteria, US, SOC, Staphylococcus aureus, LOS, EMA, Mortality, Methicillin, AES, Death, Pharmaceutical industry, ICU

The COVID-19 pandemic and the subsequent conflict in Eastern Europe limited patient enrollment from the original target sample size of 240.

Key Points: 
  • The COVID-19 pandemic and the subsequent conflict in Eastern Europe limited patient enrollment from the original target sample size of 240.
  • In the methicillin resistant S. aureus (MRSA) patients, the absolute efficacy was 28% higher than SOC alone (p=0.774).
  • The mortality due to pneumonia was: AR-301 1.6% (1/61) vs SOC 5.0% (3/59) groups among the population with confirmed S. aureus pneumonia (p=n.s.).
  • Aridis CEO Vu Truong and Dr. Jafri further discuss the Phase 3 study results in a video overview that can be viewed at: https://youtu.be/NNxqY1EkC40 .

Altamira Therapeutics Provides Update on Clinical Trials with Bentrio

Retrieved on: 
Tuesday, January 24, 2023
Nasal congestion, Virus, Particle-size distribution, Safety, Rhinitis, ANCOVA, Sudden death, COVID-19, Sneeze, Rhinorrhea, Allergen, Therapy, Omicron, Degenerative disease, CT, SAR, Research, Allergic rhinitis, Patient, Nasal mucosa, PCR, Incidence, NASAR, Severe acute respiratory syndrome coronavirus 2, Nasal spray, Pharmaceutical industry

The treatment effect of 1.55 points in favor of Bentrio was statistically significant in the ANCOVA model (LSmeans; p = 0.015; 95% confidence interval -2.78 to -0.32).

Key Points: 
  • The treatment effect of 1.55 points in favor of Bentrio was statistically significant in the ANCOVA model (LSmeans; p = 0.015; 95% confidence interval -2.78 to -0.32).
  • The interim analysis further showed good tolerability and safety both for Bentrio and the comparator.
  • Participants were randomized at a 1:1 ratio to either receive Bentrio or saline spray via self-administration three times per day, or as needed.
  • “We are very excited about the strong efficacy signals observed with Bentrio at the halfway point of the NASAR seasonal allergic rhinitis trial in Australia,” commented Thomas Meyer, Altamira Therapeutics’ founder, Chairman, and CEO.

Rest isn’t best: Getting kids back to school sooner after a concussion can mean a faster recovery

Retrieved on: 
Friday, January 20, 2023
Concussion, Particle-size distribution, Ageing, JAMA Network Open, Research, SCORE, Child, Pharmaceutical industry, Medicine, Tutoring

In fact, an early return to school may be associated with a lower symptom burden after suffering a concussion and, ultimately, faster recovery.

Key Points: 
  • In fact, an early return to school may be associated with a lower symptom burden after suffering a concussion and, ultimately, faster recovery.
  • “We know that absence from school can be detrimental to youth in many ways and for many reasons,” says Christopher Vaughan, Psy.D.
  • “The results of this study found that, in general, an earlier return to school after a concussion was associated with better outcomes.
  • Future randomized clinical trials and other research can help determine the best timing for a student to return to school after suffering a concussion.

Koneksa Launches Clinical Trial Evaluating At-Home Mobile Spirometry Using Digital Measures in Moderate Asthma

Retrieved on: 
Tuesday, January 17, 2023
Other Health, Other Science, Pharmaceutical, Research, Software, Medical Devices, Infectious Diseases, Hardware, Hospitals, Genetics, Data Management, Science, Fitness & Nutrition, Technology, Physical Therapy, Clinical Trials, General Health, Biotechnology, Health, Particle-size distribution, Standard of care, LEARN, Trial of the century, Asthma, ICS, LABA, Biomarker, Patient, Smartphone, Pharmaceutical industry, Medical imaging

Koneksa , a healthcare technology company developing evidence-based validated digital biomarkers, today announced the launch of a clinical study comparing the treatment effect between at-home mobile spirometry using digital biomarkers and in-clinic spirometry in patients with moderate asthma on long-acting beta-agonist (LABA) treatment.

Key Points: 
  • Koneksa , a healthcare technology company developing evidence-based validated digital biomarkers, today announced the launch of a clinical study comparing the treatment effect between at-home mobile spirometry using digital biomarkers and in-clinic spirometry in patients with moderate asthma on long-acting beta-agonist (LABA) treatment.
  • The LEARN study is a single arm interventional trial comparing the detection of treatment effects by means of at-home mobile spirometry using an ultrasonic spirometer and a smartphone, compared to in-clinic spirometry in participants with moderate asthma.
  • In-clinic spirometry can be done at-home with equal or better accuracy compared to in-clinic and potentially less burden to the patient.
  • The study will evaluate the LABA treatment effect in clinic and mobile spirometry, and assess the relationship between different readouts of mobile spirometry in addition to assessing asthma control as measured by ACQ-6, a patient reported outcome questionnaire.

Provectus Biopharmaceuticals Releases 2023 Stockholder Letter

Retrieved on: 
Monday, January 9, 2023
Disease, OS, RECIST, Knowledge, SOC, CR, CRS, Melanoma, Cancer, University, Dermatology, Particle-size distribution, Orphan Drug Act of 1983, H. Lee Moffitt Cancer Center & Research Institute, RCT, RBS, Cumming School of Medicine, Metastasis, Combination therapy, CB, SEER, Research, ITM, ORR, Hematology, III, Incidence, Progression-free survival, Classification, PFS, Neoplasm, Rockefeller University, AJCC, Infection, Prevalence, Lymph, Meta-analysis, Clinical trial, PV-10, Cell death, Standard of care, Safety, Vaccine, Diagnosis, PRN, Survival, Patient, Pembrolizumab, Medical device, Pharmaceutical industry, Medical imaging, Television, Veterinary medicine, Epidemiology, Medicine

This effort has been utilizing Provectus’ clinical efficacy data from approximately 180 in-transit melanoma (ITM) patients treated with single-agent PV-10, as well as safety data from more than 300 melanoma patients.

Key Points: 
  • This effort has been utilizing Provectus’ clinical efficacy data from approximately 180 in-transit melanoma (ITM) patients treated with single-agent PV-10, as well as safety data from more than 300 melanoma patients.
  • ITM diagnosis is specifically associated with an overall poor prognosis and has the potential to be seriously debilitating and life threatening.
  • Furthermore, we encourage collaboration between our various researchers to assist Provectus in building the Company’s medical science platform and associated drug pipeline.
  • Provectus’ capital raising efforts will continue in 2023.

More Than Half of Americans Deeply Concerned About Climate Change According to New Survey

Retrieved on: 
Tuesday, January 10, 2023
Environment, Sustainability, Environmental Issues, Green Technology, Environmental Health, Climate Change, Climate change, Natural Resources, Ageing, Public health, Public opinion, Risk, Water, Research, Monaam Elabed, GHG, Particle-size distribution, Ecology, Human, Life, Investment, Renewable energy, Agriculture, Veolia

The survey gauged American public opinion about climate change and measured the willingness of Americans to accept solutions.

Key Points: 
  • The survey gauged American public opinion about climate change and measured the willingness of Americans to accept solutions.
  • It found 80% of Americans agree that climate change is occurring and more than 60% believe it is caused by humans.
  • Half of all Americans are willing to accept changes to their lives caused by potential solutions to climate change, even those that may cost more.
  • According to respondents, the reality of climate change is uncontested, but the path to mitigate it is still difficult to imagine.

Arrowhead and Takeda Announce Topline Results from SEQUOIA Phase 2 Study of Fazirsiran in Patients with Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

Retrieved on: 
Monday, January 9, 2023
Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, Disease, The New England Journal of Medicine, University, Nutrition, Division, Trial of the century, Safety, University of Florida, Arrowhead, Head, F2, Arrowhead Pharmaceuticals, SEQUOIA, Patient, Week, Webcast, RNA interference, F3, Fibrosis, Serum, Particle-size distribution, Liver, Liver disease, Inflammation, Outline, Multimedia, TAK, AATD, Physician, Pharmaceutical industry, Dietary supplement, Medical imaging, Takeda, Gastroenterology

Takeda ( TSE:4502/NYSE:TAK ) and Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced topline results from the Phase 2 SEQUOIA clinical study of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD-LD).

Key Points: 
  • Takeda ( TSE:4502/NYSE:TAK ) and Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced topline results from the Phase 2 SEQUOIA clinical study of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD-LD).
  • The companies also provided an outline of a Phase 3 study that was co-developed by Takeda and Arrowhead and will be conducted by Takeda.
  • Additional SEQUOIA study results are planned to be presented at a future medical meeting and submitted for publication.
  • View the full release here: https://www.businesswire.com/news/home/20230109005210/en/
    “Currently there is no treatment for liver disease from alpha-1 antitrypsin deficiency.

EQS-News: ​​​​​​​Pareto Securities AS publishes buy recommendation for Epigenomics AG share

Retrieved on: 
Sunday, January 22, 2023
Cancer, Clinical trial, ECX, Epigenomics, Research, News, Multiomics, Colorectal cancer, Pareto, OTCQX, Research report, CRC, Centers for Medicare & Medicaid Services, Particle-size distribution, FDA, Epigenomics AG, CMS, Medicare, Pharmaceutical industry

Berlin (Germany), December 23, 2022 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") announces that Pareto Securities AS has published an updated research report upgrading Epigenomics AG's share and issuing a buy recommendation.

Key Points: 
  • Berlin (Germany), December 23, 2022 - Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "Company") announces that Pareto Securities AS has published an updated research report upgrading Epigenomics AG's share and issuing a buy recommendation.
  • Greg Hamilton, CEO of Epigenomics AG: "We are very pleased with the buy recommendation, which we believe reflects the strong test results Epi proColon "Next-Gen" has achieved in the preclinical study.
  • For the upcoming clinical trial, the number of cancer cases in our pre-clinical data exceeds the necessary number to obtain FDA approval.
  • We are very confident that our test will confirm the preclinical performance data in the prospective clinical trial and thus achieve reimbursement by CMS."

InflaRx Provides Update on Planned Phase III Study Design in Pyoderma Gangrenosum with Vilobelimab and Status of its EUA Application in Critically Ill COVID-19 Patients

Retrieved on: 
Thursday, January 5, 2023
Neutrophil, PGA, PG, OD, European Medicines Agency, COVID-19, Jean-Louis Vincent, C5a, Patient, Plasma, EUA, Particle-size distribution, Ulcer, FDA, Therapy, Dentistry, Observation, EMA, Nightclub, Pharmaceutical industry, Dermatology

The planned Phase III study is designed to enroll patients in the US, Europe and selected countries in other regions.

Key Points: 
  • The planned Phase III study is designed to enroll patients in the US, Europe and selected countries in other regions.
  • Treatment will be discontinued for patients whose disease progresses or fails to improve at defined time points during the study.
  • In September 2022, the Company submitted its application for emergency use authorization (EUA) of vilobelimab for the treatment of critically ill, intubated, mechanically ventilated COVID-19 patients with the FDA.
  • The Company will continue to interact closely with the FDA and will provide a timely update when appropriate.

Unicycive Achieves Primary Endpoint in Pivotal Bioequivalence Study of Renazorb

Retrieved on: 
Wednesday, December 28, 2022
Chronic kidney disease, Dialysis, Food, Therapy, NDA, Hyperphosphatemia, LOS, CKD, Kidney disease, Tablet, Patient, Particle-size distribution, Confidence interval, FDA, BE, Food and Drug Administration, Phosphorus, LS, Pharmaceutical industry, PD, Lanthanum carbonate

LOS ALTOS, Calif., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the primary endpoint was met in the Company’s pivotal bioequivalence (BE) study comparing Renazorb to Fosrenol®. Based on the topline results, pharmacodynamic (PD) BE of Renazorb to Fosrenol was established and met the regulatory criteria for PD BE in the healthy volunteer BE study.

Key Points: 
  • Based on the topline results, pharmacodynamic (PD) BE of Renazorb to Fosrenol was established and met the regulatory criteria for PD BE in the healthy volunteer BE study.
  • If approved, Renazorb may dramatically reduce the pill burden that patients endure with currently available medications.
  • Today's positive results are from a randomized, open-label, two-way crossover BE study to establish PD BE between Renazorb and Fosrenol.
  • The study design, including the dose, primary endpoint, and sample size, was reviewed, and aligned by the FDA before the initiation of the study.