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29, 2020 /PRNewswire/ — Phase 3 program in hospitalized patients to continue based on passing futility analysis on ability to reduce incidence of death or mechanical ventilation. As in earlier outpatient trial, immune status when patients entered the trial was a strong predictor of viral load and clinical outcomes.
Trial designed to investigate the cardioprotective properties of CardiolRx(TM) in patients hospitalized with COVID-19 who have a prior history of, or risk factors for, cardiovascular disease. The DSMC comprises independent experts who will assess the patient safety data, and, if needed, critical efficacy endpoints of the trial.
There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. Site selection presents barriers and opportunities As cell therapies expand in Asia-Pacific, areas with large hospitals are often the main hubs for innovation.
The preclinical findings, together with the early evidence of tolerability and efficacy coming from the MATCH Phase I study, laid the foundations for our characterisation and engineering platform, used to develop Resolution Therapeutics’ lead product, which will be tested in patients starting later this year.
Phase 2a study enrolled 202 non-hospitalized adults who had signs or symptoms of COVID-19 within 7 days and confirmed active SARS-CoV-2 infection. Findings from the primary efficacy and safety endpoints and additional secondary objectives will be presented at an upcoming medical meeting. This press release features multimedia.
12 November 2020 — The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. No new safety signal for Calquence was observed in the trials. No new safety signal for Calquence was observed in the trials.
(NASDAQ: REGN ) today announced that the New England Journal of Medicine (NEJM) has published initial clinical data from an ongoing seamless Phase 1/2/3 trial of the antibody cocktail casirivimab and imdevimab in non-hospitalized patients with COVID-19. grams casirivimab and imdevimab (low-dose, n=92) or placebo (n=93).
The trial will be conducted at 10 sites across Germany and led by principal investigator Prof. The FOCUS trial is Ultimovacs’ fourth Phase II clinicaltrial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We Mascha Binder, M.D.,
The governing body claims this proposal could have positive effects on mitigating burdensome requirements for gene therapy clinicaltrials in the future. In this light, Pharma IQ’s weekly round-up focuses on advancing therapies and clinicaltrials to combat Covid-19.
When added to the EMPEROR-Reduced trial results, these findings demonstrate Jardiance’s efficacy in all forms of heart failure regardless of ejection fraction. Heart failure is a leading cause of hospitalization and is becoming increasingly prevalent in Western countries due to aging populations.
30, 2020 /PRNewswire/ — The IDMC also recommends continuation of enrollment in the REGN-COV2 outpatient trial. NASDAQ: REGN) received today a recommendation from the independent data monitoring committee (IDMC) for the REGN-COV2 antibody cocktail treatment trials for COVID-19 that the current hospitalized patient trial be modified.
Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinicaltrial program, including the Phase III FIGARO-DKD and FIDELIO-DKD studies, and the prespecified pooled analysis FIDELITY at the American Society of Nephrology (ASN)’s Kidney Week 2021 from 4-7 November.
agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinicaltrial. Cessation will be measured and determined by clinical and EEG findings. hospitals participating in its study. Marinus and Ceribell, Inc. RADNOR, Pa.–(
Johnson & Johnson Posts Interim Results from Phase 1/2a ClinicalTrial of its Janssen COVID-19 Vaccine Candidate. Johnson & Johnson Posts Interim Results from Phase 1/2a ClinicalTrial of its Janssen COVID-19 Vaccine Candidate. Immune responses were similar across the age groups studied, including older adults.
Many diagnoses are made clinically based on a patient’s symptoms, as opposed to genetic testing or established biomarker profiles. This can present challenges when attempting to recruit an enriched patient population for clinicaltrials. We aim to control the epilepsy while also modifying the neurobehavioral symptoms.
The update includes an addition to the Indications and Usage section of the label (Section 1) to emphasize the disease stages studied in the clinicaltrials, as seen below ( italics to note updated language). Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).
18, 2021 /PRNewswire/ — Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, and Lonza announced today their agreement in support of ARU-1801, Aruvant’s one-time investigational gene therapy for sickle cell disease (SCD).
NEW YORK , Jan.
Fast Track designation facilitates the development and expedites the review of drugs that are intended to treat serious and life-threatening conditions and show the potential to fill an unmet medical need. Additional pre-clinical and clinical data support Brilacidin’s inhibition of IL-6, IL-1?,
Negative binomial probability distribution can be used to model the number of times a particular outcome occurs during a clinicaltrial. Here, I explain this statistical methodology and its application in adaptive group sequential clinicaltrial designs.
The data demonstrate that finerenone reduced the threat of the CV compound outgrowth ( time to CV death,non-fatal MI, nonfatal stroke or heart failure hospitalization) and the order compound outgrowth ( time to order failure, sustained ? Compared to FIGARO-DKD, FIDELIO-DKD included further cases with advanced habitual order complaint.
Starpharma strived to release DEP remdesivir to allow for less frequent dosing and for use in non-hospital settings such as care homes. DEP remdesivir enables subcutaneous or under the skin injections rather than intravenous infusion, allowing for outpatient treatments and reducing the burden on hospitals. Saama Technologies, Inc. ,
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced today the presentation of previously announced Phase 2 interim results from two Phase 2/3 clinicaltrials (MOVe-OUT and MOVe-IN) of molnupiravir (MK-4482/EIDD-2801), an investigational oral antiviral therapeutic.
– Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in cardiovascular death and hospitalization for heart failure, regardless of ejection fraction. heart failure is a leading cause of hospitalization and is becoming increasingly prevalent due to the aging population. .”
The Company plans to initiate a Phase 2 trial within the next several months. “We Agitation associated with delirium is commonly seen in numerous hospital settings, resulting in serious medical complications and extended hospital stays. Food and Drug Administration (“FDA”) for the treatment of agitation associated with delirium.
– In a new sub-analysis of the landmark EMPEROR-Preserved® phase III trial, Jardiance reduced the combined relative risk of cardiovascular death and hospitalization for heart failure and slowed kidney function decline – Jardiance consistently improved outcomes across the full range of kidney function down to an eGFR of 20 mL/min/1.73
Trial facilitated with coll a boration of Harvard Medical School and one of the world’s top Neurologist, Dr. Howard Weiner.
Clinical Data Expected by End of Year.
The clinical data from this trial is expected to available by the end of this year. Brazil has reported almost 5.5M
SQI is accelerating the clinicaldevelopment of its direct-to-consumer COVID-19 HOME Antibody Test, its COVID-19 RALI-dx Severity Triage Test and its COVID-19 RALI- fast Severity Triage Point-of-Care (POC) Test.
FDA that Emergency Use Authorization (EUA) submission is acceptable for all three COVID diagnostic tests.
SCYNEXIS has successfully completed preclinical testing of its liposomal IV formulation of ibrexafungerp and is advancing the program into human trials in healthy volunteers. JERSEY CITY, N.J., 1) L iposomal IV formulation of ibrexafungerp entering Phase 1 study. President and Chief Executive Officer of SCYNEXIS.
The first patient is expected to be enrolled in this trial in the upcoming weeks. IN FRANCE, FOUR CLINICAL CENTERS WILL ENROLL PATIENTS. “ We would like to thank the investigators and the clinical teams for their support and look forward to treating the first patients with this first Invir.IO
The appointments of Maarten and Teun come at an essential time for AM-Pharma as we finalize all preparations to move into the last stage of clinicaldevelopment for our lead program,” said Erik van den Berg , Chief Executive Officer at AM-Pharma. Dr. Kraan joins AM-Pharma from Pierre Fabre S.A.,
19, 2020 — A recently approved rheumatoid arthritis medication appears to be an effective second-line therapy when biologic treatments start to fail, a new clinicaltrial reports. She is executive medical director of immunology clinicaldevelopment for the pharmaceutical company AbbVie in North Chicago, Ill.
Nearly all patients with advanced non-small cell lung cancer experience disease progression following initial therapy, underscoring the need for novel therapeutic approaches across treatment lines,” said Yasushi Goto, MD, Division of Internal Medicine and Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Today’s data, involving an additional 524 patients from the ongoing Phase 2/3 trial, provides definitive final virology results and meets the clinical endpoint of reducing medical visits. Results showed no significant difference in virologic or clinical efficacy between the REGN-COV2 high dose (8 grams) and low dose (2.4
vice president of immunology development at Lilly. “We are looking forward to sharing the totality of data from the overall clinicaldevelopment program for baricitinib as a potential first-in-disease treatment for alopecia areata.” 10x ULN were observed in patients in Olumiant clinicaltrials.
A 30-plus valent pneumococcal candidate vaccine is also in pre-clinicaldevelopment. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”
A 30-plus valent pneumococcal candidate vaccine is also in pre-clinicaldevelopment. We look forward to working with the many talented people at Affinivax to combine our industry-leading development, manufacturing, and commercialisation capabilities to make this exciting new technology available to those in need.”.
The high rate of unvaccinated people will continue to put a strain on hospitals and healthcare systems around the world, furthering the need for effective treatments for patients hospitalised with COVID-19,” said Levi Garraway, M.D., Chief Medical Officer and Head of Global Product Development, Roche. A decision on U.S.
The approval of Verquvo by the FDA, which is the first treatment for chronic heart failure approved specifically for patients following a hospitalization for heart failure or need for outpatient IV diuretics, is based on the results of the pivotal Phase 3 VICTORIA trial and follows a priority regulatory review. 0.98; p=0.019).
The scientific approaches underlying this clinical study could potentially be effective against SARs, MERS, and all variants of coronaviruses.
This trial is the first to evaluate nasally administered Foralumab to improve the immune system’s fight against coronaviruses.
NEW YORK and LONDON, Jan.
AR-711 is currently being developed as an inhaled, self-administered treatment for non-hospitalized patients suffering from mild to moderate COVID-19. AR-301 is a fully human IgG1 mAb currently in Phase 3 clinicaldevelopment targeting gram-positive Staphylococcus aureus ( S. About Aridis Pharmaceuticals, Inc.
senior vice president, Global ClinicalDevelopment, Hematology, Bristol Myers Squibb. In the AG221-C-001 Phase 2 clinicaltrial, 14% of patients treated with IDHIFA experienced differentiation syndrome, which may be life-threatening or fatal if not treated. WARNINGS AND PRECAUTIONS.
Dr. Berk, commented “I am excited to join the Board of Inflection Biosciences as it advances its novel PIM/PI3K inhibitor, IBL-202, towards clinicaldevelopment for unmet needs in B-cell malignancies and other cancers.”. Dr. Berk most recently has served as a consultant to several companies developing oncology therapies.
Chief, Department of Head and Neck Medical Oncology, National Cancer Center Hospital East. The approval of Vitrakvi in Japan is based on data from 125 patients from the Phase II NAVIGATE trial in adult and adolescent patients and the Phase I/II pediatric SCOUT trial. with a complete response (CR) rate of 16.9%
– Designation is based on results from the EMPEROR-Preserved phase III trial, which established Jardiance as the first therapy to show statistically significant improvement in heart failure outcomes in adults with heart failure with preserved ejection fraction. vice president, Product Development, Lilly. About EMPEROR-Preserved.
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