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Available from: [link] About the author Cliff Brass, MD PhD FAASLD, Chief Medical Officer at Resolution Therapeutics Cliff Brass is an expert in clinicaldevelopment with special expertise in liver disease and over 25 years of experience in pharma. Reference 1 Brennan P et al., J Hep, 2024 (EASL ILC 2024 Abstract #LBP-007).
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. This patient population is at significant risk of developing cardiovascular complications, which are frequently fatal, during their illness.
(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. “The investigational cocktail is now available to indicated high-risk U.S.
Site selection presents barriers and opportunities As cell therapies expand in Asia-Pacific, areas with large hospitals are often the main hubs for innovation. To find success among the competition, sponsors must have access to the necessary expertise and resources to approach this burgeoning market.
(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. About the REGN-COV2 Trial in Hospitalized Patients. Cohort 1A: patients not requiring oxygen.
“We’re continuing to grow our pipeline – through our own research-and-development efforts, such as our investigational RSV vaccine programs, as well as strategic investments in companies like ReViral – with a focus on end-to-end capabilities to help protect patients from severe illness, hospitalization, and death.”.
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.
In other cases, well-established biomarker profiles enable patient enrichment strategies in early-stage clinicaldevelopment. Our subsidiary company leverages our neuroscience expertise and our mid- to late-stage clinicaldevelopment expertise. We have a dedicated team of people who are executing against GRIN every day.
I have worked in hospitals for many years and have always been committed to treating my patients in body and spirit with passion and enthusiasm. After a long career in the clinicalhospital setting, where she mainly dealt with patients affected by solid tumours, she joined holding roles of increasing responsibility.
– 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.
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.
The data were presented during the late-breaking clinical trials session at the European Congress of Clinical Microbiology & Infectious Diseases (ECCMID). In addition, Merck plans to initiate a clinical program to evaluate molnupiravir for post-exposure prophylaxis in the second half of 2021. “It
Involving more than 250 investigators based at 19 hospital sites across the UK, the study has analysed genetic signatures in lung tumours, tracking how they have evolved over the past nine years in more than 815 patients.
The CARES study is focused on hospitalized patients with invasive candidiasis caused by the multidrug-resistant Candida auris organism, which is associated with high mortality. JERSEY CITY, N.J., 1) L iposomal IV formulation of ibrexafungerp entering Phase 1 study. President and Chief Executive Officer of SCYNEXIS.
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.
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.
A 30-plus valent pneumococcal candidate vaccine is also in pre-clinicaldevelopment. “Affinivax grew out of our founders’ scientific and personal vision to drive vaccine innovation to make a meaningful impact on people’s lives, in both developed and developing countries,” said Steven Brugger, CEO of Affinivax, Inc.
A 30-plus valent pneumococcal candidate vaccine is also in pre-clinicaldevelopment. Affinivax grew out of our founders’ scientific and personal vision to drive vaccine innovation to make a meaningful impact on people’s lives, in both developed and developing countries,” said Steven Brugger, CEO of Affinivax, Inc.
– 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
It’s an exciting process—anticipating development risks, predicting outcomes, and aligning these with the greater vision of medical advancement. The true joy comes from navigating these complexities and asking the right questions early on, because these foundational steps are critical to the success of any clinicaldevelopment process.
Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinicaldevelopment arena. billion each year.
The UK team of NeoDynamics has managed to introduce physicians at key centres to the new pulse biopsy system, despite the difficulties to accessing hospitals and key staff following the pandemic. The information in this press release is information that NeoDynamics is obliged to make public pursuant to the EU Market Abuse Regulation.
Zhang completed his postdoctoral fellowship at Harvard Medical School/Boston Children’s Hospital. Dr. Kehua Fan has over 15 years of Business Development, ClinicalDevelopment of innovative drugs and other healthcare industry experience with MNCs and biotech companies. He received his B.S.
As CMO, Dr. Short will be responsible for overseeing the clinicaldevelopment of VarmX’s pipeline, including progression of its lead product, VMX-C001, into clinical proof of concept and registrational studies. Gerard Short, MBBS, as Chief Medical Officer (CMO). Dr. Short received his Bachelor of Medicine (MBBS) degree from St.
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.
Teva will continue to lead the clinicaldevelopment and regulatory process and be responsible for commercialization of this candidate treatment, with MedinCell eligible for development milestones, royalties on net sales and future commercial milestones. Source link: [link].
As part of an extensive clinicaldevelopment programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Acalabrutinib Study With Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized With COVID-19. CALAVI US). Available online.
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.
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. Verquvo (vericiguat) 2.5
Heart failure is a leading cause of hospitalization and is becoming increasingly prevalent in Western countries due to aging populations. Heart failure is a leading cause of hospitalization and is becoming increasingly prevalent in Western countries due to aging populations. vice president, Product Development, Lilly.
Food and Drug Administration (FDA) approved PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. PAXLOVID has been available in the U.S. 11) At this time, the U.S.
The FOCUS trial is Ultimovacs’ fourth Phase II clinical trial with UV1 and comes in addition to the collaboration Phase II trial announced in May 2020. “We To date, UV1 has been tested in four phase I clinical trials in a total of 82 patients and maintained a positive safety and tolerability profile as well as encouraging signals of efficacy.
The decision is based on results from the landmark EMPEROR-Preserved phase III trial, in which Jardiance demonstrated a 21% relative risk reduction for the composite primary endpoint of cardiovascular death or hospitalization for heart failure in adults with heart failure with preserved ejection fraction compared with placebo.
agree to place handheld Ceribell Rapid Response EEG systems in hospitals in connection with its Phase 3 RSE clinical trial. Cessation will be measured and determined by clinical and EEG findings. hospitals participating in its study. Approximately 80 study sites in hospitals across the U.S. 26, 2021 12:01 UTC.
It was studied specifically in patients who have experienced a recent worsening heart failure event, meaning a recent hospitalization for heart failure or the use of intravenous diuretics, in order to reduce the risk of further worsening events. Vericiguat is the first sGC stimulator to be approved for the treatment of chronic heart failure.
Specifically, it is being examined in adults who are hospitalized with COVID-19. “With the clinical program at AbbVie now underway, we are in a position to contribute a new therapeutic option to address this pandemic.” ” Under the license agreement, the development of ABBV-47D11 will be greatly advanced.
She is executive medical director of immunology clinicaldevelopment for the pharmaceutical company AbbVie in North Chicago, Ill. “Upadacitinib has shown superiority to one of the current standard-of-care treatment options in the clinic for these difficult-to-treat patients,” Pangan said. ” Rinvoq received U.S.
As a clinician, healthcare administrator, biotech entrepreneur and venture capital investor, Steve’s leadership and breadth of experience in the clinicaldevelopment of cell and gene therapies will be invaluable to PlateletBio as we progress our cell therapy platform into the clinic later this year,” said Sam Rasty, Ph.D.,
In view of the importance and urgency, scientific teams at the Harvard Medical School, Santa Casa de Misericórdia de Santos Hospital (Jabaquara, Santos, Brazil) and at Tiziana are closely collaborating to facilitate initiation of this study in expedited time frames. NEW YORK and LONDON, Nov.
Agitation associated with delirium is commonly seen in numerous hospital settings, resulting in serious medical complications and extended hospital stays. About Agitation Associated with Delirium: Delirium is a serious condition that occurs in a variety of hospital settings, including frequently in the intensive care unit.
Chief, Department of Head and Neck Medical Oncology, National Cancer Center Hospital East. We have the passion and determination to develop innovative medicines that help improve and extend the lives of people living with cancer. About Oncology at Bayer.
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