The Pharma Data

DECEMBER 29, 2020

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.

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The Pharma Data

MARCH 16, 2022

The Independent Data Monitoring Committee recommended that the EMPA-KIDNEY trial be stopped early, following a formal interim assessment EMPA-KIDNEY is the largest and broadest dedicated SGLT2 inhibitor trial in chronic kidney disease to date Detailed results are expected to be presented later this year.

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Codon

JANUARY 21, 2024

Today, refined versions of these human challenge studies have become standard practice in testing vaccines for vector-borne diseases (e.g., yellow fever, malaria, and dengue), evaluating new drugs or treatments, and studying pathogenesis, the process by which a disease develops. Why are challenge trials becoming more popular?

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Broad Institute

NOVEMBER 21, 2024

In a study published in Nature Cancer , researchers at the Broad Institute of MIT and Harvard, Dana-Farber Cancer Institute, and Massachusetts General Hospital investigated the evolution of these tumors, many of which are known to be initiated by mutations in an enzyme known as IDH.

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Broad Institute

AUGUST 7, 2024

Core institute members have a major research presence at Broad, and remain full members of their home institution (MIT, Harvard University, or one of Harvard’s primary teaching hospitals). Anna Greka ’s research focuses on fundamental mechanisms of cellular dysfunction in genetic diseases with a focus on membrane proteins.

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The Pharma Data

JANUARY 26, 2021

Zydus Cadila Healthcare’s Desidustat has demonstrated efficacy in a phase 2b clinical trial in Mexico for COVID-19 patients hospitalized with hypoxia. Zydus has two ongoing phase 3 trials evaluating Desidustat for treatment of anemia linked to chronic kidney disease and chemotherapies. Source link.

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The Pharma Data

JANUARY 20, 2021

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.

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PPD

MAY 18, 2023

For neurodegenerative disease research, the care partner, or caregiver, is equally important as the person with dementia. Even with stronger awareness of studies, drug developers must contend with the inherent lack of trust between the dementia community and clinical trials. There’s little time to lose.

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Broad Institute

AUGUST 19, 2024

Jude Children’s Research Hospital have discovered that oleic acid, one of the most abundant fatty acids in the body, restores a healthy balance of vaginal microbes in a laboratory model of BV. At the Ragon Institute, Kwon’s lab is working to move this research toward a human clinical trial. “We Paper cited Zhu M et al.

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Drug Target Review

JANUARY 12, 2024

How does the integration of Real-World Data (RWD) with genomic biomarker data contribute to a more comprehensive understanding of disease progression and treatment response? Biomarker information is also useful for tracking progression of the disease and treatment response. Most drugs do not work in all people.

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Conversations in Drug Development Trends

MARCH 20, 2024

One way to ensure customized disease management is to utilize pharmacogenomics (PGx) in your clinical trial. As the study of how an individual’s genes affect their response to drugs, pharmacogenomics is a critical factor in developing effective and safe drugs and dosages in clinical trials.

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biobide

FEBRUARY 2, 2024

Pediatric cancers exhibit differences at the genetic level compared to the same form of adult disease, which may influence the selected treatment. This New Alternative Model (NAM) provides a platform for High-Content Screening through disease modeling through the transplantation of primary patient tumors into immunocompromised lines.

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Broad Institute

JANUARY 30, 2024

Bhattacharyya wears many coats today, splitting his time between the Broad and the infectious disease ward at MGH, where a diagnostic method he developed at Broad is now being tested to see if it helps patients quickly receive the best antibiotics for their infections.

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The Pharma Data

APRIL 8, 2021

The trial did not meet statistical significance on the primary endpoint, which was defined as a difference in the proportion of participants progressing to the first occurrence of non-invasive ventilation including high flow oxygen or invasive mechanical ventilation including extracorporeal membrane oxygenation (ECMO) or death by Day 28. .

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The Pharma Data

JANUARY 17, 2021

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.

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The Pharma Data

DECEMBER 23, 2020

23, 2020 — Because COVID-19 is known to raise the odds for dangerous blood clots, blood thinners have quickly become part of routine care for many hospitalized patients. The three trials are being conducted on four continents. WEDNESDAY, Dec. “Such abnormal bleeding could be lethal if not quickly diagnosed and treated.”

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The Pharma Data

AUGUST 30, 2021

In this clinical first for adults with heart failure with preserved ejection fraction, empagliflozin demonstrated an impressive 21 percent relative risk reduction in the composite primary endpoint of cardiovascular death or hospitalization for heart failure 1. EMPEROR-Preserved included 5,988 people with heart failure.

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Drug Target Review

NOVEMBER 17, 2023

They do not induce ‘graft versus host’ disease when transplanted for allogeneic therapy and there appears little sign of immune rejection. Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients.

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Broad Institute

NOVEMBER 7, 2023

While RA therapies targeted to specific inflammatory pathways have emerged, only some patients’ symptoms improve with treatment, emphasizing the need for multiple treatment approaches tailored to different disease subtypes. They also found that patients’ CTAPs were dynamic and could change over time in response to treatment.

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PLOS: DNA Science

JULY 27, 2023

That information led, thanks to vaccine shelved from the first SARS circa 2003, to the rapid development and deployment of mRNA vaccines against the new infectious disease. Next up: testing in real-world settings and submission of clinical trial findings to the FDA. But what about seemingly healthy newborns?

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The Pharma Data

DECEMBER 17, 2020

(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.

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The Pharma Data

JUNE 2, 2022

Orencia was one of two immune modulators that improved survival for people hospitalized with COVID-19. Bristol Myers Squibb (NYSE: BMY) today announced topline results from the Phase 3 Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV-1) Immune Modulators clinical trial, sponsored by the National Institutes of Health (NIH).

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H1 Blog

SEPTEMBER 26, 2023

Breaking Down Barriers to International Clinical Trials Global Disruptions, Health Equity & Data Sharing As the U.S. When time is of the essence, like in a global pandemic, how do you scale trials internationally for success? Additionally, clinical trials are no longer confined to one country or region.

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The Pharma Data

JUNE 30, 2021

These results were consistent in people with or without cardiovascular disease. 1 “The risk of hospitalization for heart failure is up to five times higher if you have type 2 diabetes. There was a similar risk of lower limb amputation and bone fractures as with DPP-4 inhibitors.

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The Pharma Data

JULY 29, 2021

The EUA now provides for the use of baricitinib for treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO). percent (24/515) for baricitinib plus remdesivir versus 7.1

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The Pharma Data

JUNE 26, 2021

Sanofi and Translate Bio initiate Phase 1 clinical trial of mRNA influenza vaccine. The trial will evaluate the safety and immunogenicity of a monovalent flu vaccine candidate coding for the hemagglutinin protein of the A/H3N2 strain of the influenza virus. JUNE 22 , 2021. We look forward to sharing initial results by year-end. ”. “

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PPD

OCTOBER 17, 2024

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.

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The Pharma Data

APRIL 3, 2021

The CoVIg-19 Plasma Alliance today announced that the Phase 3 Inpatient Treatment with Anti-Coronavirus Immunoglobulin (ITAC) clinical trial sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), did not meet its endpoints. About the ITAC Trial.

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The Pharma Data

JANUARY 13, 2021

patients hospitalized with COVID-19. Clinical data from studies of ensifentrine in the treatment of other respiratory diseases have shown ensifentrine improved lung function, reduced inflammation in the lungs* and reduced symptoms of cough and sputum production. Patient Population: 45 hospitalized patients with COVID-19.

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The Pharma Data

JULY 8, 2021

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 poses a significant global disease burden: more than 60 million patients worldwide have heart failure, and half of them have HFpEF. .”

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KIF1A

JUNE 3, 2023

Dylan Verden of KIF1A.ORG summarizes newly published KIF1A-related research and highlights progress in rare disease research and therapeutic development. 2023 This study has a small sample size from a single hospital, and there were patients who did not have available genetic data, so we can’t generalize these statistics too much.

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The Pharma Data

JANUARY 15, 2021

15, 2021 — An inhaled medication might make every day physical activity a bit easier for patients with serious scarring of the lungs, a new clinical trial finds. 13 in the New England Journal of Medicine , involved patients with high blood pressure in the lungs caused by interstitial lung disease (ILD). FRIDAY, Jan.

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The Pharma Data

MAY 16, 2022

million symptomatic cases of the virus, as well as 690,000 hospitalizations and more than 110,000 deaths. She adds that the results, “highlight the opportunity to continue widespread vaccination uptake to prevent COVID-19 related disease and generate societal benefits.”

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The Pharma Data

MARCH 11, 2021

This was measured by improved time to hospital discharge up to day 28 in patients with severe COVID-19 pneumonia receiving standard of care. No new safety signals were identified for Actemra/RoActemra in the REMDACTA trial. The full results of the trial will be submitted for publication in a peer-reviewed journal later this year.

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The Pharma Data

SEPTEMBER 2, 2021

RSV is a significant cause of severe respiratory disease in older adults, and it can cause disability and death. There is an important unmet medical need for an effective vaccine that can help protect older adults against this highly-contagious disease,” said Kathrin U. Jansen, Ph.D., 2 In the U.S.,

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Drug Target Review

FEBRUARY 1, 2024

What challenges has the industry faced in developing and commercialising treatments for neurological diseases, including rare diseases? There are a lot of drug development challenges that are, in some cases, unique to neuroscience, including neurological diseases, psychiatric disorders, and rare diseases affecting the nervous system.

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The Pharma Data

OCTOBER 28, 2021

Bayer will present new renal and cardiovascular (CV) analyses from the comprehensive finerenone (Kerendia®) clinical trial 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.

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