Search Results for “Clinical Trial” – Page 103 – media

GSK to buy Bellus Health and its chronic cough drug for $2B

GSK on Tuesday said it will pay $2 billion to acquire Bellus Health, a Canada-based developer of an experimental drug for chronic cough that’s in late-stage clinical trials. Deal terms value each Bellus share at $14.75, roughly double their closing price on Monday. The companies expect the acquisition will close in the third quarter, and Bellus’ board has unanimously voted in its favor. Bellus’ drug, called camlipixant, is currently being tested in two Phase 3 studies of people with persistent cough that either doesn’t have a clear cause or can’t be relieved by treatment for an underlying condition. Results are expected in late 2024 and in 2025, respectively. With the Bellus deal, GSK will gain a drug that could compete with a similar treatment being developed by Merck & Co. Both medicines are designed to work by targeting a receptor known as P2X3, and could become the first ...
- Source: drugdu
- 335
- April 20, 2023
J&J study data show dramatic benefit to multiple myeloma cell therapy

A study abstract inadvertently posted online showed J&J and Legend’s therapy, Carvykti, reduced the risk of disease progression or death by more than 70% over standard drugs. The cancer cell therapy Carvykti dramatically outperformed standard drugs in a late-stage clinical trial testing its use in earlier treatment of the blood cancer multiple myeloma, according to data from a study abstract that was briefly posted online Tuesday. The abstract showed Carvykti, which is made by Johnson & Johnson and Legend Biotech, reduced the risk of disease progression or death by 74% compared to standard of care — a degree of benefit that analysts who viewed it described as “stellar” and “highly encouraging.” J&J and Legend had previously said in late January that the study met its main goal, but did not disclose any specific data at the time. The abstract, which is no longer available online, was for presentation ...
- Source: drugdu
- 109
- April 20, 2023
Ardelyx resubmits NDA for Xphozah to US FDA

Ardelyx has resubmitted a new drug application (NDA) for Xphozah (tenapanor) to the US Food and Drug Administration (FDA). A first-in-class, phosphate absorption inhibitor, Xphozah will be used to control serum phosphate in adults with chronic kidney disease (CKD) on dialysis and who had an insufficient response or intolerance to a phosphate binder therapy. It has a new action mechanism and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). This reduces the absorption of phosphate via the paracellular pathway, which is the main pathway of phosphate absorption. Diarrhea was the most common side effect using Xphozah in clinical trials. The NDA submission was supported by a comprehensive development programme, which included over 1,200 patients in three Phase III clinical trials, PHREEDOM, BLOCK and AMPLIFY, and two additional open-label Phase IV clinical trials, OPTIMIZE and NORMALIZE. The Phase III trials were ...
- Source: drugdu
- 133
- April 20, 2023
Adding new vaccine type to leading immunotherapy dramatically reduced melanoma recurrence

The combination of an experimental mRNA vaccine with an immunotherapy reduced the likelihood of melanoma recurring or causing death by 44% when compared to immunotherapy alone, a new clinical trial shows. Led by researchers at NYU Langone Health and its Perlmutter Cancer Center, the randomized phase 2b trial involved men and women who had surgery to remove melanoma from lymph nodes or other organs and were at high risk of the disease returning in sites distant from the original cancer. Among 107 study subjects who were injected with both the experimental vaccine, called mRNA-4157/V940, and the immunotherapy pembrolizumab, the cancer returned in 24 subjects (22.4%) within two years of follow-up, compared with 20 out of 50 (40%) who received only pembrolizumab. “Our phase 2b study shows that a neoantigen mRNA vaccine, when used in combination with pembrolizumab, resulted in prolonged time without recurrence or death compared with pembrolizumab alone,” said study senior investigator ...
- Source: drugdu
- 227
- April 17, 2023
Caris Life Sciences and Flare to collaborate for oncology pipeline advancement

Caris Life Sciences and Flare Therapeutics have announced a partnership to advance the precision oncology pipeline of the latter into clinical trials. The multi-year strategic partnership will leverage latest molecular profiling approaches guiding patient selection and participation to accelerate precision medicine approaches across five of the therapeutic programmes of Flare. It will use the comprehensive molecular tissue and liquid profiling services of Caris including whole transcriptome sequencing and whole exome sequencing for participants in Flare’s clinical trials. Additionally, the partnership will apply Caris’ data and analytics tools to strengthen future enrolment programme for trials and companion diagnostics capabilities. Flare Therapeutics chief development officer Michaela Bowden said: “We understand the importance of shaping translational insights early on as a major area of focus to help ensure efficient drug development at scale and clinical trial preparedness. “With access to Caris’ robust clinico-genomic real-world data, comprehensive molecular profiling and ...
- Source: drugdu
- 166
- April 17, 2023
How AI and a mobile phone app could help you quit smoking

A stop-smoking mobile app that senses where and when you might be triggered to light up could help you quit, according to University of East Anglia research. Quit Sense is the world’s first Artificial Intelligence (AI) stop smoking app that detects when people are entering a location where they used to smoke. It then provides support to help manage people’s specific smoking triggers in that location. A study published today shows how the new app helped more smokers to quit than people who were only offered online NHS support. The research team hopes that by helping people manage trigger situations, the new app will help more smokers to quit. The work is published in Nicotine and Tobacco Research. Lead researcher Prof Felix Naughton, from UEA’s School of Health Sciences, said, “We know that quit attempts often fail because urges to smoke are triggered by spending time ...
- Source: drugdu
- 124
- April 14, 2023
Identifying ‘hallmark’ Parkinson’s disease protein buildup could aid early detection, improved diagnosis and treatment

A technique that identifies the build-up of abnormal protein deposits linked to Parkinson’s disease could aid in early detection and play a key role in the disease’s clinical diagnosis and characterization, according to research published in The Lancet Neurology journal. Findings from the study confirm that the technique—known as α-synuclein seed amplification assay (αSyn-SAA)—can accurately detect people with the neurodegenerative disease and suggest it can identify at-risk individuals and those with early, non-motor symptoms prior to diagnosis. The presence of misfolded α-synuclein protein aggregates in the brain is the pathological hallmark of Parkinson’s disease. Co-lead author Professor Andrew Siderowf, of the University of Pennsylvania Perelman School of Medicine (U.S.) and Parkinson Progression Marker Initiative (PPMI) investigator, says, “Recognizing heterogeneity in underlying pathology among patients with Parkinson’s disease has been a major challenge. Identifying an effective biomarker for Parkinson’s disease pathology could have profound implications for the way we treat the condition, potentially ...
- Source: drugdu
- 118
- April 13, 2023
Mediterranean diet may lower heart disease risk in women by nearly 25%, study finds

Closely following a Mediterranean diet may cut a woman’s risk of heart disease and death by nearly 25%, according to a new analysis of 16 studies. “This study adds to what is already known about the cardiovascular benefits of a Mediterranean diet but further reiterates that it can be equally as beneficial in women as it is known to be in men,” said lead author Sarah Zaman, associate professor at the Westmead Applied Research Centre at the University of Sydney, in an email. Heart disease is the number one killer of women and men worldwide, according to the World Health Organization. Coronary artery disease kills more than twice as many women as breast cancer in the United Kingdom, while in 2020, one in five deaths among women in the United States was because of heart disease. Yet few studies on the heart have looked specifically at women, ...
- Source: drugdu
- 105
- April 13, 2023
Moderna cancer vaccine takes positive step

Company’s candidate, in combination with MSD’s Keytruda, receives PRIME designation Moderna has announced that mRNA-4157/V940 – its investigational cancer vaccine – in combination with Keytruda, Merck’s anti-PD-1 therapy, has been granted Priority Medicines (PRIME) scheme designation by the European Medicines Agency (EMA). It concerns the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection. The vaccine mRNA-4157/V940 stimulates an immune response by generating specific T cell responses based on the unique mutational signature of a patient’s tumour. The EMA awarded the PRIME scheme designation following positive data emerging from the phase 2b KEYNOTE-942/mRNA-4157-P201 clinical trial. The results from this research will be shared at the American Association for Cancer Research (AACR) in mid-April. PRIME is a regulatory system run by the EMA that provides support for the development of medicines that target unmet medical needs. Through PRIME, the EMA offers proactive and early ...
- Source: drugdu
- 106
- April 12, 2023
FDA takes only drug for premature birth off the market

On Thursday, the US Food and Drug Administration announced its final decision to withdraw its approval of Makena, a drug approved more than a decade ago to reduce the risk of preterm birth that had been the only medication approved for the condition. The FDA says that the drug is not effective and that the benefits of taking it do not outweigh the risks. “It is tragic that the scientific research and medical communities have not yet found a treatment shown to be effective in preventing preterm birth and improving neonatal outcomes – particularly in light of the fact that this serious condition has a disparate impact on communities of color, especially Black women,” FDA Commissioner Dr. Robert Califf said in a statement. “Fundamentally, however, the touchstone of FDA drug approval is a favorable benefit-risk assessment; without that favorable assessment, the drug should not have the status of ...
- Source: drugdu
- 124
- April 12, 2023

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