news
Trodelvy® improves breast cancer progression-free survival, finds study
Trodelvy® (sacituzumab govitecan-hziy) was found to significantly reduce the risk of disease progression or death in certain breast cancer patients.
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Research & Development (R&D)
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Phase III study shows safety of fezolinetant as non-hormonal treatment of VMS
The safety and efficacy of fezolinetant is being evaluated in the Phase III trial of over 1,800 women seeking relief from severe vasomotor symptoms associated with menopause (VMS).
news
Chikungunya vaccine candidate safe and immunogenic in Phase III
Valneva’s single-shot chikungunya vaccine candidate, VLA1553, offered a very high level of seroprotection in all adults, including the elderly.
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PRIME scheme benefits drug development, finds EMA report
The report outlines the positive impact the EMA’s PRIority Medicines (PRIME) scheme has had on drug development for unmet medical need over the last five years.
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£260mn in funding to support UK clinical research and medicines manufacturing
The UK Government has committed £200mn to support NHS-led diagnostics and treatment research and £60 million to expand life sciences manufacturing.
news
Empagliflozin benefits adults hospitalised for acute heart failure, shows study
Phase III trial shows that adults hospitalised for acute heart failure were 36 percent more likely to experience a clinical benefit if initiated on empagliflozin.
news
Nirsevimab first potential immunisation to protect against RSV in infants
Nirsevimab has the potential to offer RSV protection for all infants, with a single dose showing 74.5 percent efficacy in the Melody Phase III trial.
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Galenic software implementation on a rotary tablet press: IMAGO and its functionalities
In this article by IMA, discover how IMAGO software installed on rotary tablet presses supports scientists during tablet manufacturing, providing critical insights into powders.
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Clostridioides difficile vaccine shows promise in Phase III trial
Pfizer’s investigational C. difficile vaccine was shown to reduce the duration and severity of disease, but not prevent primary C. difficile infection.
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FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
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USP calls for industry input in developing mRNA quality guidelines
USP is developing mRNA quality guidelines to support the development of innovative medicines and vaccines.
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UK to support early-stage clinical research with £161 million
New funding for Clinical Research Facilities will boost delivery of first-in-human to early safety and efficacy trials across England.
whitepaper
Whitepaper: Standard versus “hybrid” FIH trial advantages and challenges
This whitepaper examines key considerations to take into account when deciding whether to run a standard FIH in HVs or a hybrid FIH clinical trial.
news
Lilly to create $700mn Institute for Genetic Medicine
Investing $700mn to establish a new site, Eli Lilly plans to fuel the development of genetic medicines through the company’s new Institute for Genetic Medicine.
news
β-thalassemia patients achieve transfusion independence with gene therapy
Over 90 percent of β-thalassemia patients treated with Betibeglogene autotemcel (beti-cel) achieved transfusion independence lasting over a year.
