Roche’s oral SERD fails in Phase III breast cancer trial
Roche’s oral selective oestrogen receptor degrader (SERD) has failed to meet its primary endpoint in a Phase III breast cancer …
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Analysts tout market potential of Xenon’s epilepsy drug on Phase III win
Analysts have touted the market potential of Xenon Pharmaceuticals’ novel epilepsy drug, azetukalner, following a positive late-stage readout in patients …
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Study explores links between gestational diabetes, prenatal depression and childhood obesity
In the US, the burden of childhood obesity has posed a formidable public health problem. Obesity in early life predisposes …
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Long-term aspirin use is associated with lower ovarian cancer risk
Ovarian cancer is a leading cause of gynaecological cancer mortality worldwide. Early symptoms of ovarian cancer can include decreased appetite, …
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Opening clinical trials to pregnant women
Pregnant and breastfeeding women have historically been excluded from medical research, resulting in substantial gaps in evidence on the safety …
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Vinay Prasad to leave the FDA again
Vinay Prasad is once again set to depart from his role at the US Food and Drug Administration (FDA), after …
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Dyne commences Phase III HARMONIA trial for DM1 therapy
Dyne Therapeutics has initiated the Phase III HARMONIA trial to evaluate the efficacy, safety, and tolerability of zeleciment basivarsen (z-basivarsen, …
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Aisa Pharma reports positive results for AISA-021
Aisa Pharma has reported positive results from its Phase II RECONNOITER trial of AISA-021 (cilnidipine), a once-daily calcium channel blocker, …
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Roche and Zealand’s Phase II obesity trial divides analyst opinion
Roche and Zealand Pharma’s co-developed amylin analogue, petrelintide, has met its primary endpoint in a Phase II trial, but the …
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Women first: the Gulf’s new healthcare blueprint
Nabta Health, a Dubai-based women's health company, is up for a prestigious MedTech award, but its founder Sophie Smith has …
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The clinical trial supply model of the future
Existing clinical trial supply models are facing a number of challenges - increased market competition, growing trial complexity, a significant …
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EMA posts draft guidance on running trials during public health emergencies
The European Medicines Agency (EMA) has released draft guidance for sponsors conducting clinical trials during public health emergencies (PHEs). The guidance, …
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DiaMedica gains Health Canada approval for Phase II preeclampsia trial
DiaMedica Therapeutics has received Health Canada clearance for its clinical trial application to begin a Phase II study assessing DM199 …
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How the AI shift is happening now in data management
The newest generation of AI-driven tools is beginning to reshape how clinical databases are built, governed, and maintained. This is …
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Seqster unveils 1-Click DataLake for clinical trials
Seqster has launched 1-Click DataLake, a real-world data platform to expedite trial design, recruitment, and evidence generation for healthcare and …
