FDA locks down post-approval pregnancy safety data framework
The US Food and Drug Administration (FDA) has debuted its final industry guidance on collecting post-marketing safety data for both …
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Actio Biosciences begins trial of ABS-1230 for epilepsy
Actio Biosciences has begun the KYRON Phase Ib/II trial of ABS-1230 for potassium sodium-activated channel subfamily T member 1 (KCNT1)-related …
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Day One concludes patient enrolment for tovorafenib’s FIREFLY-2 trial
Day One Biopharmaceuticals has concluded patient enrolment in the Phase III FIREFLY-2 trial assessing tovorafenib for paediatric low-grade glioma (pLGG). The …
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Beacon Therapeutics’ gene therapy shows 12-month benefit
Beacon Therapeutics’ gene therapy has shown a 12-month benefit in a Phase II study in patients with X-linked retinitis pigmentosa …
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enGene reports interim data from LEGEND trial of detalimogene voraplasmid
enGene Therapeutics has reported additional interim outcomes from the pivotal cohort of its ongoing LEGEND Phase II trial assessing detalimogene …
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enGene reports interim data from LEGEND trial of detalimogene voraplasmid
enGene Therapeutics has reported additional interim outcomes from the pivotal cohort of its ongoing LEGEND Phase II trial assessing detalimogene …
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Entrada’s stock drops as DMD drug’s efficacy falls short
Entrada Therapeutics’ stock value has dropped by more than 57% after the efficacy of its Duchenne muscular dystrophy (DMD) therapy, …
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Streamline data capture and automate EHR-to-EDC data transfer
As clinical trial protocols grow more complex, so does the burden on research sites managing data collection and entry. Manual …
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MEDSIR reports PHERGain and PHERGain-2 trial results for breast cancer
MEDSIR has reported data from the PHERGain and PHERGain-2 trials, which focused on targeted therapies in early human epidermal growth …
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US study explores adoption of novel colorectal cancer screening methods
Within recent years, colorectal cancer (CRC) has seen an alarming rise in the US. In response to these epidemiological trends …
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Moderna’s mRNA flu vaccine more effective than current SOC
Moderna’s mRNA flu vaccine has proved to be more effective than a standard flu vaccine in a Phase III trial. In …
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Taimei Technology and C&R Research to develop AI clinical trial operations platform
Taimei Technology and South Korea’s C&R Research have signed a strategic partnership deal to co-develop an AI-powered clinical trial operations …
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Patient enrolment concludes in Alebund’s Phase III trial of AP301
Alebund Pharmaceuticals has completed patient enrolment in its global Phase III pivotal clinical trial, RESPOND-2, Study AP301-HP-03, evaluating the fibre-iron-based …
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An essential framework to navigating technical challenges in contemporary OSD development
As requirements shift toward more complex, value-added solid formats and iAs requirements shift toward more complex, value-added solid formats and …
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WHO releases online course for clinical trial best practices
The World Health Organization (WHO) has released an online course for clinical trial good practices. The self‑paced course translates the ‘WHO Guidance …
