Rare Disease Day: Revolutionising clinical trial enrolment and retention with technology
As we mark Rare Disease Day 2026, it is worth reflecting on the developments in digitalisation, artificial intelligence (AI), and …
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AtaiBeckley’s MDMA-based drug for anxiety shows benefit in Phase IIa trial
AtaiBeckley’s social anxiety disorder (SAD) drug has shown both safety and early signs of efficacy in a Phase IIa trial. In …
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Bayer’s Xofigo plus Xtandi extends OS in mCRPC with bone metastases
Bayer’s radioligand therapy (RLT), Xofigo (radium-223 dichloride), has demonstrated its first-line, combinatory treatment potential in metastatic castration resistant prostate cancer …
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Synthekine and MSD collaborate for STK-012 combination trial to treat NSCLC
Synthekine has entered a clinical trial partnership and supply agreement with Merck (MSD) to investigate STK-012 in combination with Keytruda …
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Podcast: Rare Disease Day: FDA guidance allowing advancement
It’s been a busy year for rare disease developers, with the US Food and Drug Administration (FDA) releasing several new …
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Lilly reports ACHIEVE-3 trial outcomes for type 2 diabetes
Eli Lilly and Company has reported detailed findings from the ACHIEVE-3 Phase III trial comparing the efficacy and safety of …
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Rare disease developers applaud clarity in FDA guidance
Stakeholders in the rare disease development community say that new guidance documents, released by the US Food and Drug Administration …
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ViiV’s four-monthly HIV drug maintains viral suppression at 12 months
ViiV Healthcare’s investigational four-monthly HIV drug maintains viral suppression at 12 months in a Phase IIb trial. In the EMBRACE trial …
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Suvoda unveils split budget feature for clinical trial site management
Suvoda has introduced new split budget functionality to its clinical trial software, Budgeting & Benchmarking, supporting sponsors and contract research …
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Mahzi doses first patient in MZ-1866 trial for Pitt Hopkins syndrome
Mahzi Therapeutics has dosed the first patient in its Phase I/II UNITE study assessing MZ-1866, an investigational gene therapy targeting …
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DOR/ISL Phase III data underlines trend for shift towards two-drug STRs in HIV
A 96-week Phase III study in adults with HIV who were previously virologically suppressed on oral antiretroviral therapy (ART) has …
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EU clinical trial target could bring in additional €4bn funding
A further €4bn ($4.72bn) a year in funding could come into Europe if targets to increase clinical trials in the …
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FDA reversal on mRNA-1010 could transform the seasonal influenza vaccines market
Moderna has announced that the FDA will initiate the review of its seasonal influenza vaccine candidate, mRNA-1010. This announcement comes …
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Enhancing clinical trials in obesity by integrating clinical outcome assessments (COAs) and digital health technologies (DHTs)
As obesity reaches epidemic proportions worldwide, clinical trial teams face mounting pressure to demonstrate meaningful health benefits beyond weight loss …
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Jaguar Gene Therapy completes Cohort I patient dosing in JAG201 clinical trial
Clinical-stage biotechnology company Jaguar Gene Therapy has completed dosing in Cohort I of its first-in-human clinical trial investigating JAG201 for …
