Storm clinches $56m in Series C for Phase II on lead sarcoma drug
British cancer biotech Storm Therapeutics has secured $56m in a Series C financing round to push its sarcoma therapy, STC-15, …
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TG Therapeutics concludes enrolment in Phase III Briumvi trial
TG Therapeutics has completed enrolment in its Phase III trial investigating subcutaneous Briumvi (ublituximab-xiiy) in adults with relapsing multiple sclerosis …
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Precision receives CTA approval to expand ELIMINATE-B study
Precision BioSciences has received clinical trial application (CTA) approval to expand its global ELIMINATE-B study of PBGENE-HBV, an in vivo …
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PDS Biotech’s stock up on colorectal cancer trial success
PDS Biotech’s stock has jumped nearly 25% after its tumour-targeting fused antibody drug conjugate (ADC) elicited a 78% response in patients …
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FDA shares guide on genome editing best practices
The US Food and Drug Administration (FDA) has debuted draft guidance for gene therapy developers, focused on the use of …
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Precision receives CTA approval to expand ELIMINATE-B study
Precision BioSciences has received clinical trial application (CTA) approval to expand its global ELIMINATE-B study of PBGENE-HBV, an in vivo …
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PDS Biotech’s stock up on colorectal cancer trial success
PDS Biotech’s stock has jumped nearly 25% after its tumour-targeting fused antibody drug conjugate (ADC) elicited a 78% response in patients …
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FDA shares guide on genome editing best practices
The US Food and Drug Administration (FDA) has debuted draft guidance for gene therapy developers, focused on the use of …
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Rivus Pharmaceuticals begins patient dosing in Phase II AMPLIFY trial
Rivus Pharmaceuticals has dosed the first patients in the AMPLIFY Phase II clinical trial evaluating HU6, an investigational oral therapy …
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GlycoNex secures Japan’s PMDA approval for GNX1021 Phase I trial
GlycoNex has received Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approval to commence a first-in-human Phase I clinical trial of …
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OCT East Coast 2026: overcoming FDA volatility and global uncertainty
Since the Trump Administration reclaimed the White House a little over a year ago, several changes with global consequences have …
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Lilly’s Jaypirca racks up fourth Phase III CLL win
Eli Lilly’s Jaypirca (pirtobrutinib) has succeeded in its fourth Phase III trial in chronic lymphocytic leukaemia (CLL). The Phase III BRUIN …
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IDEAYA reports top line data from Phase II/III trial of darovasertib combo
IDEAYA Biosciences and Servier have reported positive top line results from the Phase II/III registration trial, OptimUM-02, assessing darovasertib in …
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FDA cracks down on sponsor and researchers’ failure to publish trial data
The US Food and Drug Administration (FDA) has reminded more than 2,200 sponsors and researchers to publicly publish their clinical …
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Vir Biotechnology doses first patient in Phase I VIR-5500 trial
Vir Biotechnology has dosed the first patient in one of three expansion cohorts in its ongoing Phase I clinical trial …
