Protara’s cell therapy touts BCG-naïve treatment potential in Phase II
Protara’s lead candidate, TARA-002, has demonstrated durable complete response (CR) rates in a single-arm Phase II trial in Bacillus Calmette-Guérin …
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AI can reduce R&D costs to alleviate looming patent cliff pressures
AI will be a useful tool in reducing R&D costs to help alleviate some of the pain pharma will feel …
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FDA appoints Tracy Beth Høeg as fifth CDER head this year
The US Food and Drug Administration (FDA) has selected Tracy Beth Høeg as its new head of drug research and …
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Capricor stock soars after pivotal DMD cell therapy trial meets endpoints
Capricor Therapeutics’ stock has soared by more than 370% after a pivotal trial of its Duchenne muscular dystrophy (DMD) cell …
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Remote monitoring could reduce patient burden and improve outcomes
As processes in drug development become increasingly digitalised, novel technologies that track progress of patient cohorts in real-time may allow …
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Rondo Therapeutics begins dosing in Phase I/Ib trial for solid tumours
Rondo Therapeutics has initiated dosing in its Phase I/Ib clinical trial of first-in-class bispecific antibody, RNDO-564, targeting Cluster of Differentiation …
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FDA clears VectorY’s PIONEER-ALS Phase I/II trial for ALS
VectorY Therapeutics has received clearance from the US Food and Drug Administration (FDA) for its investigational new drug (IND) application …
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Imvax to explore FDA pathway for glioblastoma candidate despite PFS miss
Imvax is preparing for discussions with US regulators about the next steps for IGV-001 in newly diagnosed glioblastoma (ndGBM) despite …
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BMS delays Alzheimer’s readout for Cobenfy over “site irregularities”
Bristol Myers Squibb (BMS) has delayed the data readout from the Phase III ADEPT-2 trial of Cobenfy (xanomeline/trospium chloride) after …
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Richard Padzur to leave FDA following recent CDER leadership shift
After less than a month in his new role as head of the US Food and Drug Administration’s (FDA) Center …
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PolarityBio concludes SkinTE’s Phase III trial for diabetic foot ulcers
PolarityBio has completed the COVER DFUS II pivotal Phase III clinical trial of its autologous heterogeneous skin construct product, SkinTE, …
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OCT DACH 2025: Geopolitics, trial equity and technology take centre stage
At Arena International’s Outsourcing in Clinical Trials (OCT) DACH 2025 conference, technology took centre stage, with emerging and established tools …
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Vandria announces topline results from Phase I trial of VNA-318
Vandria has announced positive top line data from its first-in-human Phase I clinical trial evaluating VNA-318, a central nervous system …
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FDA steps back from preclinical primate testing amid wider regulatory shift
The US Food and Drug Administration (FDA) has taken another step away from animal testing – this time through draft …
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Regulatory factors in rare disease studies
The rare disease landscape poses myriad challenges for researchers, policymakers, and CROs, particularly in navigating its intricate regulatory environment. Rare …
