Utilizing data-driven insights for digital health solutions
Digital health technologies are changing how care is delivered, but how do we substantiate claims that these innovations are effective? …
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ARCH-backed Paradigm snaps up Flatiron’s clinical research business
US-based clinical trial technology specialist Paradigm Health has agreed to purchase Roche-owned Flatiron Health’s clinical research division. Through this acquisition, Paradigm …
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Pliant Therapeutics reports interim PLN-101095 Phase I trial data
Pliant Therapeutics has reported interim results from its ongoing Phase I dose escalation trial of PLN-101095, along with pembrolizumab in …
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Debiopharm randomises first patient in Phase III acromegaly trial
Debiopharm has randomised the first patient in the global Phase III clinical trial, OXTEND-III, to assess the safety and efficacy …
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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, …
