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89bio wins EMA priority status for MASH candidate pegozafermin
The European Medicine’s Agency (EMA) has granted priority medicines (PRIME) status to 89bio’s pegozafermin, a drug being evaluated to treat …
Pfizer’s Velsipity UK approval raises competition in the ulcerative colitis market
The recent approval of Pfizer’s oral drug, Velsipity (etrasimod), by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for …
Cleerly touts new data for AI cardiovascular software
Digital healthcare company Cleerly has announced that positive data from two studies investigating its AI-QCT ISCHEMIA software device has been …
Implantica gears up for FDA approval of acid reflux device
Implantica has started the premarket approval process with the US Food and Drug Administration (FDA) for its gastroesophageal reflux disease …
Oncology in 2024: The clinical trial trends reshaping the role of CROs
Oncology is the most active area in clinical trials globally this year, as more resources than ever are being dedicated …
Auxilius Pharma to launch Phase Ib anti-anginal trial after IND application
Auxilius Pharma will be submitting an investigative new drug (IND) application for AUX-001 with plans to initiate a Phase Ib …
Atamyo obtains clearance for muscular dystrophy gene therapy trial in Europe
Atamyo Therapeutics has received regulatory clearance in Europe to initiate a Phase Ib clinical trial for its gene therapy, ATA-200, …
Valneva commences Phase I trial of second-generation Zika vaccine
Valneva has commenced the Phase I VLA1601-102 clinical trial of its second-generation adjuvanted inactivated vaccine candidate, VLA1601, against the Zika …
Viking reports positive data from Phase I oral obesity treatment trial
Viking Therapeutics has reported positive data from its Phase I multiple ascending dose (MAD) clinical trial of VK2735, an oral …
Moderna’s Phase III Covid-19 vaccine trial meets primary endpoints
Moderna has announced positive interim results from the Phase III NextCOVE clinical trial, where its next-generation Covid-19 vaccine candidate, mRNA-1283, …
Regeneron hit with FDA rejection for blood cancer therapy
The US Food and Drug Administration (FDA) has rejected Regeneron Pharmaceutical’s approval application for odronextamab in two forms of lymphoma, …
Protembis secures $30m to initiate PROTEMBO IDE trial
Germany-based Protembis has raised $30m in a Series B funding round to initiate a pivotal clinical trial of its intra-aortic …
Edgewood secures $20m in Series A for clinical development of cancer therapy
Massachusetts-based company Edgewood Oncology has raised $20m in Series A to advance the clinical development of its lead cancer therapy …
Apogee Therapeutics begins dosing in allergic disease drug trial
US-based biotechnology company Apogee Therapeutics has begun dosing healthy subjects in its Phase I clinical trial of APG808, a potential …
Syros enrols subjects in myelodysplastic syndrome drug trial
US-based biotechnology company Syros Pharmaceuticals has enrolled 190 subjects in the initial cohort of the SELECT-MDS-1 Phase III clinical trial …