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QurAlis receives authorisation to initiate ALS therapy trial in EU
QurAlis has received clinical trial authorisation (CTA) in the European Union (EU) to initiate a first-in-human, Phase I ANQUR clinical …
BPGbio doses first patients in Phase II GBM therapy trial
BPGbio has dosed the first patients in a Phase II clinical trial of BPM 31510 to treat Glioblastoma Multiforme (GBM), …
ASCO 2023: blockbuster Enhertu demonstrates efficacy across multiple tumour types
At the American Society of Clinical Oncology (ASCO) Annual Meeting, 2-6 June 2023, interim results were presented for the Phase …
FDA open for feedback on GCP draft guidance
The US Food and Drug Administration (FDA) released a draft guidance with updated recommendations for good clinical practices (GCPs). The draft …
IDE clinical trial for artificial cervical disc completes enrollment
Synergy Spine Solutions has enrolled the last patient in its investigational device exemption (IDE) clinical trial. The 1-Level Synergy Disc …
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ASCO 2023: Precigen reports positive early data for CAR-T therapy
New early data suggests Precigen Therapeutics’s CAR-T therapy PRGN-3005 could decrease tumour burden in advanced ovarian cancer. In Phase I data …
Synlogic begins Phase III trial of SYNB1934 for phenylketonuria
US-based biotechnology firm Synlogic has begun a Phase III trial of SYNB1934 for the treatment of phenylketonuria (PKU), a rare …
FogPharma doses first patient in colorectal cancer drug trial
US-based biopharmaceutical company FogPharma has dosed the first patient in its first-in-human Phase I/II clinical trial of FOG-001, a TCF-blocking …
Imbria completes patient enrolment in trial of nHCM therapy
US-based pharmaceutical company Imbria Pharmaceuticals has finished enrolling patients in its IMPROVE-HCM Phase II clinical trial of ninerafaxstat for non-obstructive …
ANeuroTech receives FDA approval for Phase IIIb MDD drug trial
The US Food and Drug Administration (FDA) has given clearance to ANeuroTech’s investigational new drug (IND) application, allowing the company …
EyePoint completes patient enrolment in study of NPDR therapy
US-based pharmaceutical company EyePoint Pharmaceuticals has finished enrolling patients in its Phase II PAVIA clinical trial of EYP-1901 for moderate …
Bellerophon’s study of fILD therapy fails to meet primary endpoint
US-based biotechnology firm Bellerophon Therapeutics has reported that its Phase III REBUILD clinical trial of INOpulse for the treatment of …
ASCO 2023: AstraZeneca’s PD-1/TIGIT shows promise in checkpoint-exposed NSCLC
Lung cancer is the second most common cancer globally, with non-small cell lung cancer (NSCLC) being the most common lung …
Akero’s NASH candidate and Ozempic reduce liver fat in Phase IIb cohort
New Phase IIb data suggests a combination therapy of Akero Therapeutics’s efruxifermin and Novo Nordisk’s Ozempic (semaglutide) can reduce liver …
ASCO 2023: Janssen present positive follow-up data for first in line therapy for lung cancer
Janssen Pharmaceuticals has presented long-term results from its CHRYSALIS study, which showed the combination of Rybrevant (amivantamab-vmjw) and lazertinib, was …