News
The most recent news and industry headlines are presented in this section. Our dedicated team closely observes the pharmaceutical industry and keeps you informed of the most recent developments around the Europe.
QurAlis Granted Clinical Trial Authorization (CTA) in the U.K. for QRL-201: A First-of-its-Kind Precision Therapy for ALS Targeting STATHMIN-2
Wednesday, July 12, 2023QurAlis Corporation recently announced that the Medicines and Healthcare Products Regulatory Agency MHRA in the United Kingdom has accepted their Clinical Trial Application CTA for QRL a potential treatment for amyotrophic lateral sclerosis ALS
Tango Therapeutics Commences TNG462 Phase 1/2 Trial, Administering Initial Dose to Patients Affected by MTAP-deleted Solid Tumors
Tuesday, July 11, 2023Tango Therapeutics Inc NASDAQ TNGX has recently initiated a phase clinical trial for their drug candidate TNG targeting patients with MTAPdeleted solid tumors TNG is a PRMT inhibitor that works in conjunction with MTA and has received Fast Track des...
Acasti Partners With Wuxi Clinical as CRO for STRIVE-ON Pivotal Phase 3 Safety Trial of GTX-104 in aSAH Patients
Tuesday, July 11, 2023Acasti Pharma Inc Nasdaq ACST has announced its partnership with WuXi Clinical Development Inc a subsidiary of WuXi AppTec to conduct the Phase safety trial for GTX an injectable nimodipine formulation developed by Acasti
FDA Grants Rare Pediatric Disease Designation to Myopax for Breakthrough Regenerative Cell Product in Exstrophy-epispadias Complex
Tuesday, July 11, 2023MyoPax an innovative European biotech startup focused on developing regenerative cell therapies for debilitating muscle disorders has achieved a significant milestone in its efforts to help children with rare diseases
European Medicines Agency Grants Orphan Drug Designation to Marker Therapeutics' MT-401 for AML Treatment
Tuesday, July 11, 2023Marker Therapeutics Inc Nasdaq MRKR has recently announced that its T cellbased immunotherapy zedenoleucel MT has been granted Orphan Drug Designation by the European Medicines Agency EMA for the treatment of acute myeloid leukemia AML
Hemogenyx Pharmaceuticals PLC Seeks Full FDA Review for HEMO-CAR-T IND
Monday, July 10, 2023Hemogenyx Pharmaceuticals plc LSEHEMO has recently received a comprehensive review letter from the US Food and Drug Administration FDA concerning the Investigational New Drug IND application for their product candidate HEMOCART
Biophytis Requests FDA Authorization to Begin SARA-31 Phase 3 Study in Sarcopenia
Monday, July 10, 2023Biophytis SA a clinicalstage biotechnology company has submitted an application to the Food and Drug Administration FDA to initiate its SARA program in the United States This program represents the firstever Phase study in sarcopenia a condition ass...
Celldex Initiates Phase 2 Study of Barzolvolimab for Eosinophilic Esophagitis With First Patient Dosed
Friday, July 07, 2023Celldex Therapeutics Inc NASDAQCLDX has announced the initiation of a Phase study for barzolvolimab in eosinophilic esophagitis EoE a chronic inflammatory disease affecting the esophagus
Revive Therapeutics Releases Findings From Phase 3 Clinical Study on Bucillamine for COVID-19 Treatment
Friday, July 07, 2023Revive Therapeutics Ltd recently announced the findings of its Phase clinical trial investigating the safety and effectiveness of oral Bucillamine in patients with mild to moderate COVID However the study did not yield statistically significant resu...
Kyverna Therapeutics Receives Regulatory Approval for Phase 1/2 Clinical Trial of KYV-101 in Germany
Friday, July 07, 2023Kyverna Therapeutics a cell therapy company focused on addressing serious autoimmune diseases has received approval from the PaulEhrlichInstitut PEI in Germany for its first Clinical Trial Application CTA The approved therapy known as KYV is a novel...
