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.
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...
Lucy Scientific Discovery, Inc. Successfully Acquires Wesana Health Assets
Thursday, July 06, 2023Lucy Scientific Discovery Inc NASDAQ LSDI has successfully completed its acquisition of Wesana Health Incs SANA assets marking a significant milestone in the field of mental health therapeutics This acquisition strengthens Lucys position as a leader...
Zenocutuzumab (Zeno) Has Been Granted a Second Breakthrough Therapy Designation by the U.s. Food & Drug Administration
Thursday, July 06, 2023Merus NV a company focused on oncology research and development has announced that the US Food and Drug Administration FDA has granted Breakthrough Therapy Designation BTD for their drug zenocutuzumab Zeno The designation is for the treatment of adva...
European Commission Grants Approval for ORKAMBI® (Lumacaftor/ivacaftor) in the Treatment of Cystic Fibrosis in Children Aged 1 to <2 Years
Thursday, July 06, 2023Vertex Pharmaceuticals announced today that the European Commission has granted approval for the label extension of ORKAMBI lumacaftorivacaftor for the treatment of children with cystic fibrosis CF aged to under years old who have two copies of the...
Sorrento Presents Positive Phase IIa Study Findings of Abivertinib for Relapsed/refractory Marginal Zone Lymphoma (R/R MZL) and Reveals Plan for Crucial Phase III Trial
Thursday, July 06, 2023Sorrento Therapeutics Inc OTC SRNEQ has released positive findings from a phase IIa study conducted in China on Abivertinib a dual inhibitor targeting mutant EGFR and BTK Abivertinib a pyrrolopyrimidinebased drug has shown potential in multiple indic...
Oxford Biotherapeutics Launches Phase Ib Clinical Trial for OBT076 in Patients With Advanced Solid Tumors, Initiating First Patient Dose With CPI Balstilimab in Europe
Wednesday, July 05, 2023Oxford BioTherapeutics OBT has recently initiated a Phase b combination trial to evaluate its lead candidate OBT in conjunction with Agenus balstilimab an antiPD checkpoint inhibitor The trial is being conducted at multiple centers in Europe specific...
