Transplant

Kidneys
#Clinical trial #EMA #Hansa Biopharma #Transplant

Hansa Biopharma reports positive PAES results from Idefirix 

Hansa Biopharma has announced positive topline results from a study investigating Idefirix (imlifidase) in patients who have undergone HLA-incompatible kidney transplantation.  The biopharmaceutical company announced the primary objective of the post-authorisation efficacy study (PAES) was met, with 90% of highly sensitised kidney transplant patients achieving one‑year graft failure‑free survival – following Idefirix pre‑treatment to convert… Read More

#News

Kidneys
#European Medicines Agency #Hansa Biopharma #Transplant

Hansa Biopharma and SERB enter €115m licensing agreement 

Hansa Biopharma and SERB have entered a licensing agreement worth €115 million for the development and commercialisation of a treatment for kidney transplant patients.  Idefirix (imlifidase) is a first-in-class treatment that targets and cleaves all classes of immunoglobulin G (IgG) antibodies within two to six… Read More

#Business & Investment #News

Auditory pathway
#Cell therapy #Hearing Loss #Lineage Cell Therapeutics #Transplant

Research collaboration targets cell-based therapy for hearing loss

Lineage Cell Therapeutics has entered a research collaboration with and through an investment from William Demant Invest (WDI), the holding company for William Demant Foundation’s investment activities and a majority shareholder of hearing healthcare company, Demant.  The parties will jointly advance Lineage’s auditory neuronal cell transplant, ReSonance… Read More

#News

Stem cell transplant
#China #Cytomegalovirus #Phase III trial #Stem cell transplant #Takeda #Transplant

China’s NMPA okays maribavir for post-transplant cytomegalovirus

Takeda’s Livtencity (maribavir) has been approved in China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease. It has been licensed by the National Medical Products Administration (NMPA) in cases where the infection is resistant… Read More

#News #Regulatory

Kidneys
#Clinical trial #Immunotherapy #Nantes University Hospital #OSE Immunotherapeutics #Phase I trial #Transplant

High hopes for immunotherapy candidate in renal transplant

OSE Immunotherapeutics and Nantes University Hospital have revealed positive interim data analysis from the FIRsT Phase I/II study evaluating FR104/VEL-101 immunotherapy in renal transplants. The data was presented the Annual Meeting of the Francophone Society of Transplantation (SFT, Société Francophone de Transplantation) held in Brest, France. Read More

#News

Bone marrow transplant operation
#Biologics / Biotechnology #Cell therapy #FDA #Graft vs Host Disease #Mesoblast #Transplant

“Off-the-shelf” cellular medicine resubmitted to the FDA

Mesoblast has resubmitted its biologics license application (BLA) to the US Food and Drug Administration (FDA) for approval of remestemcel-L in the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD).  Survival outcomes have not improved over the past two decades for the most severe… Read More

#News #Regulatory

Arsenic Trioxide
#Anti-inflammatory #Arsenic Trioxide #Autoimmune disease #Graft vs Host Disease #Phase II trial #Stem cell transplant #Transplant

Phase II success for autoimmune disease platform in GVHD

BioSenic’s arsenic trioxide (ATO) autoimmune disease platform has completed a successful Phase IIb trial in chronic Graft vs Host Disease (cGVHD) and is preparing to move to a Phase III trial.  The BioSenic autoimmune platform was created by Medsenic to target systemic autoimmune diseases using ATO as… Read More

#News