Clinical News

Agios Submits New Drug Application to FDA for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency

Agios Submits New Drug Application to FDA for Mitapivat for Treatment of Adults with Pyruvate Kinase Deficiency

Agios Pharmaceuticals, Inc. announced that it has submitted a New Drug Application (NDA) for Mitapivat to the U.S. Food and Drug Administration (FDA) for the treatment of adults with pyruvate…
TIF Is Actively Participating In The 26th EHA Annual Congress

TIF Is Actively Participating In The 26th EHA Annual Congress

TIF is excited to be participating in the 26th EHA Annual Congress, held this year virtually on 09 – 17 June 2021. Ms Lily Cannon, TIF Operations Manager, attended a…
Bluebirdbio Announces The Lifting Of FDA Clinical Hold for Sickle Cell Disease And β-Thalassaemia Studies

Bluebirdbio Announces The Lifting Of FDA Clinical Hold for Sickle Cell Disease And β-Thalassaemia Studies

bluebird bio, Inc. today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical holds on the Phase 1/2 HGB-206 and Phase 3 HGB-210 studies of LentiGlobin…
US STUDY: COVID-19 Does Not Pose A Threat To Blood And Transfusion Safety

US STUDY: COVID-19 Does Not Pose A Threat To Blood And Transfusion Safety

A new reassuring US study, published recently in the journal Transfusion, suggests that the risk of transmission of SARS-CoV2 through blood transfusion is highly unlikely. For the study, the investigators…
Chinese Sinovac COVID-19 Vaccine Approved By World Health Organization

Chinese Sinovac COVID-19 Vaccine Approved By World Health Organization

The World Health Organization (WHO) announced yesterday that it has approved a COVID-19 vaccine made by Sinovac Biotech (SVA.O) for emergency use listing, paving the way for a second Chinese shot…
Oxbryta Increased Haemoglobin And Reduced Haemolysis in Adults and Adolescents With SCD

Oxbryta Increased Haemoglobin And Reduced Haemolysis in Adults and Adolescents With SCD

Global Blood Therapeutics, Inc. announced The Lancet Haematology has published the complete analysis of 72-week data from the Phase 3 HOPE Study of Oxbryta® (voxelotor) tablets in patients with sickle cell disease…
Hemanext® Inc. Receives CE Mark Certification For Innovative Red Blood Cell (RBC) Processing & Storage System

Hemanext® Inc. Receives CE Mark Certification For Innovative Red Blood Cell (RBC) Processing & Storage System

Hemanext Inc. announced today it has received a CE Certificate of Conformity for the CE Mark for its Hemanext ONE Red Blood Cell (RBC) Processing and Storage System, allowing the…
TIF’s Public Statement on Current Developments in Gene Therapy SCD Clinical Trials and Thalassaemia Gene Therapy Zynteglo

TIF’s Public Statement on Current Developments in Gene Therapy SCD Clinical Trials and Thalassaemia Gene Therapy Zynteglo

The Thalassaemia International Federation (TIF) has been informed through official communication by both the European Medicines Agency (EMA) and bluebird bio that the latter has placed Phase 1/2 and Phase…
The Lancet: Russian Coronavirus Sputnik V Vaccine Achieves Over 90% Efficacy

The Lancet: Russian Coronavirus Sputnik V Vaccine Achieves Over 90% Efficacy

Russia’s Sputnik V vaccine was 91.6% effective in preventing people from developing Covid-19, according to peer-reviewed results from its late-stage clinical trial published yesterday in The Lancet international medical journal.…
EMA Accepts MAA For Oxbryta To Treat Haemolytic Anaemia In Sickle Cell Disease

EMA Accepts MAA For Oxbryta To Treat Haemolytic Anaemia In Sickle Cell Disease

The European Medicines Agency (EMA) has accepted Global Blood Therapeutics (GBT) marketing authorisation application (MAA) for Oxbryta® (voxelotor) for the treatment of haemolytic anaemia in sickle cell disease (SCD). According to the company,…
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