Clinical News
Coronavirus Pandemic: How Close Are We to a Vaccine?
13 ώρες ago
Coronavirus Pandemic: How Close Are We to a Vaccine?
Researchers around the world are racing to develop a vaccine against Covid-19, with more than 140 candidate vaccines now tracked by the World Health Organization (WHO). Vaccines normally require years of testing…
Novartis sickle cell drug Adakveo put on path to EU approval
1 εβδομάδα ago
Novartis sickle cell drug Adakveo put on path to EU approval
Novartis announced last Friday that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending conditional marketing authorization of Adakveo® (crizanlizumab)…
Oxford vaccine: Early Trials Show Promising Results that Suggest “Double Protection” from Coronavirus
2 εβδομάδες ago
Oxford vaccine: Early Trials Show Promising Results that Suggest “Double Protection” from Coronavirus
The experimental vaccine being developed by AstraZeneca and Oxford University against the new coronavirus produced an immune response in early-stage clinical trials, data showed on Monday, preserving hopes it could…
Early-Stage Trial Data on Oxford University COVID-19 Vaccine to be Published July 20
3 εβδομάδες ago
Early-Stage Trial Data on Oxford University COVID-19 Vaccine to be Published July 20
Early-stage human trial data on a vaccine being developed by Oxford University and AstraZeneca will be published on July 20, The Lancet medical journal announced yesterday. The potential vaccine is already…
Coronavirus Disease among Persons with Sickle Cell Disease
3 εβδομάδες ago
Coronavirus Disease among Persons with Sickle Cell Disease
Individuals with sickle cell disease (SCD) are a particularly vulnerable group of patients, with a higher risk of severe complications due to COVID-19 infection than the general public. A recent…
GBT Announces Plans to Seek Regulatory Approval for Oxbryta® (Voxelotor) to Treat Sickle Cell Patients in Europe
4 εβδομάδες ago
GBT Announces Plans to Seek Regulatory Approval for Oxbryta® (Voxelotor) to Treat Sickle Cell Patients in Europe
Global Blood Therapeutics (GBT) plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Oxbryta (Voxelotor) be approved for treating hemolytic anemia in patients with sickle cell disease…
IMR-687 Receives FDA Orphan Drug Designation for the Treatment of β-Τhalassaemia
30 Ιουνίου, 2020
IMR-687 Receives FDA Orphan Drug Designation for the Treatment of β-Τhalassaemia
IMARA Inc., a clinical-stage biopharmaceutical company operating in the haemoglobin disorders field, announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for IMR-687 for the…
European Commission Approves Reblozyl for the Treatment of Transfusion-dependent β-Thalassaemia
30 Ιουνίου, 2020
European Commission Approves Reblozyl for the Treatment of Transfusion-dependent β-Thalassaemia
Bristol Myers Squibb (BMS) & Acceleron Pharma announced today that the European Commission approved Reblozyl (luspatercept) for the treatment of Transfusion-Dependent β-#Thalassaemia (TDT) in adult patients. Reblozyl has the potential to…
FDA Grants Orphan Drug Designation to Mitapivat for Treatment of Thalassaemia
11 Ιουνίου, 2020
FDA Grants Orphan Drug Designation to Mitapivat for Treatment of Thalassaemia
Agios Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the company’s first-in-class pyruvate kinase-R (PKR) activator Mitapivat for the treatment of…
FDA Approves New Formulation for Ferriprox (Deferiprone) Twice-a-Day Tablets
22 Μαΐου, 2020
FDA Approves New Formulation for Ferriprox (Deferiprone) Twice-a-Day Tablets
Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., today announced that the U.S. Food and Drug Administration (FDA) has approved Ferriprox® (deferiprone) twice-a-day tablets for the treatment…