NVX-CoV2373 vaccine 90 percent effective in preventing symptomatic COVID-19
US trial results show NVX-CoV2373 was safe and effective in preventing symptomatic COVID-19, including in high-risk populations.
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beti-cel gene therapy demonstrates durable efficacy in beta thalassaemia patients
The betibeglogene autotemcel (beti-cel) gene therapy caused paediatric and adult beta thalassaemia patients to achieve transfusion independence lasting over two years.
Alzheimer’s vaccine shows promise in Phase II trial
Study results show AADvac1, a first-in-man Alzheimer's disease tau vaccine, is safe and potentially of benefit for patients with mild disease.
Co-administration of flu and COVID-19 vaccines safe and effective
A trial comparing co-administration of influenza and COVID-19 vaccines to COVID-19 vaccine dosing alone found little effect on vaccine efficacy.
New consortium to develop PAT for cell and gene therapies
The Cell and Gene Therapy Catapult’s new consortium aims to accelerate therapeutic development by developing process analytical technologies (PAT) for cell and gene therapy manufacturing.
Health Canada to modernise its clinical trial regulations
Health Canada has proposed a single regulatory framework for clinical trials for all health products that will support innovation and streamline drug and medical device development.
G7 to share 870 million doses of COVID-19 vaccine with poorest countries
Global leaders at the G7 summit pledged 870 million COVID-19 vaccine doses, with half to be delivered by the end of 2021, to COVAX for distribution among low- and middle-income countries.
Pharmacovigilance Risk Assessment Committee meeting highlights, June 2021
The European Medicines Agency (EMA)’s drug safety committee (PRAC) concluded three safety signal reviews, two for COVID-19 interventions, at its June meeting.
Oxbryta® significantly improves haemoglobin levels in paediatric sickle cell disease patients
Data shows treating sickle cell disease patients aged four to 11 years with Oxbryta® (voxelotor) results in increases in haemoglobin associated with improved clinical status.
Janssen COVID-19 Vaccine – one regulator blocks use, another promotes it
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
Comirnaty® COVID-19 vaccine protects against multiple viral variants
Laboratory study shows the blood sera of people vaccinated against COVID-19 with Comirnaty® can neutralise at least six viral variants including three variants of concern.
US National Institutes of Health commits to ending racism in biomedical science
Scientists, administrators, staff and leaders at the NIH have laid out their framework under the UNITE initiative to end structural racism in the biomedical industry.
COVID-19 antibody therapies safe and effective for transplant patients
Monoclonal antibody therapies found to reduce progression to severe disease, risk of hospitalisation and death in transplant recipients with mild to moderate COVID-19.
DFE pharma joins UK’s leading initiative for innovation in drug manufacturing
DFE Pharma is the latest member of the UK’s Medicines Manufacturing Innovation Centre and will work on Grand Challenge 1: improving the manufacture of oral solid dosage medicines.
Janssen COVID-19 Vaccine can protect against variants of concern
Trial shows the single-shot Janssen COVID-19 Vaccine generates robust immune responses against several COVID-19 variants.
