USA – FDA Provides Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities...
During this worldwide public health emergency, the FDA has used a variety of tools to oversee facilities that manufacture FDA-regulated products. These tools include...
France – COVID-19 – Nantes : XAV-19, le candidat médicament de Xenothera en bonne...
Le candidat médicament XAV-19 développé à Nantes par le laboratoire Xenothera et le professeur Raffi, chef du service des maladies infectieuses au CHU, termine actuellement...
Europe – AstraZeneca’s COVID-19 vaccine: EMA to provide further context on risk of very...
EMA continues to monitor very rare blood clots with low blood platelets that occurred after vaccination with Vaxzevria (previously COVID-19 Vaccine AstraZeneca).
In line with a request...
Europe – COVID-19 Vaccine Janssen: assessment of very rare cases of unusual blood clots...
As announced last week, EMA’s safety committee (PRAC) is reviewing very rare cases of unusual blood clots that occurred in the United States following the use...
International – Moderna’s booster vaccine for South African variant demonstrates promising early results
Preclinical data for Moderna’s variant-specific jabs has been submitted to the pre-print server bioRxiv and will also be submitted for peer-review publication, the company said in...
UK – NICE publishes new guidance on chronic pain management
Chronic or persistent pain is characterised by pain that lasts for more than three months and is estimated to affect between 1-6% of people...
UK – UK trial evaluating ‘mix and match’ COVID-19 vaccine regimens expanded
The Com-Cov study, announced earlier this year, is the first trial in the world to evaluate the effects of using different COVID-19 vaccines for...
Europe – ProteoGenix Receives European Funding to Develop a Therapeutic Antibody for the Treatment...
ProteoGenix, a France-based contract research organization specialized in antibody development, announces today that it has received public funding from the European Union’s Eurostars-2 Program....
USA – NIH trial of anti-CD14 antibody to treat COVID-19 respiratory disease begins
A clinical trial testing the safety and efficacy of an investigational monoclonal antibody for treating people who are hospitalized with respiratory disease and low...
Asia – Asia-Pacific Roundup
The New Zealand Medicines and Medical Devices Safety Authority (Medsafe) is going ahead with its planned changes to good manufacturing practices (GMPs) after receiving...
