Topline results with AZD1222 have shown a lower efficacy rate than the Pfizer and Moderna vaccines, but a subgroup receiving a half-dose in their first injection showed a 90% efficacy result.
Following the promising results from trials of the COVID-19 vaccine developed by AstraZeneca PLC and the University of Oxford, the UK company says it will now prepare regulatory submissions around the world, which could result in the vaccine being granted emergency use authorization before the end of the year.
The first interim analysis of the Phase III data showed that AZD1222 achieved a 70% efficacy rate, while an "intriguing" signal suggested that a lower first dose could boost this...
The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.
Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.
ISRCTN’s systems are being redesigned to facilitate compliance with upcoming requirements in the UK’s clinical trials legislation.
Spanish authorities have published more pricing and reimbursement reports as part of a new drive to increase transparency.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.
The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.
Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.
