While debate about the data behind AstraZeneca PLC and Oxford University’s COVID-19 vaccine continues in Europe and the US, countries in South and Central America seem happy to follow the UK's lead and grant temporary authorization to the product which has been hailed as a game-changer globally to tackle the coronavirus pandemic.
Argentina Follows UK In Backing Oxford/AstraZeneca COVID-19 Vaccine
Thumbs-Up From Mexico Is Imminent
While the US and EU regulators seem less than keen on the data package offered to date on COVID-19 Vaccine AstraZeneca, Latin American countries are moving quickly to follow the UK in backing the cost-effective and more-easily deliverable option.
More from Approvals
• By
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include four new products, one of which is Vimkunya, Bavarian Nordic's chikungunya vaccine.
• By
Levodopa/carbidopa (ND0612), Mitsubishi Tanabe Pharma’s investigational drug-device combination therapy for the treatment of motor fluctuations in people with Parkinson’s disease, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
• By
Japan recommends eight new drugs for approval, including two for cardiomyopathy, and will also raise prices for multiple products, including Enhertu, on 1 April.
• By
Unofficial January results showed the US FDA continued to issue full and tentative ANDA approvals in line with previous months, but recent layoffs may not help the agency maintain that pace.
More from Product Reviews
• By
Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.
• By
Sponsors of three drugs that are in the final stages of the EU regulatory review cycle are due to make the case for marketing approval before the European Medicines Agency.
• By
The European Medicines Agency is this week set to issue an opinion on whether pan-EU marketing should be granted to Lilly’s Alzheimer’s disease drug donanemab.