We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The World Health Organization (WHO) has issued interim guidance, recommending AstraZeneca’s COVID-19 vaccine for use against the variant first identified in South Africa and for individuals 65 years and older, despite limited supporting data. Read More
The European Medicines Agency (EMA) has expanded the use and scope of remote source data verification (rSDV) in clinical trials as long as patients’ private data can be protected, according to a guidance update released this week. Read More
A commonly used asthma medication, AstraZeneca’s Pulmicort (budesonide), was found to significantly reduce COVID-19 symptoms if given within seven days of symptoms appearing, UK researchers reported. Read More
A 10-member FDA advisory committee voted unanimously yesterday to defer a decision to recommend Merck’s blockbuster oncology drug Keytruda (pembrolizumab) for a new breast cancer indication and to await more data from a late stage trial. Read More
More than 100 nongovernmental organizations (NGOs) have urged the World Trade Organization (WTO) to extend a waiver of intellectual property rights to help developing nations access COVID-19 treatments and vaccines during the pandemic. Read More
The FDA is unlikely to help Merck’s chances of getting a positive recommendation from the agency’s Oncology Drugs Advisory Committee today for its blockbuster drug Keytruda (pembrolizumab) for a new indication. Read More
Former FDA Commissioner Stephen Hahn is voicing support for making the FDA its own federal agency independent of HHS and for enacting protective measures against political interference. Read More
Moderna President Stephen Hoge explained that one of the capacity constraints beyond the amount of drug product available is how many vials that can be filled in a given period. Read More
COVAX officials say 240 million doses of the AstraZeneca/Oxford University vaccine will be distributed by the Serum Institute of India during the first half of the year. Read More