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The latest annual reports from the FDA’s Office of Pharmaceutical Quality (OPQ) and its Office of Generic Drugs (OGD) both highlight the impact of the COVID-19 pandemic on their activities in the past year. Read More
The House Energy and Commerce Committee has approved a one-time $500 million in additional FDA funding for coronavirus-related support as part of the COVID-19 relief package currently making its way through the Congress. Read More
Teva Pharmaceuticals has another chance to argue it shouldn’t have to pay $235.5 million in damages to GlaxoSmithKline for patent infringement, as the full U.S. Court of Appeals for the Federal Circuit has agreed to review a ruling to that effect. Read More
The FDA has unveiled new details on its postmarket safety monitoring of COVID-19 vaccines, including its surveillance for adverse events, that should help vaccine sponsors comply with the agency’s requirements under Emergency Use Authorizations (EUAs). Read More
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