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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
Allay Pharmaceuticals, a contract drug manufacturer in Hialeah, Florida, drew a warning letter from the FDA arising from a May 5-15, 2020 inspection in which investigators found serious quality lapses, including a lack of validation for manufacturing processes and other problems. 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
A strategy President Joe Biden outlined on the campaign trail to deal with U.S. supply chain vulnerabilities for critical products, including pandemic-related supplies, is likely to be put into effect via executive order within weeks. Read More
The FDA has approved Bristol Myers Squibb’s CAR T cell therapy Breyanzi for treatment of adults with relapsed or refractory large B-cell lymphoma, an aggressive form of non-Hodgkin lymphoma. Read More