Pricing set somewhere down the middle as Moderna reaches deal with US government on initial supplies of its mRNA vaccine. Also, Evidence Accelerator's next joint parallel analysis projects are remdesivir in hospitalized patients and coagulopathy.
Moderna, Inc.’s shares jumped more than 8% in after-hours trading after the US vaccine developer announced it had reached an agreement with the US government to supply an initial 100 million doses of its mRNA coronavirus candidate mRNA-1273.
Up to $1.525bn has been awarded for the manufacture and delivery of this first tranche of doses - including incentive...
Real-world data studies conducted by the European Medicines Agency increased by 48% according to its latest report on the topic, prompting the agency to consider how it can better integrate this type of evidence into regulatory decision-making.
Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.
The FDA will use electronic health records to “get eyes” on drugs immediately after approval, Commissioner Martin Makary told the DIA 2025 Global Annual Meeting. He also wants to reduce development time with better communication and new approval pathways.
The new CBER director, once best known in the pharma world for criticizing accelerated approval, committed to expediting cancer drugs with surrogate endpoints.
