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Coronavirus Notebook: Middle Ground Pricing As Moderna Reaches 100m Dose US Agreement

Plus, Evidence Accelerator Finds No Benefit With HCQ

 
• By Pink Sheet Team

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.

Coronavirus COVID-19 medical test vaccine research and development concept. Scientist in laboratory study and analyze scientific sample of Coronavirus antibody to produce drug treatment for COVID-19.
Moderna Reaches Initial US Vaccine Supply, Option Deal • Source: Shutterstock

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...

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More from Real-World Evidence

MHRA Investigates GLP-1 And Pancreatitis Genetic Link In Personalized Medicine Push

 
• By Eliza Slawther

The UK drug regulator is collecting data to establish whether patients who are hospitalized for acute pancreatitis after taking a GLP-1 drug have a genetic predisposition to this side effect. If a “clear link” is found, the MHRA would consider regulatory action.

EMA Tackles Guidance Void As Proposals For External Controls Grow

 
• By Neena Brizmohun

The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used.

EMA Sets New Priorities As Number Of RWE Studies Climbs 48%

 
• By Eliza Slawther

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.

AI Will Bolster, Not Squelch, Patient Voice In Clinical Research, US FDA Says

 
• By Sue Sutter

Artificial intelligence tools used for clinical research should be developed with input from patients and focus on their needs and abilities, FDA experts said.

More from Clinical Trials

AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.

EMA Tackles Guidance Void As Proposals For External Controls Grow

 
• By Neena Brizmohun

The European Medicines Agency is working on defining when and how external controls can be accepted in clinical research. Among other things, it is looking at the planning, design, conduct, analysis and reporting of studies for which external controls are used.

New CTIS Feature To Bridge ‘Communication Gap’ Between Trial Sponsors & EU Assessors

 
• By Vibha Sharma

A task force set up by the EMA to identify and prioritize improvements to the Clinical Trials Information System has recommended several measures to enhance CTIS’ usability and efficiency, including the potential introduction of a communication tool for direct sponsor-assessor interaction.