Safety

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x-ray image of human head with brain and electric pulses

Sanofi pauses enrolment in ex-US tolebrutinib trials

Sanofi has paused recruitment in its international phase 3 trials of BTK inhibitor tolebrutinib for multiple sclerosis, although it says studies aimed at getting US approval are on track to

News

Liver injuries prompt clinical hold on Sanofi BTK drug

One of the main assets of Sanofi's $3.7 billion buyout of Principia Biopharma has run into trouble, after the FDA placed it on partial clinical hold while a safety signal is investigated.

News

DNA helix in a futuristic concept of the evolution of science and medicine.

Another Astellas gene therapy hits a safety hurdle

The safety of Astellas' gene therapy portfolio has been thrust into the spotlight once again, after the FDA placed a clinical hold on a trial of its Pompe disease candidate AT845.

News

Sarepta shares yo-yo as FDA places hold on Duchenne trial

Shares in Sarepta came under pressure after the biotech said it had temporarily halted a clinical trial of its new-generation Duchenne muscular dystrophy candidate, after a patient had a se

News

Is COVID in pregnancy linked to infant development issues?

Babies born to mothers who contracted COVID-19 during seem to be at slightly higher risk of neurodevelopmental delays, say US researchers, although they caution their findings are prelimina

News

Boehringer Ingelheim, Biberach, Germany, February 2007

Boehringer sells drug safety software to ArisGlobal

German drugmaker Boehringer Ingelheim has sold an artificial intelligence-powered software platform it developed to monitor drug safety data to ArisGlobal, which provides cloud software to

Sanofi pauses enrolment in ex-US tolebrutinib trials

Liver injuries prompt clinical hold on Sanofi BTK drug

Another Astellas gene therapy hits a safety hurdle

Sarepta shares yo-yo as FDA places hold on Duchenne trial

Is COVID in pregnancy linked to infant development issues?

Boehringer sells drug safety software to ArisGlobal

NICE backs Roche's non-Hodgkin lymphoma drug Columvi

How to meet your physicians where they are online

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