Whistleblowers allege that ZZ Biotech co-founder Berislav Zlokovic pressured his scientists to adjust data in favor of the investigational stroke therapy 3K3A-APC, according to a dossier obtained by Science.
Tag Archive for: patient safety
AI’s potential in drug development is often recognized with respect to saving time and money. However, its increasing deployment in drug safety studies elicits both confidence and caution from industry and researchers.
The agency’s staff reviewers said it was not clear if the limited donor cells used for assessment were adequate to evaluate the potential safety risks of the therapy.
The companies presented data from two pivotal studies of Dato-DXd, focusing on safety concerns and survival data for the investigational antibody-drug conjugate candidate in lung and breast cancer.
The patients were reported to have suffered hypoglycaemia and seizures, serious side effects that indicate the product contained insulin instead of Ozempic’s active ingredient semaglutide, the health safety regulator BASG said on Monday.
The company’s CEO said its experimental multiple sclerosis drug can be a “blockbuster”, an industry term for annual sales that exceed $1 billion, even after concerns emerged that the drug may cause liver damage.
Patients treated with Xenon Pharmaceuticals’ investigational potassium channel opener XEN1101 experienced a significant and dose-dependent reduction in seizure frequency.
The market opportunity for the drug is huge in the world’s most populous country, where obesity rates are high especially among women. Illegal copycat versions of Wegovy are already being sold through online sites.
The New England Journal of Medicine study suggests that the 2022 death of a Duchenne muscular dystrophy patient was due to an adverse effect of recombinant AAV used to deliver the gene therapy.
The US Food and Drug Administration received more than 250 reports of patients experiencing suicidal thoughts or behaviors while taking Ozempic or similar medicines since 2010, Reuters found in an examination of the FDA’s adverse-event database.