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.
Tag Archive for: patient safety
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.
The U.S. FDA is cracking down on lax testing practices by dozens of makers of healthcare products following hundreds of deaths overseas from contaminated cough syrups, a Reuters review of regulatory alerts found.
In its briefing documents, the agency said it does not believe there is sufficient evidence to support NurOwn’s clinical benefit, adding there were large amounts of missing data.
In a statement, the Drug Regulatory Authority of Pakistan (DRAP) said the health authorities in Punjab, the most populous province, had launched the investigation into the drug Avastin, which is licensed for use in Pakistan.
Thursday’s FDA advisory committee rejection is the latest regulatory defeat for the company’s drug-device combo. The panel found that the benefits of the treatment did not outweigh its risks.
Following cases of hepatobiliary toxicity leading to liver decompensation, Eiger has decided to drop its Phase III LIMT-2 trial of peginterferon lambda in chronic hepatitis delta.
The current resource-intensive approach to PV is facing real challenges as safety data evolves and makes moving to efficient and effective solutions crucial to guaranteeing continued patient safety. Integrating modern technologies, such as artificial intelligence (AI) – which also encompasses machine learning (ML), and natural language processing (NLP) – improves the process, reduces workload for PV professionals, and expedites the gathering and analysis of safety data.
The company announced Monday with its second-quarter earnings that the regulator has officially halted the Phase I study after a child with acute myeloid leukemia died following treatment.
