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.
Real-world data (RWD) improves health care – especially patient safety. The data enhances signal detection and management to identify and evaluate potential safety concerns. While it offers many advantages over traditional data sources for pharmacovigilance, simply having data is not enough. For optimal utility, healthcare entities must use effective data management tools.
The Phase III STAND trial found no significant therapeutic benefit to Novartis’ Adakveo, pushing the European Commission to revoke its conditional authorization of the SCD treatment.
India has found violations related to manufacturing and laboratory practices at drugmaker Riemann Labs, whose cough syrup was linked to the deaths of children in Cameroon, a government health official told Reuters on Wednesday.
The move comes as Indian regulators step up inspections at drugmakers after cough syrups made in the country were linked to the deaths of dozens of children overseas, denting India’s image as the “pharmacy of the world”.
Syfovre has been linked to rare cases of eye inflammation that could lead to blinding, though Apellis’ review so far has found no connection between the treatment and the complications.
Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space