Rapt Therapeutics said on Tuesday the U.S. FDA had placed on hold two mid-stage trials of the company’s drug to treat eczema and asthma, after liver failure was observed in one of the patients.
Tag Archive for: Adverse Events
MedAdNews talked to Jane Reed, director of life sciences with Linguamatics, an IQVIA company, about how pharma companies are using new AI-based technologies to advance their safety processes and other topics.
Citing America’s Poison Centers, which represents 55 regional poison centers across the U.S., Reuters revealed that all three incidences of hypoglycemia were detected by the same regional poison control center and that the FDA was investigating these reports.
The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.
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.
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.
The move comes after a review of data of 40 patients in the trial indicated potentially excessive respiratory-related events, including seven deaths and five serious adverse events.
The company and partner Seattle Children’s Therapeutics was studying its experimental therapy as a treatment for children with acute myeloid leukemia (AML), a cancer of the blood and bone marrow.
The first hearing in a German court case against BioNTech over side effects allegedly caused by its COVID-19 vaccine was postponed on Monday after the plaintiff’s lawyer petitioned for the case to be heard by different judges.
Safety, regulatory, quality and medical information executives at IQVIA discuss key industry trends and challenges for lifescience companies.
