Tag Archive for: Drug Safety

Staff reviewers said that the pattern of early deaths observed in patients treated with both the therapies in their respective trials raised uncertainty about the treatments’ overall survival benefit in patients.

The FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly’s application for its Alzheimer’s disease antibody donanemab, the company announced today.

The claims allege that the drugmaker’s tenofovir, an antiretroviral used in Gilead’s older HIV drugs, caused kidney, tooth, or bone damage to patients, and that Gilead knew its tenofovir-based drugs which were still in development, were safer.

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.

Abortion opponents on Tuesday urged a U.S. appeals court to allow the suspension of Food and Drug Administration’s approval of the abortion pill mifepristone, in a case with potentially far-reaching impact on how the government regulates medicine.

To further support pharma manufacturing partners and ensure launch delays are avoided, the company has deepened its expertise with REMS Strategy and Project Management solutions.

BioSpace sat down with Katy Powell, a psychiatric mental health nurse practitioner in Portland, Oregon, to discuss the relative risks and benefits associated with psychedelic-assisted therapy.

Intercept Pharmaceuticals said it would resubmit its application for nonalcoholic steatohepatitis (NASH) treatment to the U.S. Food and Drug Administration based on new interim analysis of data from an ongoing late-stage study. The company is seeking approval for obeticholic acid to treat fibrosis or scarring associated with NASH, a serious progressive liver disease caused by excessive fat accumulation in the liver.

Leaderboard Branding, a Fingerpaint company – the fast-growing global naming and branding firm that delivers strategic insights and world-class creativity to biopharma and healthcare companies as early as clinical phase 1 – announced the hiring of Max Straka, PharmD, FISMP, a former FDA Division of Medication Error Prevention and Analysis (DMEPA) safety evaluator. As a Director of Leaderboard Branding’s Drug Safety Division, Dr. Straka adds to the broad experience of global leaders and innovators in this important area of drug development.

Pharmacovigilance, the industry term for drug safety, was unfamiliar to most of the general public before March 2020. But as the coronavirus pandemic unfolded, its rapid spread thrust drug safety into the spotlight. The public is more aware of drug safety and health regulators’ role than ever — and as the demand for pharmacovigilance information rises, the industry has had to find ways to keep up — according to Beena Wood, VP of safety at ArisGlobal.