Dr. Reddy’s Laboratories’ Foram Vaishnav discusses the role and impact of pharmacovigilance in the pharmaceutical industry.
Johnson & Johnson’s drug Balversa won U.S. approval as the first targeted therapy for advanced bladder cancer, the Food and Drug Administration announced.
Roche’s seven-year-old rheumatoid arthritis drug Actemra is being linked to hundreds of deaths due to undisclosed side effects.
(Reuters Health) – According to a reanalysis of the original data from a 2001 study of paroxetine (Paxil) for teens with major depression, the drug was not effective and led to serious side effects, which is not how the results were presented 14 years ago. “There have been warnings about paroxetine for a long time,” […]
A medical journal criticized British drugmaker GlaxoSmithKline on Thursday for delaying access to key data from a trial of its antidepressant Seroxat that would have shown earlier that it is neither safe or effective in adolescents. The widely used medicine, known generically as paroxetine, is linked to an increased risk of suicide in young people […]
Still no Rx for patient adherence Pharma limited in what it can do, but can still have a positive impact Patient adherence remains a complex puzzle with no simple solutions, and no one stakeholder involved – physicians, insurers, or pharmaceutical companies – can provide all the answers needed. Even though the influence of pharma […]
SEATTLE, Aug. 4, 2015 /PRNewswire/ — Dr. Keesha Ewers of The Functional Sexology Institute states the potential FDA approval of flibanserin, or what is being touted as “pink Viagra,” sets women and the treatment of decreased female sexual desire back several decades. Diminished libido in women has many root causes and addressing libido as a singular […]
Companies fail to report roughly one in 10 serious and unexpected medication side effects to the U.S. Food and Drug Administration (FDA) within a 15-day window specified by federal regulations to protect patient safety, a study finds. Drug manufacturers are also less likely to disclose serious adverse events within this window when patient deaths are […]
The Food and Drug Administration is talking to Google about how the search engine could help the agency identify previously unknown side effects of medications. Agency officials held a conference call on June 9 with a senior Google researcher who co-wrote a 2013 paper about using search query data to identify adverse drug reactions, according […]