Food and Drug Administration (FDA)

NEWS
Months after GlaxoSmithKline unveiled positive long-term data that showed Nucala is an effective treatment for patients with severe asthma, a U.S. FDA staff report is casting doubts on its potential as a treatment for chronic obstructive pulmonary disease (COPD).
GlaxoSmithKline continues to make headway in the development of two-drug regimens to benefit HIV patients – even those who have high levels of the virus.
Shares of Eli Lilly jumped in premarket trading after the company reported total revenue of $6.35 billion for the second quarter, a 9 percent increase in revenue over the same period last year.
Celgene announced data from its Phase III AUGMENT clinical trial that compared Revlimid (lenalidomide) and rituximab to placebo in relapsed/refractory follicular and marginal zone lymphoma.
Despite positive Phase III clinical trial data for Allergan’s age-related macular degeneration drug, investors weren’t as positive about it.
BeiGene is starting off the week with a bang. Late Sunday the company announced positive preliminary topline results from its Phase II trial of tislelizumab, the company’s investigational checkpoint inhibitor for relapsed/refractory classical Hodgkin’s lymphoma (R/R cHL).
FDA
Shares of Agios Pharmaceuticals jumped this morning after the company said the FDA approved its oral leukemia treatment Tibsovo (ivosidenib). It’s the second approval for the company in less than a year.
FDA
The U.S. Food and Drug Administration is looking to address supply chain threats by potentially importing foreign drugs under a narrow scope.
Over the years there have been questions surrounding the efficacy of some medications used to treat mental health issues. Last year a Harvard professor argued on CBS’ 60 Minutes that there was little difference between a psychiatric drug and a placebo.
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