Biomedical Laboratory Science

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Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Thursday, September 22, 2016

Curiosity About Cigarettes, Cigars Falling among Students

Fewer middle and high school students in the United States have ever used or are curious about using cigarettes or cigars, according to new research published in the journal Preventing Chronic Disease.

However, the study - conducted by researchers from the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) - identified no change in the percentage of American students who have ever used or are curious about smokeless tobacco.


Researchers find fewer students are curious about using cigarettes and cigars.

Friday, September 2, 2016

Antibacterial Soaps Aren't Just Ineffective, They're Potentially Dangerous

With a new ban on antibacterial soap, the US government is finally acknowledging that it’s not just ineffective, it’s also dangerous

Fear is a potent marketing tool. Consider how a Listerine advertising campaign in the 1920s literally turned bad breath into a disease (and sold a ton of mouthwash along the way) or the run on potassium iodide in North America after the Fukushima nuclear power plant disaster in 2011.

Then there are antibacterial soaps and body washes, which have targeted—and arguably created—a widespread fear of disease-causing bacteria lurking on every surface of our homes and bodies. Sales of antibacterial soap skyrocketed during the 2009 H1N1 flu sale and have stayed strong since, as brands marketed their antibacterials as scientifically proven to clean better than the stuff you used to keep by your sink.


Lather up, but just use regular soap. (Mariana Bazo/Reuters)
Source: quartz

Saturday, June 25, 2016

FDA Approves First Liquid Biopsy Test for Lung Cancer Patients

On June 1, the U.S. Food and Drug Administration (FDA) approved a liquid biopsy test, a companion diagnostic test called cobas EGFR Mutation Test v2. The test uses plasma samples to identify patients with metastatic non-small cell lung cancer (NSCLC) eligible for treatment with the EGFR-targeted therapeutic erlotinib (Tarceva).

The test detects specific alterations in the gene epidermal growth factor receptor (EGFR): exon 19 deletions or exon 21 (L858R) substitution mutations. These mutations are present in about 10 to 20 percent of NSCLCs, the most common type of lung cancer.

This is the first liquid biopsy test approved for use by the FDA.


Source: aacr

Thursday, April 7, 2016

FDA approves 'Inflectra', a novel drug saving the US billions of dollars.

The US Food and Drug Administration (FDA) just approved a version of Remicade, a drug used to treat autoimmune diseases like Crohn's disease and rheumatoid arthritis.

The drug, developed by Celltrion and which will be co-marketed by Pfizer, goes by the name "Inflectra." It's a form of infliximab, but will carry the suffix "-dyyb" to differentiate itself. This is the second "biosimilar" to be approved by the FDA.

The drug is called a biosimilar because it is like a generic version of a biologic medication, a medicine produced by living cells.

But it's a bit more complicated than that. Unlike generics for chemical-based drugs — think antibiotics or birth-control pills — that can be interchangeable with branded versions, the copycats of biologic medications, produced using living cells, have a few more caveats. That's because the drugs might have different reactions in your body.

Read more: FDA approves 'Inflectra', a novel drug saving the US billions of dollars.


Source: Wikimedia Commons
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