All GLG News Analyses Filed Under: Endocrinology

Most diabetics have subclinical CAD, and a baseline risk of CAD equivalent to that of a person without diabetes and a prior MI.  This drug, by limiting its labelling is severely limiting its use in patients with diabetes.

GLG formally acknowledges FDA warnings on their TZD and further compromises physician use of product.

GlaxoSmithKline is taking a pragmatic step to safeguard diabetic patient's risk of having myocardial ischemia from the intake of Avandia, the oral antidiabetic medicine. The revised label will state that the available data on the risk of myocardial ischemia are inconclusive...

It's not easy being small, especially in the world of medical devices. Big players leverage branding, large sales forces and deep R&D organizations when they bring technologies to market. Unfortunately, most products are incremental improvements at best. Rarely does the conservative healthcare market benefit...

Though effective the liver function abnormalities are disturbing. Other drugs have not come to market because of this., or have been taken off when further liver dysfunction occurred. This remains the unanswered question. Will these LFT findings portend the possibility of liver failure in the future...

As noted in a previous post, this is the first new drug for stable angina. We now have data supporting decreased morbidity and mortality, an antiarrthymic effect and an antidiabetic effect. The drug should come to the forefront of therapy and not be only 2nd line.

Liver function (LFT's) abnormalities will kill this Phase III drug and it will never be released; or at least, with a notorious Black Box warning.  There may also be skin issues with Galvus not mentioned in this press release. Why give Galvus (if approved) when non-hepatotoxic Januvia is already...

Lantus (Insulin Glargine) is a top-seller with no true competition.  FT-105 basal insulin may finally be a cometitor of Lantus.

The article shows the novel approach taken by Apollo to administer  insulin in an oral form. US researchers (scientists at Syracuse University in New York) have furthermore confirmed about the practicality of this drug when the insulin molecules are attached to vitamin B12, especially in comparison...

Anything but a needle. Patients still have this issue despite newer technology. The issue will be can you deliver the right dose in an oral form the can be titrated as needed. This was a problem with the inhaled insulin product and we saw what happened to it.