GEN | News Highlights:Firms Report Promising Data for Type 1 and 2 Diabetes Candidates at 71st Annual ADA Meeting

Image via WikipediaGEN | News Highlights:Firms Report Promising Data for Type 1 and 2 Diabetes Candidates at 71st Annual ADA Meeting

The American Diabetes Association (ADA) meeting in San Diego included the presentation of new data from Phase III trials evaluating Bristol-Myers Squibb (BMS) and AstraZeneca’s dapagliflozin, Boehringer Ingelheim and Eli Lilly’s linagliptin, and Novo Nordisk’s insulin degludec.

Blockbuster FDA Decisions In The Next Few Months--FDA Calendar Predictions

FDA's Upcoming Blockbuster Drug Decisions for Q4 2010

October 11, 2010

Again I am predicting the upcoming FDA Calendar for the next upcoming months for the Fourth Quarter.  This is just an initial walkthrough of all the upcoming decisions.  Lets see how well I do.  I am doing pretty well from October's FDA calendar. 

The FDA has some of its biggest decisions of the year looming in the next few months. The first new lupus drug in half a century, a blood-thinner with mega-blockbuster potential, controversial weight drugs and more are all up for regulatory decisions that can move markets and either throw a bucket of cold water or high octane gasoline on stock prices.

In every case, BioPharma Investor has been following the deals and data every step of the way--from early-stage development right through to the NDA and deal-making phases. Now everyone faces the moment of truth, or at least a complete response letter.

The FDA's final decision may be signaled by an expert panel vote, but this is one area where there really is no sure thing. The agency has appeared to be taking a tough stance on safety, which has bedeviled some late-stage therapies. And its complete response letters are always opened with a mix of dread and hope. We've seen plenty of surprising decisions so far this year, and there will likely be more in the months ahead.

I have to do some more research on my Approval Decisions---Here is an preliminary list of FDA Approvals coming in the 4th Quarter of 2010.  This is just an estimated guess off the top of my head.  Some are toss-ups.  The FDA is leaning more on the Complete Response Letter side which isn't necesarily a death sentence as why the drug was not approved and how it might be possible to get approval.  Usually, it requires more Clinical Trials when a company receives a CRL from the FDA.

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FDA Calendar Predictions

New Targets, Dual Agonists Increase Possibilities for Treating Diabetes

Image via Wikipedia Fritz French, Chief Executive Officer, Marcadia Biotech, Carmel, Ind.
Drug Discovery & Development - August 16, 2010

Diabetes is a common chronic disease affecting an estimated 285 million adults worldwide. This number will continue to grow as the population ages and becomes more obese—both risk factors for type 2 diabetes. The diabetes treatment market generated over $25 billion in 2009 and the number of patients is continuously rising.

New Anti-Clotting Drugs May Have Edge Over Top-Selling Plavix

Image via Wikipedia Health Care, Bristol-Myers Squibb, Sanofi Aventis, Eli Lilly, Astrazeneca

Several recent studies of drugs used to treat and prevent strokes appear to favor AstraZeneca's (AZN) Brilinta and Eli-Lilly's (LLY) Effient over Plavix. Plavix, co-marketed by Bristol-Myers Squibb (BMY) and Sanofi-Aventis (SNY), is the second best-selling drug in the world.

Pharma's R&D Focus Shifting to Stem Cells

Another good article on Pharmaceutical companies unleashing the power of Stem Cells and increasing their research as a new wave of the future. I will comment further but it was a good read on things to come.

Pharma's R&D Focus Shifting to Stem Cells
Susan Aldridge, Ph.D.

Investors' Interest in These Cells Increases as Scientists Continue to Unleash Their Potential


Stem cells could replace and potentially improve upon at least some in vivo models in drug discovery and development. That was a key message from the “World Stem Cells and Regenerative Medicine Congress” held recently in London.

“There is a major focus now on stem cells in pharma R&D with the major investors showing an interest,” according to Ian Cotgreave, Ph.D., director of molecular toxicology and safety assessment at AstraZeneca. He noted that pharma’s current focus is on cardiomyocytes and hepatocytes, as well as on differentiation protocols and understanding phenotypic progression.