FDA cites higher cancer rate with diabetes drug from Bristol-Myers, AstraZeneca

Federal health regulators have concerns about bladder and breast cancer seen in patients taking an experimental diabetes pill from Bristol-Myers Squibb and AstraZeneca. The Food and Drug Administration said in an online review Friday that there were more cases of cancer among patients taking the company's drug than those taking a dummy pill. It was not clear whether the higher rate was caused by a statistical fluke or the drug itself. A panel of FDA advisers meets next Tuesday to discuss the drug's safety and effectiveness. Along with cancer, the FDA will also ask the panel to comment on the drug's effects on kidney and liver function. FDA will make the final decision on the drug's approval. Dapagliflozin is a once-a-day pill designed to help type 2 diabetes patients eliminate excess sugar in their urine. It differs from older drugs that decrease the amount of sugar absorbed from food. If approved, Bristol and AstraZeneca's drug would be a new option for diabetics, who must often rotate through several medications to control their disease - AP

AstraZeneca shares hit by US drug approval delay

"Shares in AstraZeneca dropped 5% in early London trading after US regulators further delayed approval of its heart drug Brilinta. Markets had expected the UK drugmaker's blood thinner to get the go-ahead. The US Food and Drug Administration (FDA) said it wanted further analysis of existing drugs studies, although no further studies are needed. Brilinta, which is already approved in Europe, is expected to reach $2bn (£1.3bn) sales in the US once approved. The FDA had already postponed its review of the heart drug since September after patients in a North American trial of the drug failed to show significant benefits. AstraZeneca is hoping Brilinta will challenge Plavix produced by rivals Bristol-Myers Squibb and Sanofi-Aventis, which is the second best-selling drug in the world with over $9.5bn sales last year. The UK company is about to see patents on some of its other major brands expire, including schizophrenia drug Seroquel and heartburn relief Nexium" - BBC

US AGAINST ATHERO (USA)

"US AGAINST ATHERO is a campaign sponsored by AstraZeneca to increase our nation’s awareness of atherosclerosis (or athero, as we call it), with hopes that all Americans will take steps to take care of their arteries. Through education and valuable information about atherosclerosis, we support people in becoming advocates for their own health and for the health of others"

Astra, Bristol diabetes drug wins EU approval

"A new diabetes drug from AstraZeneca and Bristol-Myers Squibb has been approved for sale in Europe, clearing the way for a head-to-head battle with Merck & Co's Januvia in EU markets. The green light for Onglyza from the European Commission had been widely expected, following a positive recommendation from the European Medicines Agency in June. The two pharmaceutical partners said they expected to launch Onglyza in Europe in the fourth quarter of 2009 as an add-on therapy for use alongside the older medicines metformin, thiazolidinedione or sulphonylurea. Both Onglyza and Januvia, which sold $1.4 billion worldwide in 2008, aim to enhance the body's ability to lower elevated blood sugar levels and are part of a class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors" - Reuters

AstraZeneca shares jump on blood-thinner drug study

"Shares of AstraZeneca PLC rose over 5% on Monday after the Anglo-Swedish company said a key study showed its new blood-thinner Brilinta helped prevent stroke and heart attack better than the industry leader Plavix in certain cardiac patients. Shares of AstraZeneca (AZN) had jumped 6% to $38.19 by midday. The Phase III clinical trial tested Brilinta against Plavix in 18,624 patients with acute coronary syndrome, or ACS, in 43 countries. The study was led by a professor at Sweden's Uppsala Clinical Research Center and by one at Duke Clinical Research Institute. ACS is a condition whereby the heart muscle isn't receiving enough blood, generally due to some sort of blockage in the coronary arteries. The syndrome is associated with chest pain" - Market Watch

A New Age Of Statins?

"A new study could lead millions more Americans to take cholesterol-lowering drugs and generate billions in sales for AstraZeneca, which funded it. But first comes a furious debate. The study, called Jupiter, gave either AstraZeneca's Crestor or placebo to 18,000 patients who received bad scores on a little-known blood test for C-reactive protein (CRP) that is thought to measure inflammation in the arteries. Patients who took Crestor were half as likely to have heart attacks, strokes or operations to open clogged arteries as those getting placebo, an effect that ranks among the best results seen with the two-decade old class of cholesterol drugs called statins, of which Crestor is the most potent" - Forbes