ALSO NOTED: Avastin approval may lower FDA bar; GTX shares skyrocket on cancer data; Novartis wins approval; and much more...

> Medicure shares plunged 80 percent this morning after the developer announced that its lead therapy, MC-1 for cardiovascular disease, failed to meet its primary endpoint in a late-stage trial. Company executive say they're disappointed but still hold hopes for the therapy's future. Report

> Some see the FDA's approval of Avastin for breast cancer as a sea change. In this view, the FDA has now lowered the bar for other cancer-drug approvals. That's because Avastin proved effective at stopping tumor growth but not at extending survival time, which has long been the gold standard for cancer treatments. If Avastin got an OK based on disease progression, so might many other cancer hopefuls waiting in the wings. Or so the theory goes. As we say, fortunetelling can be a dicey business. Report

> Shares of GTX shot up this morning after the company announced that late-stage data for toremifene citrate demonstrated its ability to reduce symptoms of prostate cancer. Based on the data, GTX says it will file an NDA by summer. Release

> Novartis has won approval from European regulators of its new combinatorial drug Eucreas for diabetes. Release

> In the latest round of cutbacks at Seattle companies, Rosetta Inpharmatics announced plans to lay off 12 workers. Report

> Actelion has formally withdrawn its application to the EMEA to extend approval of Zavesca. Release

> The NIH has kicked off a big trial pitting Avastin against Genentech sister med Lucentis. Eye docs have commonly used Avastin off-label, saying it's almost as effective as Lucentis, and costs significantly less. Report

> The Bush administration wants to hand the FDA more authority over food and drugs made overseas for U.S. use. But as several reports and audits have concluded recently, the FDA is already overladen with mandates and under-endowed with funding. Report

> Could Big Pharma be held to account for gray market sales of its drugs? Report

And finally… Researchers have identified a gene that plays a key role in baldness. That discovery is likely to generate new therapies for hair growth. Article

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