Gleevec wins new FDA indication; Drug shortage could boost Roche's Xeloda;

> The FDA approved Gleevec (imatinib mesylate) for a new indication--keeping cancer from growing in patients following surgical removal of a gastrointestinal stromal tumor or GIST, a rare form of GI cancer. Release [1]

> Roche could benefit from the current shortage of leucovorin, a cancer therapy administered to boost the effectiveness of another drug, 5FU; one alternative to this combo is 5FU plus the company's Xeldoa drug. Report [2]

> Teva Pharmaceutical Industries and Barr Pharmaceuticals now have regulatory approval from both U.S. and Europe for their planned merger [3] and expect to close the deal this week. Report [4]

> Medical device maker Stryker lowered its financial guidance Friday, saying the weakening economy has hurt sales of surgical equipment to hospitals. Report [5]

> Russell Upchurch has been promoted to director of quality control at Eisai's Research Triangle Park facility; he had been senior manager of quality control. Report [6]

> The pain continues at Vanda Pharmaceuticals, which has laid off another 17 employees, including two key executives, to slash expenses. Report [7]

> Aurobindo Pharma won tentative FDA approval to manufacture and market the HIV drug efavirenz, the generic form of branded drugs Sustiva and Stocrin. Release [8]

> Merck KgAA is paying $13 million for manufacturing rights to Oncothyreon's experimental lung cancer vaccine Stimuvax. Oncothyreon report [9]

> Following the FDA's demand for a new trial [10] of its experimental antibiotic oritavancin, Cambridge, MA-based Targanta is restructuring and cutting 86 employees, or 75 percent of the company's total workforce. Report [11]

> Despite the fact that 2.3 million people volunteer for clinical trials each year in the U.S., there are no rules for how companies should inform subjects of the outcomes of their trials. In fact, many participants never even find out if they were receiving the test drug or a placebo. So researchers from the University of Rochester Medical Center surveyed 114 trial participants to learn how they would prefer to find out about clinical trial outcomes. Report [12]

> AstraZeneca and MAP Pharmaceuticals have signed a development and commercialization deal covering Phase III asthma drug Unit Dose Budesonide (UDB), MAP's nebulized formulation of budesonide. MAP gets $40 million up front and another $35 million if the drug successfully completes the ongoing Phase III clinical study. MAP Pharmaceuticals could earn up to $240 million in other milestones and as much as $585 million in sales milestones. That's a grand total of $900 million in potential payments. Report [13]

> Last week, TheStreet shared their pick for the worst biotech CEO of 2008 [14]. This week, it's looking at the other end of the spectrum: Myriad Genetics' CEO Peter Meldrum earns Street writer Adam Feuerstein's vote as the best CEO of 2008. Report [15]

Emerging Drug Developer: MAP Pharmaceuticals [16]

And Finally... By examining bacteria's primitive immune systems, two Northwestern University researchers may have found a way to prevent or slow the development of drug resistance. Report [17]