Vertex Pharmaceuticals has set the stage for an ambitious Phase III program for its combo approach matching the experimental VX-809 and Kalydeco for cystic fibrosis. And if it can stick with the plan, Vertex ($VRTX) will cut a short path directly to an approval for the groundbreaking combo.
Already tapped by the FDA as two of its first drugs to win the agency's coveted "breakthrough" status--aimed at speeding development of truly innovative medicines--the Cambridge, MA-based developer says it is prepping a pair of late-stage studies that will enroll 1, 000 patients age 12 and older in 200 sites to test two doses over 24 weeks. Patients will have two copies of the F508del mutation in the CFTR gene. And it's also planning a safety and pharmacokinetics study for a group of 6 to 11-year-olds to be used for registration in the U.S. and food for discussion with European regulators.
"This Phase III development program is a significant advance in our efforts to develop new medicines that treat the underlying cause of cystic fibrosis for people with the most common type of the disease, " said Robert Kauffman, the chief medical officer at Vertex. "Importantly, these studies will evaluate two doses of VX-809 in combination with ivacaftor (Kalydeco) for 24 weeks, and pending data, enable submissions to U.S. and European regulatory authorities. People with CF are in urgent need of new treatments, and we are committed to advancing this combination through Phase III development as quickly as possible."
Source: FierceBiotech News
Global economy sucks2012-06-02 06:44:46 by jujyiui
THOUSANDS OF COMPANIES AROUND THE WORLD REVEAL THE TRUTH ABOUT THE GLOBAL ECONOMY
We are in the middle of the busiest 48 hours in the history of economics. And ahead of tomorrow's big US employment situation report, we're getting tons of leading economic data from all over the world.
At the beginning of each month, Markit, HSBC, RBC, JP Morgan, and several other major data gathering institutions publish the latest local readings of the purchasing managers index (PMI). Each reading is based on surveys of hundreds of companies in each country. From Markit:
PMIs are based on monthly surveys of carefully selected companies. These provide an advance indication of what is really happening in the private sector economy by tracking variables such as output, new orders, stock...
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