FDA: Statins not linked to ALS; Sinclair cuts buyout talks;

> A new analysis by the FDA of more than 40 clinical trials did not find a link between statins and a higher risk of amyotrophic lateral sclerosis (ALS), a neurodegenerative disease often referred to as Lou Gehrig's Disease. Report

> Analysts were in for a surprise with the news that the FDA is once again delaying any decision on prasugrel, a potential blockbuster anti-clotting drug developed by Eli Lilly and Daiichi Sankyo. Report

> Specialty pharmaceutical firm Sinclair Pharma has called off bid talks with a third party after deciding an outline proposal regarding a possible offer was unacceptable. Report

> Researchers at Columbia Laboratories say that lidocaine failed to hit the primary endpoint in a mid-stage trial for prevention and treatment of dysmenorrheal, or painful menstruation. Lidocaine report

> ImmunoGen said its president and COO Daniel Junius will become CEO Jan. 1, while current CEO and Chairman Mitchel Sayare will continue as chairman of the board. ImmunoGen release

> Biogen Idec shares rose Monday, bucking a declining market as analysts continued to maintain a positive outlook for sales of the biotechnology company's multiple sclerosis drugs. Report

> Covance is abandoning its recent partnership deal with WuXi Pharmatech to build a 323,000-square foot research center in China. Instead of chipping in $30 million on that deal, the big CRO says now that it will go it alone. Covance report

> A new study has discovered that warfarin, which is taken by hundreds of thousands of patients at risk from a blood clot, may increase bleeding and so the risk of death during a hemorrhage in the brain. Report

> Indevus ended last week on the upbeat news that it had struck a licensing deal for one of its experimental therapies and worked out an advantageous arrangement with the FDA on another drug up for approval. Shares went up 86 percent. Indevus report

And Finally... A drug that combines four inexpensive cardiovascular remedies will enter human trials this week in London. Report

Virtual Clinical Trials Summit

Virtual Clinical Trials Summit: The Premier Educational Event Focused on Decentralized Clinical Trials

In this virtual environment, we will look at current and future trends for ongoing virtual trials, diving into the many ways companies can improve patient engagement and trial behavior to enhance retention with a focus on emerging technology and harmonized data access across the clinical trial system.