FDA delays Labopharm approval; Alnylam and Cubist report positive respiratory data;

> Labopharm says that regulators have delayed an approval of its new antidepressant, Trazodone, citing manufacturing concerns. But the developer says that the concerns are not critical and added that it will respond in a matter of days. Report

> Alnylam and Cubist Pharmaceuticals report that a mid-stage study of an experimental therapy for respiratory infection met its primary endpoint. Researchers were studying the safety and tolerability of ALN-RSV01. Report

> Quantum Immunologics, which is developing cancer therapies, has raised $2.2 million in venture funds. Report

Pharma News

> Sound familiar? Big Pharma is offering to lower drug prices in the Philippines to circumvent government price controls. Report

> Personalized cancer treatment took a giant step forward today. FDA has OK'd a label change for Erbitux and Vectibix, narrowing the indication for advanced colon cancer. The label now recommends the drugs as a treatment for EGFR-expressing tumors only in patients without KRAS gene mutations. Report

> More emerging markets excitement: Sources tell Reuters that Pfizer is kicking tires at Turkey's largest drug company, Abdi Ibrahim. That fits with an executive pledge last month to line up acquisitions in the developing world. Report

> Stock analysts think they've solved the mystery surrounding that suddenly-stopped cholesterol drug trial. As you know, researchers abruptly halted the ARBITER 6 study, which pitted Abbott Laboratories' Niaspan drug against Merck/Schering-Plough's Zetia. There's been talk and rumor since, but no definitive word on why the trial was stopped. Report

> Drug co-pays could lose their effectiveness as a way to steer patients to lower-cost meds. Why? Because drugmakers are subsidizing co-pays for expensive drugs, removing the incentive for patients to pick cheaper ones. Report

Biotech IT News

> Device maker Medtronic has announced the first enrollments in a magnetic resonance imaging substudy within the global Panorama registry, collecting implanted cardiac rhythm device data from around the world. Report

> The Eucalyptus open-source cloud computing infrastructure is "well worth watching this year," says Allison Randal in Forbes. The free offering provides for continued use of familiar applications and data, while tapping into the processing power of the cloud. Report

> Yet another offering intended to aid in clinical research data sharing is ChemBioOffice 2010, the latest release of scientific desktop applications for chemists and biologists, from CambridgeSoft. Like its predecessor, the update targets both investigators at their desktop systems and those working collaboratively across an organization. Report

> In another development for drug researchers, biopharma technology and service provider ERT has launched an online interface called My Study Portal, aimed at enhancing cardiac safety data management in clinical trials. It succeeds the company's Digital ECG Community. Report

> The need for collaborative clinical research data sharing with outside organizations has driven the University of Florida Shands Cancer Center (UFSCC) to implement the OnCore informatics system for its clinical and translational research activities. Report

And Finally... Researchers at Washington University School of Medicine in St. Louis have shed new light on a process that fixes breaks in the genetic material of the body's cells. Their findings could lead to ways of enhancing chemotherapy drugs that destroy cancer cells by damaging their DNA. Release

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