Court won't throw out Crestor patent challenge; Reimportation measure would threaten safety, PhRMA says;

> The pharmaceutical industry predicted that the safety of the nation's prescription drugs would be imperiled if the Senate passed a new bipartisan measure to let American consumers buy cheaper drugs from foreign nations. Report

> AstraZeneca lost a long-shot pitch for summary judgment in a patent dispute over its blockbuster cholesterol med Crestor. Report

> Cephalon sued Icelandic generics maker Actavis over the latter's proposed launch of a copycat version of wakefulness drug Nuvigil. Report

> Merck KGaA said it still expects its pharmaceuticals division to perform better than the rest of the market even after setbacks with the Erbitux cancer medicine and an experimental multiple sclerosis treatment. Report

> Pfizer won European approval for the penumococcal vaccine Prevenar 13 it acquired along with Wyeth. Report

> FDA staff raised questions about the benefits of a proposed new use for OSI Pharmaceuticals' lung cancer pill Tarceva, documents released in advance of an advisory committee meeting said. Report

> A Manhattan federal judge rejected Merck & Co's effort to dismiss 24 cases alleging that its Fosamax drug treatment for osteoporosis causes jaw damage. Report

> Canadian contractor manufacturer Patheon will consolidate its Puerto Rican activities at its facility in Manati and sell or close its plant in neighbouring Caguas by 2011. Report

Biotech News

> Cubist Pharmaceuticals has struck a deal to buy out San Diego-based start-up Calixa Therapeutics, adding a promising mid-stage antibiotic to its pipeline in exchange for $92.5 million down and another $310 million in milestones. Report

> After watching its share price plunge in early November after the FDA demanded another late-stage trial of its experimental bone loss drug, GTx (GTXI) announced that it will have to axe 28 percent of its workforce in a restructuring. Report

> San Diego-based start-up Pfenex hasn't wasted any time in getting partnered up with a Big Pharma collaborator. The Dow Chemical spinout, which made its debut last week, announced a $52 million discovery collaboration with Merck this morning. Article

> With its biggest shareholder expected to make a power grab at an annual meeting on Wednesday, Hawaii Biotech has filed for Chapter 11 bankruptcy protection. Report

Biotech IT News

> Almac is partnering with FACIT.org for electronic distribution of patient-reported outcomes and quality of life assessments. The drug development service provider is validating FACIT assessments via phone, web and handheld device. Report

> Without doubt, most of the literature about the protein interactions of interest in drug discovery is dispersed among scientific journals. Integrating that information is one of the goals of OSDD, the open source drug discovery project being conducted by the Council of Scientific and Industrial Research. The project is attempting to create a more efficient means of discovery for tuberculosis drugs. Story

> Fundación MEDINA researchers use a variety of screening technologies and set-up modifications in their work to identify risks in cardiovascular safety and drug-drug interactions. Report

> Perceptive Informatics sees a definite uptick in the need for interoperability among automated clinical trial management applications. It has begun answering that need by enhancing the interoperability of two products in its mainstay eClinical suite: DataLabs and ClinPhone. Report

> It's been almost four years in the making, but the FDA's draft guidance on patient-reported outcome measures has now officially dropped the "draft" designation. Story

> Facebook's privacy protection upgrade last week could well be a gateway to more and safer online sharing of patient information--perhaps aiding investigators in such clinical trial activities as subject recruitment. Report

And Finally... Only a bit more than half of kids with a mental disorder sought professional treatment, a National Institute of Mental Health study found. 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.