Another biotech bites the dust. Now it's Plymouth Meeting, Pennsylvania-based Genaera, the core asset of which was MSI-1436, a clinical candidate in Phase I development for Type 2 diabetes and obesity. Genaera also developed MEDI-528, licensed to Astra Zeneca/MedImmune and being evaluated in Phase II studies of asthma. Founded in 1987 as Magainin Pharmaceuticals, Genaera never got any drugs to market. Here's a Philadelphia Business Journal article about the company's dissolution.

Pittsburgh-based electronic diary firm invivodata is now offering five complimentary webinars on patient-reported outcomes strategies. The series is a continuation of invivodata's educational initiative; each presentation is derived from talks given during the company's recent user conference in Naples, Florida. More details are available here. To register for any of the webinars, go here.

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Two customers of electronic data capture provider Medidata Solutions won awards from CIO, an IT magazine. Wyeth and Array BioPharma were chosen as part of the CIO 100. In the latter case, the firm's solution uses Medidata's software and third-party technology to enable new ways to visualize data. “Medidata Rave is key to making both tactical and strategic decisions that are critical to our clinical development program,” said Jim Rizzi, senior director of computational technology at Array BioPharma. “By making operational information in Medidata Rave available in real time to the entire clinical team, we have achieved a solution that is unique in its ability to ensure the timing and success of new drug development projects.” Here's the release.

Paris-based sponsor company Ipsen has signed an exclusive research, development and marketing agreement with Pharnext SAS regarding innovative candidates for the treatment of Charcot-Marie-Tooth disease. As part of the deal, Ipsen has an exclusive option on Pharnext's program on Charcot-Marie-Tooth disease. A release on the deal is here. Professor Jean-Michel Alexandre, Pharnext board member and former chairman of the EMEA's committee for proprietary medicinal products, says, “I am strongly convinced that the renewal of pipelines focused on therapeutic innovation comes with the settlement of new paradigms. In that context, I think that network pharmacology, based on human genetics and underpinned by robust scientific arguments, could provide satisfactory answers.”

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In a series of white papers, Quintiles Consulting is outlining new ways to handle risk in drug development. “We are applying new business models to help companies rebalance, share and hedge their risk,” says Adrian McKemey, Quintiles Consulting practice leader for product development and commercialization. Its concepts, Quintiles contends, may shift the industry's traditional boundaries of risk and domain expertise. A release on the papers is here. The first paper focuses on operational risk and is available for download here. The second paper in the series will look at portfolio risk mitigation, and a third will tackle resource risk. Here's an April ClinPage story on the firm's approach to drug safety.

The Institute for Drug Safety Sciences has just opened on the campus of Hamner Institutes for Health Sciences in Research Triangle Park, North Carolina. Paul Watkins, an expert on liver injury and drug safety, is the founding director. The parent Hamner organization was originally started by major chemical firms; the new safety group is a collaboration with UNC-Chapel Hill. The goal is to develop new drug safety initiatives in collaboration with industry and FDA. Hamner and UNC agreed to invest $10 million over the next three years. The institute has an initial staff of 20, and is planning to hire about 100 scientists and others over the next two years. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, spoke at the opening ceremony. Says William Greenlee, president and CEO of Hamner, “The Institute for Drug Safety Sciences is positioned to make transformative advances in human predictive safety sciences that will accelerate the development of new and safer therapeutics.” There's more here.

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