West Coast Biotech Roundup: BioMarin, Tocagen, Medivation, Twelve

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Xconomy’s Ben Fidler that Highline Therapeutics will work with big research institutions to assess the commercial potential of early stage R&D, and create startups around the most promising ideas.

—San Diego-based Dexcom (NASDAQ: DXCM), said the FDA approved its latest blood glucose monitoring system, which eliminates a receiver by using Bluetooth technology to transmit glucose data directly to a smartphone or iOS-based device. Users also can share their data by designating as many as five people to receive the data.

—Amgen (NASDAQ: AMGN) submitted a new drug application for etelcalcetide, its treatment for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis.

—Tocagen, a San Diego startup using gene therapy to treat brain cancer, said the FDA gave its orphan drug designation to the company’s lead candidates, Toca 511 & Toca FC, which convert a benign prodrug into an anticancer drug that kills tumor cells and activates the immune system. The company says it is poised to move into a pivotal clinical trial later this year for treating recurrent glioblastoma and anaplastic astrocytoma.

—San Diego-based Illumina (NASDAQ: ILMN) and the molecular diagnostics firm Burning Rock of Guangzhou, China, agreed to work together to develop cancer diagnostic products for the Chinese market, based on Illumina’s gene-sequencing technology.

—Another molecular diagnostics company, Sunnyvale, CA-based Cepheid (NASDAQ: CPHD) has been working to improve deficiencies in the production of Cepheid’s norovirus assay at its European plant in Solna, Sweden. In a warning letter made public this week, the FDA says the site does not meet requirements for good manufacturing practices.

—NuVasive, the San Diego maker of medical devices and tools used in spine surgery, said it plans to build a new manufacturing plant in San Diego that would employ more than 300 people.

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