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

Depositphotos-©-sborisov

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: [[ticker: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: [[ticker: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: [[ticker: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: [[ticker: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.

Pages: Page 1, Page 2

Author: Bruce V. Bigelow

In Memoriam: Our dear friend Bruce V. Bigelow passed away on June 29, 2018. He was the editor of Xconomy San Diego from 2008 to 2018. Read more about his life and work here. Bruce Bigelow joined Xconomy from the business desk of the San Diego Union-Tribune. He was a member of the team of reporters who were awarded the 2006 Pulitzer Prize in National Reporting for uncovering bribes paid to San Diego Republican Rep. Randy “Duke” Cunningham in exchange for special legislation earmarks. He also shared a 2006 award for enterprise reporting from the Society of Business Editors and Writers for “In Harm’s Way,” an article about the extraordinary casualty rate among employees working in Iraq for San Diego’s Titan Corp. He has written extensively about the 2002 corporate accounting scandal at software goliath Peregrine Systems. He also was a Gerald Loeb Award finalist and National Headline Award winner for “The Toymaker,” a 14-part chronicle of a San Diego start-up company. He takes special satisfaction, though, that the series was included in the library for nonfiction narrative journalism at the Nieman Foundation for Journalism at Harvard University. Bigelow graduated from U.C. Berkeley in 1977 with a degree in English Literature and from the Columbia University Graduate School of Journalism in 1979. Before joining the Union-Tribune in 1990, he worked for the Associated Press in Los Angeles and The Kansas City Times.