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FDA gives full approval to Amgen leukemia drug Blincyto

By   /  Tuesday, July 11th, 2017  /  Central Coast Health Watch, East Ventura County, Latest news  /  Comments Off on FDA gives full approval to Amgen leukemia drug Blincyto

Amgen’s leukemia drug Blincyto received full approval from the U.S. Food and Drug Administration on July 11 to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia in adults and children. The biotech giant, headquartered in Thousand Oaks, had previously announced that the drug had been fast-tracked for priority review. The full approval includes data Read More →

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Amgen asks FDA to consider new uses for Xgeva

By   /  Monday, June 19th, 2017  /  Central Coast Health Watch, East Ventura County, Latest news, Tri-County Public Companies  /  Comments Off on Amgen asks FDA to consider new uses for Xgeva

Thousand Oaks-based biotech giant Amgen announced June 19 that the U.S. Food and Drug Administration has accepted a supplemental application for Xgeva (denosumab) that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma. “Multiple Read More →

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Dubroff: East Ventura County should focus on creating a biotech cluster

By   /  Friday, March 31st, 2017  /  Central Coast Health Watch, Columns, East Ventura County, Latest news, Technology  /  Comments Off on Dubroff: East Ventura County should focus on creating a biotech cluster

Henry Dubroff

When the Business Times broke the story that Amgen was cutting roughly 500 support and operations jobs at its sprawling Thousand Oaks campus, there were gasps — and sighs of relief. Gasps because the world’s largest biotechnology company is the economic engine for the Conejo Valley, East Ventura County and, for that matter, a big Read More →

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FDA fast tracks Amgen’s Blincyto leukemia drug

By   /  Thursday, March 30th, 2017  /  Central Coast Health Watch, Latest news, Technology  /  Comments Off on FDA fast tracks Amgen’s Blincyto leukemia drug

Thousand Oaks-based biotech giant Amgen announced March 29 that the U.S. Food and Drug Administration has fast-tracked the company’s leukemia drug Blincyto for priority review. The drug increases the length of survival among high-risk patients, according to a study released by the New England Journal of Medicine. It almost doubled median overall survival versus chemotherapy among adult patients Read More →

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Breast implant maker Sientra battles its way back

By   /  Friday, March 17th, 2017  /  Central Coast Health Watch, South Coast, Technology, Top Stories, Top Story  /  Comments Off on Breast implant maker Sientra battles its way back

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Amgen applies for FDA approval of Blincyto

By   /  Tuesday, February 14th, 2017  /  Central Coast Health Watch, Latest news, Technology  /  Comments Off on Amgen applies for FDA approval of Blincyto

Thousand Oaks-based Amgen submitted an application for Blincyto to the U.S. Food and Drug Administration, the company announced on Feb. 14. Amgen aims to gain approval for Blincyto to treat Philadelphia chromosome-positive relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The drug was previously granted breakthrough therapy designation and accelerated approval in December 2014. “Acute Read More →

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Drug sales for biotech giant Amgen boost bottom line

By   /  Friday, February 10th, 2017  /  Central Coast Health Watch, Earnings, left, Technology, Tri-County Public Companies  /  Comments Off on Drug sales for biotech giant Amgen boost bottom line

This article is only available to Business Times subscribers Subscribers: LOG IN or REGISTER for complete digital access. Not a Subscriber? SUBSCRIBE for full access to our weekly newspaper, online edition and Book of Lists. Check the STATUS of your Subscription Account.

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