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 →
Read More →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 →
Read More →Dubroff: East Ventura County should focus on creating a biotech cluster
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 →
Read More →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
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Read More →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 →
Read More →Drug sales for biotech giant Amgen boost bottom line
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