Study shows Amgen’s Blincyto a better alternative than chemotherapy
Amgen’s new leukemia drug Blincyto increases the length of survival among high-risk patients, according to a study released by the New England Journal of Medicine. Results from its Phase 3 Tower study revealed that Blincyto almost doubled median overall survival versus chemotherapy among adult patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic 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 →
Amgen leukemia drug cures 39 percent of treated patients, study finds
Amgen’s new leukemia drug cured 39 percent of pediatric patients who received treatment, the Thousand Oaks company said Oct. 3 after publishing results of a new study in the Journal of Clinical Oncology. Blincyto, which treats a rare form of the disease known as precursor B-cell acute lymphoblastic leukemia, sent 27 patients out of 70 Read More →
FDA approves Amgen’s Blincyto
The U.S. Food and Drug Administration approved Amgen’s drug Blincyto for treating pediatric leukemia patients Sept. 1. In Dec. 2014, the FDA approved Blincyto to treat patients with precursor B-cell acute lymphoblastic leukemia, which is a rare form of the disease. On Sept. 1, the agency extended Blincyto’s approval to include pediatric patients with another Read More →
Amgen exceeds Wall Street expectations for first quarter earnings
Amgen blew away Wall Street expectations and raised its 2016 guidance when it released first quarter earnings April 28. The Thousand Oaks biotech giant had profits of $2.2 billion, up from $1.91 billion during the same quarter last year. Revenues of $5.53 billion were also up from $5 billion in 2015 and surpassed analyst estimates Read More →
Amgen seeks European OK of biosimilar drug, partners with Merck on studies
Amgen announced two developments Dec. 4 that should help the Thousand Oaks-based biotech giant compete. Amgen said it is seeking approval from the European Medicines Agency for ABP 501, a biosimilar drug similar to Humira. Amgen also announced a partnership with New Jersey-based pharmaceutical Merck to partner in a non-Hodgkins lymphoma study using drugs from Read More →