Sientra wins new FDA approval
The U.S. Food and Drug Administration approved a new breast implant on July 6 made by Goleta-based Sientra. Sientra’s Low Plus Profile Projection Breast Implant will be commercially available to plastic surgeons in the United States in late July, the company said in a news release. It is for cosmetic surgery for women at least Read More →
Atara reports patient death in cancer treatment study
Atara Biotherapeutics, a South San Francisco-based drug development company with major operations in Thousand Oaks, reported to the U.S. Food and Drug Administration on Feb. 18 that a patient died in one of its Phase 1 trials. The patient, who was being treated at a Memorial Sloan Kettering Cancer Center location in New York, suffered Read More →
Our View: Deja vu as 2022 begins, but with some big differences
We begin 2022 as we ended 2021, with the newest variant of the virus dominating the headlines. As the Business Times goes to press on its first edition of the year, it is back to the future, as most meetings and live events have moved to virtual. Virtual meetings are a poor substitute for in-person, Read More →
Amgen’s new asthma treatment gets FDA approval
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FDA accuses Amgen of misleading advertising
The U.S. Food and Drug Administration tagged Amgen with a letter July 7 that says the Thousand Oaks biotech firm made “misleading claims” in advertisements for its drug Neulasta, by suggesting it is more effective than biosimilar competitors. Neulasta is a prescription medication used to reduce infection risk from febrile neutropenia (a low level of Read More →
FDA gives Amgen priority review for asthma treatment
Thousand Oaks-based Amgen received a priority review for tezepelumab, a treatment for asthma, from the U.S. Food and Drug Administration, the biotech giant announced July 7. According to Amgen, tezepelumab is the first and only biologic to consistently and significantly reduce asthma exacerbations in a broad population of clients in phase 2 and 3 trials. Read More →
Amgen gets FDA approval for potential billion-dollar drug
Thousand Oaks-based Amgen won approval from the U.S. Food and Drug Administration on May 28 for its latest oral drug treatment, Lumakras, potentially adding another huge market for one of the largest biotech firms in the world. According to the Wall Street Journal, Amgen will charge $17,900 a month for the drug and analyst think Read More →
