FDA panel recommends Amgen biosimilar drug for approval
A Food and Drug Administration panel recommended an Amgen biosimilar drug for approval July 12, just days after it said the biosimilar performed like a drug it mimicked. ABP 501, made by Thousand Oaks biotech giant Amgen, replicates the effects of Humira, which is approved to treat nine conditions including rheumatoid arthritis, skin disorders and Read More →
FDA OKs wearable injector for Amgen’s Repatha cholesterol drug
The U.S. Food and Drug Administration approved a new type of injector for Amgen’s cholesterol reducing drug Repatha on July 11. The FDA approved a wearable injector, called the “Pushtronex” system, that sticks to patients’ bodies and delivers a dose of the drug monthly under the skin. Patients can perform moderate physical activities like walking Read More →
FDA finds Amgen biosimilar replicates effects of Humira
The Food and Drug Administration said a new Amgen biosimilar replicates the effects of a competitor’s blockbuster drug July 8. ABP 501 replicates the effects of Humira, which is approved to treat nine conditions including rheumatoid arthritis, skin disorders and colon inflammation. The drug, made by Chicago-based competitor AbbVie, typically costs $20,000 per year for Read More →
Health care nonprofits merge to expand Ventura County service
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Stellar Biotechnologies offerings raise $6.75 million
Stellar Biotechnologies, a Port Hueneme-based company which makes medicines from the blood of animals found only off the coast of California, closed two private offerings July 6. Stellar closed one offering of 1.7 million common shares sold to institutional investors for $4 per share. In a separate concurrent offering, the company also sold 1.3 million Read More →
Europeans OK Amgen’s Kyprolis for multiple myeloma treatment
European regulators approved Amgen’s potential blockbuster drug Kyprolis on July 4 as a treatment for multiple myeloma. The European Commission approved a treatment of Kyprolis and dexamethasone in patients who’ve received at least one previous multiple myeloma treatment. In November, the commission approved a Kyprolis treatment using lenalidomide and dexamethasone for patients who’ve received at Read More →