Silence is deafening when new drugs are not approved
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Read More →FDA declines to approve Novartis biosimilar for Amgen’s Neulasta
The Food and Drug Administration has declined for now to approve a copycat version of Amgen’s blockbuster drug Neulasta. Reuters reported July 19 that the FDA sent a letter to Swiss pharmaceutical Novartis at the end of June saying it was declining to approve the drug for now. Neulasta, made by Thousand Oaks-based biotech giant Read More →
Read More →Amgen wins one, loses one in biosimilar battle
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Read More →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 →
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 →
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 →
Read More →Amid losses, Sientra makes an acquisition
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