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Latest From Emily Hayes
Strong efficacy and a clean safety profile – with no cardiovascular signal – in another Phase III study bode well for filings of Zogenix's ZX008 in the fourth quarter.
Esperion is emphasizing the low list and net price of its oral bempedoic acid for cholesterol reduction, relative to the injectable PCSCK9 inhibitors, but still significantly higher than other oral cholesterol-lowering drugs.
Imbalance in deaths in study of novel cholesterol drug has been a concern, but Esperion made the case for safety during a July 10 investor day, which featured presentations by ex-FDA director John Jenkins and Cleveland Clinic cardiologist Steve Nissen.
With new branded immunotherapy-based double- or triple-drug combinations on the way, there is greater scrutiny of costs and efficiency.
Biosimilars of Amgen's blockbuster Neulasta pose a competitive threat to long-acting GSF Rolontis, but the company has experience with group purchasing and notes that large oncology clinics will make more revenue by providing higher-priced products.
Beyond Epidiolex for severe epilepsy, cannabinoid candidates are in development for a range of diseases, including acute pain, graft-versus-host disease, scleroderma, schizophrenia, pain and substance use disorder.