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Amgen has rolled out a new economic analysis of Repatha’s outcomes study, Fourier, which initially failed to wow the market when unveiled earlier this year. The PCSK9 (proprotein convertase subtilisin/kexin type 9) drug is cost-effective at $9,669 per year or less. Amgen argued that this new study is different, because it includes real-world data, including…
How it would be convenient if the companies knew about everything that could worry patients before clinical trials started. Bioverativ is about to find out. While designing an upcoming trial for a new hemophilia drug, the Biogen spinoff tapped patient social network creator MyHealthTeams to help find out what ailed hemophilia patients after their bleeding…
There was crashing news on BBC recently: they reported that US scientists were shocked by the amazing ability of cows to tackle HIV. So American scientists say that it may result in synthesizing HIV vaccine. For the time being there is no effective vaccine for HIV because the virus mutates so fast and easily. Researchers…
Information on drug impurities mutagenic potential is often quite limited. Data on mutagenic impurities of drugs developed long time ago is scarce. Nevertheless, modern regulators require mutagenicity studies to be included in registration dossier even if a generic formulation of the widely used drug is undergoing registration. So, pharma industry community has a strong need…
Novartis and Medicines for Malaria Venture (MMV) launched a patient trial for KAF156, a new generation antimalarial drug that has the potential to affect drug-resistant strains of the malaria parasite. The trial is designed to test the effectiveness of KAF156 in combination with a new, improved version of the existing antimalarial lumefantrine. The first trial center…
On the 3rd of August 2017, the U.S. Food and Drug Administration (FDA) approved Mavyret (combination of glecaprevir and pibrentasvir) to treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis or with mild cirrhosis. Mavyret may be used for patients with moderate and severe kidney disease and those who are on dialysis….