Controversy surrounds Exondys 51 approval: What to knowNew medicine for Duchenne muscular dystrophy raises questions. Here’s whose covering it and why.
Hep C drugs approved for kidsFDA approved supplemental applications for 2 primary hepatitis C medications to be used in children for the first time.
FDA approves Harvoni for new usesFDA recently approved Harvoni for expanded use in patients with genotype 4, 5 and 6 chronic hepatitis C virus infection – as well as in hepatitis C patients co-infected with HIV.
Harvoni could save US, Europe $3.2 billionThe higher cure rate of treating hepatitis C patients with a combination of ledipasvir and sofosbuvir (Harvoni) led to substantially better work productivity, according to a new study. In fact, improved work productivity and lack of absenteeism could save the United States and 5 European countries more than $3.2 billion a year.
New hep C drugs will strain the system: MD Anderson studyThe cost of treating people infected with the hepatitis C virus (HCV) with newly approved therapies is likely to place a tremendous economic burden on the country’s healthcare system, according to a study published in the March 17 issue of the Annals of Internal Medicine.
FDA warns about serious reactions to Harvoni, SovaldiBoth the Food and Drug Administration (FDA) and Harvoni and Sovaldi maker Gilead are warning Hepatitis C patients about serious bradycardia when the drugs are combined with certain other medications.
[BLOG]: Hepatitis C market competition arrives for 2015There is plenty of activity already in the hepatitis C market as competition has arrived for 2015, including CVS Health versus Express Scripts and Gilead Sciences versus AbbVie, over FDA-approved hepatitis C treatments. This will have implications for retail prescriptions as well as continuity-of-care programs within non-Medicare accountable care organizations (ACOs) and health systems.
FDA approves Viekira Pak to treat hepatitis CFDA has approved ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets (Viekira Pak, AbbVie) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis.
Novel new drugs approved in 2014FDA’s Center for Drug Evaluation and Research (CDER) reports that it has approved 35 novel new drugs in 2014. These 35 drugs include new molecular entities (NMEs) submitted to CDER in new drug applications (NDAs) and new therapeutic biologics submitted in biologics license applications (BLAs).
Cirrhosis patients benefit from new hepatitis C drugThe new combination hepatitis C drug ledipasvir/sofosbuvir (Harvoni, Gilead Sciences) has been found to be highly effective in treating patients with cirrhosis who have not benefited from previous therapies.