Given the attacks on the biopharmaceutical industry by “pharmascolds”, one would think that all of the negative terms that can be used to describe the nefarious nature of the industry have already been used. However, Gary West of West Health seems to have come up with a new twist with his use of drug cartels to describe what some believe is an important part of the healthcare system. Here is what he had to say in a recent op-ed piece in the San Diego Union Tribune.
Japan's Pharmaceuticals and Medical Devices Agency (PMDA) is reviewing approved hepatitis C drugs in the country for links to a possible reactivation of the hepatitis B virus, which could result in label changes.nnIn a notice last week, PMDA said that the review covers Gilead Sciences' ($GILD) Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) as well as AbbVie's ($ABBV) Viekirax (ombitasvir and paritaprevir and ritonavir), Bristol-Myers Squibb's ($BMY) Daklinza (daclatasvir) and Sunvepra (asunaprevir), Mitsubishi Tanabe's Telavic (telaprevir), Janssen Pharmaceutical K.K.'s Sovriad (simeprevir), and Merck's ($MRK) Vanihep (vaniprevir).
The US Food and Drug Administration (FDA) on Tuesday released a revised version of its draft guidance on direct-acting antiviral (DAA) Hepatitis C virus (HCV) drugs, which calls on sponsors to conduct head-to-head Phase III studies for drugs in development. - See more at: http://www.raps.org/Regulatory-Focus/News/2016/05/03/24862/FDA-Calls-for-Head-to-Head-Trials-in-Revised-Draft-Guidance-on-Hepatitis-C-Drugs/#sthash.N43UwJSP.dpuf
Hepatitis C was supposed to be a boon for an entire slate of drugmakers: Bristol-Myers Squibb ($BMY), Merck & Co. ($MRK), AbbVie ($ABBV), and yes, the current dominant force, Gilead Sciences ($GILD). But that's not how the market has played out.
AbbVie (NYSE: ABBV), a global biopharmaceutical company, announced today that the European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion for the use of VIEKIRAX® (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA® (dasabuvir tablets) without ribavirin (RBV) in chronic hepatitis C virus (HCV) infected genotype 1b (GT1b) patients with compensated cirrhosis (Child-Pugh A).
The U.S. Food and Drug Administration has expanded the use of Gilead Sciences Inc's blockbuster drug Harvoni to some hepatitis C patients in the advanced stage of cirrhosis, including those who have undergone liver transplant.
Risk of Serious Liver Injury associated with Hepatitis C Treatments