Epclusa was just greenlighted by China’s Drug Administration (CDA). For hepatitis C patients in China, that means the first pangenotypic treatment will soon be available to them. But for Gilead, it might be too little, too late.
Patna police and the state drug control administration under the health department seized fake medicines worth lakhs of rupees at Machhuatoli under the jurisdiction of Kadamkuan police station on Friday.
Bristol-Myers Squibb Company,a global biopharmaceutical company, announced that the China Food and Drug Administration (CFDA) has approved a direct-acting antiviral regimen comprised of Daklinza (daclatasvir) and Sunvepra (asunaprevir), for the treatment of treatment-naive or -experienced patients, with or without compensated cirrhosis, infected with genotype 1b chronic hepatitis C virus (HCV).
Driven by several novel regimens recently receiving approval in the US and in Europe, high cure rates exceeding 90% are now achievable for most patients suffering from chronic hepatitis C. As a result of this unprecedented success, the industry is reaching a new phase in the fight against this deadly infectious disease. The pressure is now shifting to the healthcare providers to determine if the future of hepatitis C treatment will include a (near) eradication in the developed world, or if hepatitis C will remain a debilitating and life-threatening factor in our society.
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).
Bristol-Myers Squibb ($BMS) unveiled Phase III results that met the primary endpoint from an all-oral chronic hepatitis C combination trial that included Chinese patients, setting up a tight race for the first approval of a cutting-edge therapy in China.
China has moved closer to approval of the nation's first state-of-the-art treatment for hepatitis C, according to researchers who presented data from their initial trial at the Liver Meeting conference in San Francisco.
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