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European Commission Approves Bristol-Myers Squibb’s Daklinza (daclatasvir) Across Multiple Genotypes for the Treatment of Chronic Hepatitis C Infection

Bristol-Myers Squibb Company today announced that the European Commission has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. Daklinza, when used in combination with sofosbuvir (Sovaldi), is an all-oral, interferon-free regimen that provided cure rates of up to 100% in clinical trials

Published
27 August 2014
From
Bristol-Myers Squibb
PegLambda discontinued by BMS

We have concluded that given the very promising developments in HCV in terms of emerging all-oral therapeutic options, Lambda would no longer fulfill the unmet need that we had envisioned upon initiation of the clinical trials.

Published
18 August 2014
From
EATG
Achillion Achieves 100 Percent Sustained Virologic Response Rate (SVR4) From an Eight Week Phase 2 Trial Evaluating a Ribavirin-Free Regimen of ACH-3102 and Sofosbuvir for Genotype 1 HCV ("Proxy Study")

Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced interim results from an ongoing Phase 2 proxy study evaluating ACH-3102, Achillion's second-generation NS5A inhibitor, in combination with sofosbuvir, without ribavirin, for eight weeks of treatment in patients with treatment-naïve genotype 1 chronic hepatitis C virus (HCV) infection.

Published
18 August 2014
From
Achillion press release
HIV, HCV and TB Pipeline Report

Drugs, diagnostics, vaccines, preventive technologies, research towards a cure, and immune-based and gene therapies in development.

Published
21 July 2014
From
Treatment Action Group & i-Base
EU nations join forces against 'exorbitant' hepatitis C drug: France

France said Thursday it has joined forces with 13 other European countries to negotiate a lower price for a promising new hepatitis C drug that has drawn controversy for its astronomical cost.

Published
10 July 2014
From
Medical Xpress
Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® (daclatasvir) and Sunvepra® (asunaprevir) Dual Regimen

Bristol-Myers Squibb Company (NYSE:BMY) announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Daklinza® (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), and Sunvepra® (asunaprevir), a NS3/4A protease inhibitor.

Published
08 July 2014
From
Bristol-Myers Squibb press release
Bristol-Myers Squibb Receives Positive CHMP Opinion for Daklinza® (daclatasvir) for Treatment of Chronic Hepatitis C in the European Union

Bristol-Myers Squibb Company (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that Daklinza® (daclatasvir), an investigational, potent pan-genotypic NS5A complex inhibitor (in vitro), be granted approval for use in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Published
30 June 2014
From
Bristol-Myers Squibb press release
HCV drug out of the running

The German pharmaceutical giant Boehringer Ingelheim is stopping development of faldaprevir, its hepatitis C virus (HCV) drug.

Published
23 June 2014
From
MedPage Today
A 4-week hep C cure? Bristol to test drugs with Gilead's Sovaldi

In the race to find a faster cure for hepatitis C, Bristol-Myers Squibb Co said it will test its experimental antiviral drug combination with Gilead Sciences Inc's blockbuster drug Sovaldi, hoping to cut treatment time to four weeks.

Published
23 June 2014
From
Reuters
UNITED STATES: FDA Approves AbbVie's Hepatitis C Regimen for Priority Review

The US Food and Drug Administration (FDA) has granted priority review for AbbVie’s experimental all-oral regimen for treating adults infected with hepatitis C virus (HCV). The drug’s application under priority review means that FDA must evaluate the safety and effectiveness of the AbbVie regimen within six months before letting the manufacturer know whether they may take the product to market. AbbVie’s new regimen consists of an antiviral called ritonavir and a protease inhibitor called ABT-450, combined with an NS5A inhibitor called ombitasvir and the polymerase inhibitor dasabuvir. When taken together, these mechanisms are powerful enough to stop HCV. [Article source: http://www.techtimes.com]

Published
19 June 2014
From
CDC
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