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New and experimental hepatitis C treatment news

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J&J makes a splash in hep C with a $1.75B deal for Alios

Johnson & Johnson ($JNJ) is taking a deep dive into antivirals, trading $1.75 billion for private biotech Alios BioPharma to get its hands on a midstage treatment and some early assets that could expand its share of the blockbuster hepatitis C market.

Published
8 hours ago
From
Fierce Biotech
After Patient's Death, Study Shows HCV Drug Cardiotoxic in 14 of 34 Treated Patients

The development of BMS-986094 (Bristol-Myers Squibb), a nucleotide-polymerase inhibitor for the treatment of chronic hepatitis C (HCV) infection, was terminated back in August 2012, but a new retrospective review analyzing adverse events provides an in-depth look at the cardiotoxicity associated with the investigational agent. The findings may have profound implications for other drugs in late-stage testing or others approved for use.

Published
29 September 2014
From
Medscape (requires registration)
Patent landscape for hepatitis issued by WHO

The World Health Organization has published an analysis of the patent situation for new hepatitis treatments, and a call for possible pharmaceutical products for prequalification.

Published
29 September 2014
From
Intellectual Property Watch
European CHMP Adopts Positive Opinion for Gilead’s Harvoni® (Ledipasvir/Sofosbuvir) for the Treatment of Chronic Hepatitis C Infection in Adults

Gilead Sciences, Inc. GILD, +0.97% today announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency, has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Harvoni®,an investigational once-daily tablet combining the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg, for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Published
29 September 2014
From
Gilead press release
AbbVie 3D hepatitis C regimen is well-tolerated in Phase 3 trials

AbbVie's 3D hepatitis C regimen containing ABT-450, ombitasvir, and dasabuvir was generally well-tolerated in the Phase 3 SAPPHIRE trials, according to a pooled analysis presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy last week in Washington, DC.

Published
15 September 2014
From
HIVandHepatitis.com
Gilead to raise price for new hepatitis C drug above $84000

The fixed-dose regimen version of Gilead Sciences Inc's $84,000 hepatitis C drug, already under fire for its record-breaking costs, is going to be even more expensive.

Published
15 September 2014
From
Reuters
MSF urges BMS to make daclatasvir accessible in low-and middle-income countries

Welcoming the EMA's approval of daclatasvir on August 27, 2014, the MSF said that the BMS must rapidly register daclatasvir in those countries with a high burden of hepatitis C, especially in those countries with a high prevalence of genotype 3. It also urged BMS to ensure daclatasvir is affordable in those countries with a high burden of hepatitis C.

Published
01 September 2014
From
Pharmabiz
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
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