Hepatitis C New Drugs Review
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Hepatitis C New Drugs Review
FDA approved Incivek(telaprevir, Vertex) on Monday 23 May by its PDUFA deadline.A paradigm shift in the treatment of Hepatitis C virus infection. http://knol.google.com/k/krishan-maggon/boceprevir-merck-telaprevir-vertex/3fy5eowy8suq3/151#
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Regulus nabs $30M in debt to keep plugging at microRNA-targeting hep C candidate | FierceBiotech

Regulus nabs $30M in debt to keep plugging at microRNA-targeting hep C candidate | FierceBiotech | Hepatitis C New Drugs Review | Scoop.it
Small cap Regulus Therapeutics has nabbed a $30 million credit facility from Oxford Finance that it said is sufficient to get it into 2018. Most of the money is already earmarked to back its Phase II clinical program for lead candidate RG-101.
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Lack of evidence of an effect of Direct Acting Antivirals on the recurrence of hepatocellular carcinoma - Journal of Hepatology

Lack of evidence of an effect of Direct Acting Antivirals on the recurrence of hepatocellular carcinoma - Journal of Hepatology | Hepatitis C New Drugs Review | Scoop.it
Lack of evidence of an effect of DAAs on the recurrence of HCC: The ANRS collaborative study group on HCC https://t.co/vqJjxK7Qp9
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5CZB HCV NS5B IN COMPLEX WITH LIGAND IDX17119-5

5CZB HCV NS5B IN COMPLEX WITH LIGAND IDX17119-5 | Hepatitis C New Drugs Review | Scoop.it
HCV NS5B IN COMPLEX WITH LIGAND IDX17119-5

HCV NS5B IN COMPLEX WITH LIGAND IDX17119-5 DOI: 10.2210/pdb5czb/pdb Classification: REPLICATION Deposited: 2015-07-31 Released: 2016-06-15 Deposition author(s): Pierra, C., Dousson, C., Augustin, M. Organism: Hepatitis C virus Expression System: Escherichia coli Structural Biology Knowledgebase: 5CZB SBKB.org
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EASL - Event - New perspectives in hepatitis C virus infection - The roadmap for cure

EASL - Event - New perspectives in hepatitis C virus infection - The roadmap for cure | Hepatitis C New Drugs Review | Scoop.it
RT @EASLnews: Submit your abstract before 27 June & share yr knowledge on #HepC! Special Conf. in Paris https://t.co/r6WM4PAUz6 https://t.c
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 Regulus Therapeutics miRNA RG-101 aiming for 4 week Hepatitis C cure?

 Regulus Therapeutics miRNA RG-101 aiming for 4 week Hepatitis C cure? | Hepatitis C New Drugs Review | Scoop.it
About RG-101 Regulus’ wholly-owned lead product candidate is RG-101, a GalNAc-conjugated anti-miR targeting miR-122 for the treatment of hepatitis C virus (HCV) infection.  miR-122 is the most abundant miR in the liver and is essential for HCV stability, replication and translation in hepatocytes. Regulus believes that its miR-122 antagonist, RG-101, has the potential to become …
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Cirrhosis-Causing Liver Cells Made Healthy in Mice

Cirrhosis-Causing Liver Cells Made Healthy in Mice | Hepatitis C New Drugs Review | Scoop.it
One major benefit of stem cells is that they could be used to create healthy cells of any type. In the lab, skin cells have already been converted into liv
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CDC - Liver Cancer

CDC - Liver Cancer | Hepatitis C New Drugs Review | Scoop.it
To lower your risk for liver cancer, get vaccinated against Hepatitis B, get tested for Hepatitis C, and don't drink too much alcohol.
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Big Pharma Bombshell: Judge Finds Merck Lied In Patent Trial, Overturns $200-Million Verdict

Big Pharma Bombshell: Judge Finds Merck Lied In Patent Trial, Overturns $200-Million Verdict | Hepatitis C New Drugs Review | Scoop.it
These days, the public doesn’t have a very high opinion of drug manufacturers. And it seems that there may now be yet another reason to be angry: federal Judge Beth Labson Freeman of San Jose has found that Merck & Co.
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Merck used confidential info from Pharmasset about chemical structure to modify its own pending patent. Merck modifications and claims now included chemicals invented by Pharmasset. 
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NGM282 | Primary Sclerosing Cholangitis | Non-alcoholic Steatohepatitis | NGM Bio

NGM282 | Primary Sclerosing Cholangitis | Non-alcoholic Steatohepatitis | NGM Bio | Hepatitis C New Drugs Review | Scoop.it

NGM Bio is a research-driven, clinical stage biopharmaceutical company with a drug discovery engine designed to generate a steady pipeline of first-in-class biologic drug candidates.


NGM282, is an engineered version of the human FGF19 hormone, a primary regulator of bile acid synthesis in the liver. It is also a key signaling molecule in metabolic processes involved in body weight maintenance, including glucose homeostasis and triglyceride regulation. However, overexpression of FGF19 has been shown to promote liver tumor development in transgenic mice. NGM282, accordingly, has been engineered to eliminate the elements of FGF19’s signaling that are associated with those tumorigenic properties while retaining both the FGFR1c- and FGFR4-mediated signaling activities of the native hormone that direct the regulation of metabolism and bile acid synthesis. Thus, we believe that NGM282 presents a unique opportunity to leverage the dual mechanism of FGF19 without the potential tumorigenicity risk, and are pursuing a multi-pronged development program to efficiently evaluate its drug profile and maximize the clinical and commercial potential of NGM282.

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NGM282 is a once-daily injectable for which we have completed Phase 1 clinical testing and two Phase 2a trials in type 2 diabetes and primary biliary cirrhosis (PBC) patients. A 52-week Phase 2b trial in PBC is ongoing for long-term safety assessment of NGM282. These studies have demonstrated proof of biological activity consistent with FGF19-like activity related to FGFR1c and FGFR4 signaling, and a favorable safety and tolerability profile with NGM282 treatment:
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Join the Drops

Join the Drops | Hepatitis C New Drugs Review | Scoop.it
Join the Drops - Biomedical pictures for June 2016.

Hepatitis C is a serious global health problem, with up to 200 million people worldwide infected every year and more than 600,000 lives lost. It’s caused by a virus that can only grow in liver cells, causing liver disease, cirrhosis and, in some cases, cancer. In order to find new ways of treating or even preventing hepatitis C infection, scientists are taking a closer look at how the virus hides and moves inside liver cells. Intriguingly, they’ve found that that virus particles like to hide in fatty droplets inside the cells (the yellow circles in this fluorescence microscope image of human liver cells), masking them from the immune system and helping them to multiply. A gene called ABHD5 – which is faulty in people with a rare fat storage disease called Chanarin-Dorfman syndrome – is involved in assembling these fatty virus-filled droplets, and could be a useful pointer towards future anti-viral therapies.
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Magnetic Resonance Imaging and Liver Histology as Biomarkers of Hepatic Steatosis in Children with Nonalcoholic Fatty Liver Disease

Magnetic Resonance Imaging and Liver Histology as Biomarkers of Hepatic Steatosis in Children with Nonalcoholic Fatty Liver Disease | Hepatitis C New Drugs Review | Scoop.it
Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease in children. In order to advance the field of NAFLD, noninvasive imaging methods for measuring liver fat are needed.
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Hepatology. Author manuscript; available in PMC 2016 Jun 1. Published in final edited form as: 
Hepatology. 2015 Jun; 61(6): 1887–1895. Published online 2015 Feb 5. doi: 10.1002/hep.27666

Jeffrey B. Schwimmer, M.D.,1,2,3 Michael S. Middleton, M.D., Ph.D.,3 Cynthia Behling, M.D., Ph.D.,1,4 Kimberly P. Newton, M.D.,1,2 Hannah I. Awai, M.D.,1,2,3 Melissa N. Paiz, B.S.,1 Jessica Lam, B.S.,3,5 Jonathan C. Hooker, B.S.,3 Gavin Hamilton, Ph.D.,3 John Fontanesi, Ph.D.,6,7,8 and Claude B. Sirlin, M.D.3
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Impact of grazoprevir and elbasvir in the treatment of hepatitis C virus–infected patients with chronic kidney disease and end-stage renal disease - Pedraza - 2016 - Clinical Liver Disease - Wiley ...

Impact of grazoprevir and elbasvir in the treatment of hepatitis C virus–infected patients with chronic kidney disease and end-stage renal disease - Pedraza - 2016 - Clinical Liver Disease - Wiley ... | Hepatitis C New Drugs Review | Scoop.it
RT @HenryEChang: Impact of grazoprevir & elbasvir in tx of #HCV infected pts with CKD & end-stage renal disease→https://t.co/KHnsDrgTK8 @AA…

CONCLUSION The approval of grazoprevir and elbasvir (Zepatier) with an indication for all levels of kidney function and dialysis has altered the landscape for the treatment of HCV in patients with CKD. Other DAAs are either not approved for use in patients with advanced CKD or no safety data are available for the dialysis population (Table 1). The C-SURFER trial has demonstrated safety and efficacy in patients with CKD and offers evidence supporting the safe and effective treatment of a group of patients with an enormous unmet medical need. Important clinical questions require further study, including the timing of therapy as it relates to the kidney transplant candidate. In addition, studies demonstrating safety and efficacy of DAAs in the kidney transplant recipient are still necessary.
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Clinical Liver Disease Volume 7, Issue 5, Version of Record online: 27 MAY 2016
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The Cost of Pharmaceuticals, the Role of Public Health | SPH | Boston University

The Cost of Pharmaceuticals, the Role of Public Health | SPH | Boston University | Hepatitis C New Drugs Review | Scoop.it
As the debate over the high cost of medication rages on, is there an opening for public health?
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AMD Projects: Tracing the Specter of Hepatitis C AMD Initiative Projects | Advanced Molecular Detection (AMD)| CDC

AMD Projects: Tracing the Specter of Hepatitis C AMD Initiative Projects | Advanced Molecular Detection (AMD)| CDC | Hepatitis C New Drugs Review | Scoop.it
Global Hepatitis Outbreak and Surveillance Technology (GHOST) is a new web-based system that harnesses the power of novel bioinformatics technology.
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CDC lists counties at high risk of injected drug-related hepatitis C and HIV

CDC lists counties at high risk of injected drug-related hepatitis C and HIV | Hepatitis C New Drugs Review | Scoop.it
The U.S. Centers for Disease Control and Prevention released a list of counties at high risk of hepatitis C and HIV, with most of the counties being in rural locations, and in Southern states.
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Sirtuin 1 Stimulation Attenuates Ischemic Liver Injury and E... : Critical Care Medicine

Sirtuin 1 Stimulation Attenuates Ischemic Liver Injury and E... : Critical Care Medicine | Hepatitis C New Drugs Review | Scoop.it
Objectives: Hepatic ischemia-reperfusion is a major clinical problem with limited treatment options.

Pharmacologic stimulation of sirtuin 1 attenuates liver injury after hepatic ischemia-reperfusion by restoring mitochondrial mass and membrane potential, which is associated with the enhancement of autophagy.
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Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus - Younossi - 2016 - Journal of Viral Hepatitis - Wiley Online L...

Sofosbuvir and ledipasvir improve patient-reported outcomes in patients co-infected with hepatitis C and human immunodeficiency virus - Younossi - 2016 - Journal of Viral Hepatitis - Wiley Online L... | Hepatitis C New Drugs Review | Scoop.it
Sofosbuvir and ledipasvir improve patient-reported outcomes in patients c... https://t.co/P2tJ3AEMHU #Psychiatry
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Systematic Review of Modelling Approaches for the Cost Effectiveness of Hepatitis C Treatment with Direct-Acting Antivirals. - PubMed - NCBI

Systematic Review of Modelling Approaches for the Cost Effectiveness of Hepatitis C Treatment with Direct-Acting Antivirals. - PubMed - NCBI | Hepatitis C New Drugs Review | Scoop.it
Pharmacoeconomics. 2016 Jun;34(6):551-67. doi: 10.1007/s40273-015-0373-9. Review

CONCLUSIONS: Most modelling studies used a similar modelling structure and could have underestimated the value of HCV treatment. Future modelling efforts should consider the benefits of HCV treatment in preventing transmission, extra-hepatic and indirect economic benefits of HCV treatment, real-world cost-effectiveness analysis and cost effectiveness of HCV treatment in low- and middle-income countries.
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Daclatasvir for the Treatment of Chronic Hepatitis C: A Critique of the Clinical and Economic Evidence. - PubMed - NCBI

Daclatasvir for the Treatment of Chronic Hepatitis C: A Critique of the Clinical and Economic Evidence. - PubMed - NCBI | Hepatitis C New Drugs Review | Scoop.it
Pharmacoeconomics. 2016 Jun 8. [Epub ahead of print] REVIEW

NICE  Review

Abstract The National Institute for Health and Care Excellence (NICE) invited the manufacturer of daclatasvir (Bristol-Myers Squibb) to submit clinical and cost-effectiveness evidence for daclatasvir in combination with other medicinal products within its licensed indication for the treatment of chronic hepatitis C, as part of the Institute’s single technology appraisal process. The Centre for Reviews and Dissemination and Centre for Health Economics at the University of York were commissioned to act as the independent Evidence Review Group (ERG). This article presents the ERG’s critical review of the evidence presented in the company submission in the context of a description of the company submission, and the resulting NICE guidance. The main clinical effectiveness data for daclatasvir in combination with sofosbuvir (daclatasvir + sofosbuvir) were derived from two uncontrolled open-label trials. Among patients with genotype 1 infection, 98–100 % of patients had a sustained virologic response at week 12 (SVR12), overall. Among genotype 3 patients, between 85 and 100 % had SVR12 across patient populations and regimens. The main evidence for daclatasvir + pegylated interferon-α and ribavirin (PR) came from one randomised controlled trial comparing daclatasvir + PR with PR in patients with genotype 4. This found an SVR12 rate of 82 % in previously untreated patients. Serious adverse event rates associated with daclatasvir were low. The lack of comparative trial evidence for daclatasvir + sofosbuvir and many of the comparators defined in the NICE scope meant that established methods for comparing interventions either directly via head-to-head trial comparisons or via adjusted indirect comparisons were not feasible. Comparisons of SVR rates were therefore largely based on unadjusted estimates drawn from individual trial arms and subgroups of individual trial arms. The ERG concluded that, despite limited evidence, daclatasvir in combination with other treatments appeared to be associated with a high SVR rate. Daclatasvir + sofosbuvir was unlikely to be inferior to comparator treatments in genotype 1 patients; but, due to limited evidence, the relative efficacy of daclatasvir and other treatments in genotype 3 and 4 patients or patients with compensated cirrhosis was uncertain. The economic evaluation compared daclatasvir + sofosbuvir and daclatasvir + PR with a wide range of NICE-approved treatments for hepatitis C. The company submission focused on a series of subgroups defined by disease severity (METAVIR fibrosis stage F3, compensated cirrhosis), genotype and treatment history. In the cost-effectiveness analysis, daclatasvir-containing regimens were cost effective at a £20,000–£30,000 per QALY threshold in the following F3 populations: genotype 1 treatment naïve (Incremental cost-effectiveness ratio [ICER] = £19,739/QALY) and treatment experienced (£15,687/QALY) and genotypes 1, 3 and 4 interferon ineligible or intolerant (£5906–£9607/QALY depending on subgroup). In patients with cirrhosis, daclatasvir-containing regimens were not cost effective. The ERG found the company’s economic analyses to be highly uncertain and in places biased. However, the ERG found that daclatasvir-containing regimens were cost effective in certain populations with significant fibrosis, and following new analyses by the company after a price reduction, in certain populations with cirrhosis, including patients who were not eligible for or who were intolerant to interferon therapy. The NICE Appraisal Committee’s preliminary recommendation was that daclatasvir + sofosbuvir should be available as an option in genotype 1 and 4 patients with significant fibrosis but without cirrhosis, who had either been treated previously or were ineligible or intolerant to interferon. In response to the preliminary recommendation, the manufacturer submitted additional information including comparator SVR rates and a revised confidential price. Following this, the Committee expanded its original recommendation in its Final Appraisal Determination. The recommendation was expanded to include daclatasvir + sofosbuvir as an option for patients with significant fibrosis but without cirrhosis (in previously untreated patients with genotype 1, and genotype 3 patients ineligible or intolerant to interferon) and genotype 1, 3 and 4 cirrhotic patients who were ineligible or intolerant to interferon. Daclatasvir + PR was also recommended as an option for genotype 4 patients who had significant fibrosis or compensated cirrhosis. PharmacoEconomicsPharmacoEconomics Look Inside Reference tools Export citation Add to Papers Other actions Register for Journal Updates About This Journal Reprints and Permissions Share Share this content on Facebook Share this content on Twitter Share this content on LinkedIn Related Content
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Pharmacoeconomics. 2016 Jun 8. [Epub ahead of print] Daclatasvir for the Treatment of Chronic Hepatitis C: A Critique of the Clinical and Economic Evidence. 

Llewellyn A1, Faria R2, Woods B2, Simmonds M3, Lomas J2, Woolacott N3, Griffin S2.
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Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free), daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/pari...

Direct-acting antivirals indicated for treatment of hepatitis C (interferon-free), daclatasvir / dasabuvir / sofosbuvir / ledipasvir / simeprevir / ombitasvir/pari... | Hepatitis C New Drugs Review | Scoop.it
On 17 March 2016, the European Medicines Agency (EMA) started a review of medicines known as direct-acting antivirals used for treating chronic (long-term) hepatitis C (an infectious disease that affects the liver, caused by the hepatitis C virus). 

 Direct-acting antivirals (Daklinza, Exviera, Harvoni, Olysio, Sovaldi and Viekirax) are important medicines for the treatment of chronic hepatitis C and can be used without interferons, which are less well tolerated. Until recently, interferons were part of treatment regimens for hepatitis C. Interferons are known to act against both hepatitis B and C viruses, which may be present at the same time in some patients.

The review was triggered by reports of hepatitis B re-activation in patients who have been infected with hepatitis B and C viruses, and who were treated with direct-acting antivirals for hepatitis C. Hepatitis B re-activation refers to a return of active infection in a patient whose hepatitis B infection had been inactive. The review will assess the extent of hepatitis B re-activation in patients treated with direct-acting antivirals for hepatitis C and evaluate whether any measures are needed to optimise the treatment. 

 In addition, in April 2016 data from a study1became available regarding the risk of liver cancer (hepatocellular carcinoma) coming back in patients who were treated with direct-acting antivirals for hepatitis C. The study suggested that these patients were at risk of their cancer coming back earlier than patients with hepatitis C who were not treated with direct-acting antivirals. The scope of the ongoing review has therefore been extended to also assess the risk of liver cancer with these medicines.
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EMA reviews direct-acting antivirals for hepatitis C

Reig, M., Mariño, Z., Perelló, C., Iñarrairaegui, M., Ribeiro, A., Lens, S., Díaz, A., Vilana, R., Darnell, A., Varela, M., Sangro, B., Calleja, J.L., Forns, X., Bruix, J., Unexpected early tumor recurrence in patients with hepatitis C virus -related hepatocellular carcinoma undergoing interferon-free therapy: a note of caution, Journal of Hepatology (2016).
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Approved Antiviral Drugs over the Past 50 Years

Approved Antiviral Drugs over the Past 50 Years | Hepatitis C New Drugs Review | Scoop.it
RT @greg_folkers: Clin. Microbiol. Rev.: Approved Antiviral Drugs over the Past 50 Years https://t.co/RK3Cyb3yk9 https://t.co/TyKDwUchNO

SUMMARY Since the first antiviral drug, idoxuridine, was approved in 1963, 90 antiviral drugs categorized into 13 functional groups have been formally approved for the treatment of the following 9 human infectious diseases: (i) HIV infections (protease inhibitors, integrase inhibitors, entry inhibitors, nucleoside reverse transcriptase inhibitors, nonnucleoside reverse transcriptase inhibitors, and acyclic nucleoside phosphonate analogues), (ii) hepatitis B virus (HBV) infections (lamivudine, interferons, nucleoside analogues, and acyclic nucleoside phosphonate analogues), (iii) hepatitis C virus (HCV) infections (ribavirin, interferons, NS3/4A protease inhibitors, NS5A inhibitors, and NS5B polymerase inhibitors), (iv) herpesvirus infections (5-substituted 2′-deoxyuridine analogues, entry inhibitors, nucleoside analogues, pyrophosphate analogues, and acyclic guanosine analogues), (v) influenza virus infections (ribavirin, matrix 2 protein inhibitors, RNA polymerase inhibitors, and neuraminidase inhibitors), (vi) human cytomegalovirus infections (acyclic guanosine analogues, acyclic nucleoside phosphonate analogues, pyrophosphate analogues, and oligonucleotides), (vii) varicella-zoster virus infections (acyclic guanosine analogues, nucleoside analogues, 5-substituted 2′-deoxyuridine analogues, and antibodies), (viii) respiratory syncytial virus infections (ribavirin and antibodies), and (ix) external anogenital warts caused by human papillomavirus infections (imiquimod, sinecatechins, and podofilox). Here, we present for the first time a comprehensive overview of antiviral drugs approved over the past 50 years, shedding light on the development of effective antiviral treatments against current and emerging infectious diseases worldwide. FOOTNOTES
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HIV, Hepatitis, Herpes, HPV, CMV Influenza antivirals.
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Lack of evidence of an effect of Direct Acting Antivirals on the recurrence of hepatocellular carcinoma - Journal of Hepatology

Lack of evidence of an effect of Direct Acting Antivirals on the recurrence of hepatocellular carcinoma - Journal of Hepatology | Hepatitis C New Drugs Review | Scoop.it
RT @JHepatology: [In press] Lack of evidence of an effect of DAAs on the recurrence of hepatocellular carcinoma
https://t.co/NPD50hght1
#HC…
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Judge Sides With Gilead Against Merck in Hepatitis C Case

Judge Sides With Gilead Against Merck in Hepatitis C Case | Hepatitis C New Drugs Review | Scoop.it
A federal judge reversed a jury verdict that Gilead Sciences should pay $200 million to Merck & Co. in a patent dispute over hepatitis C drugs.
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How to meet the first-ever global hepatitis targets

How to meet the first-ever global hepatitis targets | Hepatitis C New Drugs Review | Scoop.it
By Sébastien Morin, International AIDS Society, Eliot Ross Albers, Independent (formerly at the International Network of People Who Use Drugs), and Jürgen Rockstroh, University of Bonn
 
“For 2030,
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India buyers club: The new way for Americans to buy cheap drugs

India buyers club: The new way for Americans to buy cheap drugs | Hepatitis C New Drugs Review | Scoop.it
Americans who can't afford an $84,000 miracle drug used to treat Hepatitis C are turning to a "buyers club" in India. (via: trendolizer.com)
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