Hepatitis C New Drugs Review
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Bristol-Myers Squibb Foundation awards nine grants to support care for high-risk patients with hepatitis B and C in China and India

Bristol-Myers Squibb Foundation awards nine grants to support care for high-risk patients with hepatitis B and C in China and India | Hepatitis C New Drugs Review | Scoop.it
World Pharma News - one of the world's leading web-based pharmaceutical news publications - is committed to providing and disseminating the most prominent pharmaceutical news and achievements.
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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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Created public version #121 of the knol: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval"

Created public version #121 of the knol: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval" | Hepatitis C New Drugs Review | Scoop.it
Krishan Maggon published version 121 of a knol titled: "Boceprevir (Merck) & Telaprevir (Vertex) Hepatitis C : FDA Review & Approval"...
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Idelalisib promotes Bim-dependent apoptosis through AKT/FoxO3a in hepatocellular carcinoma

Idelalisib promotes Bim-dependent apoptosis through AKT/FoxO3a in hepatocellular carcinoma | Hepatitis C New Drugs Review | Scoop.it
Idelalisib, a selective PI3Kδ inhibitor, has been approved by the FDA for chronic lymphocytic leukemia/small lymphocytic lymphoma treatment and for follicular lymphoma treatment when combined with rituximab. However, the mechanisms of effective action of idelalisib in hepatocellular carcinoma (HCC) remain unclear. In the current study, we aimed to investigate how idelalisib inhibits the growth of HCC cells and enhances the effects of other chemotherapeutic drugs. Our results show that idelalisib treatment promotes Bim induction in HCC via the FoxO3a pathway following PI3K/AKT inactivation. Moreover, our results show that Bim is required for idelalisib-mediated apoptosis in HCC. Idelalisib also synergizes with sorafenib or doxorubicin to induce significant apoptosis in HCC, and Bim is also necessary for the induction of apoptosis by cotreatment. Furthermore, a xenograft experiment reveals that the Bim deficiency abolishes apoptosis and antitumor effects of idelalisib in vivo. In summary, our results indicate a key role of Bim in mediating the antitumor effects of idelalisib in HCC. Our results also support the clinical significance of the drug.
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Immune responses in DAA treated chronic hepatitis C patients with and without prior RG-101 dosing - ScienceDirect

Immune responses in DAA treated chronic hepatitis C patients with and without prior RG-101 dosing - ScienceDirect | Hepatitis C New Drugs Review | Scoop.it
Highlights

DAA treatment is highly effective in chronic hepatitis C patients with and without prior anti-miR-122 treatment.


Successful treatment of chronic hepatitis C patients results in reduction of broad immune activation.


There is no restoration of HCV adaptive immunity after SVR in chronic hepatitis C patients.


Plasma miR-122 levels normalise after successful treatment of chronic hepatitis C virus infection.
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Gilead to Develop Hepatitis B Therapies Using Precision's ARCUS Genome Editing Platform

Gilead to Develop Hepatitis B Therapies Using Precision's ARCUS Genome Editing Platform | Hepatitis C New Drugs Review | Scoop.it
Gilead Sciences will use Precision BioScience’s ARCUS genome editing platform to develop therapies targeting the in vivo elimination of hepatitis B virus (HBV), under a collaboration that could generate more than $445 million for Precision.
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Lymphocyte-Specific Protein-1 Controls Sorafenib Sensitivity and Hepatocellular Proliferation through Extracellular Signal-Regulated Kinase 1/2 Activation

Lymphocyte-Specific Protein-1 Controls Sorafenib Sensitivity and Hepatocellular Proliferation through Extracellular Signal-Regulated Kinase 1/2 Activation | Hepatitis C New Drugs Review | Scoop.it
The gene leukocyte-specific protein-1 (LSP1), encodes an F-actin binding protein that
directly interacts with the mitogen-activated protein kinase pathway. LSP1 has copy
number variations in 52% of human hepatocellular carcinoma (HCC).
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Inserm - Hepatitis C virus incidence in HIV-infected and in preexposure prophylaxis (PrEP)-using men having sex with men

Inserm - Hepatitis C virus incidence in HIV-infected and in preexposure prophylaxis (PrEP)-using men having sex with men | Hepatitis C New Drugs Review | Scoop.it
BACKGROUND & AIMS:
HCV incidence still appears on the rise in HIV-infected MSM in France. We assessed the incidence of HCV infection in HIV-positive and in preexposure prophylaxis (PrEP)-using MSM. METHODS: HIV-infected, HCV-negative MSM with serological follow-up in 2016 and HIV-negative,...
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Rapid hepatitis C virus clearance by antivirals correlates with immune status of infected patients - Sasaki - - Journal of Medical Virology - Wiley Online Library

Rapid hepatitis C virus clearance by antivirals correlates with immune status of infected patients - Sasaki - - Journal of Medical Virology - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
Abstract
Altered immune parameters associated with HCV genotype 1b infection and their correlation with virus eradication in DAA‐treated patients were examined. Thirty‐one HCV‐infected patients were treated with DAAs for 12 weeks. Pre‐ and post‐DAA‐treatment sera were analyzed for cytokines/chemokines using MILLIPLEX MAP. Serum complement level and antibody neutralization activity were measured separately. Sera from eleven spontaneously cleared HCV subjects were included for comparison. Rapid virological responders (RVR) or end‐of‐treatment responders (EOTR) were defined as patients with HCV RNA negative at week 4 or positive at week 4 and negative at week 12, respectively. HCV RNA eradication and a decrease in liver fibrosis‐related cytokines after treatment were observed when compared to pretreatment sera from RVR and EOTR. In pretreatment sera, IFNs and T‐helper 1 or 2 cell associated cytokines/chemokines were significantly higher among RVR as compared to EOTR. Furthermore, serum complement and virus neutralizing antibody levels were higher in pretreatment RVR sera. Eradication of HCV RNA by DAA decreased liver fibrosis related cytokines. Pretreatment sera from RVR displayed an enhanced cytokine/chemokine, complement and virus neutralizing antibody response as compared to EOTR sera. Our results suggested that enhanced host immune status may play an additive role on HCV RNA clearance by DAA.
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The changing epidemiology of liver diseases in the Asia–Pacific region

The changing epidemiology of liver diseases in the Asia–Pacific region | Hepatitis C New Drugs Review | Scoop.it
This Review presents current epidemiological trends of the most common liver diseases in Asia–Pacific countries. Hepatitis B virus (HBV) remains the primary cause of cirrhosis; despite declining prevalence in most Asian nations, this virus still poses a severe threat in some territories and regions. Mortality resulting from HBV infection is declining as a result of preventive measures and antiviral treatments. The epidemiological transition of hepatitis C virus (HCV) infection has varied in the region in the past few decades, but the medical burden of infection and the prevalence of its related cancers are increasing. The lack of licensed HCV vaccines highlights the need for novel treatment strategies. The prevalence of nonalcoholic fatty liver disease (NAFLD) has risen in the past decade, mostly owing to increasingly urbanized lifestyles and dietary changes. Alternative herbal medicine and dietary supplements are major causes of drug-induced liver injury (DILI) in some countries. Complications arising from these chronic liver diseases, including cirrhosis and liver cancer, are therefore emerging threats in the Asia–Pacific region. Key strategies to control these liver diseases include monitoring of at-risk populations, implementation of national guidelines and increasing public and physician awareness, in concert with improving access to health care.
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Spontaneous Viral Clearance in Sixteen HIV-Infected Patients with Chronic Hepatitis C - Abstract - Intervirology - Karger Publishers

Spontaneous Viral Clearance in Sixteen HIV-Infected Patients with Chronic Hepatitis C - Abstract - Intervirology - Karger Publishers | Hepatitis C New Drugs Review | Scoop.it
<b><i>Background/Aims:</i></b> Spontaneous viral clearance of the chronic hepatitis C virus (HCV) in human immunodeficiency virus (HIV)-infected patients is a rare event.We aimed to identify the clin...
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Prevalence of Sero-Molecular Markers of Hepatitis C and B Viruses among Patients with β-Thalassemia Major in Northern West Bank, Palestine

Prevalence of Sero-Molecular Markers of Hepatitis C and B Viruses among Patients with β-Thalassemia Major in Northern West Bank, Palestine | Hepatitis C New Drugs Review | Scoop.it
Canadian Journal of Infectious Diseases and Medical Microbiology is a peer-reviewed, Open Access journal that publishes original research articles, review articles, and clinical studies related to infectious diseases of bacterial, viral and parasitic origin.
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Inovio and Korean Partner Dose 1st Subject In Trial to Develop World’s First Vaccine to Prevent Hepatitis C Infection

Inovio and Korean Partner Dose 1st Subject In Trial to Develop World’s First Vaccine to Prevent Hepatitis C Infection | Hepatitis C New Drugs Review | Scoop.it
While new therapies have made hepatitis C a curable infection, no preventive vaccine has ever been approved PLYMOUTH MEETING, Pa., and SEOUL, Korea, Sept. 04, 2018 (GLOBE NEWSWIRE) - Inovio Pharmaceuticals, Inc.
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Global, regional, and country‐level estimates of hepatitis C infection among people who have recently injected drugs - Grebely - - Addiction - Wiley Online Library

Global, regional, and country‐level estimates of hepatitis C infection among people who have recently injected drugs - Grebely - - Addiction - Wiley Online Library | Hepatitis C New Drugs Review | Scoop.it
Background and Aims People who have recently injected drugs are a priority population in efforts to achieve hepatitis C virus (HCV) elimination. This study estimated the prevalence and number of people with recent injecting drug use living with HCV, and the proportion of people with recent injecting drug use among all people living with HCV infection at global, regional and country‐levels. Methods Data from a global systematic review of injecting drug use and HCV antibody prevalence among people with recent (previous year) injecting drug use were used to estimate the prevalence and number of people with recent injecting drug use living with HCV. These data were combined with a systematic review of global HCV prevalence to estimate the proportion of people with recent injecting drug use among all people living with HCV. Results There are an estimated 6.1 million [95% uncertainty interval (UI) = 3.4–9.2] people with recent injecting drug use aged 15–64 years living with HCV globally (39.2% viraemic prevalence; UI = 31.6–47.0), with the greatest numbers in East and Southeast Asia (1.5 million, UI = 1.0–2.1), eastern Europe (1.5 million, UI = 0.7–2.4) and North America (1.0 million, UI = 0.4–1.7). People with recent injecting drug use comprise an estimated 8.5% (UI = 4.6–13.1) of all HCV infections globally, with the greatest proportions in North America (30.5%, UI = 11.7–56.7), Latin America (22.0%, UI = 15.3–30.4) and eastern Europe (17.9%, UI = 8.2–30.9). Conclusions Although, globally, 39.2% of people with recent injecting drug use are living with hepatitis C virus (HCV) and 8.5% of all HCV infections occur globally among people with recent injecting drug use, there is wide variation among countries and regions.
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Viruses | Resistance Analysis of a 3-Day Monotherapy Study with Glecaprevir or Pibrentasvir in Patients with Chronic Hepatitis C Virus Genotype 1 Infection

Viruses | Resistance Analysis of a 3-Day Monotherapy Study with Glecaprevir or Pibrentasvir in Patients with Chronic Hepatitis C Virus Genotype 1 Infection | Hepatitis C New Drugs Review | Scoop.it
Glecaprevir (an NS3/4A protease inhibitor) and pibrentasvir (an NS5A inhibitor) are potent and pangenotypic hepatitis C virus (HCV) direct-acting antivirals. This report describes the baseline polymorphisms and treatment-emergent substitutions in NS3 or NS5A detected in samples from HCV genotype...
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Executive summary of the 2018 KDIGO Hepatitis C in CKD Guideline: welcoming advances in evaluation and management

Executive summary of the 2018 KDIGO Hepatitis C in CKD Guideline: welcoming advances in evaluation and management | Hepatitis C New Drugs Review | Scoop.it
Infection with the hepatitis C virus (HCV) has adverse liver, kidney, and cardiovascular
consequences in patients with chronic kidney disease (CKD), including those on dialysis
therapy and in those with a kidney transplant.
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Direct antiviral agents (DAAs) - A new age in the treatment of hepatitis C virus infection - ScienceDirect

Direct antiviral agents (DAAs) - A new age in the treatment of hepatitis C virus infection - ScienceDirect | Hepatitis C New Drugs Review | Scoop.it
Hepatitis C virus (HCV) is a global health problem, because infection frequently leads to chronic hepatitis C eventually progressing to liver cirrhosis and liver cancer. Improved insights into the HCV replication cycle and the role of HCV non-structural proteins have recently enabled to identify drugs directly acting on specific HCV target structures. Agents from three drug classes have been developed and approved by the health authorities. Combinations of two or more drugs from different classes achieve high (> 90%) HCV clearance rates and are well tolerated. This interferon-free DAA (direct antiviral agent) therapy has revolutionized antiviral therapy in hepatitis C so that successful hepatitis C treatment can be offered to virtually all patients irrespective of their co-morbidity. This review provides an overview over currently approved regimens and outlines their use in clinical practice. In addition potential short-comings of the current therapeutic options such as drug-drug interactions and selection of viral resistance are addressed. DAA combination therapy has the potential to obtain global control over hepatitis C. However, easy access to DAAs, availability of reliable HCV diagnostics, and affordable costs remain still important goals, which must be reached to globally eliminate hepatitis C.

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 Vital Therapies ELAD® Liver Treatment Fails Phase III trial in severe alcoholic hepatitis (sAH).

 Vital Therapies ELAD® Liver Treatment Fails Phase III trial in severe alcoholic hepatitis (sAH). | Hepatitis C New Drugs Review | Scoop.it

Vital Therapies has developed the ELAD® System, an investigational human hepatic cell-based therapy targeting the treatment of acute forms of liver failure. ELAD is designed to promote the recovery and regeneration of the patient’s failing liver, and potentially increase the rate of survival. ELAD incorporates approximately 440 grams, or one pound, of human liver-derived cells, or VTL C3A cells, from the Company’s proprietary cell bank, and is designed to be administered to patients during a single, continuous five-day session.

ELAD is currently being evaluated in a Phase 3 clinical trial, VTL-308 for the treatment of severe alcoholic hepatitis (sAH). 

 

Vital Therapies saw its shares crater 89% this morning after saying it has halted development of its lead candidate, Extracorporeal Liver Assist System (ELAD®) for acute forms of liver failure, which failed a pivotal trial, and will explore strategic options.

 

The announcement followed the extracorporeal human allogeneic cell therapy’s failure in a Phase III trial in patients with severe alcoholic hepatitis. ELAD failed the VTL-308 pivotal study (NCT02612428) by failing to achieve the study’s primary endpoint of a significant improvement in overall survival through at least 91 days assessed using the Kaplan Meier statistical method, Vital said.

The trial’s secondary endpoint of proportion of survivors at study day 91 also showed no statistically significant difference between the groups.

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Necroptosis microenvironment directs lineage commitment in liver cancer

Necroptosis microenvironment directs lineage commitment in liver cancer | Hepatitis C New Drugs Review | Scoop.it
Primary liver cancer represents a major health problem. It comprises hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), which differ markedly with regards to their morphology, metastatic potential and responses to therapy. However, the regulatory molecules and tissue context that commit transformed hepatic cells towards HCC or ICC are largely unknown. Here we show that the hepatic microenvironment epigenetically shapes lineage commitment in mosaic mouse models of liver tumorigenesis. Whereas a necroptosis-associated hepatic cytokine microenvironment determines ICC outgrowth from oncogenically transformed hepatocytes, hepatocytes containing identical oncogenic drivers give rise to HCC if they are surrounded by apoptotic hepatocytes. Epigenome and transcriptome profiling of mouse HCC and ICC singled out Tbx3 and Prdm5 as major microenvironment-dependent and epigenetically regulated lineage-commitment factors, a function that is conserved in humans. Together, our results provide insight into lineage commitment in liver tumorigenesis, and explain molecularly why common liver-damaging risk factors can lead to either HCC or ICC.
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Hepatitis C virus reactivation in patients receiving cancer treatment: A prospective observational study. - F1000Prime

Hepatitis C virus reactivation in patients receiving cancer treatment: A prospective observational study. - F1000Prime | Hepatitis C New Drugs Review | Scoop.it
F1000Prime Recommended Article: Hepatitis C virus reactivation in patients receiving cancer treatment: A prospective observational study.
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Patent monopoly on oral hepatitis C drug: Threat to patients and health systems in Europe

Patent monopoly on oral hepatitis C drug: Threat to patients and health systems in Europe | Hepatitis C New Drugs Review | Scoop.it
ONLINE PRESS BRIEFING Tuesday 11 September 2018, 14:30-16:00 CEST...
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In drug-induced, immune-mediated hepatitis, interleukin-33 reduces hepatitis and improves survival independently and as a consequence of FoxP3+ T-cell activity

In drug-induced, immune-mediated hepatitis, interleukin-33 reduces hepatitis and improves survival independently and as a consequence of FoxP3+ T-cell activity | Hepatitis C New Drugs Review | Scoop.it
Immune-mediated, drug-induced hepatitis is a rare complication of halogenated volatile anesthetic administration. IL-4-regulated Th2-polarized reactions initiate this type and other types of hepatitis, while the mechanisms that regulate the severity remain elusive. IL-33 is an innate, IL-4-inducing, Th2-polarizing cytokine that has been detected in patients with liver failure and has been associated with upregulated ST2+Foxp3+CD4+CD25+ T cells; however, roles for IL-33 in drug-induced hepatitis are unclear. We investigated IL-33 in an anesthetic, immune-mediated hepatitis modeled in BALB/c, IL-33−/− and ST2−/− mice, as well as in patients with anesthetic hepatitis. The hepatic IL-33 and ST2 levels were elevated in BALB/c mice (p < 0.05) with hepatitis, and anti-IL-33 diminished hepatitis (p < 0.05) without reducing IL-33 levels. The complete absence of IL-33 reduced IL-10 (p < 0.05) and ST2+Foxp3+CD4+CD25+ T cells (p < 0.05), as well as reduced the overall survival (p < 0.05), suggesting suppressive roles for IL-33 in anesthetic, immune-mediated hepatitis. All of the mice demonstrated similar levels of CD4+ T-cell proliferation following direct T-cell receptor stimulation, but we detected splenic IL-33 and ST2-negative Foxp3+CD4+CD25+ T cells in ST2−/− mice that developed less hepatitis than BALB/c mice (p < 0.05), suggesting that ST2-negative Foxp3+CD4+CD25+ T cells reduced hepatitis. In patients, serum IL-33 and IPEX levels were correlated in controls (r2 = 0.5, p < 0.05), similar to the levels in mice, but not in anesthetic hepatitis patients (r2 = 0.01), who had elevated IL-33 (p < 0.001) and decreased IPEX (p < 0.01). Our results suggest that, in anesthetic, immune-mediated hepatitis, IL-33 does not regulate the CD4+ T-cell proliferation that initiates hepatitis, but IL-33, likely independent of ST2, reduces hepatitis via upregulation of Foxp3+CD4+CD25+ T cells. Further studies are needed to translate the role of IL-33 to human liver disease.
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Bile Acids, the Microbiome, Immunity, and Liver Tumors | NEJM

Bile Acids, the Microbiome, Immunity, and Liver Tumors | NEJM | Hepatitis C New Drugs Review | Scoop.it
Clinical Implications of Basic Research from The New England Journal of Medicine — Bile Acids, the Microbiome, Immunity, and Liver Tumors

 

Bile acids affect the expression of a chemokine ligand by liver sinusoidal endothelial cells, which in turn affects the extent to which a type of natural killer cell is present in and diminishes the burden of hepatocellular carcinomas in a mouse model of the disease.

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Persistent replication of HIV, HCV and HBV results in distinct gene expression profiles by human NK cells

Persistent replication of HIV, HCV and HBV results in distinct gene expression profiles by human NK cells | Hepatitis C New Drugs Review | Scoop.it
NK cells during chronic viral infection have been well studied in the past. We performed an unbiased next-generation RNA-sequencing approach to identify commonalities or differences of the effect of HIV, HCV and HBV viremia on NK cell transcriptomes.
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Transplanting Kidneys From HCV-Infected Donors Into Uninfected Recipients | Annals of Internal Medicine | American College of Physicians

Transplanting Kidneys From HCV-Infected Donors Into Uninfected Recipients | Annals of Internal Medicine | American College of Physicians | Hepatitis C New Drugs Review | Scoop.it
Reese and colleagues provided evidence for the benefits of transplanting HCV–positive kidneys into HCV-negative recipients in the current era of direct-acting antiviral agents. The editorialist discusses the promise these results present for improving outcomes for patients requiring kidney...
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Long-Term Outcomes of Patients With HCV-Associated Cryoglobulinemic Vasculitis After Virologic Cure – Newsemia

Long-Term Outcomes of Patients With HCV-Associated Cryoglobulinemic Vasculitis After Virologic Cure – Newsemia | Hepatitis C New Drugs Review | Scoop.it

Patients with hepatitis C virus–associated cryoglobulinemic vasculitis (HCV-CV) have high rates of clinical remission after treatment with direct-acting antivirals (DAAs), but circulating cryoglobulins persist, and vascular disorders reappear in some patients shortly after DAA treatment ends. We performed a prospective study to assess the long-term clinical and immune system effects of HCV eradication with DAAs in 46 patients with HCV-CV and 42 asymptomatic patients with circulating cryoglobulins.

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Pharmacokinetics, Safety, and Tolerability of the Direct-Acting Hepatitis C Antiviral Sofosbuvir in Healthy Chinese Subjects

Pharmacokinetics, Safety, and Tolerability of the Direct-Acting Hepatitis C Antiviral Sofosbuvir in Healthy Chinese Subjects | Hepatitis C New Drugs Review | Scoop.it
The purpose of this study was to investigate the safety, tolerability, and pharmacokinetic
profile of sofosbuvir and its metabolites after a single dose of sofosbuvir 400 mg
and once daily dosing of sofosbuvir 400 mg for 7 days in healthy Chinese subjects.
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Hepatitis B & C Partnerships - Bristol-Myers Squibb

Hepatitis B & C Partnerships - Bristol-Myers Squibb | Hepatitis C New Drugs Review | Scoop.it
The Bristol-Myers Squibb Foundation works with several global partners to help communities all over the world focusing on Hepatitis B and C.
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