News

SAR 302503 (Sanofi) successs in JAKARTA study of Myelofibrosis

Sanofi has announced that the pivotal study, JAKARTA, examining the selective JAK2 inhibitor SAR 302503 for Myelofibrosis versus placebo in 289 patients, met its primary endpoint in both dose groups. The primary endpoint assessed the proportion of patients achieving >35% reduction of spleen volume. Consistent with data reported in previous trials, the most common adverse events were anemia, diarrhea, ...

FDA Advisory Committee rejects Melblez Kit (Delcath) for Ocular melanioma metastatic to the Liver

Delcath Systems, Inc. announced that the FDA Oncologic Drugs Advisory Committee (ODAC) voted 16 to 0 with no abstentions that benefits of treatment with Delcath's Melblez Kit (Melblez (melphalan) for Injection for use with the Delcath Hepatic Delivery System) for the treatment of patients with unresectable Ocular melanoma metastatic to the Liver do not outweigh the risks associated with ...

NICE confirms rejection of Jakavi(Novartis) for Myelofibrosis

NICE has confirmed that it will not recommend Jakavi(ruxolitinib) from Novartis after it found problems with its data and the costing model. NICE has published final draft guidance not recommending Jakavi for the treatment of disease-related splenomegaly (enlarged spleen) or its symptoms in adults with primary Myelofibrosis, or post polycythaemia vera Myelofibrosis or post essential thrombocythaemia Myelofibrosis.

Novartis ...

Phase II data shows ABT 450/r, ABT 267, ABT 333 (Abbvie) successful in patients with Hepatitis C

New data from AbbVie's Phase IIb Aviator trial of ABT 450/r (protease inhibitor and ritonavir), ABT 267 (NS5A inhibitor) and ABT 333 (non-nucleoside polymerase inhibitor) for the treatment of Hepatitis C virus (HCV) infection demonstrates sustained viral response rates across multiple patient types with HCV Genotype 1. Data shows that 96 percent of treatment-naive patients and 93 percent of prior ...

Phase III trial of BI 201335 (Boehringer) succesful for Hepatitis C patients

Results from the pivotal Phase III STARTVerso1 trial of BI 201335 (faldaprevir), from Boehringer, in combination with pegylated interferon and ribavirin (PegIFN/RBV) show that untreated patients with genotype-1 Hepatitis C virus (HCV) who received once-daily faldaprevir plus PegIFN/RBV, 79% and 80% in the 120mg and 240mg arms, respectively, achieved viral cure 12 weeks after treatment was completed (SVR12). This is ...

FDA approves FibroScan Elastography Imaging system(Echosens) for non-invasive liver disease diagnosis

The FibroScan device from Echosens has received 510(k) clearance from the FDA for use in non-invasive liver disease diagnosis. Based on a technology called Transient Elastography, FibroScan assesses liver shear wave speed and equivalent stiffness in a rapid, simple, non-invasive and totally painless way. Initially introduced in the European market in 2003, it has received market clearances in China, Canada, ...

Miravirsen (Santaris Pharma) Phase II trial for Hepatitis C is reported in NEJM

Santaris Pharma A/S, has announced the publication of study results online in the New England Journal of Medicine (NEJM). The publication highlights the potential benefits of miravirsen, a host-targeted, pan-HCV genotype anti-viral agent and the first microRNA-targeted drug to enter clinical trials for the treatment of Hepatitis C virus (HCV). In the study, miravirsen, given as a four-week monotherapy ...

Janssen R&D files TMC 435 to the FDA for Hepatitis C

Janssen R&D has submitted a New Drug Application (NDA) to the FDA seeking approval for TMC 435 (simeprevir) 150mg capsule with pegylated interferon and ribavirin for the treatment of genotype 1 chronic Hepatitis C in adult patients. The submission is supported in part by data from three pivotal Phase III studies: QUEST-1 and QUEST-2 in treatment-naïve patients and PROMISE in ...

CHMP rejects Defitelio (Gentium/SOBI)for Hepatic Veno- Occlusive disease

On 21 March 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Defitelio (defibrotide) from Gentium/Swedish Orphan Biovitrium)intended for the treatment and prevention of Hepatic Veno-Occlusive disease in blood stem cell transplantation therapy. The drug was withdrawn from the FDA in August 2011.

Pegasys (Roche) European indication expanded by EMA in Hepatitis C to include to children

Roche has announced that the European Medicines Agency (EMA) has expanded the approval of Pegasys (peginterferon alfa-2a) plus ribavirin for the treatment of chronic Hepatitis C virus (HCV). The new label includes children and adolescents five years of age and older, who have not received treatment and who have tested positive for the virus. Pegasys in combination with the antiviral ...

Positive results from Phase III trial of BI 201335 (Boehringer) for Hepatitis C patients

Interim results from HCVerso, a trial of BI-201335 (faldaprevir), from Boehringer, for Hepatitis C (HCV) showed that 80% of HCV/HIV co-infected patients achieved early treatment success (ETS), as defined by the study protocol. Results were consistent across patients regardless of HIV therapy or prior HCV treatment status, including patients who were HCV treatment-naive or had previously relapsed during HCV treatment ...

Gentium unlikely to get CHMP recommendation for defibrotide use in Hepatic Veno-Occlusive disease

Gentium S.p.A. had presented an oral explanation at the EMA Committee for Medicinal Products for Human Use ("CHMP") as part of its Marketing Authorization Application for Defibrotide to treat and prevent Hepatic Veno-Occlusive disease in adults and children undergoing hematopoietic stem cell transplantation therapy. Following the oral explanation,based on preliminary feedback from the CHMP,the Company expects an opinion recommending ...

FDA approves Zortress (Novartis)for prophylaxis of organ rejection in Liver Transplant patients

Novartis announced that the FDA has, on 15 February 2013 ,approved Zortress (everolimus) for the prophylaxis of organ rejection in adult patients receiving a Liver Transplant.

Zortress is the first mammalian target of rapamycin (mTOR) inhibitor approved for use following Liver Transplantation. It is also the first immunosuppressant approved by the FDA in over a decade for use following ...

NICE does not recommend Jakavi (Novartis) for Myelofibrosis

NICE (National Institute for Health and Clinical Excellence) in its draft guidance stated that it is not recommending Jakavi (ruxolitinib) from Novartis, for the treatment of disease-related splenomegaly (enlarged spleen) or symptoms in adults with primary Myelofibrosis, or Myelofibrosis secondary to polycythaemia vera or essential Thrombocythaemia.

NICE stated that although the drug might offer a survival benefit, ...

FISSION and Neutrino studies success for GS 7977 (Gilead Sciences) for Hepatitis C

Gilead Sciences has announced topline results from two Phase III studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide sofosbuvir in combination with ribavirin (FISSION) and in combination with ribavirin and pegylated interferon (NEUTRINO) among treatment-naïve patients with chronic Hepatitis C virus (HCV) infection.

In the FISSION study, patients with genotype 2 or 3 HCV ...

ThermoDox (Celsion) fails Phase III trial for Liver Cancer

Celsion Corporation has announced that ThermoDox in combination with radiofrequency ablation (RFA) did not meet the primary endpoint of the Phase III HEAT Study in patients with Hepatocellular Carcinoma (HCC), also known as Primary Liver Cancer. Specifically, Celsion has determined, after conferring with its independent Data Monitoring Committee (DMC) that the HEAT Study did not meet the goal of demonstrating ...

CHMP recommends Pegasys(Roche) for paediatric use in Hepatitis C

The CHMP recommends Pegasys (peginterferon alfa-2a) from Roche, in combination with ribavirin, be indicated for the treatment of chronic Hepatitis C in treatment-naïve children and adolescents five years of age and older, who are positive for serum hepatitis-C-virus (HCV) RNA. When deciding to initiate treatment in childhood, it is important to consider growth inhibition induced by combination therapy. The ...

Preliminary results from Phase IIb study of BI 201335 and BI 207127 (Boehringer) show positive response in Hepatitis C patients

New preliminary results from the SOUND-C3 trial, Boehringer Ingelheim's investigational Interferon-free regimen which combines BI 201335 (faldaprevir) and BI 207127, show that 100 percent (n=20) of patients with Hepatitis C GT-1b achieved sustained virologic response four weeks (SVR4) after completing a 16 week course of treatment. Two patients experienced serious adverse events and two patients discontinued treatment early due to ...

FDA approves acetylcysteine injection (APP Pharma) generic version of Acetadote

The FDA has given approval for the Abbreviated New Drug Application (ANDA) for acetylcysteine injection, from APP Pharma, indicated to prevent or lessen hepatic injury following an acetaminophen overdose. Acetylcysteine injection will be available as a 20% solution (200mg/mL) in 30mL single-dose glass vials. Acetylcysteine injection is sterile and can be used for I.V. administration. This provides the first generic ...

EU Commission approves Exjade (Novartis) for treatment of Iron Overload with Thalassemia Syndromes

Novartis announced that the European Commission has approved Exjade (deferasirox) for the treatment of chronic iron overload requiring chelation therapy when deferoxamine therapy is contraindicated or inadequate in patients aged 10 years and older with non-transfusion-dependent thalassemia (NTDT) syndromes. Exjade is the first oral treatment approved in the European Union (EU) specifically indicated for the treatment of chronic iron ...

Phase III trials of TMC 435 (Medivir/Tibotec) show positive response in patients with Hepatitis C

Top-line results from three pivotal Phase III trials examining TMC 435 (simeprevir, from Medivir/Tibotec, administered with pegylated interferon and ribavirin found that 80% and 81% of treatment-naive patients with chronic genotype 1 Hepatitis C infection who were treated with simeprevir achieved sustained virologic response 12 weeks after the planned end of treatment (SVR12). These results were from QUEST-1 and QUEST-2 ...

Phase III trial of GS 7977 plus RBV (Gilead Sciences) shows positive results in patients with Hepatitis C

Gilead Sciences has announced topline results from the Phase III POSITRON study of GS 7977 (sofosbuvir) plus ribavirin (RBV) in patients with genotype 2 or 3 chronic Hepatitis C who are not candidates to take interferon (IFN). The study found that 78 percent of patients (n=161/207) remained HCV RNA undetectable 12 weeks after completing therapy (SVR12). SVR12 rates were 93 ...

Lambda plus daclatasvir (BMS) combination success in Phase IIb trial for Hepatitis C

BMS has announced for the first time interim results from the global, D-LITE Phase IIb study, in which a 24-week regimen combining the investigational compound Peginterferon lambda-1a (Lambda) with the investigational direct-acting antiviral (DAA) daclatasvir (DCV) and ribavirin (RBV), achieved sustained virologic response 12 weeks post-treatment (SVR12) in 93% (13/14) of treatment-naïve, genotype 1b chronic Hepatitis C patients who achieved ...

IDX 184 and IDX 719 safety data presented by Indenix.

Idenix has announced the presentation of safety and antiviral activity results for the Company's clinical-stage Hepatitis C virus (HCV) drug candidates — IDX 719, a next-generation pan-genotypic NS5A inhibitor, and IDX 184, a nucleotide polymerase inhibitor. Idenix presented updated clinical findings from a three-day proof-of-concept study, which demonstrated that IDX 719 was well-tolerated at daily doses up to 100 ...

Two year results of Certican (Novartis ) in Liver Transplant rejection confirm superiority over tacrolimus

Novartis announced new two-year results from the largest Phase III study ever in Liver Transplantation that confirmed comparable efficacy to control and superior renal function results previously seen at 12 months. The trial evaluated the introduction of Certican (everolimus) with reduced exposure tacrolimus administered twice-daily starting one month after liver transplantation versus standard-exposure tacrolimus.

At 24 months, the incidence ...

Positive topline results from study of ABT 450/r, ABT 267, ABT 333 (Abbott) for Hepatitis C

Abbott announced topline results from AVIATOR, a phase IIb study of its ABT 450/r and ABT 267 and ABT 333 regimen for the treatment of Hepatitis C (HCV). The treatment demonstrated high sustained viral response rates at 12 weeks post-treatment (SVR12) in all 8- and 12-week arms, with combinations of direct acting antivirals (DAAs) given with and without ribavirin (RBV). ...

FDA award orphan status to A 4250 (Albireo) for Primary Biliary Cirrhosis and PFIC

The FDA has awarded A 4250, from Albireo, orphan-drug designation for the treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)and Primary Biliary Cirrhosis (PBC). Orphan designation was granted based on an extensive preclinical data package showing that A4250 has a high potency and a minimal systemic exposure. In addition, substantial benefits were shown in an animal model of cholestasis; the predominant ...

ABT 450/r , ABT 267, ABT 333 combination in Hepatitis C

Abbott has announced initial results from "AVIATOR," a phase IIb study of its interferon-free, investigational regimen for the treatment of Hepatitis C (HCV). Initial results show sustained virological response at 12 weeks post treatment (SVR12) in 99 percent of treatment-naïve (n=77) and 93 percent of null responders (n=41) for genotype 1 (GT1) HCV patients taking a combination of ABT-450/r, ...

Astellas submits NDA for Advagraf for prophylaxis of Organ Rejection

Astellas Pharma US has submitted a New Drug Application (NDA) to the FDA seeking approval for Advagraf (tacrolimus extended release capsules) for the prophylaxis of Organ Rejection in adult kidney transplant recipients and adult male liver transplant recipients. The NDA submission is based on six randomized and comparative studies of 2,842 (1,689 tacrolimus extended release) kidney transplant recipients and 689 ...

Phase II success for resminostat (4SC) in Liver Cancer

4SC AG announced the publication of convincing overall survival data from a Phase II study with its lead anti-cancer drug resminostat applied as a novel combination therapy approach with sorafenib in second-line advanced Liver Cancer at the 2012 annual meeting of the International Liver Cancer Association in Berlin, Germany, on 16 September 2012.

The international, open-label, two-arm SHELTER ...

IQWiG finds Incivek/Incivo (J&J Janssen Cilag) offers some advantages for Hepatitis C patients

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined whether Incivek/Incivo (telaprevir), from J&J Janssen Cilag, offers an added benefit for patients with Hepatitis C compared to conventional therapy. The assessment finds that the drug offers advantages in various groups of patients with chronic Hepatitis C infection of genotype 1. The available studies provide proof, indications ...

Development of BMS 986094 (BMS/Inhibitex) for Hepatitis C halted

BMS/Inhibitex have discontinued development of BMS 986094, for Hepatitis C, following the death of a participant in a Phase II trial. A spokesperson stated that the decision "was made in the interest of patient safety, based on a rapid, thorough and ongoing assessment of patients". The trial was voluntarily suspended on 1 August 2012. The company states that while "the ...

EMA accepts filing for Heplisav (Dynavax Technologies), a vaccine for Hepatitis B.

The EMA has accepted the filing of the Marketing Authorization Application for Heplisav vaccine, from Dynavax Technologies, pursuing an indication for immunization against infection caused by all known subtypes of Hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease. Acceptance of the MAA confirms that the submission is sufficiently complete to ...

IDX 184 (Idenix)trial for Hepatitis C halted by FDA for suspected cardiotoxicity

IDX 184 is a drug from Idenix Pharmaceuticals for treatment of Hepatitis C. The development of the drug has been placed on partial hold by the FDA as the drug may be linked to serious cardiac related adverse events. Idenix maintains that no evidence of cardiotoxicity has been found in its trials but will perform cardiac tests on its 67 ...

EMA award orphan status to A 4250 (Albireo) for the treatment of Primary Biliary Cirrhosis

The European Medicines Agency Committee for Orphan Medicinal Products (COMP) has issued a positive opinion on an application for orphan medicinal product status for A 4250, from Albireo, for the treatment of Primary Biliary Cirrhosis (PBC), Progressive Familial Intrahepatic Cholestasis (PFIC) and Alagille Syndrome. A 4250 belongs to a class of inhibitors of the ileal bile acid transporter (IBAT, syn. ...

No benefit of Tarceva (Genentech/Roche) for patients with Liver Cancer

A Phase III trial evaluating the efficacy and safety of the addition of Tarceva (erlotinib), from Genentech/Roche, to sorafenib did not improve overall survival for patients with unresectable Liver Cancer vs. sorafenib alone. The international SEARCH trial randomised 720 patients with advanced Liver Cancer and examined whether the addition of Tarceva to sorafenib prolongs survival as compared to sorafenib alone ...

Brivanib (BMS) fails Phase III trial for Hepatocellular Carcinoma

Bristol Myers Squibb (BMS) announced the results of the phase III BRISK-FL clinical trial of the investigational agent brivanib versus sorafenib as first-line treatment in patients with advanced Hepatocellular Carcinoma (liver cancer). The study did not meet its primary overall survival objective based upon a non-inferiority statistical design. BMS is considering options for the ongoing brivanib development program. Ongoing clinical ...

FDA accepts filing of Hepislav ( Dynavax Technologies) vaccine for Hepatitis B

The FDA has accepted for review the biologics license application (BLA) for the Hepatitis B vaccine, Heplisav, from Dynavax Technologies. Hepislav is an immunostimulatory sequence targeting toll-like receptor 9 (TLR9) combined with hepatitis B surface antigen. The FDA set 24 February 2013 as the Prescription Drug User Fee Act action date for Heplisav. The attraction of Hepislav is an easier ...

New drug application filed with FDA for TMC 207 (Janssen Pharmaceuticals) for multi-drug resistant Tuberculosis

Janssen Pharmaceuticals has submitted a New Drug Application to the FDA seeking accelerated approval for the use of TMC 207 (bedaquiline) to be used as part of combination therapy for pulmonary, multi-drug resistant Tuberculosis (MDR-TB) in adults. If approved, it would be the first drug with a new mechanism of action for TB in more than 40 years and the ...

IDX 184 (Idenix) in Phase II for Hepatitis C

Idenix Pharmaceuticals has reported positive data from both an interim analysis of a Phase II study of its drug candidate for Hepatitis C virus , IDX184. The company plans to begin a combination study of the IDX 184 and IDX 719, which has just completed a proof of concept study, by the end of the year....

Tivantinib (Daiichi Sankyo.) in Phase II study of Hepatocellular Carcinoma

ArQule, Inc and Daiichi Sankyo Co., have announced at ASCO 2012 (abstract number 4006)- final results from a randomized, placebo-controlled, double-blind, phase II clinical trial with the selective MET inhibitor tivantinib as a single-agent, investigational, second-line treatment in Hepatocellular Carcinoma (HCC). The 107 patients in the trial had unresectable HCC and had disease progression after first-line therapy or were unable ...

Lucassin (Ikaria) is approved for Hepatorenal Syndrome in Australia

Australian regulators have approved Lucassin (terlipressin) from Ikaria Australia for the treatment of Hepatorenal Syndrome type 1 (HRS 1) in patients who are actively being considered for a liver transplant, making it the first approved treatment for HRS 1. The product is already approved in France, Ireland, Spain and South Korea for this indication. In the US and Canada it ...

New Europe-focused Phase III Trial of TheraSphere (Nordion) for Liver Cancer

A new Phase III clinical trial for TheraSphere, a yttrium-90 (Y-90) glass microsphere treatment for Liver Cancer, from Nordion, will be focused primarily in Europe, with additional locations to be identified globally. This therapy consists of millions of microscopic, radioactive glass microspheres (20–30 micrometres in diameter) that are infused into the arteries that feed liver tumors. These microspheres then embolize, ...

FDA halts alisporivir (Novartis) Phase III trial

The FDA has placed a clinical hold on a Phase III trial testing alisporivir (DEB025), from Novartis/Debiopharm, plus pegylated interferon and ribavirin in treatment naive genotype 1 patients with Hepatitis C, after a study participant died potentially of pancreatitis.The death was the first and only fatality in the overall alisporivir clinical study programme involving about 1,800 patients. Results of an ...

EMERGE study of Lambda (BMS) in Hepatitis C genotypes 2 and 3 presented at EASL

EMERGE study findings of Peg-interferon lambda-1a (Lambda) from BMS in Hepatitis C genotype 2 and 3 patients were presented in an oral session at the International Liver Congress ,the 47th annual meeting of the European Association for the Study of the Liver in Barcelona. The Phase IIb EMERGE clinical trial involved 118 treatment-naïve patients chronically infected with genotype 2 or ...

Phase IIa results for Miravirsen (Santaris Pharma) show prolonged antiviral activity in Hepatitis C patients

Data from a Phase IIa trial shows that Miravirsen (SPC3649), from Santaris Pharma, given as a four-week monotherapy treatment for Hepatitis C provided robust dose-dependent anti-viral activity with a mean reduction of 2 to 3 logs from baseline in HCV RNA (log10 IU/mL) that was sustained well beyond the end of therapy. The data showed the drug was safe, well ...

Phase IIb data show SVR12 in Hepatitis C patients treated with BI 201335 (Boehringer Ingelheim)

A sub-analysis from SOUND-C2, a Phase IIb study in patients with Hepatitis C evaluating interferon-free treatment with investigational antiviral compounds BI 201335 and BI 207127, from Boehringer Ingelheim, plus ribavirin (RBV), show that up to 43 percent of genotype-1a (GT1a) and up to 71 percent of GT1b Hepatitis C virus (HCV) patients achieved sustained viral response (SVR12). SVR12 has been ...

ABT-450.r plus ABT 333 Phase II studies in Hepatitis C announced by Abbott Labs

Abbott Labs will present clinical trial results from two different interferon-free, Phase II studies for the treatment of Hepatitis C (HCV) at the International Liver Congress(TM) 2012 (ILC 2012), the annual meeting of the European Association for the Study of the Liver (EASL), April 18-22 in Barcelona, Spain. Abstracts for the meeting were published online today. In the study known ...

NICE recommends Incivo (J&J Janssen Cilag) for genotype 1 chronic Hepatitis C patients

NICE has issued final draft guidance recommending Incivo (telaprevir), from J&J Janssen Cilag, in combination with Peg alfa and ribavirin, as an option for the treatment of in adults with compensated Liver Disease. It recommends the drug as an option for the treatment of such patients who are previously untreated or in whom previous treatment with Peg alfa and ribavirin ...

FDA approves first generic Lexapro for Depression and Anxiety Disorder

The FDA has approved the first generic version of Lexapro (escitalopram tablets) to treat Depression and generalised Anxiety Disorder in adults. The generic is produced by Teva Pharmaceutical Industries/IVAX Pharmaceuticals who will be marketing generic escitalopram in 5 milligram, 10 mg, and 20 mg strengths. Teva has been granted a 180-day period of generic drug exclusivity, which means that FDA ...

TMC 435 (Medivir) begins two new Phase III trials for Hepatitis C

Patient dosing and screening has begun in two new Phase III clinical trials testing TMC 435, from Medivir/Tibotec, in Hepatitis C infected patients. Trial HPC3001 is an efficacy, safety and tolerability study comparing TMC 435 against telaprevir, each in combination with Pegylated Interferon alpha-2a (PegINF) and ribavirin (RBV), in 744 Hepatitis C genotype-1 infected patients. Patients will receive TMC 435 ...

TMC 435 (Medivir) begins two new Phase III trials for Hepatitis C

Patient dosing and screening has begun in two new Phase III clinical trials testing TMC 435, from Medivir/Tibotec, in Hepatitis C infected patients. Trial HPC3001 is an efficacy, safety and tolerability study comparing TMC435 against telaprevir, each in combination with Pegylated Interferon alpha-2a (PegINF) and ribavirin (RBV), in 744 Hepatitis C genotype-1 infected patients. Patients will receive TMC435 150 mg ...

Daclatasvir plus asunaprevir(BMS) in Phase II Hepatitis C trial

cThe full results were published in the New England Journal of Medicine, from a Phase II clinical trial in patients with Hepatitis C virus (HCV) genotype 1 who had not responded to prior therapy with PEG-interferon alfa and ribavirin (‘null responders’1). The study demonstrated that its primary endpoint of the achievement of sustained virologic response 12-weeks post-treatment (SVR12) is possible ...

BI-201335 (Boehringer Ingelheim) Phase III trial completes recruitment

Boehringer Ingelheim has completed recruitment for a late-stage Phase III clinical trial programme for BI-201335, its oral protease inhibitor for the treatment of chronic Hepatitis C virus. The programme, which was awarded a Fast Track designation by the FDA, consists of three studies that will be conducted to evaluate BI-201335 plus the standard treatment, pegylated interferon (pegIFN) and ribavirin (RBV) ...

Patients with Chronic Hepatitis C may benefit from Victrelis (Merck) but extent unclear

Some patients with Chronic Hepatitis C may benefit from Victrelis (boceprevir), from Merck, though the extent of added benefit is still unclear. The information comes from an early benefit assessment by the German Institute for Quality and Efficiency in Health Care (IQWiG). With the available studies on patients without cirrhosis, it is not possible to assess directly whether the combination ...

Daclatasvir (BMS) and TME 435(Tibotec) combination for Phase II for Hepatitis C

BMS will collaborate with Tibotec, a Johnson & Johnson company, to investigate the combination of oral drug daclatasvir, a NS5A replication complex inhibitor, plus TMC435 a once a day oral NS 3/4a protease inhibitor for the treatment of chronic Hepatitis C genotype 1. The combination will enter a Phase II study early next year to investigate the potential for sustained ...

FDA approves Anti-HBc IgM Assay (Roche) for Hepatitis B testing

The FDA has granted Premarket Approval for the Anti-HBc IgM Assay (IgM antibody to Hepatitis B core antigen Assay), from Roche, for use on its cobas e 601 analyzer, the immunoassay module of the cobas 6000 analyzer series, as a test for Hepatitis B. The test represents the final component of the acute panel within the Hepatitis test menu for ...

Vertex Pharma starts Phase IIIb trial in genoytpe 1 Hepatitis C patients who have 'CC' variation near the IL28B gene

Vertex Pharmaceuticals will initiate a Phase IIIb study called CONCISE that will evaluate the potential for treatment with Incivek (telaprevir) combination therapy to be shortened to 12 weeks in people with genotype 1 chronic hepatitis C who have the ‘CC' variation near the IL28B gene. Incivek is administered in combination with pegylated-interferon and ribavirin. Approximately one-third of people with hepatitis ...

Decalth PHP brings benefits to patients with Liver Cancer

Results from a Phase III study of Decalth PHP System (melphalan), from Decalth Systems, have demonstrated that the treatment significantly extends the time patients with melanoma of the eye (ocular or uveal melanoma), which has spread to the liver, can live without the disease progressing. Data presented at the 2011 European Multidisciplinary Cancer Congress showed that the length of time ...

Incivo will launch in Germany first for Hepatitis C

Virco-Virology, a Janssen Pharmaceutical subsidiary, will launch Incivo (telaprevir), the treatment for hepatitis C virus in Germany within a next week or so The European Commission gave approval on 20 September 2011....

Incivek treatment still effective when course is half as long in treatment of Hepatitis C genotype 1

A Phase III study (ADVANCE) of Incivek (telaprevir) tablets in patients with genotype 1 chronic Hepatitis C published in The New England Journal of Medicine (NEJM) reveals that a 24-week treatment course that adds Incivek to peginterferon alfa and ribavirin is just as effective as a 48-week regimen for many patients. Shortening the duration of treatment reduces a patient's exposure ...

IlLLUMINATE trial of Incivek is published in NEJM

The New England Journal of Medicine (NEJM) published data from a Phase III study of Incivek(telaprevir) tablets in people with genotype 1 chronic Hepatitis C who were new to treatment. In ILLUMINATE, Incivek was given for the first 12 weeks in combination with pegylated-interferon and ribavirin. Nearly two-thirds of patients responded early to Incivek combination treatment (measured by having undetectable ...

Selumetinib success in Phase II Biliary Cancer trial

Selumetinib, from AstraZeneca, has shown promising results in people with advanced Biliary Cancer, according to a multi-institutional clinical trial led by cancer researchers at The Ohio State University.

Selumetinib, also known as AZD 6244 (ARRY-142886), blocks a protein called MEK, which cancer cells need to proliferate and survive.- see Multi-Institutional Phase II Study of Selumetinib in Patients With Metastatic ...

BI 201335 enters Phase III for Hepatitis C

Boehringer Ingelheim announced that enrollment has commenced at North American sites in its pivotal Phase III clinical trial program for BI 201335, the Company's investigational, oral protease inhibitor for the treatment of chronic hepatitis C virus (HCV). Phase III trials have begun recruiting to evaluate BI 201335 plus standard-of-care (SOC) in both treatment-naive and -experienced patients with chronic genotype-1 HCV, ...

Phase II data for BI 201335 for Hepatitis C

New data presented EASL (European Association for Study of the Liver) in Berlin, highlighted the efficacy of Boehringer Ingelheim's once-daily oral protease inhibitor BI 201335, in both treatment-naive and -experienced patients with chronic genotype-1 hepatitis C virus (HCV) infection. Genotype-1 HCV is the most challenging genotype of HCV to treat. Results from SILEN-C1 trial show high rates of sustained viral ...

Phase II b EMERGE study of PEG-interferon lambda in Hepatitis C

The results from the Phase IIb EMERGE clinical trial conducted by BMS showed treatment with the investigational compound PEG-Interferon lambda and ribavirin achieved higher rates of rapid virologic response (RVR) in genotypes 1, 2, 3, and 4, and complete early virologic response (cEVR) in genotypes 1 and 4 than the standard regimen of PEG-Interferon alfa and ribavirin in treatment-naïve patients ...