JNJ’s Mid-Stage Study on Treating HCV Demonstrates 100% Cure-Rate after 6-weeks of Treatment- Janssen Biotech’s $JNJ said that preliminary results from mid-stage clinical trial of triple combination HVC regimen showed strong results. The interim data from Phase 2a study demonstrated that the triple combination regimen, intended to cure patients with hepatitis C virus (HCV) genotype 1 infection, had 100% cure-rate, after only six weeks of treatment. The outcome of the study was presented on Friday at the European Association for the study of the Liver Special Conference in Paris. The drug-maker on Friday also submitted Biologics License Application (BLA) to the FDA seeking approval of treatment, sirukumab, intended for adult patients having moderate to severely active rheumatoid arthritis (RA), a chronic systemic inflammatory condition affecting nearly 1.5 million Americans.
Novartis’s Lead Lung Cancer Candidate Shows Good Results in Phase 3- Novartis AG $NVS said its lead lung cancer candidate Zykadia showed good results in Phase 3 study. The company now hopes that the results would help it expand regulatory approvals. Nonetheless, it faces a stiff competition from rival Roche, which some analysts say has better treatment intended for the disease. The Swiss pharmaceutical company presented the results of Phase 3 clinical study of Zykadia or ceritinib, on previously untreated patients having advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer. Patients when treated with Zykadia showed a substantial progress in their chances of surviving without the cancer spreading compared with standard chemotherapy.
Medivir’s Mid-Stage Study of Arthritis Candidate MIV-711 to Go Ahead as Planned -Medivir AB $MVRBF said on Friday that its Phase 2a program for the treatment of Osteoarthritis would continue as planned after the Independent Data Monitoring Committee (DMC) recommended continuation of the study based on a review of unblended safety data. The first patient got enrolled into an open label phase 2a extension study, MIV-711-202. The aim of the study is to assess the clinical efficacy of the treatment for six months on patients with moderate knee osteoarthritis. The topline data of the study is expected in the second half of the next year and the outcome of the extension phase is anticipated in the first half of 2018.
AbbVie’s Viekirax + Exviera Shows High Clinical Efficacy- AbbVie Inc. $ABBV said results of Phase 3 clinical trial, GARNET, evaluating VIEKIRAX (ombitasvir/paritaprevir/ritonavir tablets) + EXVIERA (dasabuvir tablets) in untreated patients with genotype 1b chronic hepatitis C virus (HCV) infection without cirrhosis showed a cure rate of 98% (n=160/163), 12 weeks after treatment (SVR12). The outcome was presented on Friday at the 2016 EASL Special Conference: New Perspectives in Hepatitis C Virus Infection - The Roadmap for Cure in Paris.
Novo Nordisk Submits Supplemental NDA to the FDA- Novo Nordisk $NVO submitted a supplemental Drug Application (sNDA) to the FDA seeking approval allowing the drug-maker to include results from two late-stage trials to to the label of long-acting insulin Tresiba (insulin degludec injection).