Pharma Business - August 16, 2017
FDA accepts Medivir IND application
Medivir announces that the Investigational New Drug (IND) application for MIV-711 has been accepted and the IND is now open with the FDA (U.S. Food and Drug Administration). “We are very pleased to have received FDA acceptance for our IND. This is a regulatory milestone for MIV-711 and enables clinical development of MIV-711 in the […]
Clinical Trials - April 26, 2017
Update on Medivir’s development of JNJ-4178
Medivir communicates an update on the status of the development of JNJ-4178, the triple combination of simeprevir, odalasvir and AL-335, following The International Liver Congress 2017 of the European Association for the Study of the Liver (EASL), which was held in Amsterdam, on 19-23 April. Data from an ongoing phase II study presented at The […]
Clinical Trials - April 7, 2017
Positive data from Medivir
Medivir announces the completion of the phase II clinical study of the topical, skin-directed histone deacetylase (HDAC) inhibitor, remetinostat, in patients with early stage CTCL. The trial included 60 patients with the mycosis fungoides (MF) variant of CTCL, who were randomized to receive either 0.5% remetinostat gel BID, 1% remetinostat gel QD or 1% remetinostat […]
Clinical Trials - February 2, 2017
Successful review of Medivir’s osteoarthritis trial
Medivir announces that the independent Data Monitoring Committee (DMC) held its fourth and final scheduled meeting and recommended continuation of the ongoing randomized, double-blind phase IIa study (MIV-711-201) based on a review of unblinded safety data. The objective of MIV-711-201 is to evaluate the safety, tolerability and efficacy of six months of treatment with MIV-711 […]
Pharma Business - October 13, 2016
Medivir reorganizes
Medivir announces a reorganization of the company and the board has decided that the company onwards will have an exclusive focus on oncology. As a consequence of these changes, a total of around 30 colleagues will have to leave the company and affected vacancies will not be filled. A redundancy cost of approximately 20 MSEK […]
Pharma Business - August 18, 2016
Medivir licenses rights to Trek Therapeutics
Medivir and Trek Therapeutics has announced that TREKtx has licensed the exclusive rights to develop and commercialize MIV-802 globally, excluding China, Taiwan, Hong Kong and Macau. MIV-802 is a nucleotide polymerase inhibitor under development for the treatment of hepatitis C virus (HCV) infection. Under the terms of the agreement, Medivir is entitled to receive milestones based […]
