Year archive

Medivir — 2013 filings

All 93 regulatory filings released by Medivir (MVIR) in 2013, sourced directly from the official regulator.

93 Filings

2013 Period

2013 filings (93)

Filing	Released	Lang
An all-oral phase IIa study combining Simeprevir, TMC647055 and JNJ56914845 in hepatitis C patients to be initiated Regulatory Filings	2013-12-12	English
Fas IIa kombinationsstudie startas med Simeprevir, TMC647055 och JNJ56914845 för behandling av hepatit C Regulatory Filings	2013-12-12	Swedish
Simeprevir is now available for Hepatitis C patients in Japan, USA and Canada Regulatory Filings	2013-12-10	English
Simeprevir finns nu tillgängligt för hepatit C-patienter i Japan, USA och Kanada Regulatory Filings	2013-12-10	Swedish
HELIX-2, a phase II all-oral combination study of Simeprevir, TMC647055 and Samatasvir (IDX719) for the treatment of hepatitis C has been initiated Regulatory Filings	2013-12-02	English
Fas II kombinationsstudie med Simeprevir, TMC647055 och Samatasvir (IDX719) för behandling av hepatit C, HELIX-2, har inletts Regulatory Filings	2013-12-02	Swedish
Simeprevir has been approved in the USA as a new treatment for hepatitis C Regulatory Filings	2013-11-23	English
Simeprevir har godkänts i USA som behandling mot hepatit C Regulatory Filings	2013-11-23	Swedish
Interim / Quarterly Report 2013 Interim / Quarterly Report 9M 2013	2013-11-21	Swedish
Interim / Quarterly Report 2013 Interim / Quarterly Report 9M 2013	2013-11-21	English
Simeprevir has been approved in Canada as a new treatment for hepatitis C Regulatory Filings	2013-11-20	English
Simeprevir har godkänts i Kanada som ny behandling mot hepatit C Regulatory Filings	2013-11-20	Swedish
Resultat från COSMOS-studien med Simeprevir och Sofosbuviri cirrotiska och icke-cirrotiska patienter med HCV av genotyp 1 har presenterats vid AASLD Earnings Release FY 2013	2013-11-04	Swedish
Results from the COSMOS study with Simeprevir and Sofosbuvir in cirrhotic and non-cirrhotic HCV genotype 1 patients presented at AASLD Regulatory Filings	2013-11-04	English
Medivir meddelar att nya Simeprevir-data kommer att presenteras vid AASLD-mötet Regulatory Filings	2013-11-02	Swedish
Medivir announces that new Simeprevir data will be presented at the AASLD meeting Regulatory Filings	2013-11-02	English
FDA Advisory Committee recommends approval of Simeprevir for combination treatment of genotype 1 chronic hepatitis C in adult patients Legal Proceedings Report	2013-10-24	English
FDAs rådgivande kommitté rekommenderar ett godkännande av Simeprevir för kombinationsbehandling av genotyp 1 kronisk hepatit C hos vuxna Legal Proceedings Report	2013-10-24	Swedish
Den regulatoriska processen för Simeprevir i USA Regulatory Filings	2013-10-22	Swedish
The regulatory process for Simeprevir in the U.S. Regulatory Filings	2013-10-22	English
Medivir announces data from two phase III studies with Simeprevir in hepatitis C subpopulations – HCV/HIV co-infected and genotype 4 infected patients Regulatory Filings	2013-10-18	English
Medivir meddelar data från två fas III-studier med Simeprevir i hepatit C subpopulationer – HCV/HIV co-infekterade och genotyp 4 infekterade patienter Legal Proceedings Report	2013-10-18	Swedish
Medivirs valberedning tillsatt AGM Information	2013-10-14	Swedish
Medivir Nomination Committee appointed AGM Information	2013-10-14	English
MIV-247 har valts ut som kandidatläkemedel att utvecklas vidare för behandling av neuropatisk smärta Regulatory Filings	2013-10-10	Swedish
MIV-247 has been selected as a candidate drug and enters development for the treatment of neuropathic pain Legal Proceedings Report	2013-10-10	English
Positive results from a phase I study with MIV-711 for the treatment of osteoarthritis and other bone related disorders Regulatory Filings	2013-10-09	English
Positiva resultat från fas I-studie med MIV-711 för behandling av artros och andra benrelaterade sjukdomar Regulatory Filings	2013-10-09	Swedish
Janssen has acquired an NS5a replication complex inhibitor that will be evaluated with Simeprevir in future clinical development M&A Activity	2013-10-08	English
Simeprevir ska utvärderas i kombination med en NS5a replikationshämmare som har förvärvats av Janssen Regulatory Filings	2013-10-08	Swedish
Simeprevir-data från COSMOS-studien i hepatit C-patienter redovisas vid en ”late-breaking”-presentation på den internationella leverkongressen AASLD Regulatory Filings	2013-10-07	Swedish
Simeprevir data from COSMOS study in Hepatitis C patients will be presented as late-breaking presentation at AASLD Regulatory Filings	2013-10-07	English
Medivir meddelar att data för Simeprevir kommer presenteras på den kommande internationella leverkongressen AASLD Environmental & Social Information	2013-10-01	Swedish
Medivir announces that Simeprevir data will be presented at the upcoming AASLD meeting Regulatory Filings	2013-10-01	English
Simeprevir har godkänts i Japan för behandling av kronisk genotyp 1 hepatit C-infektion Regulatory Filings	2013-09-27	Swedish
Simeprevir has been approved in Japan for the treatment of genotype 1 chronic hepatitis C infection Regulatory Filings	2013-09-27	English
Medivir anordnar kapitalmarknadsdag den 10 oktober 2013 Regulatory Filings	2013-09-18	Swedish
Medivir Capital Markets Day on 10 October 2013 Report Publication Announcement	2013-09-18	English
Den japanska regulatoriska processen för simeprevir Legal Proceedings Report	2013-09-17	Swedish
The regulatory process in Japan for simeprevir Regulatory Filings	2013-09-17	English
The collaboration with Daewoong Pharmaceutical for the development of the hepatitis B compound, MIV-210 has been discontinued Legal Proceedings Report	2013-09-06	English
Medivir avbryter samarbetet med Daewoong Pharmaceutical kring utvecklingen av MIV-210 för behandling av hepatit B Regulatory Filings	2013-09-06	Swedish
Medivir announces interim results from Cohort 2 of the COSMOS study evaluating Simeprevir and Sofosbuvir in HCV patients with METAVIR scores F3-F4 Regulatory Filings	2013-08-28	English
Medivir meddelar interimsresultat från kohort 2 i COSMOS-studien som utvärderar Simeprevir och Sofosbuvir i HCV-patienter med avancerad leversjukdom Earnings Release FY 2013	2013-08-28	Swedish
Interim / Quarterly Report 2013 Interim / Quarterly Report H1 2013	2013-08-22	Swedish
Interim / Quarterly Report 2013 Interim / Quarterly Report H1 2013	2013-08-22	English
Medivir makes strategic decision to focus proprietary hepatitis C R&D efforts exclusively on nucleotide-based polymerase inhibitors Regulatory Filings	2013-08-15	English
Medivir tar strategiskt beslut att fokusera F&U-resurserna inom hepatit C-området på nukleotidbaserade polymerashämmare Regulatory Filings	2013-08-15	Swedish
Medivir streamlines operations by divesting Cross Pharma, its parallel import business M&A Activity	2013-06-25	English
Medivir renodlar verksamheten och avyttrar parallellimportverksamheten Cross Pharma M&A Activity	2013-06-25	Swedish
Medivir rekryterar ny chef för den kommersiella verksamheten Board/Management Information	2013-06-14	Swedish
Medivir recruits a new head of Commercial Operations Board/Management Information	2013-06-14	English
Major Shareholding Notification 2013 Major Shareholding Notification	2013-06-12	English
Primary efficacy and safety data from four phase III Japanese studies of Simeprevir presented at The Japan Society of Hepatology Regulatory Filings	2013-06-06	English
Primära effekt- och säkerhetsdata från fyra japanska fas III-studier med Simeprevir presenterades vid The Japan Society of Hepatology Regulatory Filings	2013-06-06	Swedish
Medivir presenterar vid Jefferies Global Healthcare konferens Report Publication Announcement	2013-05-31	Swedish
Medivir presents at the Jefferies Global Healthcare Conference Report Publication Announcement	2013-05-31	English
An all-oral combination phase II study of Simeprevir and Samatasvir (IDX719) for the treatment of hepatitis C virus infection initiated Regulatory Filings	2013-05-30	English
Fas II kombinationsstudie med Simeprevir och Samatasvir (IDX719) har inletts för behandling av hepatit C Regulatory Filings	2013-05-30	Swedish
Primary efficacy and safety findings from phase III study of Simeprevir in treatment-experienced patients demonstrate sustained virologic response Regulatory Filings	2013-05-21	English
Primära effekt- och säkerhetsresultat från fas III-studie med Simeprevir i behandlingserfarna patienter visar på varaktigt virologisk respons Legal Proceedings Report	2013-05-21	Swedish
Den amerikanska läkemedelsmyndigheten, FDA beviljar ”priority review” av Simeprevir för behandling av kronisk hepatit C genotyp 1 Legal Proceedings Report	2013-05-13	Swedish
U.S. FDA grants priority review to Simeprevir for combination treatment of genotype 1 chronic hepatitis C Regulatory Filings	2013-05-13	English
Resolutions at the annual general meeting in Medivir on 6 May 2013 AGM Information	2013-05-06	English
Beslut vid årsstämma i Medivir den 6 maj 2013 AGM Information	2013-05-06	Swedish
Interim / Quarterly Report 2013 Interim / Quarterly Report Q1 2013	2013-05-06	Swedish
Interim / Quarterly Report 2013 Interim / Quarterly Report Q1 2013	2013-05-06	English
Webcast presentation of Simeprevir phase III clinical data Report Publication Announcement	2013-05-03	English
Presentation av Simeprevir kliniska fas III-data via webcast Regulatory Filings	2013-05-03	Swedish
Marketing Authorization Application for Simeprevir to the EMA for the treatment of patients with genotype 1 and genotype 4 hepatitis C is now filed Regulatory Filings	2013-04-24	English
Registreringsansökan gällande Simeprevir för behandling av hepatit C-patienter av genotyp 1 och 4 inlämnad till de Europeiska läkemedelsmyndigheterna Regulatory Filings	2013-04-24	Swedish
Nya resultat från fas III-studierna Quest 1 och 2 med Simeprevir i hepatit C-patienter kommer att presenteras vid EASL 23-28 april i Amsterdam Regulatory Filings	2013-04-23	Swedish
New data from Simeprevir phase III studies Quest 1 and 2 in hepatitis C patients will be presented at EASL 23-28 April in Amsterdam Regulatory Filings	2013-04-23	English
Data from Simeprevir in hepatitis C patients will be presented at EASL during 24-28 April in Amsterdam Regulatory Filings	2013-04-08	English
Resultat från studier med Simeprevir i hepatit C-patienter kommer att presenteras vid EASL-mötet i Amsterdam den 24-28 april Regulatory Filings	2013-04-08	Swedish
Annual Report 2012 Annual Report FY 2012	2013-04-04	Swedish
Annual Report 2012 Annual Report FY 2012	2013-04-04	English
Notice of Annual General Meeting of Medivir AB (publ) AGM Information	2013-04-04	English
Kallelse till årsstämma i Medivir AB (publ) AGM Information	2013-04-04	Swedish
New Drug Application has been filed with FDA for Simeprevir (TMC435) for combination treatment of adult patients with genotype 1 chronic hepatitis C Regulatory Filings	2013-03-28	English
Registreringsansökan för Simeprevir (TMC435) har lämnats in till FDA för trippelbehandling av vuxna med kronisk hepatit C av genotyp 1 Regulatory Filings	2013-03-28	Swedish
Valberedningens förslag till ny styrelse inför årsstämman 2013 Board/Management Information	2013-03-21	Swedish
Nomination Committee proposes new Board of Directors ahead of 2013 AGM Board/Management Information	2013-03-21	English
Results from a phase IIa study evaluating Simeprevir and Sofosbuvir in prior null responder Hepatitis C patients have been presented at CROI Regulatory Filings	2013-03-06	English
Resultat från fas IIa-studie med Simeprevir och Sofosbuvir i hepatit C-patienter som inte svarat på tidigare behandling har presenterats Regulatory Filings	2013-03-06	Swedish
First interim results from a phase IIa study evaluating an all-oral regimen of Simeprevir and Sofosbuvir in prior null responder Hepatitis C patients Earnings Release FY 2013	2013-03-04	English
Första interimsdata från fas II-studie med Simeprevir och Sofosbuvir i hepatit C-patienter som inte svarat på tidigare behandling Regulatory Filings	2013-03-04	Swedish
Regulatory Application has now been filed for Simeprevir (TMC435) in Japan for the treatment of genotype 1 hepatitis C patients Regulatory Filings	2013-02-22	English
Registreringsansökan har lämnats in för Simeprevir (TMC435) i Japan för behandling av patienter med hepatit C genotyp 1 Regulatory Filings	2013-02-22	Swedish
Earnings Release 2012 Earnings Release FY 2012	2013-02-22	Swedish
Interim / Quarterly Report 2012 Interim / Quarterly Report FY 2012	2013-02-22	English
Fas II kombinationsstudier med Simeprevir, TMC647055 och IDX719 för behandling av hepatit C kommer att inledas inom kort Regulatory Filings	2013-01-28	Swedish
Phase II all-oral combination studies of Simeprevir, TMC647055 and IDX719 for the treatment of Hepatitis C to be initiated shortly Regulatory Filings	2013-01-28	English

Filings by year

2026 19 filings
2025 39 filings
2024 32 filings
2023 33 filings
2022 15 filings
2021 52 filings
2020 28 filings
2019 19 filings
2018 57 filings
2017 52 filings
2016 59 filings
2015 70 filings
2014 76 filings
2013 93 filings
2012 51 filings
2011 79 filings
2010 78 filings
2009 45 filings
2008 40 filings
2007 26 filings