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European CHMP Adopts Positive Opinion for Genzyme’s Cerdelga® (eliglustat) Capsules24-11-2014
Oslo, Norway, Genzyme, a Sanofi company, announced Friday, November 21, that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of Cerdelga® (eliglustat) capsules, an oral treatment for certain adults living with Gaucher disease type 1.
Mere >Genzyme Corporate
Genzyme Announces Enrollment of First Patient in Phase II Vatelizumab Trial in Relapsing Remitting Multiple Sclerosis05-11-2014
Cambridge, Mass. - Nov. 4, 2014 - Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today enrollment of the first patient in a multicenter Phase II clinical trial to evaluate Genzyme’s investigational infusion therapy vatelizumab in patients with relapsing remitting multiple sclerosis (RRMS). The trial, called EMPIRE, is designed to assess the efficacy of vatelizumab vs. placebo in RRMS patients. The safety, tolerability and pharmacokinetics of vatelizumab will also be assessed.
Mere >Genzyme Corporate
FDA Approves Genzyme’s Cerdelga (eliglustat) Capsules - Only First-Line Oral Treatment for Adult Gaucher Disease Type 122-08-2014
CAMBRIDGE, Mass.—Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has approved Cerdelga™ (eliglustat) capsules, the only first-line oral therapy for certain adult Gaucher disease type 1 patients. A small number of adult patients who metabolize Cerdelga more quickly or at an undetermined rate, as detected by an established genetic laboratory test, will not be eligible for Cerdelga treatment. Cerdelga is expected to be available to patients within a month.
Mere >Genzyme Corporate
Genzyme Recognizes Sixth Annual World MS Day28-05-2014
Cambridge, Mass. - May 28, 2014 - Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), today recognizes World MS Day, an initiative developed by the Multiple Sclerosis International Federation (MSIF) to raise awareness of MS and its impact on the lives of more than two million people around the world. With two differentiated MS therapies and a research pipeline focused on innovative approaches to treating the disease, Genzyme has a long-term commitment to the MS community.
Mere >Genzyme Corporate
FDA Grants Priority Review for Genzyme’s Cerdelga™ (eliglustat), an Investigational Oral Therapy for Gaucher Disease - - Second Major Regulatory Filing Following EMA Acceptance in Late October -12-12-2013
Cambridge, Mass – December 11, 2013 – Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today that the Food and Drug Administration (FDA) has granted Priority Review designation to its New Drug Application (NDA) for Cerdelga™ (eliglustat), an investigational oral therapy for adult patients with Gaucher disease type 1. As previously announced, the European Medicines Agency in late October validated Genzyme’s marketing authorization application (MAA) for eliglustat in the EU.
Mere >Genzyme Corporate
To nye MS-medikamenter lanseres i Norge15-11-2013
Medisinske gjennombrudd i MS-behandlingen
Lanseringen av to nye MS-medikamenter på det norske markedet representerer et betydelig fremskritt innen behandling av multippel sklerose. Nå kan mennesker med MS erstatte sprøyter med tabletter, og de med aktiv MS-sykdom får et nytt effektivt behandlingsalternativ.
Mere >Genzyme Norge
Europeiske legemiddelmyndigheter/EU-kommisjonen godkjenner Lemtrada™ (alemtuzumab), medikament for behandling av multippel sklerose19-09-2013
- Godkjenningen følger tett etter EU-kommisjonens godkjennelse av Aubagio® (teriflunomide), også et legemiddel for behandling av Multippel Sklerose - Godkjennelsene legger til rette for lanseringer i hele Europa og posisjonerer Genzyme som en sterk og langsiktig partner innen MS -

Cambridge, Mass. – September 17, 2013 – Genzyme, et Sanofi selskap (EURONEXT: SAN og NYSE: SNY) kunngjorde i dag at europeiske legemiddelmyndigheter/EU-kommisjon har gitt markedsføringstillatelse for Lemtrada™. Dette følger kort tid etter godkjennelsen av Aubagio® (30. August). Selskapet vil lansere begge produktene i Europa innen kort tid.
Mere >Genzyme Corporate
Europeiske legemiddelmyndigheter/EU kommisjonen godkjenner Aubagio® (teriflunomide), en gang daglig, oral behandling for pasienter med MS03-09-2013
Sanofi (EURONEXT: SAN and NYSE: SNY) og Genzyme kunngjorde i dag at de europeiske legemiddelmyndigheter/EU kommisjonen har gitt markedsføringstillatelse for Aubagio® (teriflunomide) 14 mg, en gang daglig, oral behandling for behandling av voksne pasienter med relapserende - remitterende multippel sklerose (RRMS).
Mere >Genzyme Corporate
Genzyme Receives Positive CHMP Opinion for LEMTRADA™ (alemtuzumab) in Europe28-06-2013
CHMP also Recommends NAS Designation for AUBAGIO® 14 mg Following Positive Opinion in March 2013 – – Decisions Set Stage for Commercial Introduction of Two New Genzyme Therapies for Multiple Sclerosis in Europe –
Mere >Genzyme Corporate
Genzyme Celebrates Fifth Annual World MS Day29-05-2013
Cambridge, Mass. – May 29, 2013 – Genzyme, a Sanofi Company (EURONEXT: SAN and NYSE: SNY), together with the global multiple sclerosis (MS) community of patients, advocates and healthcare providers, will today celebrate World MS Day, a campaign created by the Multiple Sclerosis International Federation (MSIF) to raise awareness of MS. Genzyme is committed to making a difference in the lives of people living with MS with differentiated therapies that include once-daily, oral AUBAGIO® and LEMTRADA™, as well as a research pipeline focused on innovative approaches to treating MS. LEMTRADA (alemtuzumab) is currently under regulatory review.
Mere >Genzyme Corporate


24-11-2014 - European CHMP Adopts Positive Opinion for Genzyme’s Cerdelga® (eliglustat) Capsules
05-11-2014 - Genzyme Announces Enrollment of First Patient in Phase II Vatelizumab Trial in Relapsing Remitting Multiple Sclerosis
22-08-2014 - FDA Approves Genzyme’s Cerdelga (eliglustat) Capsules - Only First-Line Oral Treatment for Adult Gaucher Disease Type 1
28-05-2014 - Genzyme Recognizes Sixth Annual World MS Day
12-12-2013 - FDA Grants Priority Review for Genzyme’s Cerdelga™ (eliglustat), an Investigational Oral Therapy for Gaucher Disease - - Second Major Regulatory Filing Following EMA Acceptance in Late October -
15-11-2013 - To nye MS-medikamenter lanseres i Norge
19-09-2013 - Europeiske legemiddelmyndigheter/EU-kommisjonen godkjenner Lemtrada™ (alemtuzumab), medikament for behandling av multippel sklerose
03-09-2013 - Europeiske legemiddelmyndigheter/EU kommisjonen godkjenner Aubagio® (teriflunomide), en gang daglig, oral behandling for pasienter med MS
28-06-2013 - Genzyme Receives Positive CHMP Opinion for LEMTRADA™ (alemtuzumab) in Europe
29-05-2013 - Genzyme Celebrates Fifth Annual World MS Day
25-04-2013 - Once-daily AUBAGIO® Delayed Onset of Clinically Definite Multiple Sclerosis (MS) in TOPIC Study
22-03-2013 - Effect of Genzyme’s LEMTRADA Maintained in Patients Beyond Two-Year Pivotal MS Studies
13-03-2013 - Multiple Presentations Highlight Continuing Progress of AUBAGIO and LEMTRADA Programs
27-02-2013 - Genzyme Receives Company Award from European Organisation for Rare Diseases (EURORDIS)
26-02-2013 - Genzyme Recognizes International Rare Disease Day with Global Awareness Programs and Launch of Third Annual Patient Advocacy Leadership (PAL) Awards
21-02-2013 - Genzyme Announces Positive New Data from Two Phase 3 Studies for Oral Eliglustat Tartrate for Gaucher Disease
01-11-2012 - Genzyme Announces Publication of LEMTRADA (alemtuzumab) Pivotal Studies in The Lancet.
09-10-2012 - Genzyme to Present New Data from AUBAGIO® and LEMTRADATM Clinical Development Programs at ECTRIMS
17-09-2012 - FDA Approves Genzyme’s AUBAGIO® (teriflunomide), a Once-Daily, Oral Treatment for Relapsing Multiple Sclerosis
28-02-2011 - International Rare Disease Day
16-02-2011 - Sanofi-aventis to Acquire Genzyme
13-10-2010 - Genzyme’s Alemtuzumab Shows Sustained Reduction in Relapses and Disability in Five-Year Review of MS Patients from Phase 2 Trial


 

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