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Preventing contamination during biopharmaceutical production
A study that analysed QA/QC incidents at several biomanufacturing plants has revealed how companies can best hope to detect and mitigate virus contamination.
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Genzyme
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Phase I/II data for neoGAA in Pompe disease presented
4 March 2016 | By Victoria White
Sanofi Genzyme says the safety and efficacy data from the NEO1 study support further development of neoGAA...
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Lemtrada treatment effects maintained over five years in RRMS
8 October 2015 | By Victoria White
Lemtrada targets CD52, a protein abundant on T and B cells. Circulating T and B cells are thought to be responsible for the damaging inflammatory process in MS...
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New data suggests Aubagio slows brain atrophy in RMS
7 October 2015 | By Victoria White
MRI data from Genzyme’s Phase III TEMSO study demonstrate that Aubagio significantly slowed brain atrophy in people with relapsing multiple sclerosis (RMS)...
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Genzyme opts into Alnylam’s ALN-AT3 haemophilia programme
1 October 2015 | By Victoria White
Genzyme has elected to opt into the programme for development and potential future commercialisation of ALN-AT3 in territories outside of North America and Western Europe...
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Genzyme initiates Phase 1/2 clinical trial to evaluate olipudase alfa in paediatric patients
16 June 2015 | By Victoria White
The first paediatric patient has begun treatment in Genzyme’s Phase 1/2 clinical trial focused on evaluating the investigational therapy olipudase alfa...
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FDA grants Breakthrough Therapy designation to Genzyme’s olipudase alfa
4 June 2015 | By Victoria White
The FDA has granted Breakthrough Therapy designation to Genzyme’s olipudase alfa for the treatment of Niemann-Pick disease type B...
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FDA grants fast track designation to Genzyme’s investigational substrate reduction therapy for the treatment of Fabry disease
29 April 2015 | By Victoria White
The FDA has granted Fast Track designation for the development of Genzyme’s GZ/SAR402671, an investigational substrate reduction therapy for Fabry disease...
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Genzyme’s Lemtrada resubmission accepted for review by FDA
30 May 2014 | By Sanofi
Sanofi and its subsidiary Genzyme announced that the U.S. Food and Drug Administration has accepted for review the company’s resubmission of its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada...
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Genzyme and Alnylam expand collaboration on rare genetic diseases
13 January 2014 | By Sanofi
Genzyme will have significant rights to Alnylam’s portfolio of clinical and pre-clinical stage drug candidates...
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Genzyme’s multiple sclerosis franchise featured at ECTRIMS
27 September 2013 | By Genzyme
18 platform and poster presentations provide deeper insight into the Clinical Development Programs for Aubagio® and Lemtrada™...
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European Commission approves Genzyme’s multiple sclerosis treatment Lemtrada™ (alemtuzumab)
17 September 2013 | By Genzyme
Follows recent European Commission approval of multiple sclerosis treatment Aubagio® (teriflunomide)...
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European Commission approves Genzyme’s once-daily, oral multiple sclerosis treatment Aubagio® (teriflunomide)
30 August 2013 | By Sanofi
Sanofi and its subsidiary Genzyme announced that the European Commission has granted marketing authorization for Aubagio® (teriflunomide)...
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Genzyme receives positive CHMP opinion for LEMTRADA™ in Europe
28 June 2013 | By Sanofi
"Today’s CHMP opinions set the stage for the approval of two important new treatment options..."
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Once-daily AUBAGIO® delayed onset of clinically definite multiple sclerosis (MS) in TOPIC study
25 April 2013 | By Sanofi
Genzyme announced positive top-line results from the TOPIC trial for AUBAGIO...
