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February 22, 2013
07:52 EDTSNYEMA gives positive recommendations for Sanofi's Hexacima, Hexyon
The Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Hexacima, 0.5 ml, suspension for injection intended for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b. The Committee also adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Hexyon, 0.5 ml, suspension for injection intended for primary and booster vaccination of infants and toddlers from six weeks to 24 months of age against the same diseases. The applicant for these medicinal products is Sanofi Pasteur.
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September 17, 2014
06:18 EDTSNYSanofi, MyoKardia announce collaboration
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September 16, 2014
07:33 EDTSNYMylan initiates Phase III clinical trials for Advair Diskus and Lantus
Mylan (MYL) announced it is initiating Phase III clinical trials for its generic version of GlaxoSmithKline's (GKS) Advair Diskus and its insulin analog to Sanofi's (SNY) Lantus. In October Mylan will commence a Phase III clinical trial to evaluate the equivalence of its product to Advair Diskus when administered by inhalation in adult asthma patients.
September 12, 2014
10:04 EDTSNYSanofi unit granted orphan status for treatment of Gaucher disease
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September 11, 2014
05:27 EDTSNYGenzyme announces positive interim results from Lemtrada extension study
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September 10, 2014
07:09 EDTSNYAmericas Committee for Treatment & Research in MS to hold a meeting
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September 8, 2014
14:16 EDTSNYSanofi announces FDA approval of Menactra vaccine
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September 3, 2014
12:49 EDTSNYSanofi reports Dengue vaccine candidate achieves its phase 3 primary endpoint
Sanofi Pasteur, the vaccines division of Sanofi, announced that the final landmark phase 3 efficacy study of its dengue vaccine candidate in Latin America successfully achieved its primary clinical endpoint. Results showed an overall significant reduction of 60.8% of dengue disease cases in children and adolescents 9-16 years old after a three-dose vaccination schedule. Importantly, efficacy was observed against each of the four dengue serotypes. Additional observations of the results showed a clinically important reduction by 80.3% in the risk of hospitalization due to dengue during the study. The results also showed in the study population an efficacy against dengue haemorrhagic fever, the severe form of dengue, which is consistent with the results released from Sanofiís phase 3 dengue study in Asia. Lastly, the results suggest better protection in case of prior exposure to dengue.

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