08:00 , Nov 3, 2014 |  BC Week In Review  |  Clinical News

DTP-HepB-Polio-Hib pediatric hexavalent vaccine regulatory update

Merck and Sanofi's Sanofi Pasteur vaccines division said FDA accepted for review a BLA for DTP-HepB-Polio-Hib pediatric hexavalent vaccine. The vaccine includes antigens for diphtheria, tetanus, pertussis and polio from Sanofi Pasteur and antigens for...
07:00 , Apr 29, 2013 |  BC Week In Review  |  Clinical News

Hexyon/Hexacima regulatory update

The European Commission approved an MAA from Sanofi for its Hexyon/Hexacima vaccine for primary and booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type b (Hib) in infants and toddlers ages...
08:00 , Feb 25, 2013 |  BC Week In Review  |  Clinical News

Hexyon/Hexacima regulatory update

EMA's CHMP issued a positive opinion recommending approval of an MAA for Hexyon/Hexacima from Sanofi for primary and booster vaccination against diphtheria, tetanus, pertussis, Hepatitis B, polio and Haemophilus influenzae type b (Hib) in infants...
01:22 , Feb 23, 2013 |  BC Extra  |  Company News

CHMP backs generics for Namenda

EMA's CHMP issued a number of positive opinions on Friday, including a recommendation to approve generic versions of Alzheimer's disease drug memantine , which H. Lundbeck A/S (CSE:LUN) markets as Ebixa in Europe. The committee...
07:00 , Oct 29, 2012 |  BC Week In Review  |  Clinical News

Hexaprim regulatory update

Sanofi Pasteur MSD submitted an MAA to EMA at the end of August for Hexaprim vaccine to vaccinate against diphtheria, tetanus, pertussis, Hepatitis B, polio and Haemophilus influenzae type B in infants. Sanofi Pasteur MSD,...
07:00 , Jun 25, 2012 |  BC Week In Review  |  Clinical News

Hexaxim regulatory update

EMA's CHMP recommended approval of Hexaxim outside the EU as a primary and booster vaccination for infants and toddlers against diphtheria, tetanus, pertussis, hepatitis B, polio and Haemophilus influenzae type B. Sanofi's Sanofi Pasteur S.A....
00:14 , Jun 23, 2012 |  BC Extra  |  Company News

CHMP backs Seebri

EMA's CHMP on Friday recommended approval of Seebri/Enurev/ Tovanor Breezhaler glycopyrronium bromide from Novartis AG (NYSE:NVS; SIX:NOVN) to treat chronic obstructive pulmonary disease (COPD). Novartis has worldwide rights to the inhaled long-acting muscarinic receptor antagonist...
07:00 , May 2, 2011 |  BC Week In Review  |  Clinical News

V419: Phase III started

Merck and sanofi-aventis' Sanofi Pasteur S.A. vaccines unit began an open-label, international Phase III trial in about 1,440 infants to evaluate 0.5 mL intramuscular V419. Subjects will receive V419 at 2, 4, 6 and 15...
07:00 , May 4, 2009 |  BC Week In Review  |  Clinical News

Unifive: Phase III discontinued

sanofi-aventis discontinued development of Unifive, which was in Phase III testing, due to a reprioritization of its R&D portfolio. Resources will be reallocated from Unifive to Hexaxim , a hexavalent vaccine in Phase III testing...
02:19 , Apr 30, 2009 |  BC Extra  |  Clinical News

sanofi-aventis gives pipeline update

sanofi-aventis Group (Euronext:SAN; NYSE:SNY) disclosed that it discontinued development of four compounds in Phase III testing and four in Phase II testing because of lack of efficacy, safety issues or limited value proposition. The Phase...