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EMA reviews new Sanofi flu vaccine

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EMA reviews new Sanofi flu vaccine

April 12, 2013

 

Sanofi says that regulators in Europe have started to evaluate its four-in-one influenza vaccine.

The French drugmaker’s Sanofi Pasteur unit announced that a decentralised marketing authorisation application has been accepted for review in the European Union for a quadrivalent formulation of its three-strain seasonal influenza vaccine Vaxigrip. France will act as the reference member state.

Currently-licensed vaccines are trivalent and are formulated every year, based on seasonal recommendations made by the World Health Organisation and national authorities. They contain inactivated strains that confer protection against two influenza A virus subtypes and one type B virus.

However, for over a decade, two distinct influenza B families have co-circulated, Sanofi noted, making it difficult to predict which B-lineage strain will predominate in a country or in a region in seasons to come. The new vaccine includes two A and two B strains corresponding to both of the aforementioned B lineages.

Olivier Charmeil, Sanofi Pasteur’s chief executive, said the inclusion of the four flu viruses anticipated to circulate in the forthcoming season “has the potential to reduce the risk of influenza disease and influenza-related complications, specifically hospitalisations and deaths among those, at risk, who contract the disease”.

In October 2012, a supplemental Biologics License Application was filed in the USA for a quadrivalent formulation of Sanofi’s Fluzone vaccine. An action date is anticipated in the second quarter of 2013.

Earlier this month, rival GlaxoSmithKline’s quadrivalent seasonal influenza vaccine, Influsplit Tetra/Fluarix Tetra, was granted marketing authorisation in Germany and the UK, the first four-strain flu jab to be approved in Europe.


2 Comments

  1. medchemnintabelle says:

    Reblogged this on medchemnintabelle.

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK LIFE SCIENCES LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 PLUS year tenure till date June 2021, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 90 Lakh plus views on dozen plus blogs, 233 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 33 lakh plus views on New Drug Approvals Blog in 233 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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