After last week partially banning Novartis' Fluad, Italian officials now say tests on the flu vaccine show the product is safe.
A couple of flu vaccine makers have new patient populations to target, thanks to a pair of recent FDA approvals in older adults.
A Sanofi spokesperson told The Wall Street Journal that it has delayed some forms of its Fluzone because the flu strains used to produce the shot did not grow as fast as expected. A GSK spokesman said in an email Monday that it has cut its production targets to 26 million to 27 million doses for the U.S. from the 28 million to 33 million doses originally anticipated.
Novartis' 8-year foray into vaccines is officially coming to a close. After divesting the bulk of its unit to GlaxoSmithKline in an April deal, the pharma giant Sunday announced it had agreed to sell its flu shot business to Australia's CSL. And with that, it'll make its exit from a field that's given it trouble since its Chiron buyout in 2006.
GlaxoSmithKline's Canadian flu vaccine plant has been in the spotlight recently for problems that spurred an FDA warning letter and a talking-to from Health Canada. But it's different problems that the British drugmaker now says will keep it from filling about 30% of its Canadian order for this season--and they could compromise some of its U.S. shipments, too.
The PharmaJet injector delivers the vaccine by means of a narrow, precise fluid stream that penetrates the skin in about one-tenth of a second.
GlaxoSmithKline's plan of action for its troubled Quebec flu vaccine has gotten the thumbs up from regulator Health Canada, but that is only a part of the puzzle for meeting its contracts to produce tens of millions of doses of four-strain and three-strain seasonal flu shots for the impending season.
While GlaxoSmithKline is eyeing a strong performance from Fluarix Quadrivalent in its sophomore year, it may have to rely on Fluarix more than it would like if it doesn't make peace with regulators over quality issues at its FluLaval plant.
Last year's flu vaccine didn't provide as much coverage as scientists had hoped, and now researchers from Canada's British Columbia Centre for Disease Control think they have discovered the culprit.
After collaborating with the University of Michigan-spinout NanoBio over the past three years, Merck has signed off on a new licensing pact for the biotech's nanoemulsion adjuvant technology.