GlaxoSmithKline is in the process of reviewing regulatory results from a June inspection that found that 10 areas of its Ste. Foy, Quebec, vaccine manufacturing plant needed improvements. But in the meantime, Health Canada has imposed a condition on the facility's license, requiring notice before Glaxo resumes production of Fluviral and FluLaval Tetra.
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 month, the FDA chided GlaxoSmithKline over issues at its Canadian flu vaccine plant, home to production of seasonal product FluLaval. Now, it's got another regulator on its case, too: Health Canada wants to see GlaxoSmithKline lay out plans for correcting problems at the facility, and it's giving the company 30 days to do it.
Novartis has started shipping vaccines for customers in the U.S. in advance of the next flu season, which doesn't include a quadrivalent offering like many of its competitors. But the shipments will include Flucelvax, which now has an FDA-licensed American plant that's poised for production whenever flu shots are needed.
AstraZeneca's flu vaccine sales may have just gotten a boost, courtesy of federal regulators. Wednesday, they recommended that healthy children 2 to 8 years old receive the company's nasal spray flu vaccine FluMist in lieu of flu shots when available.
Novartis is in the process of trying to hive off its flu vaccines business after selling off the rest of its vax unit to GlaxoSmithKline. But first, it may have to deal with an Italian fraud investigation over pricing on a pair of those products.
After getting the FDA's OK for cell-culture vaccine Flucelvax back in November 2012, Novartis now has a U.S. facility licensed by the agency to produce it. The drugmaker's Holly Springs, NC, plant is now the country's first pandemic-ready site with the regulator's green light to make cell-culture flu vaccines, it said Monday.
For the first time since the swine flu pandemic in 2009, influenza A virus pdm09 (pH1N1) predominated in the U.S. during the 2013-2014 flu season. And while this season saw overall lower levels of outpatient illness and death than in those predominated by fellow A virus H3N2, for older adults it was comparatively more severe, a CDC report found.
Virulent flu strains pose the danger of potential release, even when used in experiments for vaccine research, and investigators from the Harvard and Yale universities are calling for greater scrutiny of such studies.
After agreeing to unload most of its struggling vaccines unit to GlaxoSmithKline, Novartis now has just its influenza vaccines to ship off as it looks to focus on other core businesses. And new, promising data for the Swiss drug giant's H7N9 bird flu candidate could give the company a boost as it looks to lock down a buyer.