Phase 3 interim data showed the mRNA vaccine candidate generated a strong immune response against Influenza A; but failed to demonstrate it was at least as effective as an existing vaccine against Influenza B.
Australia’s Vaxxas has initiated a Phase I clinical trial with the first needle-free inactivated seasonal influenza vaccine quadrivalent (IIV4) candidate.
CSL Limited has entered into a collaboration and license agreement with Arcturus Therapeutics Holdings to access its late stage, next-generation self-amplifying mRNA (sa-mRNA) vaccine tech: prepared to spend more than $4bn on the deal to accelerate its...
Vaxess Technologies has launched a phase 1 trial for its H1 influenza vaccine patch: outlining its mission to increase access to vaccines via the shelf-stable, sustained-release patch.
The European Commission has granted a marketing authorization for Sanofi’s Supemtek, a quadrivalent (four-strain) recombinant influenza vaccine: representing the first and only recombinant influenza vaccine approved in the European Union.
The investment at the Gödöllö manufacturing site adds 104 jobs and comes a week before GSK breaks ground on a $170m meningitis B vaccine facility in Germany.
China’s food and drug administration recently gave the nod to the Beijing-based Sinovac to manufacture a vaccine to possibly prevent hand, foot and mouth disease (HFMD), a common contagious viral infection among young children.
Fresh of its acquisition of Novartis’ vaccine business, GlaxoSmithKline is doubling down with the purchase of GlycoVaxyn AG, a Swiss-based specialist vaccine maker, for $190m (£124m).
Baxter has sold its pandemic flu portfolio and Vero cell technology to Nanotherapeutics in preparation for the launch of its haematology and oncology-based spinout company Baxalta.
Novartis has spoken about the extensive safety testing at its production sites after its seasonal flu vaccine Fluad was found to be unconnected to 19 deaths in Italy.
Novartis’ seasonal flu vaccine Fluad has been deemed safe by the Italian Medicines Agency (AIFA) after testing the two batches connected to over a dozen deaths.
Italy has suspended the use of Fluad despite Novartis saying no causal relationship has been established between its seasonal flu vaccine and three deaths.
French biotech Calixar has developed a tech platform process it says makes flu vaccines six times more effective in terms of immunogenicity than others on the market.
Novartis has shipped the first of its cell-culture - rather than chicken egg - based vaccines for the 2014-2015 flu season from its North Carolina facility.
Japanese biotech company Unigen has implemented in only four months Werum's PAS-X Manufacturing Execution System (MES), which can help optimize production output at the world’s largest plant for the contract manufacturing of recombinant flu vaccines.
Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.
With almost three decades of recombinant protein production experience, Novartis is now seeing its work paying off as its biosimilars grew by 23% over the same quarter last year to $420m (€310.5m) in Q2.
Regulations governing the production of vaccines in China have been praised by WHO director general Margaret Chan following an assessment of the CFDA's oversight of the sector conducted last October.
GSK is confident it can meet Flulaval production targets ahead of this winter’s flu season despite ongoing endotoxin contamination problems at a Canadian plant hit with US FDA warning letter.
Texas-based Kalon Biotherapeutics is in the process of building two new biomanufacturing facilities, including a $91m facility to produce flu vaccines for GlaxoSmithKline.
A long dead cocker spaniel will play a key role in helping people avoid the flu this winter after a landmark approval from the US FDA for Novartis’ cell culture based vaccine plant.
Armed with a $285m investment from the US Department of Health and Human Services – the largest of three investments -- the Texas A&M Center for Innovation in Advanced Development and Manufacturing (CIADM) is now using advanced manufacturing techniques...
Recent outbreaks of a strain of meningitis, known as “serogroup B” or “MenB”, on US college campuses have caused both Pfizer and Novartis to develop new vaccines.
The US Department of Health and Human Services has awarded almost $40m (29m Euros) in contracts to four contract flu vaccine manufacturers as part of an effort to increase fill and finish capacity by 20%.
The US FDA approval of the new quadrivalent flu vaccine in June has not quite given manufacturers enough time to meet demand expectations, as production time can take up to about six months.
Cell culture, LAIV vaccines and recombinant DNA technology should be supported by the US government as part of a long-term overhaul of pandemic response capabilities, according to PCAST.
Late last week the US Department of Health and Human Services (HHS) awarded Novartis a $490m contract to continue work on its cell-culture influenza vaccine plant in Holly Springs, North Carolina, US. in-PharmaTechnologist spoke with Novartis spokesman...
