In its first year of operations, IDT Biologika’s contract manufacturing facility in Rockville, Maryland has experienced rapid growth, which it expects to continue as construction carries on.
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.
Just in time for the holidays, GSK can ‘give thanks’ to the US Federal Trade Commission (FTC) which has approved the $7bn acquisition of Novartis’ vaccine business.
Two major influenza vaccine producers have run into manufacturing issues that have delayed and reduced the number of doses that will be provided for the US.
A seasonal flu vaccine taken in the form of an oral solid dose has been found comparable to currently available jabs, according to data presented by developer Vaxart.
Bacterial contamination issues at a GlaxoSmithKline flu vaccine production plant are now being dealt with by an action plan that Health Canada has approved.
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.
Novartis has agreed to acquire GlaxoSmithKline’s oncology pipeline for as much as $16bn, while GSK will acquire Novartis’ vaccine business, excluding the flu vaccines, for as much as $7bn.
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.
IDT Biologika.says demand for vaccines in emerging markets is big chance for Big Pharma and hence a growing niche for contractors with the technical capabilities to carry out such work.
Novartis will use technology from Synthetics Genomics Vaccines to speed up the development of influenza vaccines for seasonal and pandemic flu outbreaks.
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.
Abbott Laboratories has confirmed it is considering the sale of the vaccines unit it gained with the €4.5bn ($6.2bn) acquisition of Solvay Pharmaceuticals in February.
Zydus Cadila has become the first Indian pharma company to begin multi-centre clinical trials of a H1N1 vaccine after it received approval from the Drug Controller General of India (DCGI).
Sanofi Aventis has revamped operations at its sterile injectables plant in Le Trait, France, adding three new production units that double syringe making capacity and diversify its vaccine manufacturing capability.
Unilife Medical Solutions has filed US patents for Unifill Select, which it claims is the first ready-to-fill (RTF) syringe specifically designed for vaccine delivery.
Novartis says its new cell culture plant in Holly Springs, North Carolina could begin making its flu vaccine boosting MF59 adjuvant as early as next month if approved by US regulators.
West Pharmaceutical Services is laying off 100 staff as part of restructuring efforts after its third quarter results fell short of expectations, despite operating profit increasing by 45 per cent.
Novavax says its new Indian vaccine plant will be operational in four months with sufficient capacity to help meet local demand for seasonal influenza vaccines.
In the next week the Chinese SFDA is expected to approve licences for two locally produced H1N1 vaccines, which unlike some alternatives only require one dose to confer immunity.
US contract services firm KBI Biopharma has begun using the PER.C6 platform for cell line generation as part of its offering to meet growing demand for biomanufacturing services.
The growth of the Chinese vaccine market is set to outstrip the country’s pharma sector, according to a Frost & Sullivan (F&S) report that predicts 14-15 per cent CAGR.
Millipore is collaborating with Microbix Biosystems to improve influenza vaccine manufacturing by developing a purification process using novel chromatographic technology.
Novartis is looking to buy an additional 39 per cent of its majority-owned subsidiary Novartis India for around 4.4bn rupees ($87m), or 351 rupees per share.
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...
Baxter has successfully produced H5N1 influenza vaccine in African
green monkey kidney cells in quantities sufficient for clinical
testing, according to an article published in The New England
Journal of Medicine.
The US Department of Health and Human Services (HHS) has accepted a
bulk stock of H5N1 influenza virus antigen, consisting of both
hemagglutinin and neuraminidase, worth $192m (€123m) from French
vaccines specialist Sanofi Pasteur.
Novartis has been given a warning by US regulators detailing
significant failures in its investigation into tracking down the
source of contamination in some of its vaccines.
GE Healthcare and Novavax have a vision - a state-of-the-art
pandemic influenza vaccine manufacturing facility solution with the
ability to produce vaccines quickly, which can be marketed as a
product to international countries.
Sanofi-Aventis has opened its first Asian research and development
centre in Goa, India, signalling its ambition to further tap in to
this region's budding pharma scene.
