The WHO has called for recall and destruction of all batches of Indian drugmaker Shantha Biotechnics’ Shan5 vaccine after the discovery of “white sediment” in some vials.
PPD and Southern Research are collaborating to strengthen their pandemic and seasonal influenza development services by working together on client bids and projects.
Merck & Co has joined a coalition to build a vaccine facility which is capable of simultaneously manufacturing multiple products and can quickly switch in response to a crisis.
iBio has agreed in principle to license its iBioLaunch platform, which uses Nicotiana to produce therapeutics, to G-Con for the development and manufacture of plant-expressed influenza vaccines.
SAFC Pharma is preparing for the shift towards cell culture-based vaccines, while still supplying and growing in the traditional sector, to ensure it can grow in coming years, according to a company director.
US biotechnology firm NexBio has received a patent for “pioneering” host cell-targeting influenza drugs that can cut the risk of viral mutation and the emergence of drug resistant strains.
In a busy week of Big Phama results Pfizer reports sales boost from Wyeth, Roche says Genentech hit profits and GSK unveils surge in Relenza sales and plans to expand R&D restructuring.
The EFPIA’s European Vaccine Manufacturers (EVM) group has denied allegations that its members were involved in hyping up the threat of the H1N1 pandemic to boost vaccine sales.
Vaccines could be produced in less than 10 weeks from first isolation of the RNA sequence by using insect cell derived influenza VLPs, according to research which has implications for H1N1 and H5N1.
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 Pasteur has recalled four lots of its pediatric H1N1 vaccine in the US that were found to have fallen below potency limits despite being be in spec at the time of manufacture.
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.
Intercell’s needle-free patch delivery technology has the potential to change the way vaccines are delivered, according to Jean Stephenne, president of GSK Biologicals.
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.
Early-stage CDC research suggests that the anti-inflammatory properties of cholesterol-busting statin drugs can help mitigate the impact of flu infection.
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.
Novavax has entered into a deal with Xcellerex to boost production of its H1N1 vaccine, which is entering clinical trials in Mexico, using the CMO’s FlexFactory disposable biomanufacturing platform.
The FDA has warned consumers about the spread of counterfeit H1N1 treatments after the agency bought products advertised as Tamiflu (oseltamivir) that contained none of the active ingredient.
GSK has won 22 government orders for its H1N1 swine flu vaccine in the past two months, taking total sales to 440m doses which media reports suggest will earn the company £2.2bn ($3.5bn).
The FDA has approved four H1N1 vaccines, made by CSL, AstraZeneca, Novartis and Sanofi-Aventis, that will be distributed in the next four weeks as part of the US’ swine flu preparation.
Encorium has outlined plans to specialise in vaccines, which it believes is an area it can be more flexible than big CROs, and inked a swine flu deal as part of $8.7m (€6m) of new contracts.
Dutch authorities have completed validation of Solvay Biologicals cell-based production facility which the company will use to meet growing worldwide demand for influenza vaccines.
Novavax’ VLP delivery system has been the subject of industry excitement this week after the US firm released Ph II data showing that a combination seasonal influenza vaccine based on the technology is effective and well tolerated.
Researchers claim tobacco plants provide an economical method of manufacturing norovirus vaccine, a product that would have low profit margins, and achieve commercial scale in two to four months.
The EMEA is fast tracking the review of data on H1N1 pandemic vaccines to ensure it has checked submissions before the northern hemisphere flu season, which starts in September.
The Spanish Ministry of Health is leading a €60m ($84.9m) programme that will build the country’s first vaccine production facility and use Novavax’s recombinant virus-like-particle (VLP) technology.
Industry response to the H1N1 pandemic suggests that cell culture vaccine production is about to come of age with two firms that use the technique, Novartis and Baxter, claiming it will cut development and manufacturing timelines by months.
UK drug major GSK has had a busy week in the Asia, signing an influenza vaccine manufacturing deal with China’s Shenzhen Neptunus Interlong Bio-Technique just days after it opened a new S$600m (EUR294m) production facility in Singapore.
Sanofi Pasteur, the vaccines unit of French drug major Sanofi Aventis, has received a reference strain of the H1N1 swine flu virus from the US CDC and expects to complete work on an industrial “seed stock” in the next two weeks.
Sanofi Pasteur has landed what it believes will be the first of a series of orders from the US Department of Health and Human Services (HHS) to produce H1N1 vaccines.
A new $60m (€43m) manufacturing suite is operational at the South Carolina, US plant where Roche makes APIs for some of its leading products, including for its anti-flu drug Tamiflu (oseltamivir).
Greek authorities have banned the export of the anti-virals Relenza and Tamiflu to prevent the country’s stockpile being sold off through parallel trade as global demand for the drugs increases on concerns about a H1N1 influenza pandemic.
Millipore is collaborating with Microbix Biosystems to improve influenza vaccine manufacturing by developing a purification process using novel chromatographic technology.
Novartis, Roche, GSK and Sanofi Pasteur are poised to start the months of work required to make a vaccine for the swine flu virus that, according to an AFP interview with Health Minister Jose Angel Cordova, is linked to 103 deaths in Mexico.
Sinovac’s recently opened vaccine filling and packaging facility in Beijing, China has received SFDA GMP certification, which the firm says will increase production capacity to around 40m doses a year.
Pandemic influenza vaccine manufacturing technology will be made available to developing countries through a collaboration between the WHO and Schering-Plough.
Within Obama’s $819bn economic stimulus package are numerous provisions relevant to the pharmaceutical industry, including funding to construct or renovate private manufacturing facilities.
Novavax believes its new $5m vaccine facility, which became operational this week, shows the cost and efficiency advantages of manufacturing with disposable, single use systems.
The US HHS says that healthcare workers and emergency service personnel should be given antivirals before this year’s flu season or any pandemic kick in and also calls for the private sector to take more of a role in stockpiling.
3M’s drug delivery division and US biotechnology firm VaxInnate have teamed up to develop transdermal influenza vaccine delivery patch in preparation for the anticipated pandemic.
CSL Biotherapies, part of Australia’s CSL group, has begun shipping the first of six million doses of its thimerosal-free vaccine Afluria to the US CDC ahead of this year’s flu season.
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.
US firms Sepragen and Neugenesis are teaming up to develop a
high-throughput platform for monoclonal antibody and influenza
vaccine production that is rapid, scalable and flexible enough to
respond to a potential pandemic.
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.
