Japan will only be receiving 50 per cent of its usual supply of the
blockbuster flu drug Tamiflu (oseltamivir) this year, thanks to
significantly reduced demand following reports of suicidal
behaviour in adolescents taking the medication.
The excessive use of a popular influenza drug, and the
associated build up of its waste in the environment, is
heightening the risk of creating viruses in nature that are
resistance to the therapy.
The latest in a series of periodic roundups of drugs that have
moved from preclinical research into clinical testing via the
announcement of a Phase I trial or an application for a trial to
industry regulators.
Roche has just had the child-size, lower strength version of its
blockbuster flu treatment Tamiflu (oseltamivir) approved by EU
authorities, though possibly just a little too late for this year's
flu season.
A statin-based drug candidate is being touted as a potential rival
to Roche's flu vaccine Tamiflu (oseltamivir phosphate) after its
developers revealed yesterday that it showed "superiority"
in the preclinic.
Several major manufacturers have pledged millions of doses of H5N1
vaccine to go towards a global stockpiling scheme initiated by the
World Health Organization to protect against the threat of an avian
flu pandemic.
Biopharma firm Vivalis has announced several licence agreements for
its proprietary cell line technology, adding to the list of
companies applying the technology to develop and commercialise new
human influenza vaccines.
A live attenuated replication-defective vaccine against the
influenza virus has started a Phase I clinical trial at the Medical
University of Vienna in Austria.
A new human vaccine to be used in the case of a flu pandemic has
gained approval in the EU. The Novartis vaccine, Focetria,
will be manufactured containing the offending virus should the
World Health Organization's warning system...
Roche gave an update on its manufacturing of influenza drug Tamiflu
(oseltamivir) today, saying that while it had reached its target
capacity of 400 million doses a year, demand is running much lower.
Reports of a €200m expansion at Sanofi Pasteur's production plant
in Rouen, France, have come hot on the heels of news that the US
Food and Drug Administration (FDA) has approved the company's
vaccine to protect humans against...
Sanofi-Aventis' H5N1 bird flu vaccine has won approval from the US
Food and Drug Administration (FDA) as a limited protection measure
in case of a pandemic.
US firm Vical has announced study results revealing a flu vaccine
reinforced with the firm's Vaxfectin adjuvant results in an
antibody response 60 times higher than the vaccine alone, and
allowed a 10-fold reduction in vaccine...
An experimental flu vaccine produced in insect cells could be a
potential money-saver for pharma firms, and has proved just as
effective as vaccines produced using conventional egg-based
techniques.
Pharmaceutical companies manufacturing vaccines to protect against
avian flu outbreaks will be protected from product liability claims
according to new regulations announced by the US Department of
Health and Human Services (HHS).
Russian researchers have developed an intranasal influenza vaccine
using a novel adjuvant technology, with plans to develop what could
become the first tablet flu vaccine formulation.
Drug giants Novartis and GlaxoSmithKline (GSK) have been awarded
contracts with the US government to develop adjuvant technology for
pandemic influenza, to potentially increase the number of doses to
be distributed among US citizens.
MedImmune's latest version of their inhalable flu vaccine, FluMist,
has been approved by the US Food and Drug Administration (FDA). The
new formulation can now be stored in a refrigerator rather than
frozen, which proved a major...
Drug giant GlaxoSmithKline (GSK) has been awarded a contract with
the US government to supply 800,000 doses of flu vaccine to the US,
where a bird flu pandemic still remains a threat.
California's Health and Human Services (HHS) has decided to
temporarily suspend a ban on mercury-based flu vaccines given to
children under three, citing a vaccine shortage caused by
production delays.
US drug heavyweight Pfizer is pushing through into the increasingly
profitable vaccine market with the purchase of privately held UK
firm PowderMed for an undisclosed sum.
A new study has discovered what seems to be a novel compound that
offers protection against influenza viruses, including the bird flu
virus. The compound could represent a new class of antiviral drugs
to prevent and treat this killer...
Responding to Roche's licensing agreements for Tamiflu (oseltamivir
phosphate) around the world, GlaxoSmithKline (GSK) has granted
China's Simcere Pharmaceutical Group the right to make generic
copies of its influenza drug...
The US Food and Drug Administration (FDA) has issued new advice to
aid manufacturers in developing safe and effective cell-based viral
vaccines, hoping it can modernise America's manufacturing network
and speed up production.
With sales of its vaccines expected to triple in the next ten
years, GlaxoSmithKline (GSK) has decided to invest more than €500m
in a new manufacturing facility in St-Amand-Les-Eaux in order to
increase production capacity for paediatric...
With the first clinical trial of its cell culture-based seasonal
influenza vaccine commencing in the US, Sanofi Pasteur has
demonstrated the production scale potential of a cell line in a
successful bioreactor run of 20,000L.
Nastech Pharmaceutical Company has received a new $1.9m (€1.5m)
research grant from the US National Institutes of Health (NIH) to
further develop its RNAi therapeutics to fight and prevent
bird-flu.
Moving from egg-based production of vaccines to the use of
cell-culture technologies in existing manufacturing plants is
cheaper and quicker than building new facilities to handle a flu
pandemic within the next five years, new research...
Roche has boosted annual manufacturing capacity for Tamiflu
(oseltamivir phosphate) to 80m treatment courses, as demand for the
flu drug shows no sign of abating.
Chinese researchers may have solved the problem of vaccine shortage
in the event of an avian influenza pandemic after a clinical trial
showed that their formulation containing the whole H5N1 virus
instead of virus particles resulted...
The National Institute of Allergy and Infectious Diseases (NIAID)
has awarded Nastech Pharmaceuticals a development grant for RNAi
therapeutics to prevent and treat influenza.
Agricultural firm Embrex has installed its in ovo delivery
system and egg remover at the production facility of Shenzhen
Neptunus Interlong, believed to be the largest and most advanced
human influenza vaccine manufacturing plant...
Chugai Pharmaceutical has decided to manufacture a modified version
of Roche's Tamiflu (oseltamivir) in a dry syrup formulation which
can be stored at room temperature after the bottle is opened,
allowing for more storage capacity...
After a ruthless battle between US states, Novartis has selected
Holly Springs in North Carolina for its vaccine manufacturing plant
which will use novel cell culture technology to dramatically speed
up production - the first facility...
In a landmark decision that will speed up the manufacturing of
influenza vaccines, the US Food and Drug Administration (FDA) has
approved the use of reverse genetics technology in the production
of MedImmune's seasonal intranasal...
Cardinal Health is the latest firm to benefit from Roche's global
recruitment drive for manufacturers to help boost its supplies of
the bird flu drug coveted by governments across the world -
Tamiflu.
Maryland is no longer in the running for a $500m (€392m) vaccine
manufacturing plant Novartis is seeking to build in the US, as
speculation about which state will host America's first cell
culture-derived influenza vaccine plant...
A dry powder nasal flu vacccine is being hailed by its developers
at DelSite Biotechnologies as a unique storage solution, providing
delivery advantages over traditional flu vaccines in the event of a
bird flu pandemic.
As America desperately waited for its influenza vaccines, Chiron
had to deal with major quality control issues between July and
October 2005 at its troubled vaccine manufacturing plant in
Liverpool according to a US Food and Drug...
Sanofi pasteur's vaccine manufacturing plant in Pennsylvania, where
half of America's influenza vaccines are made, has been served with
a warning letter by the US Food and Drug Administration (FDA),
asking for measures to...
Frost & Sullivan has awarded biopharmaceutical firm Cytogenix
with its 2006 award for innovation in biotechnology processing for
its cell-free manufacturing method that enables generation of large
quantities of high-purity DNA...
Tests have begun on a new bird flu vaccine that its US developer
MedImmune hopes will prove more effective and provide several
advantages over current injectable flu vaccines in the event of a
bird flu pandemic.
China's State Food and Drug Administration (SFDA) has authorised
Shanghai Sunve Pharmaceutical and Yichang Changjiang Pharmaceutical
to produce a licensed version of Roche's Tamiflu (oseltamivir
phosphate), the first such...
Vaccine developer Iomai has solidified its position in
transcutaneous immunisation (TCI) by receiving a new US patent
which outlines methods for inducing an immune response to Iomai's
novel skin-patch-based vaccines.
