GSK has confirmed that material from the PCV1 virus has been detected in Rotarix and, although there is no evidence of a safety risk, the FDA has recommended use is temporarily suspended.
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.
Novavax has completed cGMP scale up of its RSV-F vaccine candidate, with the material being used in preclinical studies, and amended the terms of the H1N1 collaboration with Xcellerex.
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.
US CRO PharmaNet will conduct early phase clinical trials of therapeutic cancer vaccines being developed by UK group Scancell under a contract announced yesterday.
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.
Encorium has abandoned plans to sell its Finnish unit, Encorium OY, citing its new strategic focus and recent contract wins as the basis for the decision.
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.
Researchers have presented new microneedle drug delivery patches, which, using technology developed in the electronics sector, could improve compliance and treat ocular diseases.
A dry powder measles vaccine formulation and inhalers that could be as affordable as needle treatments are due to enter Phase I in 2010, according to researchers at the ACS meeting.
Sanofi-Aventis is continuing to expand in emerging markets by agreeing to acquire Indian vaccine manufacturer Shantha Biotechnics in a deal that values the company at €550m ($784m).
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.
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.
Flugen has secured the exclusive rights to Ratio’s novel vaccine delivery technology, which is a disposable micro-device that it claims can improve efficacy and compliance.
Novartis has recalled two batches of meningitis C vaccine from the UK after the solvent used in their preparation was discovered to be contaminated with Staphylococcus aureus.
An open house at GSK’s plant in Pennsylvania, US gave the world its first glimpse of the facility that the firm hopes will become the global hub of its vaccine packaging and filling business.
Merck & Co has completed start-up activities at its vaccine manufacturing plant in Durham, North Carolina, which is intended to further the company’s ambitions in the sector.
Bioprocessing specialist Sartorius Stedim Biotech’s (SSB) net profit for the first half of 2008 rose by 3.5 per cent in comparison with last year, although the company continues to face difficulties in North America.
A pump-powered nebulizer for delivering vaccinations in the developing world is being worked on by researchers at Aerovax, at the Massachusetts Institute of Technology (MIT).
The first European approval application for a vaccine delivered via
a new intradermal (ID) microinjection system developed by BD
(Becton, Dickinson & Company) has been filed by Sanofi-Pasteur,
the vaccines division of the Sanofi-Aventis...
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.
Novartis has been keen to shout about data published this week in
the Journal of the American Medical Association (JAMA)
that backs up claims that it has developed the first vaccine to
protect infants against the most common meningitis...
Merck has been hit with a contamination threat prompting the recall
of a million of its childhood Hib vaccines across the US, right
alongside the Canadian suspension of its MMR vaccine.
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.
Specialty pharmaceutical company Akorn has signed up with
India-based Cipla in an exclusive manufacturing and supply
agreement for an undisclosed inhaled drug.
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.
Research being carried out at the University of Utrecht in the
Netherlands to replace standard vaccination schedules with a
single-shot alternative could do away with the need for repeated
jabs.
One of the most significant deals to take place in the vaccine
industry in the last ten years was signed late last night between
vaccine heavyweight Novartis and biotech firm Intercell.
A novel super adjuvant is to be put to the test as a new seasonal
flu vaccine enters Phase I trials, and is expected to offer
enhanced immunity and broader protection than other vaccines on the
market.
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.
UK biotech firm Acambis has decided to bring the manufacturing of
its soon to be approved smallpox vaccine in-house while its
agreement with contract manufacturer Baxter comes to an end.
Lower than expected yields of varicella zoster virus (VZV) have
forced Merck & Co to run down US supplies of ProQuad, its
all-in-one children's vaccine for measles, mumps, rubella (German
measles) and varicella (chickenpox).
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.
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...
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.
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...
Crucell yesterday announced it had received the first orders from
US-headquartered Wyeth Biotech. The order represents the first move
following the finalisation of the contract manufacturing agreement
between the two companies at...
Indian pharma firm Panacea Biotec has taken a 10 percent stake in
UK-based vaccine maker Cambridge Biostability (CBL) for £1.9m
(€1.4m) under a new joint venture deal signed between the two
companies.
Dutch biotech company Crucell said last week that it had completed
its acquisition of SBL Vaccin in an agreement worth €39.4m, but
remained tight-lipped about its plans for the Swedish firm's
contract manufacturing business.
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.
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...
Danish biopharmaceutical firm Bavarian Nordic has received approval
from Denmark's government to begin large-scale commercial
production of smallpox vaccine based on its Modified Vaccinia
Ankara (MVA) virus strain which demonstrates...