Vaccines

There are a variety of vaccine types, each varying in safety and efficacy, and each possessing its own formulation challenges. To overcome potential instabilities when developing vaccines, one formulation strategy is to produce a dried product.

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

Hoping to prevent the deaths of eight million children over the next decade, Bill and Melinda Gates recently committed $10 billion for child-immunization programs in the world's poorest countries.

Vaccine R&D is surging, but continues to raise manufacturing and regulatory challenges.

The vaccine sector is challenging for both R&D and manufacturing because a wide variety of technologies and techniques are required — even the largest companies find it difficult to cover all the relevant areas of expertise — and this drives up development costs and often forces companies into multiple collaborations to obtain the required expertise and technologies.

Influenza vaccines can be produced faster using a new insect cell-based technology compared with traditional egg-based processes, according to scientists in Vienna (Austria).

Zydus Cadila, a pharmaceutical company based in Ahmedabad, Gujarat, India, will begin conducting trials for a H1N1 vaccine.

There is a pressing need to improve the storage stability of currently available vaccines, and achieving this could facilitate mass vaccination campaigns and increase vaccination coverage on a global scale — particularly to underserved and remote regions of the world.

Also, Abbott to acquire Starlims Technologies; GSK Biologicals to form alliance with Intercell.

Novartis officially inaugurated its large-scale flu cell-culture vaccine and adjuvant manufacturing facility in Holly Springs, North Carolina.

After further reviewing data on the H1N1 pandemic vaccines approved in Europe, the EMEA has reaffirmed their balance of benefits and risks in the context of the current H1N1 influenza pandemic. Additionally, the World Health Organization (WHO) has issued an update on the H1N1 situation in Europe.

The European Medicines Agency confirmed the safety and efficacy of Focetria and Pandermix, and noted that data on Celvapan are still being analyzed.

GlaxoSmithKline (GSK) has agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO).

Last week, GlaxoSmithKline (GSK, London) agreed to donate 50 million doses of its adjuvanted pandemic influenza A (H1N1) vaccine to the World Health Organization (WHO).

FDA has approved a fifth influenza A (H1N1) vaccine, manufactured by ID Biomedical.

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Novartis reported that German regulatory authorities approved its adjuvanted cell culture-based Influenza A (H1N1) 2009 monovalent vaccine, Celtura. The company also said it will acquire a stake in Chinese vaccines company Zhejiang Tianyuan Bio-Pharmaceutical.

The European Medicines Agency, the European Center for Disease Prevention and Control, and the Heads of Medicines Agencies issued a European strategy for H1N1 vaccine benefit–risk monitoring.

GlaxoSmithKline (GSK), Novartis, sanofi aventis and Baxter International have provided updates regarding the development, manufacture and shipment of pandemic (H1NI) vaccines.

A long-term joint venture between GlaxoSmithKline (GSK) and China's Jiangsu Walvax Biotech Company hopes to develop and manufacture paediatric vaccines for use in China.

GlaxoSmithKline (London), Novartis (Basel, Switzerland), sanofi Aventis (Paris), and Baxter International (Deerfield, IL) recently provided updates as to the development, manufacture, or shipment of pandemic (H1NI) vaccines.

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Two vaccines manufactured by Novartis and GlaxoSmithKline (GSK) against influenza H1N1 have been recommended by the EMEA for marketing authorization.

On September 25, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended the authorization of two vaccines for use in Europe against the H1N1 influenza: GlaxoSmithKline's (GSK) Pandemrix and Novartis's Focetria.

A joint venture between a charity and a pharma giant has led to the creation of the Hilleman Laboratories, which will use a not-for-profit operating model to develop and deliver vaccines to low-income countries.

The US Food and Drug Administration approved on Tuesday four H1N1 flu vaccines that demonstrated in clinical studies that a single dose produced a strong immune response in healthy adults after 8?10 days. But clinical trials of the vaccine are still underway on pregnant women and children, two groups that the Centers for Disease Control and Prevention (CDC) says are especially vulnerable to the H1N1 flu.

The FDA has approved four vaccines for the H1N1 influenza virus, while other companies, including UK pharma giant GlaxoSmithKline (GSK), have reported promising results from clinical studies with a single dose vaccine.

The US Food and Drug Administration has approved four vaccines for the H1N1 influenza virus, while other companies, including GlaxoSmithKline (GSK), have reported promising results from clinical studies with a single dose vaccine.

Now expected to obtain its production license during the next few days, an H1N1 vaccine developed by Sinovac Biotech (China) has passed the experts' evaluation by the Chinese State Food and Drug Administration (SFDA).

An H1N1 vaccine developed by biopharmaceutical company Sinovac Biotech (Beijing, China) has passed the experts evaluation organized by the Chinese State Food and Drug Administration (SFDA) and the company is expected to obtain a production license before the week's end.