Pandemrix-narcolepsy link

Finland’s National Institute for Health and Welfare (THL) suggests that the link between swine flu vaccine Pandemrix and narcolepsy – a sleeping disorder that leads to extreme fatigue and can cause patients to fall asleep at unexpected times – is high.

Pandemrix was first approved for use by the European Medicines Agency (EMA) in 2009 during the H1N1 flu pandemic and was given to over 31 million people. Following concerns about the link to narcolepsy, the EMA carried out a review, but found no evidence to the fact.

Now an interim report by the THL suggests a clear association of Pandemrix and the sleeping disorder among those vaccinated aged between 4 and 19 years old. The report states that the risk of developing narcolepsy is nine times higher for vaccine patients in this age range than people who have not been vaccinated.

In 2009 and 2010, 90 per cent of children and adolescents that fell ill with narcolepsy had received Pandemrix. In a statement the THL said: ‘The observed association is so evident that it is unlikely that other so-called confounding factors could fully explain the phenomenon.’

BASF research spending reaches record level…..

In 2010, chemical giant BASF’s research and development (R&D) expenditure rose to a record high of nearly €1.5 billion (£1.3 billion), compared to €1.4 billion in 2009.

‘Research and development are the foundations to secure our future. BASF will therefore also be increasing its R&D spending in 2011, the International Year of Chemistry,’ said Andreas Kreimeyer, research executive director and member of BASF’s board of executive directors.

In 2010, BASF set itself the target of €6 billion sales of new and improved products and applications that have been on the market for less than five years. And by 2015 it is hoped that the company will be generating between €6 and €8 billion in sales through innovation.

…. whilst it realigns paper dyes business

In other news, BASF is to realign its paper chemicals division. It will be closing its production facility for the manufacture of basazol dyes at the Ludwigshafen site in Germany.

Going forward, the demand for paper dyes in Europe will be met by two BASF productions sites in Ankleshwar, in India, and Altamira, in Mexico.

The realignment signifies the completion of BASF’s restructuring of its paper dye business at the global level.

AstraZeneca halts zibotentan trial

Pharma giant AstraZeneca (AZ) has announced that the Phase III trial (Enthuse Study 15) of zibotentan, for the treatment of non-metastatic castrate resistant prostate cancer (CRPC), will be stopped following a review by the independent data monitoring committee (IDMC).

Zibotentan tablets work by blocking the endothelin pathway. As prostate cancer advances, the pathway becomes uncontrolled and the cancer spreads. By blocking the endothelin A receptor, zibotentan can slow tumour growth.

The review showed that zibotentan did not show a significant improvement in the overall survival in patients and was therefore unlikely to benefit patients with non-metastatic CRPC.

Manufacturing Humaneered antibodies

KaloBios Pharmaceuticals has signed a research and commercial agreement with BioWa (subsidiary of Kyowa Hakko Kirin – Japan’s leading pharma company) and Lonza (supplier to the pharmaceutical, healthcare and life sciences industries) to use their Potelligent CHOK1SV cell line for the development and production of Humaneered antibodies.

Spotlight on toxic metals

Researchers warn that even exposure to low levels of toxic metals can harm human health. Among the toxic metals that researchers have been looking at are arsenic, cadmium and lead.

The European Union funded project PHIME (Public health impact of long-term, low-level mixed element exposure in susceptible population strata) is calling for policy makers to systematically monitor toxic metal levels in populations and take steps to reduce the release of these substances into the environment.

Mike Brown

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