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17 September 2010
Viajes: Descubrir la belleza intacta del Alentejo( Portugal)

Novartis withdraws application for EU approval of Rasival
In its letter, the drugmaker said its decision not to pursue approval of the drug was based on its inability to address requests from the agency's Committee for Medicinal Products for Human Use and provide additional data within the allowed timeframe.
Reference Articles
Novartis Europharm withdraws its marketing authorisation application for Rasival (aliskiren/valsartan) - (EMA)
EU drug panel: Novartis Europharm withdraws drug marketing application - (Morningstar)
**Published in "First Word"
La Fundación Española de la Contracepción indica que se ha duplicado la venta de la píldora postcoital
La venta en farmacias de la píldora postcoital o del "día después" ha aumentado en un 100% desde septiembre de 2009, cuando el Gobierno dio luz verde a la libre dispensación de este producto sin necesidad de receta médica. Así lo ha asegurado el presidente de la Fundación Española de Contracepción, Ezequiel Pérez, con motivo del Día Mundial de Anticoncepción que se celebra este viernes, ya que desde esta aprobación se han vendido más de medio millón de unidades (unas 600.000) cuando en años anteriores las farmacias no superaban las 300.000. De hecho, ha añadido este experto, ha habido algunos meses en los que el incremento al mismo periodo de 2009 ha sido "mucho mayor", como en julio (las ventas aumentaron un 133%) o en abril (un 191% más).
A estas ventas habría que añadir la dispensación que haya tenido lugar en los centros de salud o de planificación familiar y que han tenido una con lo que "no se puede hacer una valoración real del impacto que ha podido tener la libre dispensación en el aumento del uso de este método", ha señalado.
Sin embargo, pese a ello, Pérez no considera que se esté haciendo un uso "abusivo" como se esperaba "ni se ha provocado ninguna apocalipsis" o una "demanda masiva", así como también ha reconocido que "no se ha notificado ningún efecto secundario grave". Pese a estas cifras, este experto ha insistido en la necesidad de hacer un seguimiento "para ver qué pasa después" y recuerda que "sólo debe usarse cuando falla el anticonceptivo habitual y no como anticonceptivo regular".
-RELACIÓN CON UN DESCENSO DE LOS ABORTOS
Según el presidente de la FEC, este mayor uso de la píldora postcoital "puede tener que ver" con el descenso del número de abortos que las comunidades dicen haber experimentado en el último año, ya que "ese era uno de los motivos de su libre dispensación". Además, la presidenta de la Federación Española de Contracepción, Esther de la Viuda, ha reconocido que en otros países también se produjo este aumento en las ventas que quedan justificadas en que "es un método seguro y eficaz".
La doctora De la Viuda ha apuntado que a este descenso del número de abortos también contribuirá la Ley de Salud Sexual y Reproductiva, pese a que "se ha visto mediatizada con la modificación de la ley del aborto". Por su parte, Ezequiel Pérez ha criticado al Gobierno por haber trabajado con "improvisación" a la hora de elaborar esta normativa, ya que les llegó una circular con las medidas que modificaciones que incluía la ley "tres días antes de su publicación en el BOE".
Interview with Sabine Kostevc on behalf of Roche
Boehringer Ingelheim Initiates Phase III Clinical Trial with Novel Oral Agent in Advanced Breast Cancer
This pivotal phase III clinical trial, called the “LUX-Breast 1 Trial” is the first to evaluate afatinib in breast cancer, and this investigation widens the scope of potential cancer types for which Boehringer Ingelheim’s oncology portfolio may be suitable. Afatinib is currently investigated in an extensive clinical trial programme, the LUX-Lung Programme in lung cancer. Results from LUX -Lung 1 are due to be reported this year.
LUX-Breast I, is a global, open-label randomised phase III pivotal study in patients with advanced breast cancer after prior treatment with trastuzumab who have an over expression of the HER2 protein (HER2-positive patients). The study investigates whether treatment with afatinib can extend the lives of these patients before their cancer progresses (i.e. progression-free survival, PFS) as compared to continuing treatment with trastuzumab when both are added to the standard chemotherapy treatment vinorelbine. Overall survival, tolerability and safety will also be assessed in the study.
“We have seen positive results in our proof-of-concept studies for afatinib in breast cancer and are glad to advance the programme into pivotal phase III. We are delighted to be able to initiate this important trial together with a range of leading investigators to assess the value of afatinib for women with advanced breast cancer.” said Prof. Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.
Breast cancer is the leading cause of cancer deaths in women globally, resulting in more than 411,000 deaths each year ii. HER2-positive breast cancer is a particularly aggressive form of the disease and is associated with a greater risk of disease progression and death compared to women with HER2-negative tumours iii. It is thought that in approximately 30% of advanced breast cancer cases, women overexpress the HER2 protein iv.
The initiation of the LUX-Breast I trial represents yet another important milestone for Boehringer Ingelheim to broaden and amplify its oncology development activities beyond lung cancer, again initiating the development of a potential novel agent for the treatment of an aggressive advanced cancer type.
**Published in "PharmPro"
IVF has best chance of success in spring
A team led by Daniela Braga of the Assisted Fertilisation Centre in São Paulo, Brazil, measured hormone levels in 1932 women undergoing IVF treatment. They found that levels of oestradiol - which is vital for reproduction - were significantly higher in the spring, and correlated with a 45 per cent higher fertilisation rate during this season.
Another survey presented at the conference, by the International Federation of Fertility Societies, highlighted the lack of consistent global safety standards for IVF. Ian Cooke of the IFFS, who co-authored the survey, is now developing an international code of practice
**Published in "News Scientist Health"
Antibiotics play hell with gut flora

Les Dethlefsen and David Relman of Stanford University in California collected more than 50 stool samples from three people over a 10-month period that included two courses of the antibiotic ciprofloxacin. They used gene sequencing to identify the microbial strains present in each sample. They found that each person had a unique set of microbial flora, the composition of which fluctuated around an equilibrium which was disrupted by each course of drugs.
In most cases, the composition quickly returned to its previous state, but in a few, bacterial species present before treatment were replaced by related species. One person completely lost a common genus of bacteria, which did not return for the duration of the study (Proceedings of the National Academy of Sciences, DOI: 10.1073/pnas.1000087107).
Each round of antibiotics is a roll of the dice that could lead to lasting changes in a person's gut microbes, says Dethlefsen. The work shows that antibiotics should be used only when truly necessary, he says.
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