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2012 review

This page shows the latest 2012 review news and features for those working in and with pharma, biotech and healthcare.

Vertex submits Kalydeco combo for cystic fibrosis

Vertex submits Kalydeco combo for cystic fibrosis

Vertex is seeking additional review advantages from the FDA, including a priority review designation, which, if granted, would shorten the assessment time from one year to eight months. ... The combination treatment has already been granted accelerated

Latest news

  • Amgen leukaemia drug gets FDA priority review Amgen leukaemia drug gets FDA priority review

    Amgen acquired rights to blinatumomab and other BiTE antibodies when it bought German biotech Micromet for $1.16bn in 2012. ... Breakthrough status also makes drugs eligible for priority review, which reduces the review time by up to six months.

  • Amgen and Boehringer drugs win FDA breakthrough status Amgen and Boehringer drugs win FDA breakthrough status

    The FDA introduced its breakthrough status designation in 2012 to speed up the review process for important new drugs in serious or life threatening conditions that have shown substantial improvements over

  • Going off-label? Going off-label?

    First Amendment arguments have long factored into discussions in promotional enforcement cases, but until recently, these arguments have not had the benefit of meaningful court scrutiny and review. . ... On December 3, 2012, however, the US Court of

  • EU nod for Bayer’s Stivarga as Nexavar gets US priority review EU nod for Bayer’s Stivarga as Nexavar gets US priority review

    cancer and Nexavar given a priority review in the US for thyroid cancer. ... sales have started to plateau a little with turnover actually a little down on the same period of 2012.

  • FDA delays GlaxoSmithKline's pandemic flu vaccine FDA delays GlaxoSmithKline's pandemic flu vaccine

    According to agency regulations, the FDA had been scheduled to conclude its review for the vaccine in December 2012, and at the moment the likely length of the delay is unknown. ... GSK and the FDA are actively working together to complete the review in

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Latest Intelligence

  • Unfolding the biosimilar landscape in Latin America Unfolding the biosimilar landscape in Latin America

    In fact, according to the World Health Organization (WHO), spending on healthcare in the region has more than doubled in the last 10 years, reaching over $350bn in 2012. . ... In Colombia, where  there are still no biosimilars regulation in place,

  • Pharma deals during January 2013 Pharma deals during January 2013

    In this first review of 2013, as normal, we are focusing on the top headline value transactions (where financial terms are disclosed) announced during January. ... January is also a good opportunity for us to test the water with the predictions made by

  • Pharma deals during September 2012 Pharma deals during September 2012

    In this regular review of deals we focus on transactions announced during September 2012. ... In this regular review of deals we focus on the transactions announced during September 2012.

  • Pharma deals during July 2012 Pharma deals during July 2012

    In this regular review of deals we focus on transactions announced during July 2012. ... The latest biosimilar deal with the Dutch company Synthon is demonstration that the alliance established in December 2012 between Amgen and Watson to develop and

  • Country report: The healthcare market in Japan Country report: The healthcare market in Japan

    A 'price premium' was created to reward innovative drugs on a trial basis and some form of this is likely to be adopted after the biennal price review of April 2012. ... The FPMAJ is concerned that the 2012 price review may not include full

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