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The higher price of new cancer drugs is rarely justified

News 27 September 2019 0

Most cancer drugs introduced since 2004 provide low added value compared to previously approved medications, but have much higher prices, according to a French study presented at the congress of the European Society for Medical Oncology [more]

Trials on anticancer drugs often have inadequate control arms

News 13 May 2019 0

Randomized controlled trials that have been used for the FDA approval of new anticancer drugs were sometimes based on a flawed design, with suboptimal control arms: “Using a suboptimal control arm may bias a trial in [more]

FDA warns that we are trusting surgeon-robots too much

News 15 April 2019 0

The US Food and Drug Administration issued a safety communication about robotically-assisted surgical procedures for cancer prevention or treatment, pointing out that their safety and effectiveness has not been established yet. In the Unites States, the [more]

For the first time, the FDA approves a cancer drug for use based on biomarker and not origin

News 29 May 2017 0

Pembrolizumab is the first drug approved by the U.S. Food and Drug Administration for use based on a biomarker (a specific genetic feature) rather than the location in the body where the tumor originated. The drug is indicated [more]

Approval rating: how do the EMA and FDA compare?

Number 58

Cutting Edge 1 January 2014 0

When new cancer therapies regularly become available more than half a year earlier in the US than in Europe, or get regulatory approval on one side of the Atlantic but not on the other, patients [more]

We don’t have to be a year behind

Number 11

Editorial 1 March 2006 0

Late last year, US patients with advanced renal cell cancer gained access to an oral multi-kinase inhibitor, Nexavar (sorafinib) – the first new drug approved for this disease in the last 10 years. Manufacturer Bayer [more]

LATEST PRINTED ISSUE

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  • Four steps to eliminating HPV infections across Europe: an ECCO call for EU action

    News 16 October 2020 0
    A new report underlines that vaccination, screening, treatment and public awareness, provide the cornerstone for eliminating human papillomavirus (HPV) in Europe. The report was published by The European [more]

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