6 September 2016 - More light than shadow? Beneficial and hindering factors for successful clinical studies. ...
4 September 2016 - Assessment ignores unprecedented overall survival benefit for eribulin in advanced liposarcoma. ...
1 September 2016 - The only study available was unsuitable for the benefit assessment. ...
16 August 2016 - Plans by the European Medicines Agency to expand its fast track approach to approving new drugs have ...
15 August 2016 - in pointed remarks, Germany’s cost-effectiveness watchdog has criticized an effort by European regulators to accelerate approval ...
9 August 2016 - Current EMA report on the pilot project again documents perplexity regarding the use of “real world data”. ...
4 August 2016 - The new indirect comparison is methodologically better but there is still no evidence of an additional ...
25 July 2016 - Germany wants to extend a price brake for drugs covered by statutory health insurance for five years ...
1 August 2016 - Former orphan drug undergoes regular early benefit assessment; submitted studies unsuitable for assessment. ...
1 August 2016 - Advantages in overall survival and side effects. ...
1 August 2016 - Benefits in overall survival, morbidity and side effects. ...
1 August 2016 - Submitted comparisons for the benefit assessment are unsuitable. ...
1 August 2016 - Incorrect study population, studies were too short. ...
1 July 2016 - EMA safety review invokes reassessment but still no relevant data. ...
1 July 2016 - Survival advantage, but also disadvantages. ...