Emmaus Life Sciences announces withdrawal of marketing authorisation application to European Medicines Agency

19 September 2019 - Emmaus Life Sciences today announced the withdrawal of its marketing authorisation application to the European Medicines ...

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5 people setting EU drug prices

19 September 2019 - Politic’s guide to the policy makers debating how to calculate the cost of cures. ...

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Novartis has submitted application to EMA for approval of Cosentyx in nr-axSpA, which would be the fourth indication

17 September 2019 - 52-week data from the PREVENT study, to support FDA submission, are expected later in the year. ...

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Flawed evidence underpins approval of new cancer drugs

18 September 2019 - We must raise the bar to ensure real benefits for patients ...

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Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis

18 September 2019 - In this study, the investigators examined the characteristics of randomised controlled trials that supported approval of cancer ...

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Baby Pia: almost 1 million Belgians pay for life-saving drug

18 September 2019 - More than 950,000 Belgians have responded to a couple seeking €1.9m ($2m; £1.7m) to cover the ...

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Biofrontera files label extension for Ameluz in EU to include treatment of actinic keratosis on extremities and trunk/neck

17 September 2019 - Biofrontera has filed a label extension for Ameluz with the EMA on August 28, 2019 to include ...

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HTA in the European Union: osteoporosis screening without proof of benefit

16 September 2019 - For the first time, an IQWiG team is in charge of assessing health technology for the ...

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EMA publishes agenda for 16-19 CHMP meeting

13 September 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...

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Defining capacity building in the context of HTA: a proposal by the HTAi Scientific Development and Capacity Building Committee

11 September 2019 - A review of capacity building activities undertaken by HTAi members, members of the International Network of Agencies ...

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Biosimilar and interchangeable: inseparable scientific concepts?

4 September 2019 - As defined by the European Commission, the term interchangeability refers to “the possibility of exchanging one medicine ...

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The use of validated and non-validated surrogate endpoints in two EMA expedited approval pathways: A cross-sectional study of products authorised 2011–2018

10 September 2019 - In situations of unmet medical need or in the interests of public health, expedited approval pathways, ...

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Allergan and Molecular Partners announce acceptance of U.S. FDA biologics license application and validation of EMA marketing authorisation for abicipar pegol in patients with neovascular (wet) age-related macular degeneration

9 September 2019 - Filing includes data from two Phase 3 trials which evaluated the safety and efficacy of abicipar quarterly ...

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European Commission approves Roche’s new Tecentriq-based combination therapy as an initial treatment for most common form of advanced lung cancer

6 September 2019 - Decision based on data showing that the Tecentriq plus chemotherapy combination demonstrated a significant overall survival ...

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European Commission approves Roche’s Tecentriq in combination with chemotherapy for the initial treatment of people with extensive-stage small cell lung cancer

6 September 2019 - Tecentriq in combination with chemotherapy (carboplatin and etoposide) is the first and only cancer immunotherapy approved by ...

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