Blog
RSS FeedPosted by Michael Wonder on 20 Sep 2019
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 ...
Posted by Michael Wonder on 19 Sep 2019
5 people setting EU drug prices
19 September 2019 - Politic’s guide to the policy makers debating how to calculate the cost of cures. ...
Posted by Michael Wonder on 19 Sep 2019
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. ...
Posted by Michael Wonder on 19 Sep 2019
Flawed evidence underpins approval of new cancer drugs
18 September 2019 - We must raise the bar to ensure real benefits for patients ...
Posted by Michael Wonder on 19 Sep 2019
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 ...
Posted by Michael Wonder on 18 Sep 2019
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 ...
Posted by Michael Wonder on 18 Sep 2019
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 ...
Posted by Michael Wonder on 16 Sep 2019
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 ...
Posted by Michael Wonder on 16 Sep 2019
EMA publishes agenda for 16-19 CHMP meeting
13 September 2019 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 14 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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 ...
Posted by Michael Wonder on 11 Sep 2019
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, ...
Posted by Michael Wonder on 09 Sep 2019
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 ...
Posted by Michael Wonder on 07 Sep 2019
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 ...
Posted by Michael Wonder on 07 Sep 2019
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 ...