Blog
RSS FeedPosted by Michael Wonder on 02 Oct 2018
Boosting the development of medicines for children
2 October 2018 - The EMA and the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) have published ...
Posted by Michael Wonder on 28 Sep 2018
Harnessing the potential of real world data through a ‘learning health care system'
28 September 2018 - Real world data hold the promise to substantially increase the effectiveness and efficiency of all processes ...
Posted by Michael Wonder on 26 Sep 2018
EMA takes issue with BMJ article on Pandemrix vaccine
27 September 2018 - A recent article in the BMJ suggested that one pandemic flu vaccine was less safe than ...
Posted by Michael Wonder on 26 Sep 2018
EMA launches new corporate website
26 September 2018 - The European Medicines Agency (EMA) has launched a new version of its corporate website (www.ema.europa.eu) today. ...
Posted by Michael Wonder on 25 Sep 2018
Bydureon receives positive EU CHMP opinion for EXSCEL cardiovascular outcomes data
25 September 2018 - Label now includes data that demonstrated favourable cardiovascular safety profile for patients with type 2 diabetes mellitus ...
Posted by Michael Wonder on 25 Sep 2018
European Commission approves Imfinzi for locally-advanced, unresectable NSCLC
24 September 2018 - Phase III PACIFIC trial demonstrated compelling overall survival benefit and progression-free survival of more than 11 ...
Posted by Michael Wonder on 25 Sep 2018
Astellas receives positive CHMP opinion for Xtandi (enzalutamide) for adult men with high-risk non-metastatic castration-resistant prostate cancer
25 September 2018 - Results from the PROSPER trial show a median metastasis-free survival of 36.6 months for enzalutamide plus androgen ...
Posted by Michael Wonder on 25 Sep 2018
Companies stepping up efforts to ensure medicine supply post Brexit
24 September 2018 - Focus is now on 39 centrally authorised medicines, down from 108. ...
Posted by Michael Wonder on 24 Sep 2018
EMA to launch new corporate website on 27 September 2018
24 September 2018 - Fresh design and improved features to provide better user experience ...
Posted by Michael Wonder on 24 Sep 2018
Trelegy Ellipta receives positive CHMP opinion supporting expanded COPD indication in Europe
21 September 2018 - GlaxoSmithKline and Innoviva announced that the EMA CHMP has issued a positive opinion today supporting the use ...
Posted by Michael Wonder on 24 Sep 2018
Takeda receives positive CHMP opinion recommending Alunbrig (brigatinib) for the treatment of ALK+ non-small cell lung cancer in patients previously treated with crizotinib
21 September 2018 - Opinion based on pivotal Phase 2 ALTA trial, in which Alunbrig demonstrated an objective response rate of ...
Posted by Michael Wonder on 24 Sep 2018
Bayer receives positive CHMP opinion for its haemophilia A treatment BAY94-9027
21 September 2018 - The safety and efficacy profile of BAY94-9027 has been demonstrated in more than five years of clinical ...
Posted by Michael Wonder on 24 Sep 2018
Melinta Therapeutics receives positive CHMP opinion for Vabomere (meropenem and vaborbactam)
21 September 2018 - Recommended to be approved for treatment of patients with bacterial infection of various sites. ...
Posted by Michael Wonder on 24 Sep 2018
Ipsen receives positive CHMP opinion for Cabometyx (cabozantinib) for the second-line treatment of patients with hepatocellular carcinoma
21 September 2018 - Ipsen announced today that the CHMP, the scientific committee of the EMA), provided a positive opinion for ...
Posted by Michael Wonder on 24 Sep 2018
Merck receives positive CHMP opinion for Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) and Pifeltro (doravirine) in the European Union for the treatment of HIV-1 infection
20 September 2018 - Merck today announced that the CHMP of the EMA has adopted a positive opinion recommending granting of ...