Blog
RSS FeedPosted 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
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 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 ...
Posted by Michael Wonder on 07 Sep 2019
Lonsurf (trifluridine/tipiracil) receives marketing authorisation in Europe for patients with previously treated metastatic gastric cancer
6 September 2019 - Servier and its partner Taiho Pharmaceutical announced today that the European Commission has approved the use ...
Posted by Michael Wonder on 05 Sep 2019
European Commission approves Merck’s Keytruda (pembrolizumab) in combination with Inlyta (axitinib) as first-line treatment for patients with advanced renal cell carcinoma
4 September 2019 - European approval based on KEYNOTE-426 trial results demonstrating significant improvement in overall survival with Keytruda in combination ...
Posted by Michael Wonder on 05 Sep 2019
European Commission approves expanded use of Janssen’s Stelara (ustekinumab) for the treatment of moderately to severely active ulcerative colitis in the European Union
4 September 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission has approved the ...
Posted by Michael Wonder on 03 Sep 2019
Added therapeutic benefit and drug licensing
3 September 2019 - One aspect of the ongoing debate about drug pricing is the added therapeutic benefit of new drugs ...
Posted by Michael Wonder on 02 Sep 2019
La Jolla Pharmaceutical receives European Commission approval for Giapreza (angiotensin II)
29 August 2019 - La Jolla Pharmaceutical Company today announced that the European Commission has approved Giapreza (angiotensin II) for ...
Posted by Michael Wonder on 29 Aug 2019
EMA offers edits on FDA draft guidance on biosimilars
29 August 2019 - Although regulators rarely offer public comments on another regulator’s guidance, the European Medicines Agency (EMA) late ...
Posted by Michael Wonder on 29 Aug 2019
European Commission approves Roche’s Tecentriq in combination with Abraxane for people with PD-L1-positive, metastatic triple-negative breast cancer
29 August 2019 - Approval based on the Phase III IMpassion130 study, which showed that the combination improved outcomes in people ...
Posted by Michael Wonder on 28 Aug 2019
European Commission approves Soliris (eculizumab) for the treatment of adults with neuromyelitis optica spectrum disorder
27 August 2019 - 98% of adult anti-aquaporin-4 antibody-positive patients treated with Soliris were relapse free compared to 63% receiving placebo ...