Blog
RSS FeedPosted by Michael Wonder on 01 Aug 2016
EMA to review marketing authorisation application for sarilumab
1 August 2016 - Sanofi and Regeneron Pharmaceuticals have announced the EMA has accepted for review the marketing authorisation application for ...
Posted by Michael Wonder on 31 Jul 2016
Modelling and simulation in the development and regulatory review of medicines
29 July 2016 - Comments on new guidance invited until 31 January 2017. ...
Posted by Michael Wonder on 28 Jul 2016
EMA publishes EPAR for Zepatier (grazoprevir with elbasvir)
28 July 2016 - The EMA has published an EPAR for Merck's Zepatier. ...
Posted by Michael Wonder on 28 Jul 2016
EMA publishes EPAR for Epclusa (sofosbuvir with velpatasvir)
28 July 2016 - The EMA has published an EPAR for Gilead's Epclusa. ...
Posted by Michael Wonder on 26 Jul 2016
Allergan receives positive opinion for Truberzi (eluxadoline) for treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults
25 July 2016 - Significant step towards bringing the only licensed prescription medication for IBS-D to patients in 28 countries of ...
Posted by Michael Wonder on 25 Jul 2016
What constitutes a new medicine?
26 July 2016 - The EMA's definition of a new medicine is a very liberal one. ...
Posted by Michael Wonder on 25 Jul 2016
CHMP issues positive opinion for Orencia (abatacept) in the treatment of highly active and progressive disease in adult patients with rheumatoid arthritis not previously treated with methotrexate in the EU
25 July 2016 - Bristol-Myers Squibb Company today announced that the CHMP of the EMA has issued a positive opinion, recommending ...
Posted by Michael Wonder on 25 Jul 2016
Onivyde receives positive CHMP opinion for treatment of patients with metastatic adenocarcinoma of the pancreas who have progressed following gemcitabine based therapy
25 July 2016 - The positive opinion is based on a pivotal Phase 3 study showing that Onivyde combined with chemotherapy ...
Posted by Michael Wonder on 25 Jul 2016
CHMP grants positive opinion for shorter treatment duration with AbbVie's Viekirax (ombitasvir/paritaprevir/ritonavir tablets) for patients with genotype 4 chronic hepatitis C with compensated cirrhosis (Child-Pugh A)
25 July 2016 - The CHMP opinion represents a positive advance toward approval of the 12-week regimen of Viekirax with ribavirin ...
Posted by Michael Wonder on 22 Jul 2016
Highlights from the CHMP 18-21 July 2016 meeting
22 July 2016 - Eight medicines recommended for approval; use of Truvada extended to include pre-exposure prophylaxis (PrEP) against HIV-1 infection. ...
Posted by Michael Wonder on 22 Jul 2016
Two new medicines for advanced kidney cancer
21 July 2016 - Cabometyx and Kisplyx provide additional treatment options for patients with unmet medical need. ...
Posted by Michael Wonder on 22 Jul 2016
First medicine for HIV pre-exposure prophylaxis recommended for approval in the EU
22 July 2016 - Truvada to enhance existing HIV prevention strategies. ...
Posted by Michael Wonder on 22 Jul 2016
Mylan and Biocon announce regulatory submission for proposed biosimilar pegfilgrastim accepted for review by European Medicines Agency
21 July 2016 - Mylan and Biocon Ltd. announced today that the EMA has accepted for review, Mylan's marketing authorization application ...
Posted by Michael Wonder on 21 Jul 2016
Proposals to revise guidance on first-in-human clinical trials
21 July 2016 - Comments invited on a concept paper on changes intended to support best practices. ...
Posted by Michael Wonder on 20 Jul 2016
AstraZeneca receives approval in the EU for Qtern (saxagliptin and dapagliflozin) for treatment of type 2 diabetes mellitus
19 July 2016 - AstraZeneca today announced that the European Commission has approved Qtern (saxagliptin/dapagliflozin) tablets for the treatment of type ...