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RSS FeedPosted by Michael Wonder on 05 Aug 2015
EU approves Sanofi's new Gardasil jab
A new version of Sanofi Pasteur MSD’s Gardasil has been approved by European regulators for protection against nine strains of ...
Posted by Michael Wonder on 05 Aug 2015
Agenda for the 20-23 October 2014 CHMP meeting
The European Medicines Agency has published the agenda for this week's Committee for medicinal products for human use (CHMP) meeting. The ...
Posted by Michael Wonder on 05 Aug 2015
Novartis lung cancer drug Zykadia recommended for EU approval in patients with ALK+ NSCLC previously treated with crizotinib
27 February 2015 - Novartis announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
Posted by Michael Wonder on 05 Aug 2015
New indication for Bayer/Regeneron's Eylea in EU
European regulators have expanded the use of Bayer and Regeneron’s Eylea (aflibercept), approving the drug’s use to treat visual impairment ...
Posted by Michael Wonder on 05 Aug 2015
Boehringer Ingelheim submits applications for approval of idarucizumab, specific reversal agent to dabigatran etexilate (Pradaxa), to EMA, FDA and Health Canada
Boehringer Ingelheim today announces that idarucizumab has been submitted for approval of marketing authorisation to the European Medicines Agency (EMA), ...
Posted by Michael Wonder on 05 Aug 2015
CHMP grants positive opinions of AbbVie/s Viekirax (ombitasvir with paritepravir and ritonavir) and Exviera (dasabuvir sodium) for the treatment of chronic hepatitis C in Europe
The European Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted positive opinions ...
Posted by Michael Wonder on 05 Aug 2015
Agenda for the CHMP meeting to be held on 19-22 January 2015
16 January 2015 - The EMA has published the agenda for this week's CHMP meeting. Minutes are made available once they have ...
Posted by Michael Wonder on 05 Aug 2015
New INN publication: “Biological Qualifier An INN Proposal”
The “Biological Qualifier An INN Proposal” document has been published on the INN website. ...
Posted by Michael Wonder on 05 Aug 2015
Alimera Sciences' Iluvien receives marketing authorization in Denmark for the treatment of chronic diabetic macular edema
Alimera Sciences, Inc, a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced ...
Posted by Michael Wonder on 05 Aug 2015
Amgen submits marketing authorization application for talimogene laherparepvec to the European Medicines Agency
Amgen today announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for talimogene ...
Posted by Michael Wonder on 05 Aug 2015
Shire receives European approval to use Resolor (prucalopride succinate) in men for the symptomatic treatment of chronic constipation
Shire plc announced today that Resolor (prucalopride succinate) has been approved by the European Commission for use in adults for the ...
Posted by Michael Wonder on 05 Aug 2015
Tresiba receives positive opinion from CHMP for treatment of children with diabetes
Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for ...
Posted by Michael Wonder on 05 Aug 2015
Lynparza approved in the European Union as first-in-class treatment for advanced BRCA-mutated ovarian cancer
AstraZeneca today announced that the European Commission (EC) has granted Marketing Authorisation for Lynparza (olaparib) capsules (400mg twice daily) as the ...
Posted by Michael Wonder on 05 Aug 2015
Novo Nordisk receives positive opinion from the European regulatory authorities for Saxenda (liraglutide 3 mg) for the treatment of obesity
Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) ...
Posted by Michael Wonder on 05 Aug 2015
Conflicts of interests: revised EMA policy reflects more balanced approach
The EMA has published its revised policy on handling declarations of interests for scientific committee members and experts. The revisions reflect ...