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RSS FeedPosted by Michael Wonder on 02 Sep 2015
Heart failure drug gets onto UK's early access scheme
2 September 2015 - Certain patients with heart failure in the UK could get treatment with Novartis’ LCZ696 before it is ...
Posted by Michael Wonder on 01 Sep 2015
EMA’s medical literature monitoring enters into full operation
1 September 2015 - The European Medicines Agency (EMA) starts its full medical literature monitoring service on 1 September 2015. ...
Posted by Michael Wonder on 31 Aug 2015
ALK obtains European approval for its house dust mite sublingual allergy immunotherapy tablet against allergic rhinitis and allergic asthma
31 August 2015 - ALK today announced that it has successfully completed the registration procedure for its house dust mite (HDM) ...
Posted by Michael Wonder on 05 Aug 2015
Jinarc recommended for approval in rare kidney disease
The European Medicines Agency (EMA) has recommended granting a marketing authorisation to Jinarc (tolvaptan). Jinarc is indicated to slow the progression of ...
Posted by Michael Wonder on 05 Aug 2015
European CHMP adopts positive opinion for Genzyme’s Cerdelga (eliglustat) capsules
Genzyme, a Sanofi company, announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines ...
Posted by Michael Wonder on 05 Aug 2015
Duaklir Genuair approved in the European Union for chronic obstructive pulmonary disease
AstraZeneca today announced that Duaklir Genuair (aclidinium bromide/formoterol fumarate 340/12 mcg) has been granted Marketing Authorisation by the European Commission (EC) to ...
Posted by Michael Wonder on 05 Aug 2015
Stivarga (regorafenib) from Bayer approved in the European Union for the treatment of gastrointestinal stromal tumors
The oncology compound Stivarga (regorafenib) from Bayer has been approved by the European Commission (EC) for the treatment of adult patients ...
Posted by Michael Wonder on 05 Aug 2015
EU green light for Lilly's Cyramza
European regulators have approved Eli Lilly's Cyramza (ramucirumab) giving patients with difficult-to-treat stomach cancers a new treatment option. ...
Posted by Michael Wonder on 05 Aug 2015
Submissions received: orphan drugs program
The TGA sought comments from interested parties on the orphan drugs program discussion paper in a consultation that closed on 15 ...
Posted by Michael Wonder on 05 Aug 2015
Agenda for 23-26 March 2015 CHMP meeting
The agenda for the 23-26 March 2015 CHMP meeting is now available. Minutes will be made available once they have been endorsed ...
Posted by Michael Wonder on 05 Aug 2015
Novartis lung cancer drug Zykadia gains EU approval, providing new therapy for certain patients with ALK+ NSCLC
Novartis announced today that the European Commission has approved Zykadia (ceritinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced ...
Posted by Michael Wonder on 05 Aug 2015
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 April 2015
Eleven new medicines were recommended for approval at the April 2015 meeting of the Committee for Medicinal Products for Human Use (CHMP). ...
Posted by Michael Wonder on 05 Aug 2015
Scientific advice leads to stronger applications from industry
Adherence to EMA scientific advice on trial design results in higher success rates, shorter overall assessment time and fewer major objections during ...
Posted by Michael Wonder on 05 Aug 2015
European Medicines Agency selects first two medicines to be included in its adaptive licensing pilot project
The European Medicines Agency has received 20 applications so far as part of its adaptive licensing pilot project. Following an ...
Posted by Michael Wonder on 05 Aug 2015
Major European research project on monitoring and evaluation of medicines concludes
The European Medicines Agency (EMA) will host and broadcast a symposium on 19 and 20 February to mark the conclusion of the ...