Blog
RSS FeedPosted by Michael Wonder on 15 Mar 2017
Can a statistical method speed drug approvals?
13 March 2017 - Not likely, says F. Perry Wilson, MD. ...
Posted by Michael Wonder on 10 Mar 2017
EBE, EFPIA and IFPMA have today launched a position paper entitled “Considerations for physicians on switching decisions regarding biosimilars”
9 March 2017 - Switching describes a physician's decision to exchange one product that a patient receives for another. ...
Posted by Michael Wonder on 13 Dec 2016
Approving a problematic muscular dystrophy drug: implications for FDA policy
13 December 2016 - In September 2016, the US FDA approved eteplirsen (Exondys 51), a new drug for Duchenne muscular ...
Posted by Michael Wonder on 16 Nov 2016
Drug makers to FDA: Let us share off-label study data with payers
16 November 2016 - Now that pharma has prevailed in free-speech legal battles concerning off-label marketing, it’s pushing the FDA ...
Posted by Michael Wonder on 16 Oct 2016
Bad medicine
15 October 2016 - Approving an unproven drug sets a worrying precedent. ...
Posted by Michael Wonder on 18 Jul 2016
Generic drug approvals since the 1984 Hatch-Waxman Act
18 July 2016 - This study uses US FDA data to identify approved generic drugs manufactured between September 30, 1984, and ...
Posted by Michael Wonder on 20 May 2016
Accessing key EMA information on human medicines
20 May 2016 - New guide to information about medicines evaluated by the EMA. ...
Posted by Michael Wonder on 28 Apr 2016
Involving general practitioners in regulatory decisions on medicines
28 April 2016 - EMA workshop with general practitioners and family doctors kicks off strengthened collaboration. ...
Posted by Michael Wonder on 24 Feb 2016
FDA statement on Senate confirmation of Dr. Robert M. Califf
24 February 2016 - Today the U.S. Senate voted in support of the confirmation of Dr. Robert Califf, M.D. to ...
Posted by Michael Wonder on 06 Oct 2015
FDA approves new injectable drug to treat schizophrenia
7 October 2015 - On October 5, the U.S. Food and Drug Administration approved Aristada (aripiprazole lauroxil) extended release injection to ...
Posted by Michael Wonder on 03 Oct 2015
FDA approves Keytruda for advanced non-small cell lung cancer
3 October 2015 - The U.S. Food and Drug Administration today granted accelerated approval for Keytruda (pembrolizumab) to treat patients with ...
Posted by Michael Wonder on 01 Oct 2015
European Medicines Agency’s Management Board nominates Guido Rasi as Executive Director
1 October 2015 - The European Medicines Agency’s (EMA’s) Management Board has nominated Professor Guido Rasi as the Executive Director of ...
Posted by Michael Wonder on 29 Sep 2015
Management Board expected to nominate EMA Executive Director on 1 October 2015
29 September 2015 - The European Medicines Agency’s (EMA) Management Board will meet on Thursday 1 October for an extraordinary session. ...
Posted by Michael Wonder on 26 Sep 2015
EMA fast-tracks antidote to anticoagulant Pradaxa
25 September 2015 - The European Medicines Agency (EMA) has recommended granting a marketing authorisation, following accelerated assessment, for Praxbind (idarucizumab) ...
Posted by Michael Wonder on 26 Sep 2015
New medicine to treat heart failure recommended for approval
25 September 2015 - The European Medicines Agency (EMA) has recommended granting a marketing authorisation for Entresto (sacubitril with valsartan) for ...