Blog
RSS FeedPosted by Michael Wonder on 25 Aug 2017
Vertex announces acceptance of its applications for review of the tezacaftor/ivacaftor combination treatment in people with cystic fibrosis by the FDA and EMA
24 August 2017 - FDA grants priority review of the application and sets action date of 28 February 2018. ...
Posted by Michael Wonder on 24 Aug 2017
FDA grants priority review to Genentech's emicizumab for haemophilia A with inhibitors
23 August 2017 - Application based on positive results of Phase III study in adults and adolescents with haemophilia A with ...
Posted by Michael Wonder on 24 Aug 2017
FDA, EMA and EC sign new confidentiality commitment
24 August 2017 - The US FDA can now share non-public and commercially confidential information, including trade secrets relating to ...
Posted by Michael Wonder on 24 Aug 2017
Multidimensional evidence generation and FDA regulatory decision making
22 August 2017 - Evidence linking interventions with health outcomes is the basis for good health care decision making. ...
Posted by Michael Wonder on 24 Aug 2017
Do the American Society of Clinical Oncology Value Framework and the European Society of Medical Oncology Magnitude of Clinical Benefit Scale measure the same construct of clinical benefit?
23 August 2017 - Whether the ASCO Value Framework and the European Society for Medical Oncology Magnitude of Clinical Benefit Scale ...
Posted by Michael Wonder on 24 Aug 2017
Octapharma USA announces FDA approval of Nuwiq new product strengths, expanding haemophilia A patient treatment options
22 August 2017 - New higher vial strengths will provide added dosing flexibility & convenience. ...
Posted by Michael Wonder on 24 Aug 2017
Cardiome provides U.S. regulatory update for Brinavess
21 August 2017 - Cardiome Pharma Corporation today announced that it has received a response from the U.S. FDA regarding the ...
Posted by Michael Wonder on 23 Aug 2017
Breakthrough cancer drug could be astronomical in price
22 August 2017 - A new leukaemia drug being hailed by doctors as a breakthrough could prove among the most ...
Posted by Michael Wonder on 22 Aug 2017
Novartis CEO opens door to cancer patient demanding ‘fair’ CAR-T pricing
21 August 2017 - David Mitchell had just finished a five-hour infusion of drugs to keep his multiple myeloma under ...
Posted by Michael Wonder on 22 Aug 2017
What should patients be told about non-inferiority studies?
21 August 2017 - A non-inferiority trial is a study in which a new treatment is compared with an existing, already ...
Posted by Michael Wonder on 22 Aug 2017
Alkermes initiates rolling submission of ALKS 5461 new drug application for major depressive disorder
21 August 2017 - Company expects to complete submission for fast track designated medicine by year-end 2017. ...
Posted by Michael Wonder on 22 Aug 2017
Ironwood Pharmaceuticals announces FDA approval of Duzallo (lesinurad and allopurinol) for the treatment of hyperuricaemia in patients with uncontrolled gout
21 August 2017 - Once daily Duzallo is the first FDA approved fixed-dose combination treatment that addresses both causes of ...
Posted by Michael Wonder on 21 Aug 2017
FDARA: making a difference for industry and patients
21 August 2017 - For decades, user fees paid by the medical products industry have provided critical resources needed to ...
Posted by Michael Wonder on 20 Aug 2017
Trump quietly signs new FDA user fee agreement into law
18 August 2017 - President Trump on Friday quietly signed into law a sweeping measure that will help ensure the ...
Posted by Michael Wonder on 17 Aug 2017
Lynparza receives additional and broad approval in the US for ovarian cancer
17 August 2017 - Newly-approved tablet formulation means improved patient convenience. ...