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RSS FeedPosted by Michael Wonder on 30 Jul 2017
Roche leukaemia drug gets FDA breakthrough therapy designation
28 July 2017 - Roche Holding AG's Venclexta has won breakthrough therapy designation in acute myeloid leukaemia from the U.S. ...
Posted by Michael Wonder on 29 Jul 2017
Lundbeck and Takeda receive complete response letter from the FDA for Trintellix (vortioxetine) sNDA
23 June 2017 - Lundbeck and Takeda today announced that after providing additional analysis, the U.S. FDA has issued a ...
Posted by Michael Wonder on 29 Jul 2017
U.S. FDA grants priority review for an epinephrine auto-injector in development by Kaléo specifically for infants and small children
27 July 2017 - AUVI-Q (epinephrine injection) 0.1 mg could be the first auto-injector approved with a needle length and dose ...
Posted by Michael Wonder on 29 Jul 2017
FDA grants priority review for Amgen's supplemental biologics license application for Repatha (evolocumab) to include data on reducing risk of cardiovascular events
28 July 2017 - FDA priority review status underscores need to reduce heart attacks and strokes. ...
Posted by Michael Wonder on 29 Jul 2017
Abilify Maintena® (aripiprazole) for extended-release injectable suspension approved by the U.S. FDA for maintenance monotherapy treatment of bipolar I disorder
28 July 2017 - New indication for Abilify Maintena is based on studies evaluating efficacy and safety in adult patients with ...
Posted by Michael Wonder on 29 Jul 2017
Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?
26 July 2017 - Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to ...
Posted by Michael Wonder on 28 Jul 2017
Aradigm submits new drug application to FDA for U.S. marketing approval of Linhaliq in non-cystic fibrosis bronchiectasis
27 July 2017 - Aradigm Corporation today announced it has submitted its new drug application to the U.S. FDA for ...
Posted by Michael Wonder on 28 Jul 2017
Eiger announces FDA fast track designation granted for pegylated interferon lambda in hepatitis delta virus infection
27 July 2017 - Eiger BioPharmaceuticals today announced that the U.S. FDA has granted fast track designation for pegylated interferon lambda ...
Posted by Michael Wonder on 27 Jul 2017
Eagle Pharmaceuticals receives complete response letter from FDA on Ryanodex for exertional heat stroke application
26 July 2017 - Eagle Pharmaceuticals announced today that it has received a complete response letter from the U.S. FDA ...
Posted by Michael Wonder on 27 Jul 2017
Challenges in international comparison of health care systems
27 July 2017 - International comparisons of health system performance exert major influence on the public and on policy makers. ...
Posted by Michael Wonder on 27 Jul 2017
FDA announces new steps to empower consumers and advance digital health care
27 July 2017 - When people think about personalised medicine, they often think of genetic testing and sequencing of the human ...
Posted by Michael Wonder on 27 Jul 2017
Priority review vouchers for tropical disease drugs simply aren’t working
25 July 2017 - A controversial program created by Congress to spur development of new drugs for neglected tropical diseases ...
Posted by Michael Wonder on 27 Jul 2017
The expanded access navigator – helping patients in need of potentially life-saving drug treatments
24 July 2017 - Patients with serious or immediately life-threatening diseases or conditions who have no comparable or satisfactory alternative therapy ...
Posted by Michael Wonder on 27 Jul 2017
FDA sets inaugural meeting of first-ever patient engagement advisory committee
25 July 2017 - Imagine checking your blood sugar levels several times a day with a glucose meter to keep your ...
Posted by Michael Wonder on 27 Jul 2017
FDA approves Eisai's Fycompa (perampanel) for use as monotherapy for the treatment of partial-onset seizures
26 July 2017 - First anti-epileptic drug to apply FDA's regulatory pathway of extrapolation for monotherapy use; FDA proposed using this ...