Blog
RSS FeedPosted by Michael Wonder on 29 Nov 2016
Quality of life, overall survival, and costs of cancer drugs approved based on surrogate endpoints
29 November 2016 - The lack of evidence of a clinically meaningful benefit for many cancer drugs approved by the US ...
Posted by Michael Wonder on 29 Nov 2016
Improving the accelerated pathway to cancer drug approvals
29 November 2016 - The US FDA must balance the need to bring potentially lifesaving drugs to market with the need ...
Posted by Michael Wonder on 29 Nov 2016
Cancer immunology community seeks better end points
29 November 2016 - Drug developers are still hunting for surrogate end points that can better capture the benefits of checkpoint ...
Posted by Michael Wonder on 29 Nov 2016
Amicus Therapeutics announces U.S. regulatory pathway for migalastat hydrochloride for Fabry disease
28 November 2016 - Regulatory plan for full approval pathway based on generation of additional gastro-intestinal symptoms data. ...
Posted by Michael Wonder on 29 Nov 2016
Epizyme announces fast track designation for tazemetostat in DLBCL and provides solid tumour program update
28 November 2016 - FDA grants tazemetostat fast track designation for DLBCL with EZH2 activating mutations. ...
Posted by Michael Wonder on 28 Nov 2016
Advanced Accelerator Applications reports feedback from the FDA for Lutathera, an investigational treatment for neuroendocrine tumours
28 November 2016 - Last week, the FDA issued feedback to the new drug application for Lutathera for the treatment ...
Posted by Michael Wonder on 28 Nov 2016
FDA grants priority review to Merck’s supplemental biologics license application seeking approval for Keytruda (pembrolizumab) for new indication in microsatellite instability-high cancer
28 November 2016 - Merck today announced that the U.S. FDA accepted for review the supplemental biologics license application for Keytruda ...
Posted by Michael Wonder on 28 Nov 2016
Could the FDA be dismantled under Trump?
22 November 2016 - Has President-elect Donald Trump put a bull’s-eye on the FDA? ...
Posted by Michael Wonder on 28 Nov 2016
Republicans reach deal to pass Cures Act by end of year, but Democrats pushing for changes
27 November 2016 - House and Senate leaders announced late Friday night that they had finally hammered out a deal ...
Posted by Michael Wonder on 27 Nov 2016
Japan drug-pricing reform to get blueprint by year-end
26 November 2016 - The Japanese government will draw up an outline for a comprehensive revision of the country's prescription ...
Posted by Michael Wonder on 27 Nov 2016
TherapeuticsMD announces FDA acceptance of new drug application and PDUFA date for Yuvvexy (TX-004HR)
19 September 2016 - PDUFA target action date of 7 May 2017. ...
Posted by Michael Wonder on 27 Nov 2016
Neurocrine announces Ingrezza (valbenazine) new drug application for the treatment of tardive dyskinesia has been accepted for priority review by U.S. FDA
11 October 2016 - Neurocrine Biosciences today announced that the U.S. FDA has accepted for priority review the new drug application ...
Posted by Michael Wonder on 27 Nov 2016
Drug makers find competition doesn’t keep a lid on prices
27 November 2016 - Makers of Viagra, Cialis show how rivals tend to raise prices in tandem, a reason for the ...
Posted by Michael Wonder on 26 Nov 2016
Many in Florida count on Obama’s health law, even amid talk of its demise
25 November 2016 - Dalia Carmeli, who drives a trolley in downtown Miami, voted for Donald J. Trump on Election ...
Posted by Michael Wonder on 26 Nov 2016
Emmaus’ new drug application for sickle cell disease accepted for review by FDA
8 November 2016 - Emmaus Life Sciences announced today that the FDA has accepted for review the new drug application ...