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RSS FeedPosted by Michael Wonder on 30 Nov 2016
Ariad announces FDA full approval and label update for Iclusig (ponatinib) based on long-term efficacy and safety data from Phase 2 PACE clinical trial
29 November 2016 - Full approval granted through completion of accelerated approval commitments for rare cancer patients who may have ...
Posted by Michael Wonder on 29 Nov 2016
FDA accepts the biologics license application for avelumab for the treatment of metastatic Merkel cell carcinoma for priority review
29 November 2016 - Avelumab has previously received FDA breakthrough therapy and fast track designations for metastatic Merkel cell carcinoma, ...
Posted by Michael Wonder on 29 Nov 2016
Why can't device makers and insurers get along?
26 November 2016 - After a spinal stroke in 2007 robbed Rick Batty of his ability to use his arms ...
Posted 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 ...