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RSS FeedPosted 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 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
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 ...
Posted by Michael Wonder on 26 Nov 2016
Arog Pharmaceuticals receives FDA fast track designation for crenolanib for advanced gastro-intestinal stromal tumours with a D842V mutation in the PDGFRA gene
16 November 2016 - Arog Pharmaceuticals, today announced that the U.S. FDA has granted fast track designation for crenolanib for the ...
Posted by Michael Wonder on 26 Nov 2016
Melinta Therapeutics submits Baxdela new drug application for hospital-treated skin infections
24 October 2016 - Melinta Therapeutics announced today that it has submitted new drug applications to the U.S. FDA for approval ...
Posted by Michael Wonder on 24 Nov 2016
USA’s BIO slams Japan’s pharma reimbursement and pricing system
23 November 2016 - The US trade group the Biotechnology Innovation Organization, has declared its disappointment in Japan's price modification ...
Posted by Michael Wonder on 24 Nov 2016
Eli Lilly’s experimental Alzheimer’s drug fails in large trial
23 November 2016 - An experimental Alzheimer’s drug that had previously appeared to show promise in slowing the deterioration of ...
Posted by Michael Wonder on 22 Nov 2016
High prices for some leukaemia drugs will make them less cost-effective
21 November 2016 - Pills used to treat a form of leukaemia may be more effective and convenient than chemotherapy, ...
Posted by Michael Wonder on 22 Nov 2016
Mallinckrodt will initiate company-sponsored clinical trial of H.P. Acthar Gel in treatment of amyotropic lateral sclerosis
21 November 2016 - Investigational new drug application for use of H.P Acthar Gel in amyotropic lateral sclerosis awarded fast ...