Blog
RSS FeedPosted by Michael Wonder on 02 Jan 2018
FDA accepts supplemental biologics license application and grants priority review for Adcetris (brentuximab vedotin) in front-line advanced Hodgkin's lymphoma
2 January 2018 - Submission based on positive results from the Phase 3 ECHELON-1 clinical trial. ...
Posted by Michael Wonder on 02 Jan 2018
Why the U.S. spends so much more than other nations on health care
2 January 2018 - Studies point to a simple reason, the prices, not to the amount of care. And lowering prices ...
Posted by Michael Wonder on 30 Dec 2017
GW Pharmaceuticals submits marketing authorisation application in Europe for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
29 December 2017 - GW Pharmaceuticals today announced it has submitted its marketing authorisation application to the EMA for Epidiolex (cannabidiol) ...
Posted by Michael Wonder on 29 Dec 2017
New drug approvals for FDA: 2017 hits 21 year high
21 December 2017 - The number of new molecular entities approved by the US FDA in 2017 (46 so far, ...
Posted by Michael Wonder on 29 Dec 2017
Progenics Pharmaceuticals announces FDA acceptance of new drug application for Azedra (iobenguane I 131) in pheochromocytoma and paraganglioma
29 December 2017 - Progenics Pharmaceuticals announced today that the U.S. FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 29 Dec 2017
GW Pharmaceuticals announces acceptance of NDA filing for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
28 December 2017 - GW Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently ...
Posted by Michael Wonder on 29 Dec 2017
ICER’s guideline on the acceptance and use of “in-confidence” data from manufacturers of pharmaceuticals, devices, and other health care interventions
22 December 2017 - ICER takes its obligations to transparency and fairness seriously. ...
Posted by Michael Wonder on 28 Dec 2017
Prices of generic drugs associated with numbers of manufacturers
28 December 2017 - Low-cost generic drugs have improved outcomes in patients while saving the health care system more than $1 ...
Posted by Michael Wonder on 28 Dec 2017
Horizon Pharma announces FDA approval to expand the indication for Procysbi (cysteamine bitartrate) delayed-release capsules to include children one year of age and older living with nephropathic cystinosis
27 December 2017 - Horizon Pharma today announced the U.S. FDA has approved an expansion to the indication for Procysbi (cysteamine ...
Posted by Michael Wonder on 28 Dec 2017
Sun Pharma announces US FDA acceptance of NDA for OTX-101
27 December 2017 - OTX-101 is being evaluated for treatment of dry eye disease. ...
Posted by Michael Wonder on 28 Dec 2017
Portola Pharmaceuticals provides update on biologics license application for AndexXa (andexanet alfa)
22 December 2017 - Portola Pharmaceuticals today announced that the U.S. FDA will extend its review of the biologics license application ...
Posted by Michael Wonder on 27 Dec 2017
Agios submits new drug application to the FDA for ivosidenib for the treatment of patients with relapsed/refractory acute myeloid leukaemia and an IDH1 mutation
26 December 2017 - Ivosidenib has potential to be a first-in-class therapy for patients with relapsed/refractory AML and an IDH1 mutation. ...
Posted by Michael Wonder on 27 Dec 2017
DelMar Pharmaceuticals announces fast track designation for VAL-083 in recurrent glioblastoma
26 December 2017 - Supports lead program, VAL-083, in on-going clinical trials. ...
Posted by Michael Wonder on 27 Dec 2017
FDA grants Insys Therapeutics ‘fast track’ designation for cannabidiol oral solution as investigational treatment for Prader-Willi syndrome
26 December 2017 - INSYS Therapeutics announced today that the U.S. FDA has granted fast track designation to the company’s cannabidiol ...
Posted by Michael Wonder on 26 Dec 2017
Cancer drug price rises 1,400% with no generic to challenge it
25 December 2017 - Lomustine among 319 drugs with expired patents but no copies; FDA trying to boost competition. ...