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RSS FeedPosted by Michael Wonder on 21 Dec 2017
TherapeuticsMD announces FDA acceptance of new drug application and Prescription Drug User Fee Act Date for TX-004HR
20 December 2017 - PDUFA target action date of 29 May 2018. ...
Posted by Michael Wonder on 21 Dec 2017
Bristol-Myers Squibb receives FDA approval for Opdivo (nivolumab) as adjuvant therapy in patients with completely resected melanoma with lymph node involvement or metastatic disease
20 December 2017 - Opdivo, the first and only anti-PD-1 immune checkpoint inhibitor approved for adjuvant treatment of melanoma, is indicated ...
Posted by Michael Wonder on 20 Dec 2017
Soaring cost of cancer treatment: moving beyond sticker shock
19 December 2017 - In Seligman’s famous series of experiments, two groups of dogs were shocked at random intervals. Dogs in ...
Posted by Michael Wonder on 20 Dec 2017
U.S. Food and Drug Administration approves prior approval supplement for commercial launch of Portola Pharmaceuticals’ novel oral anti-coagulant Bevyxxa (betrixaban)
19 December 2017 - Bevyxxa available to patients in January 2018. ...
Posted by Michael Wonder on 20 Dec 2017
Institute for Clinical and Economic Review releases draft evidence report on CAR-T therapy for B-cell cancers
19 December 2017 - Public comment period open now until 24 January; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 19 Dec 2017
Amazon hasn’t figured out drug stores yet. But it will have to.
18 December 2017 - Jeff Bezos has eyed the pharmacy business for years without plunging in. The upside may be too ...
Posted by Michael Wonder on 19 Dec 2017
Ovid Therapeutics announces OV101 granted fast track designation by U.S. FDA for treatment of Angelman syndrome
19 December 2017 - Ovid Therapeutics today announced that the U.S. FDA has granted fast track designation to OV101 for the ...
Posted by Michael Wonder on 19 Dec 2017
FDA approves novel gene therapy to treat patients with a rare form of inherited vision loss
19 December 2017 - Luxturna is the first gene therapy approved in the U.S. to target a disease caused by mutations ...
Posted by Michael Wonder on 19 Dec 2017
Republican bill to reduce tax credits for rare disease drugs
18 December 2017 - The target comes as a surprise under a Republican administration that has shown little interest in addressing ...
Posted by Michael Wonder on 19 Dec 2017
Aerie Pharmaceuticals announces U.S. FDA approval of Rhopressa (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intra-ocular pressure in patients with open-angle glaucoma or ocular hypertension
18 December 2017 - Product approved ahead of the Scheduled PDUFA date of 28 February 2018. ...
Posted by Michael Wonder on 19 Dec 2017
60° Pharmaceuticals submits new drug application to US FDA for anti-malarial drug tafenoquine
18 December 2017 - 60P will continue global regulatory strategy and pursue additional dossier submissions. ...
Posted by Michael Wonder on 19 Dec 2017
Novartis multiple sclerosis therapy fingolimod granted FDA breakthrough therapy designation for paediatric multiple sclerosis
18 December 2017 - In a pivotal Phase III study, oral fingolimod significantly reduced relapses by 82% in a paediatric patient ...
Posted by Michael Wonder on 19 Dec 2017
Stealth BioTherapeutics granted fast track designation for elamipretide for the treatment of Leber’s hereditary optic neuropathy
18 December 2017 - Stealth BioTherapeutics today announced that the U.S. FDA has granted fast track designation for its lead candidate, ...
Posted by Michael Wonder on 18 Dec 2017
Canada as single-payer exemplar for universal health care in the United States; a borderline option
18 December 2017 - The late great Uwe Reinhardt still called himself a Canadian decades after moving to the United ...
Posted by Michael Wonder on 18 Dec 2017
Is single payer the answer for the US health care system?
18 December 2017 - The recent challenges to the Affordable Care Act, which has increased the number of individuals with health ...