Tesaro's ovarian cancer drug gets FDA nod | Four mistakes that doom specialty pharmacies | Initial rejection rate for PCSK9 inhibitor prescriptions: 80%
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March 28, 2017
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Leading News
Tesaro's ovarian cancer drug gets FDA nod
Tesaro's Zejula, or niraparib, has received FDA approval as a maintenance treatment for adults with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer whose tumors have shrunk completely or in part because of platinum-based chemotherapy. The approval was based on a clinical study in which Zejula showed higher median progression-free survival of patients with BRCA mutation compared with placebo.
Pharmacy Times online (3/27) 
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Specialty Pharmacy Update
Four mistakes that doom specialty pharmacies
Specialty pharmacies won't survive in a competitive market unless they avoid a series of errors that have caused some of their predecessors to fail. Those mistakes include competing against too broad a market segment, failing to progress with technology, neglecting social media and exaggerating capabilities.
Specialty Pharmacy Times (3/27) 
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Initial rejection rate for PCSK9 inhibitor prescriptions: 80%
First-attempt claims for PCSK9 inhibitor prescriptions were rejected about 80% of the time, according to an analysis of two large claims databases. The ultimate approval rate improved to 43% or better after followup with additional paperwork.
MedPage Today (free registration) (3/27) 
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Legislation & Regulation
House speaker says he will continue targeting ACA
House Speaker Paul Ryan, R-Wis., told donors that Republicans will continue to pursue their health care agenda along with other policy priorities. "We're not going to just all of a sudden abandon health care and move on to the rest," Ryan said.
The Washington Post (tiered subscription model) (3/27) 
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Synergy seeks FDA approval for expanded use of Trulance
A supplemental new drug application has been submitted by Synergy Pharmaceuticals to the FDA for expanded use of Trulance, or plecanatide, as a treatment for adult patients who have irritable bowel syndrome with constipation. Trulance was approved in January to treat chronic idiopathic constipation in adults.
Seeking Alpha (free registration) (3/27) 
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UK health service sets price cap on automatic drug approvals
Any drug that costs England's National Health Service more than about $25 million a year will not be eligible for automatic coverage, even if the drug is deemed cost-effective.
Reuters (3/27) 
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EMA panel recommends approval of Novo Nordisk's hemophilia B drug
Novo Nordisk has received backing from the European Medicines Agency's Committee for Medicinal Products for Human Use for approval to market the hemophilia B drug Refixia, or nonacog beta pegol, in Europe. The opinion will be evaluated by the EMA.
Reuters (3/24) 
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Clinical & Research News
Brain study could lead to treatment reversing MS damage
Treatment for multiple sclerosis could progress from limiting relapses to repairing damage, thanks to a new study that reveals how the brain uses immune cells to repair myelin. The study, published in Nature Neuroscience, shows how proteins created by immune cells trigger the development of oligodendrocytes, which repair myelin.
Specialty Pharmacy Times (3/27) 
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Trends & Technology
Sales of rheumatoid arthritis drugs to approach $30B by 2025
The market for rheumatoid arthritis drugs in eight major markets will rise from $19.5 billion in 2015 to $28.5 billion in 2025, according to a report by GlobalData. The expected growth is based on multiple factors, including anticipation of increased RA prevalence, interleukin-6 inhibitor introductions, biosimilars for established biologics and early diagnosis and treatment.
Specialty Pharmacy Times (3/27) 
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