Business In Brief
AMAG's Feraheme gets CMS Q-codes: AMAG Pharmaceuticals' novel I.V. anemia therapyFeraheme (ferumoxytol) brought in about $3 million in third-quarter sales, largely due to launch pilots. But non-dialysis chronic kidney disease providers are buying significantly more product than dialysis organizations, execs said during an Oct. 29 earnings call. "This does not mean that our sales will continue to be weighted towards non-dialysis CKD, but it's indicative of the differences in the sales cycle between the two segments," said Timothy Healey, Senior VP-Commercial Operations. Before switching products, dialysis organizations consider how a drug performs, how it will affect work flow and contractual incentives - reimbursement is crucial since that is how the dialysis businesses get paid. In a positive nod, CMS assigned Feraheme two unique temporary Medicare Q-codes for dialysis and pre-dialysis patients just a few months after the drug gained FDA approval in June (1"The Pink Sheet," July 6, 2009). The Q-codes, effective Jan. 1 2010, will speed reimbursement since they are product-specific and don't require a claim-by-claim manual review
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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Two US FDA advisory committees will discuss results from epidemiological studies that attempted to quantify the prevalence, incidence and risk factors for misuse, abuse, overdose and death with opioid analgesics.
Manufacturers are engaging the European Commission and individual countries to allocate more health care spending to innovative medicines and align prices more closely to those in the US.
Non-Submissions To UK HTA Body Could Increase Unless Commercial Environment Improves, Warns Industry
Finding ways to lower the rebates paid by the pharmaceutical industry to the UK government and fostering partnerships to make the UK a more attractive launch market could help reduce the number of terminated technology appraisals conducted by NICE, the health technology appraisal institute, says the UK pharmaceutical industry.