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.’
While the government announces eight to 15% cuts to the four products, industry groups urges for its operational improvement without expansion.
Returning FDA biologics center director Vinay Prasad used the Papzimeous approval announcement to reinforce his flexibility on rare disease therapies after several complete response letters and his brief departure from the agency.
Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.
