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BioPlus promotes Shelley Moore to lead bleeding disorders program

BY Alaric DeArment

ALTAMONTE SPRINGS, Fla. — BioPlus Specialty Pharmacy has appointed a new person to head its bleeding disorders program, the company said Tuesday.

BioPlus announced the promotion of Shelley Moore to the position of national director of hemophilia. Moore already has served as head of the company’s bleeding disorders program for Tennessee and has six years’ nursing experience and a career specialty in bleeding disorders.

"BioPlus continues to see patients respond better when they have close contact with our local nurse specialists," BioPlus chief strategic officer Russell Gay said. "The comfort they have with friendly and skilled professionals like Shelley enriches their lives and quietly saves healthcare dollars by reducing hospitalization and drug waste. We all win with Shelley’s approach of high-touch care."


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Senate votes down Durbin supplement regulation by almost 4 to 1

BY Michael Johnsen

WASHINGTON — Dietary supplement industry champion Sen. Orrin Hatch, R-Utah, last week led efforts to strike down an amendment that would have dramatically overregulated the dietary supplement industry.

The Senate voted 77-20 to table an amendment to the pending FDA Safety and Innovation Act that was proposed by Dick Durbin, D-Ill. The amendment would have expanded the current registration requirements for anyone involved with the manufacturing, processing, packaging or storage of dietary supplements to register with the Food and Drug Administration. The Durbin Amendment also would have required that all registered facilities would need to submit to the FDA a list of all ingredients for each of the products they sell as well as a copy of every label.

Speaking on the Senate Floor in advance of a vote on the Durbin Amendment, Hatch said the Amendment “is based on the misguided presumption that the current regulatory framework for dietary supplements is flawed and that the FDA lacks authority to regulate these products.”  Hatch added that instead of allowing the FDA to utilize the resources it already has under DSHEA, the Durbin Amendment “serves to punish all responsible companies with its overreaching mandates.”




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Mylan launches generic Lipitor

BY Allison Cerra

PITTSBURGH — Mylan on Tuesday announced that its subsidiary has received final approval from the Food and Drug Administration for its abbreviated new drug application for atorvastatin calcium tablets, a generic version of Pfizer’s Lipitor.

The drug maker said Mylan Labs (formerly Matrix Labs) received the go-ahead to market the drug in the 10-mg, 20-mg, 40-mg and 80-mg strengths. Lipitor had U.S. sales of $8.1 billion for the 12 months ended in March, according to IMS Health.

"We are very pleased to have received final approval for our ANDA for generic Lipitor, the most widely prescribed drug in U.S. history," Mylan CEO Heather Bresch said. "Through Mylan’s launch of atorvastatin calcium Tablets, we look forward to be able to offer our customers, the American consumer and the U.S. government significant savings and expanded access to this important product."


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