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BioPlus Specialty Pharmacy awarded VIPPS accreditation

BY Alaric DeArment

ALTAMONTE SPRINGS, Fla. — Less than one month after joining the specialty pharmacy network of health insurer Blue Cross and Blue Shield of North Carolina, BioPlus Specialty Pharmacy has received an accreditation from the National Association of Boards of Pharmacy, the company said.

BioPlus, which joined the health insurer’s network at the beginning of August, announced that it received the NABP’s Verified Internet Pharmacy Practice Sites, or VIPPS, seal of approval. The company said the accreditation recognized it as a fully licensed pharmacy in compliance with all applicable state boards of pharmacy statutes, and would assure patients and physicians that it offers a safer, more secure pharmacy experience.

"It is very rewarding to see that the National Association of Boards of Pharmacy recognizes the trust, reliability and quality of BioPlus that makes our specialty pharmacy deserving of this accreditation," BioPlus president and CEO Stephen Vogt said. "VIPPS is a voluntary program that provides U.S. consumers with concrete information regarding the safety and quality of online pharmacies. The U.S. Food and Drug Administration urges consumers to check for the VIPPS accreditation for their online prescription drug purchases."

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Amgen expects FDA decision on new indication for cancer drug by next April

BY Alaric DeArment

THOUSAND OAKS, Calif. — The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

Amgen said the FDA would seek to take action by April 26 on its application seeking approval for Xgeva (denosumab) for preventing prostate cancer that has persisted despite castration surgery from spreading to the bones, also known as bone metastasis, one of the most common places for cancer to spread. The action date is an estimate made under the terms of the Prescription Drug User Fee Act of 2007, also known as a PDUFA date, meaning that the agency will try to complete its review of Amgen’s application and make a decision by then.

Xgeva originally received approval in November 2010 for preventing skeletal injuries in patients whose cancer has spread to the bones.

The drug maker is seeking the new approval based on results of a 1,432-patient late-stage clinical trial announced in May that showed the drug reduced chances of prostate-resistant prostate cancer spreading to the bones by 15%, compared with placebo.

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Sandoz announces FDA approval, U.S. launch of chemotherapy drug

BY Alaric DeArment

PRINCETON, N.J. — The Food and Drug Administration has approved a chemotherapy drug made by Sandoz, the drug maker said Tuesday.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval and launch of docetaxel, an injectable chemotherapy drug that the company said was the 11th cancer drug it has launched in the United States.

The drug is a ready-to-use formulation of Sanofi’s Taxotere in a single vial.* Various versions of Taxotere had sales of about $1.1 billion during the 12-month period ended in June, according to IMS Health. The drug is used to treat cancers of the lung, breast, prostate, stomach, head and neck, in combination with various other drugs.

* CORRECTION: An earlier version of this story referred to the drug as a generic version of Taxotere, based on an error in Sandoz’s original press release. The drug was approved under an FDA New Drug Application, as opposed to an Abbreviated New Drug Application, as is the case with generic drugs, so Sandoz’s product is not technically a generic drug.

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