PHARMACY

Manitoba pharmaceutical regulator tries to end online pharmacies

BY Drew Buono

MANITOBA, Canada The Manitoba Pharmaceutical Association is attempting to put a stranglehold on the province’s Internet pharmacy business, according to CBC news. Manitoba conducts a good deal of online pharmacy business.

The association has approved a new rule that would prevent pharmacies from filling out-of-province prescriptions starting June 30. If pharmacies don’t comply with this new rule, they can have their licenses revoked.

Troy Harwood-Jones, of the Manitoba International Pharmacy Association, said that kind of rule is unheard of in other provinces, and in a recent vote, more than 70 percent of pharmacists voted against it.

In response, the province has assigned a mediator to try to work something out between the Internet pharmacies and the association. Although, Harwood-Jones said that if a deal wasn’t reached, he thought many of the 20 Internet pharmacies in the province would leave.

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FDA to review ulcer gel, HIV medications

BY Drew Buono

WASHINGTON The Food and Drug Administration is conducting two safety reviews of the drugs Regranex gel, used for leg and foot ulcers and the HIV medications Ziagen and Videx.

Diabetic patients using Johnson & Johnson’s Regranex face an increased risk of cancer from using the gel.

Data analyses from another study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking GlaxoSmithKline’s Ziagen or Bristol-Myers Squibb’s Videx as part of their drug therapy.

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FDA OKs Dendreon’s phase III Provenge trial

BY Drew Buono

SEATTLE The Food and Drug Administration has agreed to allow Dendreon to get the final results from its phase III trial for its prostate cancer drug Provenge.

Last May, the FDA requested additional clinical data from Dendreon to support its effectiveness claim for Provenge despite a vote by the Cellular, Tissues and Gene Therapies Advisory Committee in favor of approving the drug. The committee voted 13 to 4 that the product was effective and 17 to 0 that it was safe.

That request led three congressmen: Reps. Mike Michaud, D-Maine, Dan Burton, R-Ind., and Tim Ryan, D-Ohio, to point accusations that conflicts of interest on the advisory committee might have led some of its members to send written requests to the FDA asking that the drug not be approved. One of the members of the committee is a lead investigator for a competing cancer drug made by Novacea.

According to the company, interim results from the IMPACT study of Provenge still are expected later this year, but final results are now expected in the second half of next year rather than the second half of 2010.

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